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WO2022022064A1 - Granulation system for traditional chinese medicine extract powder for treating cervical spine disease, and method - Google Patents

Granulation system for traditional chinese medicine extract powder for treating cervical spine disease, and method Download PDF

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Publication number
WO2022022064A1
WO2022022064A1 PCT/CN2021/098702 CN2021098702W WO2022022064A1 WO 2022022064 A1 WO2022022064 A1 WO 2022022064A1 CN 2021098702 W CN2021098702 W CN 2021098702W WO 2022022064 A1 WO2022022064 A1 WO 2022022064A1
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Prior art keywords
mixing device
chinese medicine
traditional chinese
medicine extract
channel
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PCT/CN2021/098702
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French (fr)
Chinese (zh)
Inventor
刘杰
江玉娟
许敏
高超
潘瑞雪
王莉
张亚欣
陈克欣
郝洪慧
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Shandong Mingren Freda Pharmaceutical Co Ltd
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Shandong Mingren Freda Pharmaceutical Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/236Ligusticum (licorice-root)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/237Notopterygium
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/25Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258Panax (ginseng)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/488Pueraria (kudzu)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/65Paeoniaceae (Peony family), e.g. Chinese peony
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/66Papaveraceae (Poppy family), e.g. bloodroot
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A61K36/716Clematis (leather flower)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J2/00Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic

