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CN111135087A - Industrialized preparation method of solvent type transdermal patch - Google Patents

Industrialized preparation method of solvent type transdermal patch Download PDF

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Publication number
CN111135087A
CN111135087A CN202010022775.4A CN202010022775A CN111135087A CN 111135087 A CN111135087 A CN 111135087A CN 202010022775 A CN202010022775 A CN 202010022775A CN 111135087 A CN111135087 A CN 111135087A
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CN
China
Prior art keywords
coating
solvent
stirring
transdermal patch
glue
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202010022775.4A
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Chinese (zh)
Inventor
王爱爱
王峰
范小玲
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Individual
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Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to CN202010022775.4A priority Critical patent/CN111135087A/en
Publication of CN111135087A publication Critical patent/CN111135087A/en
Pending legal-status Critical Current

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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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Dermatology (AREA)
  • Epidemiology (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention discloses an industrial preparation method of a solvent type transdermal patch, which comprises the following steps of S1. mixing, S2. stirring and homogenizing, and uniformly stirring materials passing through S1; s3, defoaming, namely after the homogenization of the material in the step S2 is finished, vacuumizing to defoam until the material is free of bubbles, and then discharging the glue to a coating glue storage tank and sealing; s4, coating, namely coating the adhesive cement with the chemicals, which is subjected to the S3, on a coating substrate, and then compounding the adhesive cement with the composite film; and S5, slitting, die cutting and packaging. The invention can effectively improve the problems of the uniformity of the medicated adhesive in the production process of the solvent-based transdermal patch, the layering of the medicated adhesive in the coating process and the uniformity of the coating thickness, ensure the uniform content of the solvent-based transdermal patch and ensure that the release behavior meets the controlled release characteristic.

