CN110559257A - Imiquimod vesicle gel and preparation method thereof - Google Patents
Imiquimod vesicle gel and preparation method thereof Download PDFInfo
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- CN110559257A CN110559257A CN201910884910.3A CN201910884910A CN110559257A CN 110559257 A CN110559257 A CN 110559257A CN 201910884910 A CN201910884910 A CN 201910884910A CN 110559257 A CN110559257 A CN 110559257A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4738—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
- A61K31/4745—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
-
- 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
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
-
- 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
- A61K9/10—Dispersions; Emulsions
- A61K9/127—Liposomes
- A61K9/1271—Non-conventional liposomes, e.g. PEGylated liposomes, liposomes coated with polymers
- A61K9/1273—Polymersomes; Liposomes with polymerisable or polymerised bilayer-forming substances
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
Abstract
the invention discloses an imiquimod vesicle gel and a preparation method thereof, wherein the imiquimod vesicle gel comprises the following raw materials in parts by weight: 10-20 parts of imiquimod, 10-20 parts of poloxamer, 5-8 parts of polyethylene glycol, 12-15 parts of phosphate buffer, 4-8 parts of Span, 10-12 parts of PVP, 9402-4 parts of CP, 5-10 parts of glycerol, 5-8 parts of dexamethasone and 3-5 parts of pH regulator, wherein the phosphate buffer is prepared by adding deionized water into potassium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride and potassium chloride, mixing and stirring. The imiquimod vesicle gel and the preparation method thereof have the advantages that the integral drug effect is strong, the drugs are concentrated after the gel is used, the toxicity to the whole body is low, the skin swelling phenomenon and the skin itching phenomenon are avoided, the side effect is low, the integral applicability is improved, the damage to a patient is reduced, the quality of the imiquimod vesicle gel is ensured, the skin of the patient is protected to a certain extent, skin problems of the patient after the gel is used are avoided, and the gel is safe and reliable.
Description
Technical Field
The invention relates to the technical field of imiquimod, in particular to an imiquimod vesicle gel and a preparation method thereof.
background
Imiquimod is an imidazole quinoline compound, is a small molecule immunomodulator, has unknown action mechanism for treating external genitalia and perianal warts, does not have direct antiviral activity, and does not cause direct and nonspecific cytolytic destruction, but clinical researches suggest that the imiquimod can generate antiviral activity by inducing in vivo cytokines including INF-alpha, and the clinical relevance of the findings is unknown. The existing clinical preparation has low drug concentration at the drug application part of the skin, has large dosage, and quite part of the drug is absorbed into the body through the skin, so that local toxic and side effects such as itch, erythema, burning sensation, tenderness, ulcer, erosion, pain and the like exist, and systemic adverse reactions such as fatigue, fever, flu-like symptoms, headache, diarrhea, myalgia and the like are occasionally seen, so that the skin and the human body are damaged to a certain extent, but the existing imiquimod vesicle gel has poor protection on the skin, and the integral quality is influenced.
Traditional imiquimod vesicle gel, whole drug effect is not strong, and the medicine disperses after using, and is big to whole body toxicity, and the skin red and swollen phenomenon and the skin itch phenomenon appear and explain the side effect big, have reduced holistic suitability, have increased and have harmd the patient, are difficult to guarantee the quality of imiquimod vesicle gel, do not have certain guard action to patient's skin, and some skin problems appear after the patient uses easily, safe and reliable inadequately.
Disclosure of Invention
Technical problem to be solved
aiming at the defects of the prior art, the invention provides an imiquimod vesicle gel and a preparation method thereof, and solves the problems that the imiquimod vesicle gel is poor in effect and cannot protect the skin of a patient to a certain extent.
(II) technical scheme
In order to achieve the purpose, the invention is realized by the following technical scheme: an imiquimod vesicle gel comprises the following raw materials in parts by weight: 10-20 parts of imiquimod, 10-20 parts of poloxamer, 5-8 parts of polyethylene glycol, 12-15 parts of phosphate buffer, 4-8 parts of Span, 10-12 parts of PVP, 9402-4 parts of CP, 5-10 parts of glycerol, 5-8 parts of dexamethasone and 3-5 parts of pH regulator.