Definitions

  • the invention belongs to the technical field of traditional Chinese medicine granulation, and in particular relates to a traditional Chinese medicine extract powder granulation system and method for treating cervical spondylosis.
  • the extract is filtered and boiled to remove large particles to obtain fine powder, and the boiling process is used to increase the fluidity, and then spray granulation is performed.
  • the boiling process is used to increase the fluidity, and then spray granulation is performed.
  • some effective substances contained in the traditional Chinese medicine are removed, which affects the retention effect of the medicinal effect.
  • the obtained powder composition is not uniform, and it is easy to agglomerate and agglomerate. Due to the non-uniform composition, the structure of the obtained dry powder is non-uniform, and the particle size of the particles is non-uniform. If the fluidity of the extract is improved through complex processing technology, it will affect the retention of the medicinal effect and the quality of the Chinese medicine granules.
  • the purpose of this invention is to provide a kind of Chinese medicine extract powder granulation system and method for the treatment of cervical spondylosis.
  • a granulation system and method are proposed, so that the obtained traditional Chinese medicine granules have a uniform quality and improve the retention rate of the active ingredients of the medicine.
  • the technical scheme of the present invention is:
  • a traditional Chinese medicine extract powder granulation system for the treatment of cervical spondylosis comprising a mixing device, a low-temperature drying device, and a dry granulation device connected in sequence, and the mixing device includes an upper mixing device and a lower mixing device.
  • the feeding end is provided with a feeding port
  • the discharging end of the upper mixing device is provided with a discharging port
  • the lower mixing device is located below the discharging port of the discharging end of the upper mixing device
  • a discharging channel is set in the lower mixing device.
  • the discharge port of the upper mixing device is connected, and a cooling structure is arranged in the lower mixing device.
  • the traditional Chinese medicine extract for the treatment of cervical spondylosis involves two clear pastes and one Panax notoginseng powder and volatile oil.
  • a kind of better fluidity and certain compressibility can be obtained.
  • the mixture is relatively uniform.
  • Clear paste is a miscible dispersion, a complex system of organic compounds. Miscible dispersions containing eutectic mixtures, solid solutions, amorphous precipitates, and the like. Such miscible dispersions have larger surface areas and surface energies, thus increasing the properties of moisture absorption and blocking.
  • the properties of the ointment obtained by different preparation methods of the ointment are different, and the properties of the ointment obtained from the traditional Chinese medicine with different components are also different.
  • the surface energy of the mixture is reduced by the mixing device. After the surface energy is reduced, the wettability of the mixture is better, so that the material in the mixture is more uniform and has better fluidity, so the granulation quality is better.
  • the second aspect the granulation method of Chinese medicine extract powder for the treatment of cervical spondylosis, the concrete steps are:
  • the raw materials and auxiliary materials are mixed at normal temperature and low temperature in turn;
  • the mixture is freeze-dried at low temperature
  • the mixture obtained by low temperature freeze drying is dry granulated.
  • the difference in fluidity and compressibility of different extracts is satisfied, and the fluidity of the mixture is improved from the point of view of the surface energy that affects the fluidity of the mixture.
  • the raw materials and auxiliary materials are comprehensively proportioned, so that the fluidity and compressibility of the mixture are within a suitable range, which is conducive to the obtained granulation particles, and has better surface smoothness and particle uniformity.
  • Fig. 1 is the structure diagram of the traditional Chinese medicine extract powder granulation system for the treatment of cervical spondylosis of the embodiment
  • Fig. 2 is the top structure view of the upper mixing device of the embodiment
  • Fig. 3 is the cross-sectional structure diagram of the discharge channel of the embodiment
  • mixing device 2. low temperature drying equipment, 3. dry granulation equipment, 4. discharging channel, 5. mixing channel, 6. feeding channel, 7. cooling chamber, 8. cooler.
  • a traditional Chinese medicine extract powder granulation system for the treatment of cervical spondylosis comprising a mixing device, a low-temperature drying device, and a dry granulation device connected in sequence, and the mixing device includes an upper mixing device and a lower mixing device.
  • the feeding end is provided with a feeding port
  • the discharging end of the upper mixing device is provided with a discharging port
  • the lower mixing device is located below the discharging port of the discharging end of the upper mixing device
  • a discharging channel is set in the lower mixing device.
  • the discharge port of the upper mixing device is connected, and a cooling structure is arranged in the lower mixing device.
  • the discharge channel is arranged vertically, the cross-section of the discharge channel is double circles, the double circles are partially overlapped, and the outer sides of the double circles have convex structures of different sizes.
  • the material channel is a hollow tube structure.
  • the upper mixing device includes a middle mixing channel and several oppositely arranged feeding channels on both sides of the mixing channel, the feeding channels are located above the sides of the mixing channel and are inclined in the axial direction perpendicular to the mixing channel set up.
  • several feeding channels are provided independently, and a screw conveyor is provided in the mixing channel.
  • the lower mixing device includes a discharge channel and a cooling chamber, and the discharge channel is located in the cooling chamber and is sealed with the cooling chamber.
  • the mixing device further includes a cooler, the cooler is arranged below the upper mixing device, on one side of the upper mixing device, and the cooler communicates with the cooling chamber through a medium pipe.
  • each raw material Pueraria Radix Paeoniae Alba, Chuanqiongyanhu Suoqing Cream, Panax notoginseng powder
  • the mixing device 1 the mixing device 1
  • the mixed materials pass through the lower mixing equipment.
  • the mixed material passes through the shrinkage of the discharge channel and the cooling effect of the cooling equipment, the material in the mixed material has the effect of shrinkage, the surface energy is reduced, the fluidity is enhanced, and the fluidity-enhanced mixture passes through the low-temperature drying equipment.
  • the dry granulation equipment 3 performs granulation. During the granulation process, the mixing effect of the materials is better, which is beneficial to the obtained granules with better uniformity.
  • the top of the upper mixing device of the mixing device is an open or closed structure.
  • a feed port is set at a position opposite to the side wall of the upper mixing device in the feed channel, so that feeding can be carried out through the feed port. Or if it is an open setup, this allows feeding directly into the feed channel.
  • the mixture is driven by the screw conveyor to move.
  • the mixture moves to the top of the discharge channel, under the action of the gravity of the mixture, it enters the discharge channel, between the top of the discharge channel and the upper mixing device.
  • An opening is provided at the junction.
  • the mixed material passes through the discharge channel 4, which is equivalent to extruding the mixed material.
  • the upper mixing device is located above the lower mixing device, and the mixed material passes downward through the discharge channel 4 under the action of gravity. Under the constraints of gravity and the discharge channel, the material passes through the discharge channel 4.
  • the outlet channel 4 is designed in the shape of a double circle, and the double circles are partially overlapped. In this way, the materials in each circular channel are in contact with each other at the overlapping part, and the outer sides of the double circles have convex structures of different sizes.
  • the shape of the discharge channel 4 through which the mixed cleaning solution passes is variable, so that the surface of the formed agglomeration structure is rougher and more variable, which is beneficial to the tendency of the mixture to reduce the surface energy. And after the mixture passes through the discharge channel, the mixture is further mixed evenly.
  • each feeding channel 6 and the mixing channel 5 are arranged obliquely, so that the material can be inclined to fall into the mixing channel 5, and the two opposite feeding channels 6 collide and overlap each other in the mixing channel 5, which is beneficial to improve the mixing.
  • the effect is that the feeding of the adjacent or opposite feeding channels 6 is different, so that the two kinds of clear paste and Panax notoginseng powder can be wrapped and mixed with each other. Avoid wrapping too much clear cream or Panax notoginseng powder in one location.
  • the cooling chamber 7 is filled with a cooling medium, so that the discharge channel 4 can be cooled.
  • the cooler 8 is connected to the cooling chamber 7, and the cooling liquid can be pumped into the cooling chamber. .
  • the mixture contributes to the reduction of the surface energy at low temperature and improves the fluidity.
  • the raw materials and auxiliary materials are sequentially mixed at normal temperature and low temperature;
  • the mixture is freeze-dried at low temperature
  • the mixture obtained by low temperature freeze drying is dry granulated.
  • the raw materials are successively mixed at normal temperature and low temperature.
  • the feeding of two adjacent feeding channels is different, and the opposite two feeding channels have different feeding materials.
  • the feeding of each feeding channel is different, and the low temperature is 5-18°C; preferably: 8-15°C; more preferably 10-12°C.
  • the auxiliary materials are dextrin and carboxymethyl cellulose, and the mass ratio of dextrin and carboxymethyl cellulose is 10:3-5; preferably 10:4.
  • the mass ratio of the total mass of each raw material to the total mass of the auxiliary materials is 10:3-6; preferably 10:5.
  • the total mass of each raw material and the mass ratio of auxiliary materials affect the fluidity and compressibility of the mixture, and indirectly affect the uniformity and surface morphology of the obtained particles.
  • each raw material includes Pueraria lobatae clearing paste, Chuanqiongyanhusuo clearing paste, and Panax notoginseng powder
  • the particle size of Panax notoginseng powder is 100-120 mesh.
  • different proportions of auxiliary materials are added to the raw materials, and different treatment methods can be set to obtain better granulation effect.
  • the granulated granules are mixed with Qiang Huo Wei Ling Xian volatile oil to obtain a product.
  • the vacuum degree of low-temperature freeze-drying is -0.1 ⁇ -0.5MPa, and the temperature is -10 ⁇ -15°C; preferably, the vacuum degree of low-temperature freeze-drying is -0.2 ⁇ -0.5MPa, and the temperature It is -10 ⁇ -12°C.
  • dry granulation is carried out using a dry granulator, and the granulation conditions are: the main pressure is 5-8 MPa, the side pressure is 0.5-2 MPa, and the rolling speed is 10- 30 rpm, and the propeller speed is 50-80 rpm.
  • step (1) pulverizes Panax notoginseng powder into 100-120 mesh fine powder (panax notoginseng powder of the present invention);
  • step (2) extracts volatile oil from Qianghuo and Weilingxian , the distilled aqueous solution is collected in another device, the medicinal residues are decocted with water for 1h, and the filtrate is for subsequent use;
  • step (3) Pueraria lobata and Paeonia lactiflora are decocted twice with water, the first time is 2 hours, the second time is 1 hour, the filtrate and the above two aqueous solutions Merge, concentrate, alcohol precipitation, reclaim ethanol, become clear paste with relative density 1.25-1.30 (50 °C) after concentrating (Pueraria Radix Paeoniae Alba clear paste of the present invention);
  • Step (4) Zhongchuan Qiong, Corydalis fragrans are extracted with ethanol reflux, and the residue is discarded , the
  • the Pueraria lobatae clearing paste, the Chuanqiongyanhusuo clearing paste, the Panax notoginseng powder and the auxiliary materials were first mixed at room temperature in a mixing device, and then mixed at 10 ° C, and the obtained mixture was freeze-dried at a low temperature (-0.3 MPa, -12 ° C) ); the mixture obtained by low temperature freeze drying is carried out dry granulation (main pressure is 6 MPa, side pressure is 1 MPa, roll speed is 20 rev/min, propeller speed is 60 rev/min).
  • the mass ratio of the total mass of Pueraria Baishao Qing ointment, Chuanqiong Yanhusuo Qing ointment and Panax notoginseng powder to the auxiliary materials is 10:5, the auxiliary materials are dextrin and carboxymethyl cellulose, and the mass ratio of dextrin and carboxymethyl cellulose in the auxiliary materials 10:4.
  • the pueraria white peony root clearing paste, Chuanqiongyanhusuo clearing paste, Panax notoginseng powder and auxiliary materials were first mixed at room temperature in a mixing device, and then mixed at 12 ° C, and the obtained mixture was freeze-dried at a low temperature (-0.4MPa, -10 °C ); the mixture obtained by low temperature freeze drying is carried out dry granulation (the main pressure is 7 MPa, the side pressure is 1.5 MPa, the rotational speed of the roll is 25 rpm, and the rotational speed of the propeller is 70 rpm).
  • the mass ratio of the total mass of Schmidt Baishao Qing ointment, Chuanqiong Yanhu Suo Qing ointment and Panax notoginseng powder to the auxiliary materials is 10:4, the auxiliary materials are dextrin and carboxymethyl cellulose, and the mass ratio of dextrin and carboxymethyl cellulose in the auxiliary materials 10:3.
  • the pueraria white peony root clearing paste, Chuanqiongyanhusuo clearing paste, Panax notoginseng powder and auxiliary materials were first mixed at room temperature in a mixing device, and then mixed at 11 °C, and the obtained mixture was freeze-dried at low temperature (-0.5MPa, -11 °C). ); the mixture obtained by low-temperature freeze-drying is carried out dry granulation (main pressure is 8 MPa, side pressure is 2 MPa, roll speed is 30 rev/min, propeller speed is 75 rev/min).
  • the mass ratio of the total mass of Schmidt Baishao Qing ointment, Chuanqiong Yanhu Suo Qing ointment and Panax notoginseng powder to the auxiliary materials is 10:3, the auxiliary materials are dextrin and carboxymethyl cellulose, and the mass ratio of dextrin and carboxymethyl cellulose in the auxiliary materials 10:5.
  • the Pueraria lobatae clearing paste, the Chuanqiongyanhusuo clearing paste, the Panax notoginseng powder and the auxiliary materials were first mixed at room temperature in a mixing device, and then mixed at 10 ° C, and the obtained mixture was freeze-dried at a low temperature (-0.3 MPa, -12 ° C) ); the mixture obtained by low temperature freeze drying is carried out dry granulation (main pressure is 6 MPa, side pressure is 1 MPa, roll speed is 20 rev/min, propeller speed is 60 rev/min).
  • the mass ratio of the total mass of Schmidt Baishao Qing ointment, Chuanqiong Yanhu Suo Qing ointment and Panax notoginseng powder to the auxiliary materials is 10:8, the auxiliary materials are dextrin and carboxymethyl cellulose, and the mass ratio of dextrin and carboxymethyl cellulose in the auxiliary materials 10:7.
  • Example 1 Compared with Example 1, the particle size of Panax notoginseng powder is 150 meshes, and other granulation methods are the same as those in Example 1.
  • Fluidity Determine the fluidity of the clear paste according to the method specified in GB8077. Fluidity of Example 1 and Example 3, and Comparative Example 1. The results shown in Table 1 are obtained. As shown in Table 1, the mixing effect of the mixing device of Example 1 can be obtained. The obtained mixed powder is relatively uniform and has good fluidity. After the addition ratio of the adjuvant in Comparative Example 1 was changed, the fluidity decreased relative to that of Example 1. In Comparative Example 2, the particle size of the raw materials changed, and the fluidity of the obtained mixture became poor, so the fluidity of different raw materials was different.
  • Example 1 The materials obtained after freeze-drying in Example 1 and Comparative Example 1 were compressed using a tablet machine, and the powder obtained by drying each raw material by a method of spray drying was compressed into tablets.
  • the clear paste was mixed, boiled for 5 minutes, then added with Panax notoginseng powder and auxiliary materials (the ratio of each raw material and auxiliary material was the same as that in Example 1), and then sprayed and granulated, and the results were shown in Table 2. It can be seen from Figure 2 that the freeze-dried mixture in Example 1 has better compressibility, better viscosity and punchability than spray drying, and better brittle hardness of the powder.
  • Comparative Example 1 the mixing ratio of the auxiliary materials was changed, and although it had better hardness, the viscosity and punchability were reduced compared with that of Example 1.
  • Example 1 Comparative Example 1 and the spray drying method and the comparison of the surface morphology of the particles obtained after dry granulation, as shown in Table 3, the spray drying method is the same as the spray drying method in Test Example 2, and the dry granulation method is the same.
  • the operating conditions were the same as those of Example 1. It can be obtained from Table 3 that the particle size after granulation in Example 1 is uniform, indicating that the granulation method of Example 1 improves the granulation quality.
  • the granules obtained by spray drying and dry granulation methods vary in size, with a small amount of agglomeration.
  • the diameter of the particles obtained in Comparative Example 1 is relatively regular, but there are some small pits on the surface of the particles, which affect the overall granulation effect.

