CN110538166A - Polyvinyl alcohol sustained-release film, polyvinyl alcohol sustained-release microneedle and preparation method thereof - Google Patents
Polyvinyl alcohol sustained-release film, polyvinyl alcohol sustained-release microneedle and preparation method thereof Download PDFInfo
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- CN110538166A CN110538166A CN201910752318.8A CN201910752318A CN110538166A CN 110538166 A CN110538166 A CN 110538166A CN 201910752318 A CN201910752318 A CN 201910752318A CN 110538166 A CN110538166 A CN 110538166A
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- polyvinyl alcohol
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
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- 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
- A61K9/7007—Drug-containing films, membranes or sheets
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0023—Drug applicators using microneedles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0053—Methods for producing microneedles
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Abstract
The inventor provides a polyvinyl alcohol sustained-release microneedle or film and a preparation method thereof, and the preparation method comprises the following steps: preparing polyvinyl alcohol solution, preparing medicine-containing solution and carrying out heat treatment. According to the technical scheme, the alcoholysis degree of the polyvinyl alcohol with the alcoholicity higher than 87% is realized by a high-temperature heat treatment mode, so that the polyvinyl alcohol is crosslinked and gelatinized, and the sustained and controlled release of the polyvinyl alcohol micro-needle or the micro-membrane is realized. Meanwhile, the slow controlled release of the drug in the microneedle or the membrane is further realized by selecting the matching of polyvinyl alcohols with different alcoholysis degrees and controlling the temperature and time of heat treatment by adjusting the types and the proportion of the polyvinyl alcohols with different alcoholysis degrees.
Description
Technical Field
The invention relates to the field of medical cosmetology, in particular to a polyvinyl alcohol slow-release film, a polyvinyl alcohol slow-release microneedle and a preparation method thereof.
Background
Polyvinyl alcohol has been used for preparing soluble microneedles, and is generally used alone or mixed with polyvinylpyrrolidone in a certain ratio, and then after being mixed with a drug, the soluble microneedles are prepared using a mold. The soluble microneedle prepared by the method has the advantages that the matrix material is very soluble in water, and after the soluble microneedle penetrates into the skin, the matrix material of the microneedle absorbs tissue fluid in the skin and is quickly dissolved, so that the release speed of the drug in the skin is very high, and the slow controlled release effect cannot be realized. Soluble microneedles are therefore less suitable for clinical treatment of some diseases where sustained low dose administration is required. In addition, after the microneedle prepared in this way is applied to the skin, the matrix material may enter the body along with the release of the drug, and if the drug is frequently administered, the microneedle matrix material may have toxic and side effects on the human body. One of the improvement methods is to chemically crosslink polyvinyl alcohol, which can realize the sustained and controlled release of the drug and reduce the penetration of matrix materials into the skin, but the crosslinking agents such as formaldehyde or glutaraldehyde used in the chemical crosslinking method have high toxicity.
disclosure of Invention
for this reason, it is desirable to provide a sustained-release microneedle and a sustained-release microfilm capable of non-chemical crosslinking for controlled release of a drug. In order to achieve the above object, the inventors provide a method for preparing a sustained-release microneedle or sustained-release microfilm, comprising the steps of:
preparing a polyvinyl alcohol solution: preparing a polyvinyl alcohol solution with the mass percentage concentration of 3% -10%; the polyvinyl alcohol solution contains polyvinyl alcohol with alcoholysis degree higher than 87%;
Preparing a drug-containing solution: adding the medicine into the polyvinyl alcohol solution, and uniformly stirring to obtain a medicine-containing solution;
And (3) heat treatment: and (3) injecting the drug-containing solution into a mold, after the mold is filled with the drug-containing solution, carrying out heat treatment on the mold at 60-200 ℃ for 10-1200 min, and carrying out demolding after the temperature is reduced to obtain the polyvinyl alcohol sustained-release microneedle or film.
Further, the heat treatment temperature is 130-150 ℃.
Further, the heat treatment time is 10min-60 min.
further, the polyvinyl alcohol with the alcoholysis degree higher than 87% is selected from one or more of polyvinyl alcohol with the alcoholysis degree of 88%, polyvinyl alcohol with the alcoholysis degree of 95%, polyvinyl alcohol with the alcoholysis degree of 97% and polyvinyl alcohol with the alcoholysis degree of 99%.
further, the polyvinyl alcohol solution also comprises polyvinyl alcohol with alcoholysis degree lower than 87%.