Preferably, the phosphate buffer solution is prepared by adding potassium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride and potassium chloride into deionized water, mixing and stirring.
Preferably, the poloxamer has an HLB value of 29.
Preferably, the glycerol is natural glycerol prepared from natural oil and fat as raw materials.
Preferably, the PH adjusting agent is composed of triethanolamine.
The invention also discloses a preparation method of the imiquimod vesicle gel, which comprises the following steps:
s1, respectively putting poloxamer, polyethylene glycol and Span into a reaction container, then magnetically stirring at the water bath condition of 60 ℃ to enable the poloxamer, the polyethylene glycol and the Span to be completely dissolved, stirring at the speed of 2000r/min, and adding imiquimod after stirring for 20 minutes;
s2, adding imiquimod into S1, then decompressing and rotating the reaction container, evaporating to remove the organic solvent inside, forming a thin film layer on the inner wall of the reaction container, adding phosphate buffer solution while stirring, standing for a period of time, and then self-assembling to form a multi-chamber vesicle;
S3, adding PVP and CP-940 into another reaction vessel, adding a proper amount of deionized water, standing to fully swell the PVP and the CP-940, adding a pH regulator to regulate the pH of the solution to 5-8 to obtain a gel matrix, and standing for later use;
S4, rapidly stirring glycerol and dexamethasone through a stirrer, mixing the glycerol and dexamethasone with the vesicle in the S2 and the object placed for later use in the S3 after stirring for 10 minutes, and stirring for 20 minutes again to obtain fine and uniform milky white semisolid;
S5, randomly sampling and inspecting the prepared vesicle gel in S4, subpackaging the qualified vesicle gel into a bottle body, labeling, and sealing the bottle body.
Preferably, in the step S3, when the solution is adjusted by the PH adjuster, the PH adjuster is added while stirring.
(III) advantageous effects
The invention provides an imiquimod vesicle gel and a preparation method thereof. The method has the following beneficial effects: the imiquimod vesicle gel and the preparation method thereof comprise the following raw materials in parts by weight: 10-20 parts of imiquimod, 10-20 parts of poloxamer, 5-8 parts of polyethylene glycol, 12-15 parts of phosphate buffer solution, 4-8 parts of Span, 10-12 parts of PVP, 5-4 parts of CP-9402, 5-10 parts of glycerol, 5-8 parts of dexamethasone and 3-5 parts of pH regulator, wherein the phosphate buffer solution is prepared by adding deionized water into potassium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride and potassium chloride and mixing and stirring, the HLB value of the poloxamer is 29, the overall drug effect is strong, the drug is concentrated after use, the toxicity to the whole body is small, the skin red swelling phenomenon and skin itching phenomenon are avoided, the side effect is low, the overall applicability is improved, the damage to a patient is reduced, the quality of imiquimod gel vesicles is ensured, a certain protection effect is realized on the skin of the patient, and skin problems of the patient after use are avoided, is safe and reliable.
Drawings
FIG. 1 is a statistical table of comparative experimental data according to the present invention.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
referring to fig. 1, the embodiment of the present invention provides three technical solutions: an imiquimod vesicle gel and a preparation method thereof specifically comprise the following embodiments:
example 1
s1, respectively putting 10 parts of poloxamer, 5 parts of polyethylene glycol and 4 parts of Span into a reaction container, then magnetically stirring at the water bath condition of 60 ℃ to enable the poloxamer, the 5 parts of polyethylene glycol and the 4 parts of Span to be completely dissolved, stirring at the speed of 2000r/min for 20 minutes, and then adding 15 parts of imiquimod;
S2, adding imiquimod into S1, then decompressing and rotating the reaction container, evaporating to remove the organic solvent inside, forming a thin film layer on the inner wall of the reaction container, adding 12 parts of phosphate buffer solution while stirring, standing for a period of time, and then self-assembling to form a multi-chamber vesicle;
S3, adding 15 parts of PVP and 2 parts of CP-940 into another reaction vessel, adding a proper amount of deionized water, standing to enable the solution to be fully swelled, adding 3 parts of a PH regulator to regulate the PH of the solution to 5-8 to obtain a gel matrix, and then standing for later use;
S4, rapidly stirring 10 parts of glycerol and 8 parts of dexamethasone through a stirrer, mixing the glycerol and the dexamethasone with the vesicle in the S2 and the object placed for later use in the S3 after stirring for 10 minutes, and stirring for 20 minutes again to obtain fine and uniform milky semisolid;
s5, randomly sampling and inspecting the prepared vesicle gel in S4, subpackaging the qualified vesicle gel into a bottle body, labeling, and sealing the bottle body.
