CN111135087A - Industrialized preparation method of solvent type transdermal patch - Google Patents
Industrialized preparation method of solvent type transdermal patch Download PDFInfo
- 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
- Authority
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- China
- Prior art keywords
- coating
- solvent
- stirring
- transdermal patch
- glue
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- Pending
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- 239000002904 solvent Substances 0.000 title claims abstract description 34
- 238000002360 preparation method Methods 0.000 title claims abstract description 16
- 238000000576 coating method Methods 0.000 claims abstract description 61
- 239000011248 coating agent Substances 0.000 claims abstract description 52
- 238000003756 stirring Methods 0.000 claims abstract description 39
- 239000003292 glue Substances 0.000 claims abstract description 25
- 239000000853 adhesive Substances 0.000 claims abstract description 20
- 230000001070 adhesive effect Effects 0.000 claims abstract description 19
- 239000000758 substrate Substances 0.000 claims abstract description 15
- 239000000463 material Substances 0.000 claims abstract description 14
- 238000000265 homogenisation Methods 0.000 claims abstract description 13
- 238000005520 cutting process Methods 0.000 claims abstract description 10
- 239000004568 cement Substances 0.000 claims abstract description 9
- 239000002131 composite material Substances 0.000 claims abstract description 7
- 238000013329 compounding Methods 0.000 claims abstract description 7
- 238000004806 packaging method and process Methods 0.000 claims abstract description 7
- 238000003860 storage Methods 0.000 claims abstract description 7
- 238000002156 mixing Methods 0.000 claims abstract description 5
- 239000000126 substance Substances 0.000 claims abstract description 4
- 238000007599 discharging Methods 0.000 claims abstract description 3
- 238000007789 sealing Methods 0.000 claims abstract description 3
- 238000000034 method Methods 0.000 claims description 14
- 239000003960 organic solvent Substances 0.000 claims description 11
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 9
- XEKOWRVHYACXOJ-UHFFFAOYSA-N Ethyl acetate Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 claims description 9
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims description 9
- YXFVVABEGXRONW-UHFFFAOYSA-N Toluene Chemical compound CC1=CC=CC=C1 YXFVVABEGXRONW-UHFFFAOYSA-N 0.000 claims description 9
- VLKZOEOYAKHREP-UHFFFAOYSA-N n-Hexane Chemical compound CCCCCC VLKZOEOYAKHREP-UHFFFAOYSA-N 0.000 claims description 9
- 239000004480 active ingredient Substances 0.000 claims description 7
- IMNFDUFMRHMDMM-UHFFFAOYSA-N N-Heptane Chemical compound CCCCCCC IMNFDUFMRHMDMM-UHFFFAOYSA-N 0.000 claims description 6
- 239000003814 drug Substances 0.000 claims description 6
- 239000004820 Pressure-sensitive adhesive Substances 0.000 claims description 5
- 239000006185 dispersion Substances 0.000 claims description 4
- 239000011505 plaster Substances 0.000 claims description 4
- XDTMQSROBMDMFD-UHFFFAOYSA-N Cyclohexane Chemical compound C1CCCCC1 XDTMQSROBMDMFD-UHFFFAOYSA-N 0.000 claims description 3
- CTQNGGLPUBDAKN-UHFFFAOYSA-N O-Xylene Chemical compound CC1=CC=CC=C1C CTQNGGLPUBDAKN-UHFFFAOYSA-N 0.000 claims description 3
- YRKCREAYFQTBPV-UHFFFAOYSA-N acetylacetone Chemical compound CC(=O)CC(C)=O YRKCREAYFQTBPV-UHFFFAOYSA-N 0.000 claims description 3
- 238000004945 emulsification Methods 0.000 claims description 3
- TZMFJUDUGYTVRY-UHFFFAOYSA-N ethyl methyl diketone Natural products CCC(=O)C(C)=O TZMFJUDUGYTVRY-UHFFFAOYSA-N 0.000 claims description 3
- 239000011229 interlayer Substances 0.000 claims description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 3
- 239000008096 xylene Substances 0.000 claims description 3
- 238000004519 manufacturing process Methods 0.000 abstract description 8
- 238000013270 controlled release Methods 0.000 abstract description 4
- 230000000694 effects Effects 0.000 description 5
- 239000002002 slurry Substances 0.000 description 4
- 229920000715 Mucilage Polymers 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000009776 industrial production Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 230000000069 prophylactic effect Effects 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS 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
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal 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
Landscapes
- 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
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.
Priority Applications (1)
| 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 |
Applications Claiming Priority (1)
| 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 |
Family
ID=70524217
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202010022775.4A Pending CN111135087A (en) | 2020-01-09 | 2020-01-09 | Industrialized preparation method of solvent type transdermal patch |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN111135087A (en) |
Cited By (1)
| 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)
| 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 |
-
2020
- 2020-01-09 CN CN202010022775.4A patent/CN111135087A/en active Pending
Patent Citations (6)
| 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)
| 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 |