Further, the method comprises the following steps:
preparing a polyvinyl alcohol solution: weighing polyvinyl alcohol, and preparing a polyvinyl alcohol solution with the mass percentage concentration of 10% by using distilled water; the polyvinyl alcohol comprises polyvinyl alcohol with equal alcoholysis degree of 97% and polyvinyl alcohol with alcoholysis degree of 78%;
Preparing a drug-containing solution: adding the medicine into the polyvinyl alcohol solution, and uniformly stirring to obtain a medicine-containing solution;
And (3) heat treatment: and (3) injecting the drug-containing solution into a mold, after the mold is filled with the drug-containing solution, carrying out heat treatment on the mold at 130 ℃ for 60min, and carrying out demolding after the temperature is reduced to obtain the polyvinyl alcohol sustained-release microneedle or film.
The inventor also provides a polyvinyl alcohol sustained-release microneedle which is prepared by the preparation method.
The inventor also provides a polyvinyl alcohol slow-release film, which is prepared by any one of the preparation methods.
Compared with the prior art, the technical scheme adopts a mode of carrying out high-temperature heat treatment on the polyvinyl alcohol with the alcoholysis degree higher than 87%, so that the polyvinyl alcohol with the alcoholysis degree higher than 87% is subjected to crosslinking gelation at high temperature, the sustained and controlled release of the polyvinyl alcohol microneedle or the microfilm is realized, and the polyvinyl alcohol with the alcoholysis degree lower than 87% is not subjected to such reaction. Meanwhile, the slow controlled release of the drug in the microneedle or the micro-membrane is further realized by selecting the matching of polyvinyl alcohols with different alcoholysis degrees and controlling the temperature and time of heat treatment by adjusting the types and the proportion of the polyvinyl alcohols with different alcoholysis degrees. According to the technical scheme, a chemical cross-linking agent is not used, so that the use safety of the microneedle is improved.
Drawings
FIG. 1 is a graph showing the sustained release of the microneedles prepared in examples 1 to 3 at different times;
FIG. 2 is a graph showing the sustained release of the microneedles prepared in examples 3 to 6 at different heat treatment temperatures;
FIG. 3 is a graph showing the sustained release of the microneedles prepared in examples 7 to 11 at different heat treatment times.
Detailed Description
To explain technical contents, structural features, and objects and effects of the technical solutions in detail, the following detailed description is given with reference to the accompanying drawings in conjunction with the embodiments.
Degree of alcoholysis: is the percentage of hydroxyl groups in the product obtained after alcoholysis to the original groups.
Example 1 preparation of sustained-Release microneedle
Weighing equivalent polyvinyl alcohol with alcoholysis degree of 97% and polyvinyl alcohol with alcoholysis degree of 78%, and preparing polyvinyl alcohol solution with mass percentage concentration of 10% by using distilled water; adding the medicine into the polyvinyl alcohol solution, and uniformly stirring to obtain a mixed solution; and (3) injecting the mixed solution into a mold, after the mold is filled, placing the mold in an oven with a preset temperature of 130 ℃ for heat treatment for 60min, and demolding after cooling to obtain the polyvinyl alcohol slow-release microneedle.
example 2 preparation of sustained-Release microneedle
Weighing equivalent polyvinyl alcohol with alcoholysis degree of 97% and polyvinyl alcohol with alcoholysis degree of 72%, and preparing polyvinyl alcohol solution with mass percentage concentration of 10% by using distilled water; adding the medicine into the polyvinyl alcohol solution, and uniformly stirring to obtain a mixed solution; and (3) injecting the mixed solution into a mold, after the mold is filled, placing the mold in an oven with a preset temperature of 130 ℃ for heat treatment for 60min, and demolding after cooling to obtain the polyvinyl alcohol slow-release microneedle.
Example 3 preparation of sustained Release microneedle
Weighing polyvinyl alcohol with alcoholysis degree of 97%, and preparing polyvinyl alcohol solution with mass percentage concentration of 10% by using distilled water; adding the medicine into the polyvinyl alcohol solution, and uniformly stirring to obtain a mixed solution; and (3) injecting the mixed solution into a mold, after the mold is filled, placing the mold in an oven with a preset temperature of 130 ℃ for heat treatment for 60min, and demolding after cooling to obtain the polyvinyl alcohol slow-release microneedle.
sustained release of the drug-containing microneedles prepared in examples 1 to 3 at different times is shown in fig. 1, which illustrates that the sustained release rate of the drug can be adjusted by mixing polyvinyl alcohol microneedles with different alcoholysis degrees.
The inventor finds in the research that: polyvinyl alcohol with alcoholysis degree higher than 87% can generate crosslinking gelation in heat treatment, and finally cause the slow release of the drug. Polyvinyl alcohols with alcoholysis levels below 87% do not crosslink after heat treatment. Therefore, the polyvinyl alcohol solution for preparing the sustained release microneedle or the membrane must include polyvinyl alcohol having alcoholysis degree higher than 87%. However, in order to adjust the sustained-release time of the drug, polyvinyl alcohols with different alcoholysis degrees can be selected for matching, and the sustained-release time of the drug can be influenced by different proportions of the contained polyvinyl alcohols.