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Abstract

A granulation system for a traditional Chinese medicine extract powder for treating a cervical spine disease, and a method, which belong to the field of traditional Chinese medical granulation technology, said system comprising a mixing apparatus (1), a low temperature drying device (2), and a dry granulation device (3) which are sequentially connected; the mixing apparatus comprises an upper mixing device and a lower mixing device, a material feed opening is arranged on a material feed end of the upper mixing device, a material outlet opening is arranged on a material outlet end of the upper mixing device, the lower mixing device is located below the material outlet opening of the material outlet end of the upper mixing device, a material outlet channel (4) is arranged within the lower mixing device, and a top part of the material outlet channel (4) is in communication with the material outlet opening of the upper mixing device. After raw materials undergo ambient temperature and low temperature mixing, low temperature freeze-drying is performed, and subsequently dry granulation is performed. Granules obtained from granulation possess good flowability and compressibility.

Description

一种治疗颈椎病的中药浸膏粉制粒系统和方法A kind of traditional Chinese medicine extract powder granulation system and method for treating cervical spondylosis 技术领域technical field

本发明属于中药制粒技术领域,具体涉及一种治疗颈椎病的中药浸膏粉制粒系统和方法。The invention belongs to the technical field of traditional Chinese medicine granulation, and in particular relates to a traditional Chinese medicine extract powder granulation system and method for treating cervical spondylosis.

背景技术Background technique

公开该背景技术部分的信息仅仅旨在增加对本发明的总体背景的理解,而不必然被视为承认或以任何形式暗示该信息构成已经成为本领域一般技术人员所公知的现有技术。The information disclosed in this Background section is only for enhancement of understanding of the general background of the invention and should not necessarily be taken as an acknowledgement or any form of suggestion that this information forms the prior art already known to a person of ordinary skill in the art.

现有的制粒方法,将浸膏进行过滤和煮沸,去除大颗粒,得到细粉,并且利用煮沸的过程增加流动性,然后进行喷雾造粒。但是经过这个过程,将中药包含的一些有效物质去除了,影响药效的保留效果。In the existing granulation method, the extract is filtered and boiled to remove large particles to obtain fine powder, and the boiling process is used to increase the fluidity, and then spray granulation is performed. However, after this process, some effective substances contained in the traditional Chinese medicine are removed, which affects the retention effect of the medicinal effect.

但是在复杂的中药组分制备方法中,需要不同的组分,分别单独进行萃取,然后再组合在一起进行造粒,并且最后各种浸膏混合在一起之前的物理状态不同,比如流动性和可压性、粉体结构特征等。并且由于不同的中药种类,经过不同的方法得到的提取物的物理性质不同。However, in the complex preparation method of traditional Chinese medicine components, different components are required to be extracted separately, and then combined together for granulation, and the physical states of the various extracts before being mixed together are different, such as fluidity and Compressibility, powder structure characteristics, etc. And due to different types of traditional Chinese medicines, the physical properties of the extracts obtained by different methods are different.

所以如果采用现有的喷雾造粒方法,药物成分在流动的过程中,由于流动性不同,所以得到的粉体成分不均匀,并且容易团聚和结块。由于成分不均匀,得到的干燥粉体的结构不均匀,颗粒的粒径不均匀。如果经过复杂的处理工艺,提高浸膏的流动性,会影响药效的存留,影响中药颗粒的质量。Therefore, if the existing spray granulation method is adopted, due to the different fluidity of the pharmaceutical ingredients in the process of flowing, the obtained powder composition is not uniform, and it is easy to agglomerate and agglomerate. Due to the non-uniform composition, the structure of the obtained dry powder is non-uniform, and the particle size of the particles is non-uniform. If the fluidity of the extract is improved through complex processing technology, it will affect the retention of the medicinal effect and the quality of the Chinese medicine granules.

发明内容SUMMARY OF THE INVENTION

针对上述现有技术中存在的问题,本发明的目的是提供一种治疗颈椎病 的中药浸膏粉制粒系统和方法。根据中药提取物的流动性和可压性、粉体结构特征等,提出了制粒的系统和方法,使得到的中药颗粒质量均匀,提高药物有效成份的保留率。For the problems existing in the above-mentioned prior art, the purpose of this invention is to provide a kind of Chinese medicine extract powder granulation system and method for the treatment of cervical spondylosis. According to the fluidity, compressibility and powder structure characteristics of traditional Chinese medicine extracts, a granulation system and method are proposed, so that the obtained traditional Chinese medicine granules have a uniform quality and improve the retention rate of the active ingredients of the medicine.

为了解决以上技术问题,本发明的技术方案为:In order to solve the above technical problems, the technical scheme of the present invention is:

第一方面,一种治疗颈椎病的中药浸膏粉制粒系统,包括依次连接的混合装置、低温干燥设备、干法造粒设备,混合设备包括上混合设备和下混合设备,上混合设备的进料端设置进料口,上混合设备的出料端设置出料口,下混合设备位于上混合设备出料端的出料口下方,下混合设备内设置出料通道,出料通道的顶部与上混合设备的出料口连通,下混合设备中设置冷却结构。A first aspect, a traditional Chinese medicine extract powder granulation system for the treatment of cervical spondylosis, comprising a mixing device, a low-temperature drying device, and a dry granulation device connected in sequence, and the mixing device includes an upper mixing device and a lower mixing device. The feeding end is provided with a feeding port, the discharging end of the upper mixing device is provided with a discharging port, the lower mixing device is located below the discharging port of the discharging end of the upper mixing device, and a discharging channel is set in the lower mixing device. The discharge port of the upper mixing device is connected, and a cooling structure is arranged in the lower mixing device.

