Compound chlorhexidine vaginal expansion suppository as well as preparation method and detection method thereof

Abstract

The invention relates to a compound chlorhexidine vaginal expansion suppository as well as a preparation method and a detection method thereof. The expansion suppository comprises an active ingredient, a matrix and an expansion carrier, wherein the active ingredient comprises chlorhexidine and also comprises metronidazole and borneol; the compound chlorhexidine vaginal expansion suppository is an effervescent suppository, and when the expansion suppository meets water, carbon dioxide is rapidly generated, so that the active ingredient can achieve the part of the common suppository which cannot exert the function, and the curative effect of the medicine is improved; the gel matrix can promote absorption of the vagina on the active ingredient, and the effects of increasing the curative effect and covering the odor of the active ingredient are achieved; moreover, the compound chlorhexidine vaginal expansion suppository employs seven ingenious advanced technologies and has the effective effects of preventing external flow of liquid medicine, along with high stability, lasting curative effect and the like.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, in particular to a compound chlorhexidine salt vaginal expansive suppository, a preparation method and a detection method thereof. Background technique [0002] Chlorhexidine salts include chlorhexidine acetate, chlorhexidine hydrochloride, chlorhexidine citrate, chlorhexidine gluconate, and the like. It is well known that chlorhexidine salt is suitable for making suppositories and compound medicines with other drugs, including compound chlorhexidine acetate suppository (containing chlorhexidine acetate, metronidazole, borneol), bizoate suppository (containing chlorhexidine acetate Ding, metronidazole, clotrimazole), etc. [0003] For example, the compound chlorhexidine acetate suppository is recorded in the tenth volume of "National Standards for Local Standards of Chemical Drugs", which is made of 120g of metronidazole, 20g of chlorhexidine acetate, 8g of borneol, appropriate amount of eth...

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Problems solved by technology

[0004] In the prior art, there are some technical problems in the compound chlorhexidine salt suppository. Some bases such as gelatin and active ingredient compound chlorhexidine acetate suppository are easy to breed microorganisms, and preservatives need to be added, which leads to too many auxiliary materials in the suppository, affecting (Guan Yanbin, Tian Yudong. Preparation and quality evaluation of compound metronidazole chlorhexidine suppository [J]. Medical Journal, 32 (4): 514-516) disclosed a combination of chlorhexidine acetate, formazan The suppositories made of nitrazole, camphor, mixed fatty acid glycerides, paraffin, lanolin and dehydrated alcohol, though overcome the defect that suppositories are easy to breed microorganisms, the matrix used affects the release of medicine and affects the curative effect of active ingredients; lanolin The use of chlorhexidine acetate has stability problems. Chinese patent CN1069521C discloses that glyceryl monostearate can be used as an emulsifier and can improve the stability of suppositories, but it still cannot completely solve the problem of chlorhexidine acetate. All Technical Problems with Salt

[0005] In a word, prior art is not much to the research of compound chlorhexidine salt suppository, and following problem still needs to be solved: 1. the tampon in the suppository of traditional compound chlorhexidine salt has no expansion effect, or expansion disorder, The clinical application is greatly reduced; 2. The drug release is fast, and there is a "peak-valley" phenomenon; 3. The quality control method is unreliable, resulting in large changes in the content, stability, and melting time limit between batches in the actual production process; 4 .Simple mixing of active ingredients and excipients cannot give full play to the curative effect of active ingredients, etc.

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