Vagina swelling metronidazole clotrimazole suppository and preparation method and detection method thereof

A vaginal expansion suppository, bisazotide technology, applied in the directions of suppository delivery, measuring device, pharmaceutical formula, etc., can solve the problems of disordered expansion, reduced clinical application, no quality control method for bisazotide suppository, etc., to avoid two problems. secondary infection and prevention of outflow

Active Publication Date: 2013-09-11
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

However, in the prior art, there are still the following problems to be solved: 1. The sliver in the traditional Shuangzotai suppository has no expansion effect, or the expansion is disordered, which greatly reduces the clinical application; 2. The quality control method is unreliable, resulting in In the actual production process, the content, stability, and melting time between batches vary greatly; although the 2010 edition of the Chinese Pharmacopoeia is more reasonable to use HPLC for the determination of metronidazole, clotrimazole, and chlorhexidine acetate. The controllability of Zoltai suppository, but there is still no quality control method for sliver of Shuangzotai suppository; 3. Simple mixing of multiple compound ingredients cannot exert their respective curative effects

Method used

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  • Vagina swelling metronidazole clotrimazole suppository and preparation method and detection method thereof
  • Vagina swelling metronidazole clotrimazole suppository and preparation method and detection method thereof
  • Vagina swelling metronidazole clotrimazole suppository and preparation method and detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0081] Preparation:

[0082] a. Take semi-synthetic fatty acid glycerides, paraffin and lanolin according to the prescription amount, and place them in a water bath for heating and melting;

[0083] b. add metronidazole, clotrimazole and chlorhexidine acetate under constant stirring and mix uniformly to obtain a mixture;

[0084] c. The mixture in step b is poured into the suppository mold, inserted into the tampon, cooled and shaped to make an egg-shaped suppository.

Embodiment 2

[0086] Composition of expansive suppositories

[0087] Preparation method: make a torpedo-shaped suppository according to the method of Example 1.

Embodiment 3

[0090] Preparation:

[0091] a. Take semi-synthetic fatty acid glycerides, paraffin and lanolin according to the prescription amount, and place them in a water bath for heating and melting;

[0092] b. add metronidazole, clotrimazole, chlorhexidine acetate and carbomer under constant stirring, and mix uniformly to obtain a mixture;

[0093] c. Take the prescription amount of polyethylene glycol 1500, place it in a water bath and heat and melt it;

[0094] d. Stir continuously, add the mixture of step b to step c, and mix evenly to prepare the mixture;

[0095] e. The mixture in step d is poured into a suppository mold, inserted into a tampon, cooled and shaped to make a spherical suppository.

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Abstract

The invention relates to a vagina swelling metronidazole clotrimazole suppository which comprises an active component consisting of clotrimazole, metronidazole and chlorhexidine acetate, a fat-soluble matrix and a swelling carrier. The metronidazole clotrimazole is fully swelled, so that a medicine-containing layer can be in full contact with the inner wall of the vagina to prevent medicine liquid from flowing out; the swelling metronidazole clotrimazole suppository is an inner and outer layer swelling suppository; and the active component is mixed with different matrixes to prepare an inner layer and an outer layer, so that double effects of quick release and slow release can be achieved. According to the vagina swelling metronidazole clotrimazole suppository provided by the invention, seven unique leading technologies are adopted; and furthermore, the vagina swelling metronidazole clotrimazole suppository has the beneficial effects of preventing the medicine liquid from flowing out, quickly making a response and preventing secondary infection along with long medicine working time and the like.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, in particular to a Shuangzotai vaginal expansion suppository and a preparation method and detection method thereof. Background technique [0002] Shuangzoltai suppository refers to Shuangzoltai suppository containing cotton sliver. The Shuangzoltai cotton suppository released by Shenyang Nuoya Pharmaceutical Factory on May 9, 2003 is made of metronidazole 200g, clotrimazole 160g, and chlorhexidine acetate. 8g, appropriate amount of lanolin, appropriate amount of paraffin, appropriate amount of semi-synthetic fatty acid glyceride. The 2010 edition of the Chinese Pharmacopoeia disclosed the same Shuangzotai suppository. The curative effect of Shuangzotai Suppository has been clinically proven for many years, and it is widely used in gynecological sterilization. However, Shuangzotai Suppository has always had various technical problems, and most of them have been solved. Shuangzotai suppositor...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4174A61K9/02A61K47/46A61P15/02G01B5/08G01G17/00A61K31/4164A61K31/155
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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