治疗颈椎病的中药浸膏涉及两个清膏和一个三七粉和挥发油。利用上述系统,实现得到一种流动性较好,具有一定的可压性。混合料较为均匀。The traditional Chinese medicine extract for the treatment of cervical spondylosis involves two clear pastes and one Panax notoginseng powder and volatile oil. By using the above system, a kind of better fluidity and certain compressibility can be obtained. The mixture is relatively uniform.

清膏是一种混相分散体,是一个复杂的有机化合物体系。包含低共熔混合物、固体溶液、无定型沉淀等的混相分散体。这种混相分散体具有较大的表面积和表面能,所以增加了吸潮和粘连等特性。Clear paste is a miscible dispersion, a complex system of organic compounds. Miscible dispersions containing eutectic mixtures, solid solutions, amorphous precipitates, and the like. Such miscible dispersions have larger surface areas and surface energies, thus increasing the properties of moisture absorption and blocking.

不同的清膏制备方法得到的清膏的性质不同,不同成分的中药得到的清膏的性质也是不同的。The properties of the ointment obtained by different preparation methods of the ointment are different, and the properties of the ointment obtained from the traditional Chinese medicine with different components are also different.

通过混合装置实现降低混合料的表面能,表面能降低后,混合料的润湿性更好,这样混合料中的物料更均匀,流动性更好,所以制粒质量更好。The surface energy of the mixture is reduced by the mixing device. After the surface energy is reduced, the wettability of the mixture is better, so that the material in the mixture is more uniform and has better fluidity, so the granulation quality is better.

第二方面,治疗颈椎病的中药浸膏粉制粒方法,具体步骤为:The second aspect, the granulation method of Chinese medicine extract powder for the treatment of cervical spondylosis, the concrete steps are:

将各原料与辅料依次进行常温和低温下混合;The raw materials and auxiliary materials are mixed at normal temperature and low temperature in turn;

将混合料进行低温冷冻干燥;The mixture is freeze-dried at low temperature;

将低温冷冻干燥得到的混合料进行干法造粒。The mixture obtained by low temperature freeze drying is dry granulated.

本发明一个或多个技术方案具有以下有益效果:One or more technical solutions of the present invention have the following beneficial effects:

从中药提取物的中间各个成分的物理性质出发,对其流动性、可压性等方面进行考量,得到适合这种中药的制粒方法。Based on the physical properties of the middle components of the traditional Chinese medicine extract, and considering its fluidity and compressibility, a granulation method suitable for this traditional Chinese medicine was obtained.

通过制粒系统的混合处理后,满足了不同浸膏的流动性和可压性差别,从影响混合料的流动性的表面能的角度出发,实现提高混合料的流动性。After the mixing process of the granulation system, the difference in fluidity and compressibility of different extracts is satisfied, and the fluidity of the mixture is improved from the point of view of the surface energy that affects the fluidity of the mixture.

各原料和辅料进行综合配比,使混合料的流动性和可压性在适合的范围内,有助于得到的制粒颗粒,具有较好的表面光滑度和颗粒的均匀性。The raw materials and auxiliary materials are comprehensively proportioned, so that the fluidity and compressibility of the mixture are within a suitable range, which is conducive to the obtained granulation particles, and has better surface smoothness and particle uniformity.

保证中药颗粒的质量及临床疗效,提高制粒效率,同时可为中药成型工艺、药剂处方研究提供可靠、快速的技术平台,在提高中药提取工艺研究水平,促进中药制剂的研制、促进中药产业现代化、促进中药制剂出口方面具有广阔的应用前景。Guarantee the quality and clinical efficacy of traditional Chinese medicine granules, improve the granulation efficiency, and provide a reliable and fast technical platform for the research of traditional Chinese medicine molding process and pharmaceutical prescription. , It has broad application prospects in promoting the export of traditional Chinese medicine preparations.

附图说明Description of drawings

构成本发明的一部分的说明书附图用来提供对本申请的进一步理解,本发明的示意性实施例及其说明用于解释本发明,并不构成对本发明的不当限定。The accompanying drawings forming a part of the present invention are used to provide further understanding of the present application, and the exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention.

图1为实施例的治疗颈椎病的中药浸膏粉制粒系统结构图;Fig. 1 is the structure diagram of the traditional Chinese medicine extract powder granulation system for the treatment of cervical spondylosis of the embodiment;

图2为实施例的上混合设备的俯视结构图;Fig. 2 is the top structure view of the upper mixing device of the embodiment;

图3为实施例的出料通道的横截面结构图;Fig. 3 is the cross-sectional structure diagram of the discharge channel of the embodiment;

其中,1、混合装置,2、低温干燥设备,3、干法造粒设备,4、出料通道,5、混合通道,6、进料通道,7、冷却腔,8、冷却器。Among them, 1. mixing device, 2. low temperature drying equipment, 3. dry granulation equipment, 4. discharging channel, 5. mixing channel, 6. feeding channel, 7. cooling chamber, 8. cooler.

具体实施方式detailed description

应该指出,以下详细说明都是例示性的,旨在对本发明提供进一步的说明。除非另有指明,本文使用的所有技术和科学术语具有与本发明所属技术领域的普通技术人员通常理解的相同含义。It should be noted that the following detailed description is exemplary and intended to provide further explanation of the invention. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

需要注意的是,这里所使用的术语仅是为了描述具体实施方式,而非意图 限制根据本申请的示例性实施方式。如在这里所使用的,除非上下文另外明确指出,否则单数形式也意图包括复数形式,此外,还应当理解的是,当在本说明书中使用术语“包含”和/或“包括”时,其指明存在特征、步骤、操作、器件、组件和/或它们的组合。It should be noted that the terminology used herein is for the purpose of describing specific embodiments only, and is not intended to limit the exemplary embodiments according to the present application. As used herein, unless the context clearly dictates otherwise, the singular is intended to include the plural as well, furthermore, it is to be understood that when the terms "comprising" and/or "including" are used in this specification, it indicates that There are features, steps, operations, devices, components and/or combinations thereof.

第一方面,一种治疗颈椎病的中药浸膏粉制粒系统,包括依次连接的混合装置、低温干燥设备、干法造粒设备,混合设备包括上混合设备和下混合设备,上混合设备的进料端设置进料口,上混合设备的出料端设置出料口,下混合设备位于上混合设备出料端的出料口下方,下混合设备内设置出料通道,出料通道的顶部与上混合设备的出料口连通,下混合设备中设置冷却结构。A first aspect, a traditional Chinese medicine extract powder granulation system for the treatment of cervical spondylosis, comprising a mixing device, a low-temperature drying device, and a dry granulation device connected in sequence, and the mixing device includes an upper mixing device and a lower mixing device. The feeding end is provided with a feeding port, the discharging end of the upper mixing device is provided with a discharging port, the lower mixing device is located below the discharging port of the discharging end of the upper mixing device, and a discharging channel is set in the lower mixing device. The discharge port of the upper mixing device is connected, and a cooling structure is arranged in the lower mixing device.

在本发明的一些实施方式中,出料通道竖直设置,出料通道的横截面为双圆形,双圆形部分重叠,双圆形的外侧边具有大小不同的凸起的结构,出料通道为中空的管体结构。In some embodiments of the present invention, the discharge channel is arranged vertically, the cross-section of the discharge channel is double circles, the double circles are partially overlapped, and the outer sides of the double circles have convex structures of different sizes. The material channel is a hollow tube structure.

在本发明的一些实施方式中,上混合设备包括中间混合通道及混合通道两侧的若干相对设置的进料通道,进料通道位于混合通道的侧上方,在垂直于混合通道的轴向上倾斜设置。In some embodiments of the present invention, the upper mixing device includes a middle mixing channel and several oppositely arranged feeding channels on both sides of the mixing channel, the feeding channels are located above the sides of the mixing channel and are inclined in the axial direction perpendicular to the mixing channel set up.

