Preparation method for adapalene gel

A gel and prescription technology, applied in the field of medicine, can solve problems such as easy aggregation, and achieve the effect of solving the problem of particle size of preparations

Inactive Publication Date: 2016-03-23
FRONT PHARM PLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the existing adapalene gel preparation process, since adapalene is insoluble in water and propylene glycol, it is easy to aggregate when directly added to the gel, and the particle size is much larger than the 50 μm required by the preparation standard

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] In the embodiment of the present invention, a preparation method of adapalene gel, the adapalene gel is composed according to the prescription of mass parts: 0.01 part of adapalene, 1880.01 part of poloxamer, 9340.1 part of carbomer, propylene glycol 1 part, 0.01 part of sodium hydroxide, 10 parts of purified water, 0.01 part of disodium edetate, 0.01 part of methylparaben; its preparation method comprises the following steps:

[0024] (1) Weigh the prescription amount of Carbomer 934 and add an appropriate amount of purified water, soak for 24 hours, pass through a 40-mesh sieve to obtain a Carbomer solution, and set aside;

[0025] (2) Weigh the prescribed amount of adapalene and an appropriate amount of propylene glycol into a stainless steel bucket, then weigh an appropriate amount of sodium hydroxide and dissolve it with an appropriate amount of purified water, add it to the stainless steel bucket, and place it in a water bath at a temperature of 55°C for 1 hour to ...

Embodiment 2

[0031] In the embodiment of the present invention, a preparation method of adapalene gel, the adapalene gel is composed according to the prescription of mass parts: 1 part of adapalene, 1882 parts of poloxamer, 93410 parts of carbomer, propylene glycol 30 parts, 1 part of sodium hydroxide, 90 parts of purified water, 1 part of disodium edetate, 1 part of methylparaben; its preparation method comprises the following steps:

[0032] (1) Weigh the prescription amount of Carbomer 934 and add an appropriate amount of purified water, soak for 24 hours, pass through a 40-mesh sieve to obtain a Carbomer solution, and set aside;

[0033] (2) Weigh the prescribed amount of adapalene and appropriate amount of propylene glycol into a stainless steel barrel, then weigh an appropriate amount of sodium hydroxide and dissolve it with an appropriate amount of purified water, add it to the stainless steel barrel, and bathe in water at 55°C for 1.5 hours to ensure that the raw materials are compl...

Embodiment 3

[0039] In the embodiment of the present invention, a kind of preparation method of adapalene gel, adapalene gel is composed according to the prescription of mass parts: 0.5 part of adapalene, 1881 parts of poloxamer, 9345 parts of carbomer, propylene glycol 15 parts, 0.5 part of sodium hydroxide, 50 parts of purified water, 0.5 part of disodium edetate, 0.5 part of methylparaben; its preparation method comprises the following steps:

[0040] (1) Weigh the prescription amount of Carbomer 934 and add an appropriate amount of purified water, soak for 24 hours, pass through a 40-mesh sieve to obtain a Carbomer solution, and set aside;

[0041] (2) Weigh the prescribed amount of adapalene and appropriate amount of propylene glycol into a stainless steel bucket, then weigh an appropriate amount of sodium hydroxide and dissolve it with an appropriate amount of purified water, add it to the stainless steel bucket, and bathe in water at 55°C for 1.2 hours to ensure that the raw material...

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PUM

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Abstract

The invention discloses a preparation method for adapalene gel. The preparation method comprises the steps that carbomer 934 is soaked in purified water for 24h and screened to obtain a carbomer solution; adapalene, propanediol and sodium hydroxide are taken, dissolved in purified water and added into a stainless steel barrel for a water bath to obtain a main drug solution; methylparaben, poloxamer188 and propanediol are taken, poured into a beaker, stirred and dissolved in a water bath to be clarified; purified water and edetate disodium are taken and placed in a main pot to be stirred at a low speed for dissolution, the solution in the beaker is poured into the main pot, sodium hydroxide is added, and the mixture is stirred to be dissolved; the carbomer solution is poured into the main pot and stirred slowly into uniform gel; the main drug solution is poured into the gel, the stainless steel barrel is rinsed with propanediol before the gel is poured into the main pot, and the mixture is stirred on a vacuum condition to obtain a material; the pH of the material is regulated to 4.75-5.25, quick stirring is started, and vacuum degassing, slow stirring and discharge are performed in sequence. The granularity of the adapalene gel prepared through the method reaches 50 micrometers, meeting the standard requirement for preparations.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a preparation method of adapalene gel. Background technique [0002] Adapalene is a retinoid compound, stable to light and oxygen, and is an inert substance. The mechanism of action of adapalene is mainly to reduce the formation of microcomedone by regulating the differentiation of hair follicle epithelial cells. At the same time, in vivo and in vitro experiments showed that the anti-inflammatory effect of adapalene was stronger than that of other retinoic acid drugs. [0003] Adapalene Gel, Indications: This product is suitable for the skin treatment of acne vulgaris mainly manifested by acne, papules and pustules. It can also be used to treat acne on the face, chest and back. [0004] At present, the particle size of suspension gels listed in my country is about 150nm or more. Referring to the imported drug Daphne Adapalene Gel, its particle size is controlled below 50um, and it is u...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K31/192A61K47/10A61K47/02A61P17/10
Inventor 戴小华罗传国
Owner FRONT PHARM PLC
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