Examples 4 to 6 preparation of sustained-release microneedles
Examples 4 to 6 are different from example 3 in that the heat treatment temperatures for the examples 4 to 6 were 80 ℃ and 100 ℃ and 150 ℃.
The sustained release conditions of the drug-containing microneedles prepared in examples 3 to 6 at different heat treatment temperatures are shown in fig. 2, which illustrates that the sustained release rate of the drug can be adjusted by adjusting the heat treatment temperature.
example 7 preparation of sustained Release microneedle
Weighing polyvinyl alcohol with alcoholysis degree of 99%, and preparing polyvinyl alcohol solution with mass percentage concentration of 10% by using distilled water; adding the medicine into the polyvinyl alcohol solution, and uniformly stirring to obtain a mixed solution; and (3) injecting the mixed solution into a mold, after the mold is filled, placing the mold in an oven with a preset temperature of 130 ℃ for heat treatment for 60min, and demolding after cooling to obtain the polyvinyl alcohol slow-release microneedle.
Examples 8-11 preparation of sustained-Release microneedles
Examples 8 to 11 are different from example 7 in that the heat treatment times of examples 8 to 11 were 30min, 20min, 10min and 0min, respectively.
The sustained release of the drug-containing microneedles prepared in examples 7 to 11 at different heat treatment times is shown in fig. 3, which illustrates that the sustained release rate of the drug can be adjusted by adjusting the heat treatment time.
Example 12 preparation of sustained Release microneedles
weighing polyvinyl alcohol with alcoholysis degree of 95%, and preparing polyvinyl alcohol solution with mass percentage concentration of 3% by using distilled water; adding the medicine into the polyvinyl alcohol solution, and uniformly stirring to obtain a mixed solution; and (3) injecting the mixed solution into a mold, after the mold is filled with the mixed solution, placing the mold in an oven with a preset temperature of 200 ℃ for heat treatment for 10min, and demolding after cooling to obtain the polyvinyl alcohol slow-release microneedle.
EXAMPLE 13 preparation of a sustained Release microfilm
Weighing polyvinyl alcohol with the alcoholysis degree of 95% and polyvinyl alcohol with the alcoholysis degree of 64% in a mass ratio of 1:2, and preparing the polyvinyl alcohol solution with the mass percentage concentration of 5% by using distilled water; adding the medicine into the polyvinyl alcohol solution, and uniformly stirring to obtain a mixed solution; and (3) injecting the mixed solution into a mold, after the mold is fully filled, placing the mold in an oven with the preset temperature of 60 ℃ for heat treatment for 1200min, and demolding after the temperature is reduced to obtain the polyvinyl alcohol slow-release microfilm.
The polyvinyl alcohol with alcoholysis degree higher than 87% is crosslinked to form gel through heat treatment, and meanwhile, the residual water content of a modified polyvinyl alcohol system can be regulated and controlled, the crystalline structure of the polyvinyl alcohol is improved, the mechanical property (rigidity is reduced, tensile and anti-fracture properties are improved), and the water resistance of the polyvinyl alcohol micro-needle or micro-membrane is improved; the safety and effectiveness of the use of the microneedle or the microfilm are increased.
It is noted that, herein, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or terminal that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or terminal. Without further limitation, an element defined by the phrases "comprising … …" or "comprising … …" does not exclude the presence of additional elements in a process, method, article, or terminal that comprises the element. Further, herein, "greater than," "less than," "more than," and the like are understood to exclude the present numbers; the terms "above", "below", "within" and the like are to be understood as including the number.
It should be noted that, although the above embodiments have been described herein, the invention is not limited thereto. Therefore, based on the innovative concepts of the present invention, the technical solutions of the present invention can be directly or indirectly applied to other related technical fields by making changes and modifications to the embodiments described herein, or by using equivalent structures or equivalent processes performed in the content of the present specification and the attached drawings, which are included in the scope of the present invention.
Claims (8)
1. A preparation method of a polyvinyl alcohol sustained-release microneedle or film is characterized by comprising the following steps:
Preparing a polyvinyl alcohol solution: preparing a polyvinyl alcohol solution with the mass percentage concentration of 3% -10%; the polyvinyl alcohol solution contains polyvinyl alcohol with alcoholysis degree higher than 87%;
Preparing a drug-containing solution: adding the medicine into the polyvinyl alcohol solution, and uniformly stirring to obtain a medicine-containing solution;
and (3) heat treatment: and (3) injecting the drug-containing solution into a mold, after the mold is filled with the drug-containing solution, carrying out heat treatment on the mold at 60-200 ℃ for 10-1200 min, and carrying out demolding after the temperature is reduced to obtain the polyvinyl alcohol sustained-release microneedle or film.