在本发明的一些实施方式中,若干进料通道分别独立设置,混合通道中设置螺旋输送机。In some embodiments of the present invention, several feeding channels are provided independently, and a screw conveyor is provided in the mixing channel.

在本发明的一些实施方式中,下混合设备包括出料通道和冷却腔,出料通道位于冷却腔内,与冷却腔之间密封设置。In some embodiments of the present invention, the lower mixing device includes a discharge channel and a cooling chamber, and the discharge channel is located in the cooling chamber and is sealed with the cooling chamber.

在本发明的一些实施方式中,混合装置还包括冷却器,冷却器设置在上混合设备的下方,上混合设备的一侧,冷却器与冷却腔通过介质管道连通。In some embodiments of the present invention, the mixing device further includes a cooler, the cooler is arranged below the upper mixing device, on one side of the upper mixing device, and the cooler communicates with the cooling chamber through a medium pipe.

如图1所示,中药浸膏粉制粒系统中,各原料(葛根白芍清膏、川穹延胡索清膏、三七粉)先经过混合装置1进行充分的混合,混合后的物料经过下混 合设备,在下混合设备中,混合物料经过出料通道的收缩作用和冷却设备的冷却作用,混合物料中的物质具有收缩的作用,表面能降低,流动性增强,流动性增强的混合料经过低温干燥设备2干燥后,干法造粒设备3进行制粒,制粒的过程中,物料的混合效果比较好,有利于得到的颗粒具有更好的均匀性。As shown in Figure 1, in the traditional Chinese medicine extract powder granulation system, each raw material (Pueraria Radix Paeoniae Alba, Chuanqiongyanhu Suoqing Cream, Panax notoginseng powder) is fully mixed first through the mixing device 1, and the mixed materials pass through the lower mixing equipment. , In the lower mixing equipment, the mixed material passes through the shrinkage of the discharge channel and the cooling effect of the cooling equipment, the material in the mixed material has the effect of shrinkage, the surface energy is reduced, the fluidity is enhanced, and the fluidity-enhanced mixture passes through the low-temperature drying equipment. 2. After drying, the dry granulation equipment 3 performs granulation. During the granulation process, the mixing effect of the materials is better, which is beneficial to the obtained granules with better uniformity.

如图2所示,混合装置的上混合设备的顶部为敞口或闭口的结构。进料通道与上混合设备的侧壁相对的位置设置进料口,这样可以通过进料口进行进料。或者如果是敞口设置,这样便可以直接向进料通道进行进料。As shown in Figure 2, the top of the upper mixing device of the mixing device is an open or closed structure. A feed port is set at a position opposite to the side wall of the upper mixing device in the feed channel, so that feeding can be carried out through the feed port. Or if it is an open setup, this allows feeding directly into the feed channel.

如图2所示,混合料被螺旋输送机带动移动,当混合料运动到出料通道上方时,在混合料重力的作用下,进入出料通道,出料通道的顶部与上混合设备之间的相接处设置开口。As shown in Figure 2, the mixture is driven by the screw conveyor to move. When the mixture moves to the top of the discharge channel, under the action of the gravity of the mixture, it enters the discharge channel, between the top of the discharge channel and the upper mixing device. An opening is provided at the junction.

如图3所示,混合料经过出料通道4,相当于对混合料进行了挤压,上混合设备位于下混合设备的上方,混合料在重力的作用下向下经过出料通道4。在重力和出料通道的约束下,使物料经过出料通道4。出料通道4设计为双圆形的形状,并且双圆形部分重叠。这样每个圆形通道中的物料在重叠部分相互接触,双圆形的外侧边具有大小不同的凸起的结构,混合料中清膏充分的吸附三七粉,使三七粉充分的融合在清膏中,混合清膏经过的出料通道4的形状多变,使形成的团聚结构的表面更粗糙多变,有利于混合料趋向于表面能降低。并且混合料经过出料通道后,使混合料进一步混合均匀。As shown in Figure 3, the mixed material passes through the discharge channel 4, which is equivalent to extruding the mixed material. The upper mixing device is located above the lower mixing device, and the mixed material passes downward through the discharge channel 4 under the action of gravity. Under the constraints of gravity and the discharge channel, the material passes through the discharge channel 4. The outlet channel 4 is designed in the shape of a double circle, and the double circles are partially overlapped. In this way, the materials in each circular channel are in contact with each other at the overlapping part, and the outer sides of the double circles have convex structures of different sizes. In the cleaning process, the shape of the discharge channel 4 through which the mixed cleaning solution passes is variable, so that the surface of the formed agglomeration structure is rougher and more variable, which is beneficial to the tendency of the mixture to reduce the surface energy. And after the mixture passes through the discharge channel, the mixture is further mixed evenly.

如图2所示,各个进料通道6与混合通道5倾斜设置,可以使物料倾斜落到混合通道5中,两个相对的进料通道6在混合通道5中相互碰撞重叠,有利于提高混合效果,相邻或相对的进料通道6的进料不同,这样可以将两种清膏、三七粉,相互包裹混合。避免某个位置包裹太多的清膏或三七粉。As shown in FIG. 2 , each feeding channel 6 and the mixing channel 5 are arranged obliquely, so that the material can be inclined to fall into the mixing channel 5, and the two opposite feeding channels 6 collide and overlap each other in the mixing channel 5, which is beneficial to improve the mixing. The effect is that the feeding of the adjacent or opposite feeding channels 6 is different, so that the two kinds of clear paste and Panax notoginseng powder can be wrapped and mixed with each other. Avoid wrapping too much clear cream or Panax notoginseng powder in one location.

冷却腔7中充入冷却介质,这样可以对出料通道4进行冷却,冷却器8与 冷却腔7连通,可以对冷却腔中泵入冷却液,然后冷却液返回后,再进行重复冷凝再利用。The cooling chamber 7 is filled with a cooling medium, so that the discharge channel 4 can be cooled. The cooler 8 is connected to the cooling chamber 7, and the cooling liquid can be pumped into the cooling chamber. .

混合料在低温下有助于表面能的降低,提高流动性。The mixture contributes to the reduction of the surface energy at low temperature and improves the fluidity.

第二方面,利用上述治疗颈椎病的中药浸膏粉制粒系统的中药浸膏粉制粒方法,具体步骤为:Second aspect, utilize the Chinese medicine extract powder granulation method of the above-mentioned Chinese medicine extract powder granulation system for the treatment of cervical spondylosis, and the concrete steps are:

将各原料与辅料依次进行常温和低温下的混合;The raw materials and auxiliary materials are sequentially mixed at normal temperature and low temperature;

将混合料进行低温冷冻干燥;The mixture is freeze-dried at low temperature;

将低温冷冻干燥得到的混合料进行干法造粒。The mixture obtained by low temperature freeze drying is dry granulated.

在本发明的一些实施方式中,将各原料先后在常温和低温下进行混合,常温混合时,在上混合设备的各个进料通道,相邻两个进料通道的进料不同,相对的两个进料通道的进料不同,低温的温度为5-18℃;优选为:8-15℃;进一步优选为10-12℃。In some embodiments of the present invention, the raw materials are successively mixed at normal temperature and low temperature. When mixing at normal temperature, in each feeding channel of the upper mixing device, the feeding of two adjacent feeding channels is different, and the opposite two feeding channels have different feeding materials. The feeding of each feeding channel is different, and the low temperature is 5-18°C; preferably: 8-15°C; more preferably 10-12°C.

在本发明的一些实施方式中,辅料为糊精和羧甲基纤维素,糊精和羧甲基纤维素的质量比为10:3-5;优选为10:4。In some embodiments of the present invention, the auxiliary materials are dextrin and carboxymethyl cellulose, and the mass ratio of dextrin and carboxymethyl cellulose is 10:3-5; preferably 10:4.