Description

Industrialized preparation method of solvent type transdermal patch
Technical Field
The invention relates to the technical field of industrialized preparation of transdermal patches, in particular to a method for industrially preparing a solvent-type transdermal patch.
Background
Transdermal patch is a transdermal patch which is applied by means of pharmaceutical, physical and chemical means to promote the penetration of the drug through the skin into the circulatory system for therapeutic and prophylactic purposes. The solvent-based transdermal patch has the advantages that the required pressure-sensitive adhesive viscosity is conventionally distributed at about 300-30000 cp in the industrial preparation process, so that the coating uniformity and the content uniformity are difficult to realize in industrial production, the key production process steps are optimized on the basis of solving the precision of production equipment, the key process parameters influencing the coating uniformity are found out, and the content uniformity of the product is finally ensured.
The treatment effect of the solvent-based transdermal patch is closely related to the coating uniformity and the content uniformity of the medicine, and at present, the solvent-based transdermal patch prepared by the existing preparation method has poor coating uniformity and content uniformity, so that the treatment effect of the solvent-based transdermal patch is seriously influenced; in addition, the solvent-based transdermal patch is easy to generate bubbles in the preparation process, and the generated bubbles enter the coating surface along with the mucilage in the coating process to cause uneven coating surface, so that the coating uniformity is influenced finally; therefore, on the basis of solving the problem of the precision of production equipment, key production process steps are optimized, key process parameters influencing the coating uniformity are found out, and finally the content uniformity of the product is ensured.
Disclosure of Invention
In order to solve the problems in the prior art, the invention aims to provide the industrial preparation method of the solvent type transdermal patch, which has reasonable design and convenient operation, can effectively improve the problems of uniformity of the medicated glue slurry and coating thickness uniformity in the production process of the solvent type transdermal patch, and finally ensures that the content of the solvent type transdermal patch is uniform and the release behavior conforms to the controlled release characteristic.
In order to solve the technical problems, the invention adopts the following technical scheme:
the industrialized preparation method of the solvent-based transdermal patch is characterized in that the preparation method for preparing the solvent-based transdermal patch comprises the following steps
S1, preparing materials
Mixing the active ingredients with the organic solvent, stirring by a stirring device, uniformly dispersing the active ingredients in the organic solvent by adopting a solvent dispersion method to obtain a premixed solution, then adding the premixed solution and the solvent-type pressure-sensitive adhesive into a vacuum emulsification homogenizing pot, closing a homogenizing pot cover, and preparing into adhesive cement with the medicine;
s2, stirring and homogenizing
Uniformly stirring and homogenizing the material which passes through the S1;
s3, defoaming
After the material homogenization of S2 is finished, vacuumizing and defoaming until the material is free of bubbles, and then discharging the glue into a coating glue storage tank and sealing;
s4. coating
Coating the adhesive plaster with the chemicals which is processed by S3 on a coating substrate, and then compounding the adhesive plaster with a composite film;
s5, slitting, die cutting and packaging
Cutting, die cutting and packaging according to the product specification.
In a preferred embodiment of the present invention, the organic solvent in S1 is any one of ethyl acetate, ethanol, heptane, hexane, methanol, pentanedione, toluene, xylene, and cyclohexane, the stirring frequency of the stirring device is 50-600rpm, and the stirring time is 10-30 min.
In a preferred embodiment of the present invention, in S2, slow stirring is started first, the stirring speed is 40rpm, and the stirring time is 5 min; then, continuously stirring at a low speed, carrying out intermittent rapid stirring and homogenization, and controlling the homogenization frequency for 2-10 times according to the batch, wherein the homogenization frequency is 25-50 Hz.
In a preferred embodiment of the present invention, a coating knife and a coating substrate are required to be installed in S4, after the preparation is ready, the temperature of the oven is set in a gradient manner, the interlayer circulating water pipe of the coating glue storage tank is connected, and the glue temperature is controlled within a range of 20 ± 1 ℃ to 25 ± 1 ℃;
and after the temperature of the oven and the glue temperature reach the process requirements, starting a power supply of a glue supply pump to start coating, adjusting the coating knife distance and the pump flow according to the control requirements of the thickness and the weight of the dry glue in the coating process, and compounding the coated substrate with the composite film after the coated substrate is taken out of the oven.
Compared with the prior art, the invention has reasonable design and convenient operation, can effectively improve the problems of the uniformity of the medicated glue slurry in the production process of the solvent-based transdermal patch and the uniformity of the coating thickness in the coating process, ensures the uniform content of the solvent-based transdermal patch, ensures that the release behavior conforms to the controlled release characteristic, and effectively improves the treatment effect of the solvent-based transdermal patch.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.
FIG. 1 is a flow chart of the preparation method of the present invention.
Detailed Description
In order to make the technical means, the creation characteristics, the achievement purposes and the effects of the invention easy to understand, the invention is further explained below by combining the specific drawings.
Referring to fig. 1, an industrial preparation method of a solvent-based transdermal patch is provided, and the preparation method for preparing the solvent-based transdermal patch comprises
S1. batching 100
Mixing the active ingredients and the organic solvent, stirring the mixture by a stirring device, wherein the stirring frequency of the stirring device is 50-600rpm, the stirring time is 10-30 min, the active ingredients are uniformly dispersed in the organic solvent by adopting a solvent dispersion method to obtain a premixed solution, then adding the premixed solution and the solvent type pressure-sensitive adhesive into a vacuum emulsification homogenizing pot, closing a cover of the homogenizing pot, and preparing the adhesive cement with the medicine.
The organic solvent is any one of ethyl acetate, ethanol, heptane, hexane, methanol, pentanedione, toluene, xylene, and cyclohexane, and may be selected according to the actual situation, and is not limited to the above.
The active ingredients are uniformly dispersed in the organic solvent by adopting a solvent dispersion method, so that the raw material medicaments are prevented from caking when being added into the solvent type pressure-sensitive adhesive, and the uniform mixing is ensured by stirring and homogenizing at high speed for a plurality of times.
S2, stirring and homogenizing 200
Uniformly stirring and homogenizing the material which passes through the S1; firstly, starting low-speed stirring, wherein the stirring speed is 40rpm, and the stirring time is 5 min; then, continuously stirring at a low speed, carrying out intermittent rapid stirring and homogenization, and controlling the homogenization frequency for 2-10 times according to the batch, wherein the homogenization frequency is 25-50 Hz.
S3, defoaming 300
After the material homogenization of S2, the vacuum is opened for defoaming until the material has no bubbles, then the glue is discharged to a coating glue storage tank and is sealed, and the vacuum defoaming is adopted to prevent the generated bubbles from entering the coating surface along with the glue slurry in the coating process to cause uneven coating surface and finally influence the coating uniformity.
In addition, the glue is supplied in a closed mode to prevent organic solvent from volatilizing to influence the solid content and viscosity of the adhesive cement with the coating, so that the coating uniformity is ensured.
S4, coating 400
Coating the adhesive-carrying adhesive cement which passes through S3 on a coating substrate, then compounding the adhesive-carrying adhesive cement with a composite film, wherein a coating knife and the coating substrate are required to be installed in the process, after the coating substrate is ready, the temperature of an oven is set in a gradient manner, a coating adhesive storage tank interlayer circulating water pipe is connected, the adhesive temperature is controlled within the range of 20 +/-1-25 +/-1 ℃, and the adhesive cement temperature in the coating process is controlled to ensure the balance of the adhesive supply amount, so that the coating uniformity is ensured.
And after the temperature of the oven and the glue temperature reach the process requirements, starting a power supply of a glue supply pump to start coating, adjusting the coating knife distance and the pump flow according to the control requirements of the thickness and the weight of the dry glue in the coating process, and compounding the coated substrate with the composite film after the coated substrate is taken out of the oven.
S5, slitting, die cutting and packaging 500
Cutting, die cutting and packaging according to the product specification.
In conclusion, the invention has reasonable design and convenient operation, can effectively improve the problems of the uniformity of the medicated adhesive slurry in the production process of the solvent-based transdermal patch and the uniformity of the coating thickness in the coating process, ensures the uniform content of the solvent-based transdermal patch, ensures that the release behavior conforms to the controlled release characteristic, and effectively improves the treatment effect of the solvent-based transdermal patch.
The foregoing shows and describes the general principles, essential features, and advantages of the invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, which are given by way of illustration of the principles of the present invention, and that various changes and modifications may be made without departing from the spirit and scope of the invention as defined by the appended claims. The scope of the invention is defined by the appended claims and equivalents thereof.

