External clindamycin phosphate solution and preparation method of external solution

A technology of clindamycin phosphate and solution, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc. It can solve the problem that the validity period is only 18-24 months and the impurities increase rapidly , poor stability of clindamycin and other issues, to achieve a good expiration date, solve irritation, and improve the effect of the expiration date

Inactive Publication Date: 2020-01-17
四川健能制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The disadvantage of the above-mentioned clindamycin phosphate topical solution that is currently on the market is that the stability of clindamycin is poor, resulting in a rapid increase in impurities during the product’s storage process, and the validity period is only 18-24 months

Method used

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  • External clindamycin phosphate solution and preparation method of external solution
  • External clindamycin phosphate solution and preparation method of external solution
  • External clindamycin phosphate solution and preparation method of external solution

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Embodiment Construction

[0024] The present invention will be further described below in conjunction with specific experimental groups, but it should not be understood that the scope of the above subject of the present invention is limited to the following experimental groups. All technologies realized based on the above contents of the present invention belong to the scope of the present invention. The excipients in the following experimental groups can be replaced, or reduced or increased, with the same pharmaceutically acceptable excipients.

[0025] Experimental group 1

[0026] 1. Prescription:

[0027]

[0028]

[0029] 2. Process steps:

[0030] (1) take by weighing the menthol of prescription quantity and add in the ethanol of prescription quantity, stir and make it dissolve completely;

[0031] (2) The clindamycin phosphate that takes prescription quantity is dissolved in the pure water of full amount 40%, stirs to make it dissolve completely;

[0032] (3) Take isopropanol and propy...

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PUM

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Abstract

The invention provides an external clindamycin phosphate preparation composition. The composition comprises components as follows: every 20 ml of external clindamycin phosphate solution contains 0.1-0.3 g of clindamycin phosphate, 0.2-0.5 g of ethanol, 6-12 g of isopropyl alcohol, 0.5-2.0 g of propylene glycol, 0.002-0.008 g of menthol, 0.05-0.2 g of sulfobutyl-beta-cyclodextrin and 0.005-0.015 gof disodium hydrogen phosphate. The invention further provides a preparation method of the external clindamycin phosphate preparation composition. The components of the external clindamycin phosphatesolution have synergistic effects, and the finally prepared external clindamycin phosphate solution has higher stability and safety.

Description

technical field [0001] The invention relates to a pharmaceutical preparation composition, in particular to a clindamycin phosphate external solution preparation composition and a preparation method thereof. Background technique [0002] Clindamycin phosphate is a chemically semi-synthesized clindamycin derivative. The clindamycin phosphate preparations currently on the market at home and abroad include external solution, gel, lotion, injection for injection, vaginal injection, etc. Suppositories and oral capsules. [0003] Clindamycin Phosphate Topical Solution, as a drug already on the market, is used to treat acne vulgaris, such as acne, pustules, papules, comedones, and blackheads. Three or four companies, including North China Pharmaceutical Co., Ltd., Shenzhen Dafo Pharmaceutical Co., Ltd., and Chongqing Huabang Pharmaceutical Co., Ltd., have marketed solutions for external use. After reviewing the listing instructions, the prescriptions are: clindamycin phosphate, iso...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/10A61K47/40A61K47/02A61K31/7056A61P17/10A61P17/02
CPCA61K9/0014A61K9/08A61K31/7056A61K47/02A61K47/10A61K47/40A61P17/02A61P17/10
Inventor 叶世春李于林罗成文
Owner 四川健能制药有限公司
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