在本发明的一些实施方式中,各原料的总质量与辅料总质量的质量比为10:3-6;优选为10:5。各原料的总质量和辅料的质量比影响混合料的流动性和可压性,间接影响得到的颗粒的均匀性和表面形貌。In some embodiments of the present invention, the mass ratio of the total mass of each raw material to the total mass of the auxiliary materials is 10:3-6; preferably 10:5. The total mass of each raw material and the mass ratio of auxiliary materials affect the fluidity and compressibility of the mixture, and indirectly affect the uniformity and surface morphology of the obtained particles.

在本发明的一些实施方式中,各原料包括葛根白芍清膏、川穹延胡索清膏、三七粉,三七粉的粒度为100-120目。针对特殊的原料,对原料加入不同比例的辅料,设置不同的处理方法,才能够得到较好的造粒效果。In some embodiments of the present invention, each raw material includes Pueraria lobatae clearing paste, Chuanqiongyanhusuo clearing paste, and Panax notoginseng powder, and the particle size of Panax notoginseng powder is 100-120 mesh. For special raw materials, different proportions of auxiliary materials are added to the raw materials, and different treatment methods can be set to obtain better granulation effect.

在本发明的一些实施方式中,造粒后的颗粒与羌活威灵仙挥发油混合得到产品。In some embodiments of the present invention, the granulated granules are mixed with Qiang Huo Wei Ling Xian volatile oil to obtain a product.

在本发明的一些实施方式中,低温冷冻干燥的真空度为-0.1~-0.5MPa,温 度为-10~-15℃;优选的,低温冷冻干燥的真空度为-0.2~-0.5MPa,温度为-10~-12℃。In some embodiments of the present invention, the vacuum degree of low-temperature freeze-drying is -0.1~-0.5MPa, and the temperature is -10~-15°C; preferably, the vacuum degree of low-temperature freeze-drying is -0.2~-0.5MPa, and the temperature It is -10~-12℃.

在本发明的一些实施方式中,干法造粒利用干式造粒机进行,造粒的条件为:主压为5-8兆帕,侧压为0.5-2兆帕,轧辊转速为10-30转/分,螺旋浆转速为50-80转/分。In some embodiments of the present invention, dry granulation is carried out using a dry granulator, and the granulation conditions are: the main pressure is 5-8 MPa, the side pressure is 0.5-2 MPa, and the rolling speed is 10- 30 rpm, and the propeller speed is 50-80 rpm.

CN1228071C中的药剂制备方法得到的各中间产物,其中步骤(1)将三七粉粉碎成100-120目的细粉(本发明的三七粉);步骤(2)将羌活、威灵仙提取挥发油,蒸馏后的水溶液另器收集,药渣加水煎煮1h,滤液备用;步骤(3)葛根、白芍加水煎煮两次,第一次2小时,第二次1小时,滤液与上述两水溶液合并,浓缩、醇沉,回收乙醇,浓缩后成为相对密度1.25-1.30(50℃)的清膏(本发明的葛根白芍清膏);步骤(4)中川穹、延胡索用乙醇回流提取,弃去残渣,提取液回收乙醇,浓缩成相对密度1.25-1.30(50℃)的清膏(本发明的川穹延胡索清膏)。三七1-15份、川穹3-20份、延胡索2-15份、白芍3-20份、威灵仙4-25份、葛根3-20份、羌活4-25份。Each intermediate product obtained by the pharmaceutical preparation method in CN1228071C, wherein step (1) pulverizes Panax notoginseng powder into 100-120 mesh fine powder (panax notoginseng powder of the present invention); step (2) extracts volatile oil from Qianghuo and Weilingxian , the distilled aqueous solution is collected in another device, the medicinal residues are decocted with water for 1h, and the filtrate is for subsequent use; step (3) Pueraria lobata and Paeonia lactiflora are decocted twice with water, the first time is 2 hours, the second time is 1 hour, the filtrate and the above two aqueous solutions Merge, concentrate, alcohol precipitation, reclaim ethanol, become clear paste with relative density 1.25-1.30 (50 ℃) after concentrating (Pueraria Radix Paeoniae Alba clear paste of the present invention); Step (4) Zhongchuan Qiong, Corydalis fragrans are extracted with ethanol reflux, and the residue is discarded , the extracting solution recovers ethanol, and is concentrated into a clearing paste with a relative density of 1.25-1.30 (50° C.) (the Chuanqiongyanhusuo clearing paste of the present invention). 1-15 copies of Panax notoginseng, 3-20 copies of Chuanqiong, 2-15 copies of Yanhusuo, 3-20 copies of Baishao, 4-25 copies of Weilingxian, 3-20 copies of Gegen, and 4-25 copies of Qianghuo.

下面结合实施例对本发明进一步说明Below in conjunction with embodiment, the present invention is further described

实施例1Example 1

将葛根白芍清膏、川穹延胡索清膏、三七粉与辅料在混合装置中先在常温下进行混合,然后在10℃下混合,得到的混合料进行低温冷冻干燥(-0.3MPa、-12℃);将低温冷冻干燥得到的混合料进行干法造粒(主压为6兆帕,侧压为1兆帕,轧辊转速为20转/分,螺旋浆转速为60转/分)。The Pueraria lobatae clearing paste, the Chuanqiongyanhusuo clearing paste, the Panax notoginseng powder and the auxiliary materials were first mixed at room temperature in a mixing device, and then mixed at 10 ° C, and the obtained mixture was freeze-dried at a low temperature (-0.3 MPa, -12 ° C) ); the mixture obtained by low temperature freeze drying is carried out dry granulation (main pressure is 6 MPa, side pressure is 1 MPa, roll speed is 20 rev/min, propeller speed is 60 rev/min).

葛根白芍清膏、川穹延胡索清膏、三七粉的总质量与辅料的质量比为10:5,辅料为糊精和羧甲基纤维素,辅料中糊精和羧甲基纤维素的质量比为10:4。The mass ratio of the total mass of Pueraria Baishao Qing ointment, Chuanqiong Yanhusuo Qing ointment and Panax notoginseng powder to the auxiliary materials is 10:5, the auxiliary materials are dextrin and carboxymethyl cellulose, and the mass ratio of dextrin and carboxymethyl cellulose in the auxiliary materials 10:4.

实施例2Example 2

将葛根白芍清膏、川穹延胡索清膏、三七粉与辅料在混合装置中先在常温下进行混合,然后在12℃下混合,得到的混合料进行低温冷冻干燥(-0.4MPa、-10℃);将低温冷冻干燥得到的混合料进行干法造粒(主压为7兆帕,侧压为1.5兆帕,轧辊转速为25转/分,螺旋浆转速为70转/分)。The pueraria white peony root clearing paste, Chuanqiongyanhusuo clearing paste, Panax notoginseng powder and auxiliary materials were first mixed at room temperature in a mixing device, and then mixed at 12 ° C, and the obtained mixture was freeze-dried at a low temperature (-0.4MPa, -10 °C ); the mixture obtained by low temperature freeze drying is carried out dry granulation (the main pressure is 7 MPa, the side pressure is 1.5 MPa, the rotational speed of the roll is 25 rpm, and the rotational speed of the propeller is 70 rpm).

葛根白芍清膏、川穹延胡索清膏、三七粉的总质量与辅料的质量比为10:4,辅料为糊精和羧甲基纤维素,辅料中糊精和羧甲基纤维素的质量比为10:3。The mass ratio of the total mass of Gegen Baishao Qing ointment, Chuanqiong Yanhu Suo Qing ointment and Panax notoginseng powder to the auxiliary materials is 10:4, the auxiliary materials are dextrin and carboxymethyl cellulose, and the mass ratio of dextrin and carboxymethyl cellulose in the auxiliary materials 10:3.