example 2
S1, respectively putting 20 parts of poloxamer, 8 parts of polyethylene glycol and 8 parts of Span into a reaction container, then magnetically stirring at the water bath condition of 60 ℃ to enable the poloxamer, the 8 parts of polyethylene glycol and the Span to be completely dissolved, wherein the stirring speed is 2000r/min, stirring for 20 minutes, and then adding 20 parts of imiquimod;
s2, adding imiquimod into S1, then decompressing and rotating the reaction container, evaporating to remove the organic solvent inside, forming a thin film layer on the inner wall of the reaction container, adding 15 parts of phosphate buffer solution while stirring, standing for a period of time, and then self-assembling to form a multi-chamber vesicle;
s3, adding 10 parts of PVP and 2 parts of CP-940 into another reaction vessel, adding a proper amount of deionized water, standing to fully swell the PVP and the CP-940, adding 3 parts of a pH regulator to regulate the pH of the solution to 5-8 to obtain a gel matrix, and standing for later use;
s4, rapidly stirring 5 parts of glycerol and 5 parts of dexamethasone through a stirrer, mixing the glycerol and the dexamethasone with the vesicle in the S2 and the object placed for later use in the S3 after stirring for 10 minutes, and stirring for 20 minutes again to obtain fine and uniform milky semisolid;
s5, randomly sampling and inspecting the prepared vesicle gel in S4, subpackaging the qualified vesicle gel into a bottle body, labeling, and sealing the bottle body.
Example 3
S1, respectively putting 15 parts of poloxamer, 6 parts of polyethylene glycol and 6 parts of Span into a reaction container, then magnetically stirring at the water bath condition of 60 ℃ to enable the poloxamer, the 6 parts of polyethylene glycol and the 6 parts of Span to be completely dissolved, stirring at the speed of 2000r/min for 20 minutes, and then adding 10 parts of imiquimod;
S2, adding imiquimod into S1, then decompressing and rotating the reaction container, evaporating to remove the organic solvent inside, forming a thin film layer on the inner wall of the reaction container, adding 13 parts of phosphate buffer solution while stirring, standing for a period of time, and then self-assembling to form a multi-chamber vesicle;
S3, adding 11 parts of PVP and 2 parts of CP-940 into another reaction vessel, adding a proper amount of deionized water, standing to enable the solution to be fully swelled, adding 5 parts of a PH regulator to regulate the PH of the solution to 5-8 to obtain a gel matrix, and then standing for later use;
s4, rapidly stirring 7 parts of glycerol and 6 parts of dexamethasone through a stirrer, mixing the glycerol and the dexamethasone with the vesicle in the S2 and the object placed for later use in the S3 after stirring for 10 minutes, and stirring for 20 minutes again to obtain fine and uniform milky semisolid;
s5, randomly sampling and inspecting the prepared vesicle gel in S4, subpackaging the qualified vesicle gel into a bottle body, labeling, and sealing the bottle body.
comparative experiment
each 10 parts of the finished products of example 1, example 2 and example 3 were randomly selected by a certain imiquimod vesicle gel pharmaceutical factory for testing, and 10 parts of the commercial product was taken as a control group, and after the finished products of example 1, example 2, example 3 and the commercial group were tested, the tested effects were recorded.
As can be seen from table 1, the test effect of example 1 of the present invention is the best of the three comparative items, so the best effect can be achieved by the preparation method of example 1, the produced imiquimod vesicle gel has strong drug effect, high intradermal retention, no skin red swelling phenomenon and no skin itching phenomenon, the high intradermal retention indicates concentrated drug, and has low systemic toxicity, no skin red swelling phenomenon and no skin itching phenomenon indicates low side effect, the whole applicability is improved, and the damage to patients is reduced.
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 apparatus 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 apparatus. Without further limitation.
Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.
Claims (7)
1. An imiquimod vesicle gel, characterized in that: the raw materials comprise the following components in parts by weight: 10-20 parts of imiquimod, 10-20 parts of poloxamer, 5-8 parts of polyethylene glycol, 12-15 parts of phosphate buffer, 4-8 parts of Span, 10-12 parts of PVP, 9402-4 parts of CP, 5-10 parts of glycerol, 5-8 parts of dexamethasone and 3-5 parts of pH regulator.
2. An imiquimod vesicle gel according to claim 1, characterized in that: the phosphate buffer solution is prepared by adding potassium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride and potassium chloride into deionized water, mixing and stirring.
3. An imiquimod vesicle gel according to claim 1, characterized in that: the poloxamer had an HLB value of 29.
4. An imiquimod vesicle gel according to claim 1, characterized in that: the glycerol is natural glycerol prepared by taking natural oil as a raw material.
5. An imiquimod vesicle gel according to claim 1, characterized in that: the pH regulator consists of triethanolamine.
6. A preparation method of an imiquimod vesicle gel is characterized in that: the method specifically comprises the following steps:
s1, respectively putting poloxamer, polyethylene glycol and Span into a reaction container, then magnetically stirring at the water bath condition of 60 ℃ to enable the poloxamer, the polyethylene glycol and the Span to be completely dissolved, stirring at the speed of 2000r/min, and adding imiquimod after stirring for 20 minutes;
S2, adding imiquimod into S1, then decompressing and rotating the reaction container, evaporating to remove the organic solvent inside, forming a thin film layer on the inner wall of the reaction container, adding phosphate buffer solution while stirring, standing for a period of time, and then self-assembling to form a multi-chamber vesicle;
S3, adding PVP and CP-940 into another reaction vessel, adding a proper amount of deionized water, standing to fully swell the PVP and the CP-940, adding a pH regulator to regulate the pH of the solution to 5-8 to obtain a gel matrix, and standing for later use;
S4, rapidly stirring glycerol and dexamethasone through a stirrer, mixing the glycerol and dexamethasone with the vesicle in the S2 and the object placed for later use in the S3 after stirring for 10 minutes, and stirring for 20 minutes again to obtain fine and uniform milky white semisolid;
s5, randomly sampling and inspecting the prepared vesicle gel in S4, subpackaging the qualified vesicle gel into a bottle body, labeling, and sealing the bottle body.
7. The method for preparing an imiquimod vesicle gel according to claim 6, wherein the steps of: in step S3, when the solution is adjusted by the PH adjuster, the PH adjuster needs to be added while stirring.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910884910.3A CN110559257A (en) | 2019-09-19 | 2019-09-19 | Imiquimod vesicle gel and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201910884910.3A CN110559257A (en) | 2019-09-19 | 2019-09-19 | Imiquimod vesicle gel and preparation method thereof |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1738587A (en) * | 2002-10-25 | 2006-02-22 | 希尔皮肤医药公司 | Topical skin care composition |
| CN101756886A (en) * | 2010-02-09 | 2010-06-30 | 华中师范大学 | Imiquimod micro emulsion gels for local skin and preparation method thereof |
| CN103202803A (en) * | 2012-12-18 | 2013-07-17 | 苏州大学 | Imiquimod vesicle gel and preparation method for same |
| CN109125252A (en) * | 2018-09-25 | 2019-01-04 | 太仓欧典新材料有限公司 | A kind of preparation method of alkannin liposome gel |
-
2019
- 2019-09-19 CN CN201910884910.3A patent/CN110559257A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1738587A (en) * | 2002-10-25 | 2006-02-22 | 希尔皮肤医药公司 | Topical skin care composition |
| CN101756886A (en) * | 2010-02-09 | 2010-06-30 | 华中师范大学 | Imiquimod micro emulsion gels for local skin and preparation method thereof |
| CN103202803A (en) * | 2012-12-18 | 2013-07-17 | 苏州大学 | Imiquimod vesicle gel and preparation method for same |
| CN109125252A (en) * | 2018-09-25 | 2019-01-04 | 太仓欧典新材料有限公司 | A kind of preparation method of alkannin liposome gel |
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Application publication date: 20191213 |