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Adapalene and hydrochloric clindamycin compound gel preparation and preparation method thereof

A technology of clindamycin hydrochloride and compound gel, which is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the problem of difficulty in obtaining hydrogel preparations and unsatisfactory treatment effects. , low stability of preparations, etc., to achieve broad application and market prospects, significant therapeutic effect, and convenient administration.

Active Publication Date: 2009-07-22
ZHAOKE GUANGZHOU OPTHALMIC DRUG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Since adapalene is a fat-soluble drug with poor solubility in water, it is difficult to obtain a stable hydrogel preparation, and the fat-soluble adapalene preparation will not only produce a greasy feeling, but also the drug absorption is relatively slow
At present, the preparation formula for treating acne is relatively single, the stability of the preparation is not high, and the therapeutic effect is not satisfactory.

Method used

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  • Adapalene and hydrochloric clindamycin compound gel preparation and preparation method thereof
  • Adapalene and hydrochloric clindamycin compound gel preparation and preparation method thereof
  • Adapalene and hydrochloric clindamycin compound gel preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Embodiment 1 The preparation of compound gel of the present invention

[0037] Table 1 shows the amount of raw and auxiliary materials used in the preparation examples I-III of the compound gel preparation of the present invention.

[0038] Table 1 Raw materials and auxiliary material formulas used in preparation examples I-III

[0039] Element Preparation I

preparation Embodiment I

[0041] (1) prepare bulk drug and adjuvant by the preparation embodiment 1 in table 1;

[0042] (2) Preparation of gel matrix:

[0043] Take a 10L container, add 50g Carbomer 940, 5g disodium edetate, 10g methylparaben, 400g 1,2-propanediol, 16g poloxamer 188 into the container, add 2075.5g deionized water, stir until a uniform jelly-like matrix is ​​formed. A 0.2 g / ml triethanolamine solution was prepared, and the remaining amount of 1,2-propanediol and 20 g of ethylene glycol phenyl ether were mixed. The jelly matrix, 0.2 g / ml triethanolamine solution, poloxamer 188 aqueous solution, 1,2-propanediol and ethylene glycol phenyl ether mixture, and deionized water were sterilized by heating at 121° C. for 20 minutes. Remove, cool, and set aside.

[0044] (3) Add bulk drug: dissolve 50g clindamycin hydrochloride with 375.1g deionized water under aseptic conditions, dissolve 5g adapalene with the above-mentioned sterilized good 1,2-propanediol and ethylene glycol phenyl ether mi...

Embodiment 2

[0046] Embodiment 2 The stability research of compound gel preparation of the present invention

[0047] The stability investigation data of this product (batch number: 20040204) is shown in Table 2.

[0048] Table 2 The stability test results of adapalene hydrochloride clindamycin compound gel

[0049]

[0050] As can be seen from the 36-month stability test results of the compound preparation of the present invention, each quality index meets the standard requirements, and there is no obvious change. Stability study data show that the quality of the preparation is stable within the validity period.

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Abstract

The invention discloses an adapalene clindamycin hydrochloride compound gel preparation and a preparation method thereof. The preparation contains 0.08 to 0.12 percent of adapalene and 0.8 to 1.2 percent of clindamycin hydrochloride according to the weight percentage. The preparation method for the adapalene clindamycin hydrochloride compound gel comprises the steps of: preparing a gel matrix, swelling, sterilizing, dissolving the adapalene and the clindamycin hydrochloride into the gel matrix respectively, and using triethanolamine to adjust the pH value to form the steady gel. The product can effectively treat acne.

Description

technical field [0001] The invention relates to a compound gel preparation containing adapalene and hydrochloric clindamycin and a preparation method thereof. The gel preparation can be used for treating acne. Background technique [0002] Acne is a common inflammatory disease of the pilosebaceous glands. There are many pathogenic factors, and in the puberty stage of people, the onset is wide, and the degree of symptoms shown is different. [0003] Adapalene is a retinol compound that can inhibit the chemotaxis of human polymorphonuclear leukocytes, and can inhibit the metabolism of polymorphonuclear leukocytes by inhibiting the conversion of arachidonic acid lipid oxidation into inflammatory mediators. It can dissolve acne and relieve the inflammatory reaction of acne. [0004] Clindamycin hydrochloride can inhibit the elongation of the peptide chain during protein synthesis, thus affecting the protein synthesis of bacterial cells. Clindamycin hydrochloride has a good cu...

Claims

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Application Information

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IPC IPC(8): A61K31/7056A61K9/00A61K47/34A61P17/10A61K31/192A61K47/10A61K47/32
Inventor 周冠群郑伟杨中强张国辉李小羿
Owner ZHAOKE GUANGZHOU OPTHALMIC DRUG
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