实施例3Example 3

将葛根白芍清膏、川穹延胡索清膏、三七粉与辅料在混合装置中先在常温下进行混合,然后在11℃下混合,得到的混合料进行低温冷冻干燥(-0.5MPa、-11℃);将低温冷冻干燥得到的混合料进行干法造粒(主压为8兆帕,侧压为2兆帕,轧辊转速为30转/分,螺旋浆转速为75转/分)。The pueraria white peony root clearing paste, Chuanqiongyanhusuo clearing paste, Panax notoginseng powder and auxiliary materials were first mixed at room temperature in a mixing device, and then mixed at 11 °C, and the obtained mixture was freeze-dried at low temperature (-0.5MPa, -11 °C). ); the mixture obtained by low-temperature freeze-drying is carried out dry granulation (main pressure is 8 MPa, side pressure is 2 MPa, roll speed is 30 rev/min, propeller speed is 75 rev/min).

葛根白芍清膏、川穹延胡索清膏、三七粉的总质量与辅料的质量比为10:3,辅料为糊精和羧甲基纤维素,辅料中糊精和羧甲基纤维素的质量比为10:5。The mass ratio of the total mass of Gegen Baishao Qing ointment, Chuanqiong Yanhu Suo Qing ointment and Panax notoginseng powder to the auxiliary materials is 10:3, the auxiliary materials are dextrin and carboxymethyl cellulose, and the mass ratio of dextrin and carboxymethyl cellulose in the auxiliary materials 10:5.

对比例1Comparative Example 1

将葛根白芍清膏、川穹延胡索清膏、三七粉与辅料在混合装置中先在常温下进行混合,然后在10℃下混合,得到的混合料进行低温冷冻干燥(-0.3MPa、-12℃);将低温冷冻干燥得到的混合料进行干法造粒(主压为6兆帕,侧压为1兆帕,轧辊转速为20转/分,螺旋浆转速为60转/分)。The Pueraria lobatae clearing paste, the Chuanqiongyanhusuo clearing paste, the Panax notoginseng powder and the auxiliary materials were first mixed at room temperature in a mixing device, and then mixed at 10 ° C, and the obtained mixture was freeze-dried at a low temperature (-0.3 MPa, -12 ° C) ); the mixture obtained by low temperature freeze drying is carried out dry granulation (main pressure is 6 MPa, side pressure is 1 MPa, roll speed is 20 rev/min, propeller speed is 60 rev/min).

葛根白芍清膏、川穹延胡索清膏、三七粉的总质量与辅料的质量比为10:8,辅料为糊精和羧甲基纤维素,辅料中糊精和羧甲基纤维素的质量比为10:7。The mass ratio of the total mass of Gegen Baishao Qing ointment, Chuanqiong Yanhu Suo Qing ointment and Panax notoginseng powder to the auxiliary materials is 10:8, the auxiliary materials are dextrin and carboxymethyl cellulose, and the mass ratio of dextrin and carboxymethyl cellulose in the auxiliary materials 10:7.

对比例2Comparative Example 2

相比于实施例1,三七粉的粒径为150目,其它制粒方法与实施例1相同。Compared with Example 1, the particle size of Panax notoginseng powder is 150 meshes, and other granulation methods are the same as those in Example 1.

试验例1Test Example 1

流动性按照GB8077规定的方法测定清膏的流动度。实施例1和实施例3、对比例1的流动性。得到如表1所示的结果,如表1所示可以得到实施例1的混合装置的混合效果得到的混合粉料较为均匀,流动性较好。对比例1辅料的加入比例改变之后,流动性相对于实施例1有所下降。对比例2中原料的粒度变化了,得到的混合料的流动性变差,所以不同的原料的流动性是有差异的。Fluidity Determine the fluidity of the clear paste according to the method specified in GB8077. Fluidity of Example 1 and Example 3, and Comparative Example 1. The results shown in Table 1 are obtained. As shown in Table 1, the mixing effect of the mixing device of Example 1 can be obtained. The obtained mixed powder is relatively uniform and has good fluidity. After the addition ratio of the adjuvant in Comparative Example 1 was changed, the fluidity decreased relative to that of Example 1. In Comparative Example 2, the particle size of the raw materials changed, and the fluidity of the obtained mixture became poor, so the fluidity of different raw materials was different.

表1中未设置冷却腔,是在实施例1的基础上,在混合装置中,没有对混合料进行冷却。未设置冷却腔的混合料相比于实施例1的混合料,流动性稍有降低。In Table 1, no cooling chamber is provided, which is based on Example 1, in the mixing device, the mixture is not cooled. Compared with the mixture of Example 1, the fluidity of the mixture without the cooling cavity was slightly reduced.

表1 流动度Table 1 Mobility

流动度(mm)Fluidity(mm) 进入混合装置前Before entering the mixing unit 混合装置流出后After the mixing device flows out 未设置冷却腔No cooling chamber provided 葛根+白芍清膏Pueraria Root + Bai Shao Qing Cream 180180       川穹+延胡索清膏Chuanqiong + Yanhu Suo Qing ointment 160160       混合清膏+三七粉Mixed clear cream + Panax notoginseng powder 140140 250(实施例1)250 (Example 1) 240240 混合清膏+三七粉Mixed clear cream + Panax notoginseng powder 140140 200(对比例1)200 (Comparative Example 1)    混合清膏+三七粉Mixed clear cream + Panax notoginseng powder 140140 210(对比例2)210 (Comparative Example 2)   

试验例2Test Example 2

将实施例1、对比例1的冷冻干燥后得到的物料使用压片机进行压片,另外将各原料利用喷雾干燥的方法进行干燥得到的粉料进行压片,喷雾干燥的方法具体为将两种清膏混合,煮沸5分钟,然后加入三七粉、辅料(各原料与辅料的配比与实施例1相同),然后进行喷雾造粒,得到结果如表2所示。从图2可以得到实施例1冷冻干燥后的混合料具有较好的可压性,黏冲性相比于喷雾干燥法更好,粉末的脆硬度较为良好。对比例1中改变了辅料的掺入比例, 虽然具有较好的硬度,但是黏冲性相对于实施例1降低了。The materials obtained after freeze-drying in Example 1 and Comparative Example 1 were compressed using a tablet machine, and the powder obtained by drying each raw material by a method of spray drying was compressed into tablets. The clear paste was mixed, boiled for 5 minutes, then added with Panax notoginseng powder and auxiliary materials (the ratio of each raw material and auxiliary material was the same as that in Example 1), and then sprayed and granulated, and the results were shown in Table 2. It can be seen from Figure 2 that the freeze-dried mixture in Example 1 has better compressibility, better viscosity and punchability than spray drying, and better brittle hardness of the powder. In Comparative Example 1, the mixing ratio of the auxiliary materials was changed, and although it had better hardness, the viscosity and punchability were reduced compared with that of Example 1.

表2 可压性Table 2 Compressibility

Figure PCTCN2021098702-appb-000001
Figure PCTCN2021098702-appb-000001

试验例3Test Example 3

实施例1、对比例1和喷雾干燥法及干燥制粒后得到的颗粒的表面形貌的对比,如表3所示,喷雾干燥法与试验例2中的喷雾干燥法相同,干法制粒的操作条件与实施例1的操作条件相同。从表3中可以得到,实施例1造粒后的颗粒大小均匀,说明实施例1的制粒方法提高了制粒质量。喷雾干燥与干法制粒的方法得到的颗粒大小不一,有少量的结块。对比例1得到的颗粒直径较为规则,但是颗粒表面会有一些小坑,所以影响整体的制粒效果。Example 1, Comparative Example 1 and the spray drying method and the comparison of the surface morphology of the particles obtained after dry granulation, as shown in Table 3, the spray drying method is the same as the spray drying method in Test Example 2, and the dry granulation method is the same. The operating conditions were the same as those of Example 1. It can be obtained from Table 3 that the particle size after granulation in Example 1 is uniform, indicating that the granulation method of Example 1 improves the granulation quality. The granules obtained by spray drying and dry granulation methods vary in size, with a small amount of agglomeration. The diameter of the particles obtained in Comparative Example 1 is relatively regular, but there are some small pits on the surface of the particles, which affect the overall granulation effect.