2. The method of claim 1, wherein the heat treatment temperature is 130 ℃ to 150 ℃.
3. The method of claim 2, wherein the heat treatment time is 10min to 60 min.
4. The method of claim 1, wherein the polyvinyl alcohol with alcoholysis degree higher than 87% is selected from one or more of polyvinyl alcohol with alcoholysis degree of 88%, polyvinyl alcohol with alcoholysis degree of 95%, polyvinyl alcohol with alcoholysis degree of 97%, and polyvinyl alcohol with alcoholysis degree of 99%.
5. The method of claim 1, wherein the polyvinyl alcohol solution further comprises polyvinyl alcohol with alcoholysis degree of less than 87%.
6. The method of claim 1, comprising the steps of:
Preparing a polyvinyl alcohol solution: weighing polyvinyl alcohol, and preparing a polyvinyl alcohol solution with the mass percentage concentration of 10% by using distilled water; the polyvinyl alcohol comprises polyvinyl alcohol with equal mass alcoholysis degree of 97% and polyvinyl alcohol with alcoholysis degree of 78%;
Preparing a drug-containing solution: adding the medicine into the polyvinyl alcohol solution, and uniformly stirring to obtain a medicine-containing solution;
and (3) heat treatment: and (3) injecting the drug-containing solution into a mold, after the mold is filled with the drug-containing solution, carrying out heat treatment on the mold at 130 ℃ for 60min, and carrying out demolding after the temperature is reduced to obtain the polyvinyl alcohol sustained-release microneedle or film.
7. A polyvinyl alcohol sustained release microneedle characterized in that it is produced by the production method according to any one of claims 1 to 6.
8. A polyvinyl alcohol sustained-release film, which is prepared by the preparation method of any one of claims 1 to 6.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910752318.8A CN110538166B (en) | 2019-08-15 | 2019-08-15 | Polyvinyl alcohol sustained-release film, polyvinyl alcohol sustained-release microneedle and preparation method thereof |
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| CN201910752318.8A CN110538166B (en) | 2019-08-15 | 2019-08-15 | Polyvinyl alcohol sustained-release film, polyvinyl alcohol sustained-release microneedle and preparation method thereof |
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| CN110538166A true CN110538166A (en) | 2019-12-06 |
| CN110538166B CN110538166B (en) | 2022-10-25 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113426004A (en) * | 2021-07-06 | 2021-09-24 | 尹忠 | Strong hydrophilic microneedle substrate, drug-loaded microneedle and application of strong hydrophilic microneedle substrate and drug-loaded microneedle in treatment of diseases |
| CN116440062A (en) * | 2023-06-15 | 2023-07-18 | 北京市心肺血管疾病研究所 | Soluble microneedle patch carrying levosimendan for treating heart failure and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE2905033A1 (en) * | 1979-02-09 | 1980-08-28 | Thilo & Co Gmbh Dr | Prolonged release medicament carrier esp. for ocular use - contg. physico-chemically modified polyvinyl alcohol, water, softening agents, and agents for isotonic regulation |
| CN1302606A (en) * | 1999-12-23 | 2001-07-11 | 强生消费者公司 | Method of preparing water soluble film |
| CN102391530A (en) * | 2011-06-29 | 2012-03-28 | 郝喜海 | Method for manufacturing polyvinyl alcohol slow/controlled release film |
-
2019
- 2019-08-15 CN CN201910752318.8A patent/CN110538166B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE2905033A1 (en) * | 1979-02-09 | 1980-08-28 | Thilo & Co Gmbh Dr | Prolonged release medicament carrier esp. for ocular use - contg. physico-chemically modified polyvinyl alcohol, water, softening agents, and agents for isotonic regulation |
| CN1302606A (en) * | 1999-12-23 | 2001-07-11 | 强生消费者公司 | Method of preparing water soluble film |
| CN102391530A (en) * | 2011-06-29 | 2012-03-28 | 郝喜海 | Method for manufacturing polyvinyl alcohol slow/controlled release film |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113426004A (en) * | 2021-07-06 | 2021-09-24 | 尹忠 | Strong hydrophilic microneedle substrate, drug-loaded microneedle and application of strong hydrophilic microneedle substrate and drug-loaded microneedle in treatment of diseases |
| CN113426004B (en) * | 2021-07-06 | 2023-02-14 | 尹忠 | Strong hydrophilic microneedle substrate, drug-loaded microneedle and application of strong hydrophilic microneedle substrate and drug-loaded microneedle in treatment of diseases |
| CN116440062A (en) * | 2023-06-15 | 2023-07-18 | 北京市心肺血管疾病研究所 | Soluble microneedle patch carrying levosimendan for treating heart failure and preparation method thereof |
| CN116440062B (en) * | 2023-06-15 | 2023-09-26 | 北京市心肺血管疾病研究所 | Soluble microneedle patch carrying levosimendan for treating heart failure and preparation method thereof |
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