Claims (4)

1. The industrialized preparation method of the solvent-based transdermal patch is characterized in that the preparation method for preparing the solvent-based transdermal patch comprises the following steps
S1, preparing materials
Mixing the active ingredients with the organic solvent, stirring by a stirring device, uniformly dispersing the active ingredients in the organic solvent by adopting a solvent dispersion method to obtain a premixed solution, then adding the premixed solution and the solvent-type pressure-sensitive adhesive into a vacuum emulsification homogenizing pot, closing a homogenizing pot cover, and preparing into adhesive cement with the medicine;
s2, stirring and homogenizing
Uniformly stirring and homogenizing the material which passes through the S1;
s3, defoaming
After the material homogenization of S2 is finished, vacuumizing and defoaming until the material is free of bubbles, and then discharging the glue into a coating glue storage tank and sealing;
s4. coating
Coating the adhesive plaster with the chemicals which is processed by S3 on a coating substrate, and then compounding the adhesive plaster with a composite film;
s5, slitting, die cutting and packaging
Cutting, die cutting and packaging according to the product specification.
2. The method for industrially preparing the solvent-based transdermal patch according to claim 1, wherein: in the S1, the organic solvent is any one of ethyl acetate, ethanol, heptane, hexane, methanol, pentanedione, toluene, xylene and cyclohexane, the stirring frequency of the stirring device is 50-600rpm, and the stirring time is 10-30 min.
3. The method for industrially preparing the solvent-based transdermal patch according to claim 1, wherein: in the step S2, firstly, starting slow stirring, wherein the stirring speed is 40rpm, and the stirring time is 5 min; then, continuously stirring at a low speed, carrying out intermittent rapid stirring and homogenization, and controlling the homogenization frequency for 2-10 times according to the batch, wherein the homogenization frequency is 25-50 Hz.
4. The method for industrially preparing the solvent-based transdermal patch according to claim 1, wherein: installing a coating knife and a coating substrate in the S4, after the coating knife and the coating substrate are ready, setting the temperature of an oven in a gradient manner, connecting a coating glue storage tank interlayer circulating water pipe, and controlling the glue temperature within the range of 20 +/-1-25 +/-1 ℃;
and after the temperature of the oven and the glue temperature reach the process requirements, starting a power supply of a glue supply pump to start coating, adjusting the coating knife distance and the pump flow according to the control requirements of the thickness and the weight of the dry glue in the coating process, and compounding the coated substrate with the composite film after the coated substrate is taken out of the oven.
CN202010022775.4A 2020-01-09 2020-01-09 Industrialized preparation method of solvent type transdermal patch Pending CN111135087A (en)

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Application Number Priority Date Filing Date Title
CN202010022775.4A CN111135087A (en) 2020-01-09 2020-01-09 Industrialized preparation method of solvent type transdermal patch

Publications (1)

Publication Number Publication Date
CN111135087A true CN111135087A (en) 2020-05-12

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115443796A (en) * 2022-09-03 2022-12-09 王爱爱 Trimming machine for garden lawn

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110086086A1 (en) * 2005-07-26 2011-04-14 Pfizer Inc Transdermal system for varenicline
CN102319229A (en) * 2011-07-27 2012-01-18 蚌埠丰原涂山制药有限公司 Preparation method of diclofenac sodium transdermal patch
CN105250241A (en) * 2014-07-18 2016-01-20 南京蓝登生物科技有限公司 Transdermal patch preparation process
CN105395521A (en) * 2015-11-24 2016-03-16 遵义医学院 Rutaecarpin transdermal patch and preparation method thereof
EP3100744A1 (en) * 2014-01-29 2016-12-07 Nitto Denko Corporation Composition for accelerating penetration through skin, preparation for transdermal administration, and skin patch preparation
CN106924223A (en) * 2017-03-13 2017-07-07 沈阳药科大学 A kind of meloxicam patch and its preparation method and application

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110086086A1 (en) * 2005-07-26 2011-04-14 Pfizer Inc Transdermal system for varenicline
CN102319229A (en) * 2011-07-27 2012-01-18 蚌埠丰原涂山制药有限公司 Preparation method of diclofenac sodium transdermal patch
EP3100744A1 (en) * 2014-01-29 2016-12-07 Nitto Denko Corporation Composition for accelerating penetration through skin, preparation for transdermal administration, and skin patch preparation
CN105250241A (en) * 2014-07-18 2016-01-20 南京蓝登生物科技有限公司 Transdermal patch preparation process
CN105395521A (en) * 2015-11-24 2016-03-16 遵义医学院 Rutaecarpin transdermal patch and preparation method thereof
CN106924223A (en) * 2017-03-13 2017-07-07 沈阳药科大学 A kind of meloxicam patch and its preparation method and application

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115443796A (en) * 2022-09-03 2022-12-09 王爱爱 Trimming machine for garden lawn
CN115443796B (en) * 2022-09-03 2024-06-04 张家界市帅弋园林工程有限公司 Pruning machine for garden lawn

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Application publication date: 20200512