表3 粉体结构Table 3 Powder structure

Figure PCTCN2021098702-appb-000002
Figure PCTCN2021098702-appb-000002

以上所述仅为本发明的优选实施例而已,并不用于限制本发明,对于本领域的技术人员来说,本发明可以有各种更改和变化。凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。The above descriptions are only preferred embodiments of the present invention, and are not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and changes. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims (10)

一种治疗颈椎病的中药浸膏粉制粒系统,其特征在于:具体步骤为:包括依次连接的混合装置、低温干燥设备、干法造粒设备,混合设备包括上混合设备和下混合设备,上混合设备的进料端设置进料口,上混合设备的出料端设置出料口,下混合设备位于上混合设备出料端的出料口下方,下混合设备内设置出料通道,出料通道的顶部与上混合设备的出料口连通,下混合设备中设置冷却结构。A traditional Chinese medicine extract powder granulation system for treating cervical spondylosis, characterized in that the specific steps are: comprising a mixing device, a low-temperature drying device, and a dry granulation device connected in sequence, and the mixing device comprises an upper mixing device and a lower mixing device, The feeding port of the upper mixing device is provided with a feeding port, the discharging end of the upper mixing device is provided with a discharging port, the lower mixing device is located below the discharging port of the discharging end of the upper mixing device, and a discharging channel is set in the lower mixing device, and the material is discharged. The top of the channel is communicated with the discharge port of the upper mixing device, and a cooling structure is arranged in the lower mixing device. 如权利要求1所述的治疗颈椎病的中药浸膏粉制粒系统,其特征在于:出料通道竖直设置,出料通道的横截面为双圆形,双圆形部分重叠,双圆形的外侧边具有大小不同的凸起的结构,出料通道为中空的管体结构。The traditional Chinese medicine extract powder granulation system for treating cervical spondylosis according to claim 1, characterized in that: the discharge channel is arranged vertically, the cross-section of the discharge channel is a double circle, the double circle parts overlap, and the double circle The outer side of the tube has a raised structure of different sizes, and the discharge channel is a hollow tube structure. 如权利要求1所述的治疗颈椎病的中药浸膏粉制粒系统,其特征在于:上混合设备包括中间混合通道及混合通道两侧的若干相对设置的进料通道,进料通道位于混合通道的侧上方,在垂直于混合通道的轴向上倾斜设置;优选的,若干进料通道分别独立设置,混合通道中设置螺旋输送机。The traditional Chinese medicine extract powder granulation system for treating cervical spondylosis according to claim 1, wherein the upper mixing device comprises a middle mixing channel and a plurality of oppositely arranged feeding channels on both sides of the mixing channel, and the feeding channel is located in the mixing channel Above the side of the mixing channel, it is inclined in the axial direction perpendicular to the mixing channel; preferably, several feeding channels are independently arranged, and a screw conveyor is arranged in the mixing channel. 如权利要求1所述的治疗颈椎病的中药浸膏粉制粒系统,其特征在于:下混合设备包括出料通道和冷却腔,出料通道位于冷却腔内,与冷却腔之间密封设置。The traditional Chinese medicine extract powder granulation system for treating cervical spondylosis according to claim 1, wherein the lower mixing device comprises a discharge channel and a cooling cavity, and the discharge channel is located in the cooling cavity and is sealed with the cooling cavity. 如权利要求1所述的治疗颈椎病的中药浸膏粉制粒系统,其特征在于:混合装置还包括冷却器,冷却器设置在上混合设备的下方,上混合设备的一侧,冷却器与冷却腔通过介质管道连通。The traditional Chinese medicine extract powder granulation system for treating cervical spondylosis according to claim 1, characterized in that: the mixing device further comprises a cooler, the cooler is arranged below the upper mixing device, on one side of the upper mixing device, the cooler is connected to a cooler. The cooling chambers are communicated through medium pipes. 利用权利要求1-5任一所述的治疗颈椎病的中药浸膏粉制粒系统进行中药浸膏粉制粒的方法,其特征在于:具体步骤为:Utilize any described Chinese medicine extract powder granulation system for the treatment of cervical spondylosis of claims 1-5 to carry out the method for Chinese medicine extract powder granulation, it is characterized in that: the concrete steps are: 将各原料与辅料依次进行常温和低温下的混合;The raw materials and auxiliary materials are sequentially mixed at normal temperature and low temperature; 将混合料进行低温冷冻干燥;The mixture is freeze-dried at low temperature; 将低温冷冻干燥得到的混合料进行干法造粒。The mixture obtained by low temperature freeze drying is dry granulated. 如权利要求6所述的中药浸膏粉制粒的方法,其特征在于:将各原料先后在常温和低温下进行混合,低温的温度为5-18℃;优选为:8-15℃;进一步优选为10-12℃。The method for granulating traditional Chinese medicine extract powder according to claim 6, characterized in that: the raw materials are successively mixed at normal temperature and low temperature, and the low temperature temperature is 5-18°C; preferably: 8-15°C; further It is preferably 10-12°C. 如权利要求6所述的中药浸膏粉制粒的方法,其特征在于:辅料为糊精和羧甲基纤维素,糊精和羧甲基纤维素的质量比为10:3-5;优选为10:4。The method for granulating traditional Chinese medicine extract powder as claimed in claim 6, characterized in that: the auxiliary materials are dextrin and carboxymethyl cellulose, and the mass ratio of dextrin and carboxymethyl cellulose is 10:3-5; preferably 10:4. 如权利要求6所述的中药浸膏粉制粒的方法,其特征在于:各原料的总质量与辅料总质量的质量比为10:3-6;优选为10:5;The method for granulating traditional Chinese medicine extract powder as claimed in claim 6, characterized in that: the mass ratio of the total mass of each raw material to the total mass of auxiliary materials is 10:3-6; preferably 10:5; 各原料包括葛根白芍清膏、川穹延胡索清膏、三七粉;The raw materials include Pueraria Radix Paeoniae Alba clearing paste, Chuanqiongyanhusuo clearing paste, Panax notoginseng powder; 或,造粒后的颗粒与羌活威灵仙挥发油混合得到产品。Or, the granulated granules are mixed with Qiang Huo Wei Ling Xian volatile oil to obtain a product. 如权利要求6所述的中药浸膏粉制粒的方法,其特征在于:低温冷冻干燥的真空度为-0.1~-0.5MPa,温度为-10~-15℃;优选的,低温冷冻干燥的真空度为-0.2~-0.5MPa,温度为-10~-12℃;The method for granulating traditional Chinese medicine extract powder as claimed in claim 6, characterized in that: the vacuum degree of low temperature freeze drying is -0.1~-0.5MPa, and the temperature is -10~-15 ℃; The vacuum degree is -0.2~-0.5MPa, and the temperature is -10~-12℃; 或,干法造粒利用干式造粒机进行,造粒的条件为:主压为5-8兆帕,侧压为0.5-2兆帕,轧辊转速为10-30转/分,螺旋浆转速为50-80转/分。Or, dry granulation is carried out using a dry granulator, and the granulation conditions are: the main pressure is 5-8 MPa, the side pressure is 0.5-2 MPa, the rolling speed is 10-30 rpm, the propeller The speed is 50-80 rpm.
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