Clindamycin phosphate vaginal expansive suppository as well as preparation method and detection method thereof

A technology of clindamycin phosphate and vaginal expansion suppository, which is applied in the directions of suppository delivery, measuring device, pharmaceutical formulation, etc., can solve the problems of difficult cleaning, easily polluted clothes, unsatisfactory suppository stability, etc., to prevent outflow, avoid The effect of secondary infection

Active Publication Date: 2014-04-23
哈尔滨田美药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For example, Yao Rongcheng et al. (Yao Rongcheng, Yuan Jianping, Zhou Hui. Development of Clindamycin Phosphate Suppository [J], Chinese Journal of Biochemical Medicine, 2002, 23 (2): 87-88) disclosed a A suppository made of mycin phosphate and semi-synthetic fatty acid ester; the preparation process of the suppository is simple, and the stability has been further investigated, but the stability

Method used

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  • Clindamycin phosphate vaginal expansive suppository as well as preparation method and detection method thereof
  • Clindamycin phosphate vaginal expansive suppository as well as preparation method and detection method thereof
  • Clindamycin phosphate vaginal expansive suppository as well as preparation method and detection method thereof

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Experimental program
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Effect test

Embodiment 1

[0096]

[0097] Preparation:

[0098] 1) Preparation of drug-containing matrix:

[0099] a. heating and melting the semi-synthetic fatty acid glyceride in a water bath to obtain a melt;

[0100] b. adding clindamycin phosphate to the melt obtained in step a, and mixing uniformly to obtain a drug-containing matrix;

[0101] 2) Preparation of expansive suppository: Pour the drug-containing matrix into a suppository mold, insert a tampon, cool and shape, and make 100 bullet-shaped suppositories, each weighing about 3.5g.

Embodiment 2

[0103]

[0104] Preparation:

[0105] 1) Preparation of drug-containing matrix:

[0106] a. heating and melting witepsol and cocoa butter in a water bath to obtain a melt;

[0107] b. mixing clindamycin phosphate with xylitol and lauryl gallate uniformly to obtain the first mixture;

[0108] c. adding the first mixture to the melt obtained in step a, and mixing evenly to obtain a drug-containing matrix;

[0109] 2) Preparation of expansive suppositories: Pour the drug-containing matrix into a suppository mold, insert a tampon, cool and shape, and make 100 egg-shaped suppositories, each weighing about 1.8g.

Embodiment 3

[0111]

[0112] Preparation method: make 100 conical suppositories according to the method in Example 2, each weighing about 5.0g.

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Abstract

The invention relates to a clindamycin phosphate vaginal expansive suppository as well as a preparation method and a detection method thereof. The expansive suppository consists of a medicated substrate consisting of clindamycin phosphate and a substrate as well as an expansion carrier, wherein the medicated substrate is added with xylitol, dodecyl gallate and triglycerin octyl caprate. The prepared expansive suppository has the effects of high stability, uniform dispersion and the like; meanwhile, the expansive suppository, which is coated with a film coating outside, overcomes hygroscopicity of clindamycin phosphate, and is rapid in drug release and rapid to become effective in the vagina; the disclosed clindamycin phosphate vaginal expansive suppository, through six unique leading technologies, has the beneficial effects of being capable of preventing medicine liquid leakage, avoiding secondary infection and the like.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, in particular to a clindamycin phosphate vaginal expansive suppository, a preparation method and a detection method thereof. Background technique [0002] Clindamycin phosphate, chemical name (2S-trans)-6-(1-methyl-4-propyl-2-pyrrolidinecarbonamido)-1-thio-methyl-7-chloro -6,7,8-trideoxy-L-threo-α-D-galactopyranoside-2-dihydrogen phosphate; it is a white or off-white crystalline powder, odorless or almost odorless, with a taste Bitter, hygroscopic; easily soluble in water, slightly soluble in methanol, almost insoluble in ethanol; clindamycin phosphate is a semi-synthetic derivative of lincomycin, which is an anti-anaerobic and aerobic bacteria It is a broad-spectrum antibiotic that has no antibacterial activity in vitro, and is rapidly hydrolyzed into clindamycin to exert pharmacological activity after entering the body; it mainly has strong antibacterial activity against Gram-positive cocc...

Claims

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Application Information

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IPC IPC(8): A61K9/02A61K31/7056A61K47/26A61K47/14A61P31/04A61P31/02A61P15/02G01N33/15G01N5/04G01N30/02
Inventor 邱学良邱明世
Owner 哈尔滨田美药业股份有限公司
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