Metronidazole expandable vaginal suppository, and preparation method and detection method thereof

Abstract

The invention relates to a metronidazole expandable vaginal suppository, and a preparation method and a detection method thereof. The expandable vaginal suppository comprises metronidazole, a matrix and an expansion carrier. The drug-containing matrix also includes a resin; a resin compound formed by the resin with metronidazole can improve stability of the suppository and cooperate with an acidifier to prolong effect time of metronidazole on the vagina, extend therapeutic effect and maintain the specific acid environment and self-cleaning function of the vagina; and the chitosan can promote the absorption of metronidazole by the vagina and improve the bioavailability of the suppository. The metronidazole expandable vaginal suppository employs seven unique technologies and has beneficial effects of prevention of outflow liquid and secondary infection.

Description

Technical field [0001] The invention belongs to the field of vaginal suppositories, and particularly relates to a metronidazole vaginal expansion suppository and a preparation method and a detection method thereof. Background technique [0002] Metronidazole, whose chemical name is 2-methyl-5-nitroimidazole-1-ethanol, has the following structure: [0003] [0004] Metronidazole has poor solubility. It is slightly soluble in ethanol and slightly soluble in water. It is mainly used clinically for trichomonas vaginitis; commonly used dosage forms include oral preparations, injections and suppositories, but oral and injections, 15-30% of cases Adverse reactions dominated by the digestive tract; metronidazole suppositories are administered rectal, which overcomes the adverse reactions of oral or injection, and there is no liver first pass effect. [0005] The first edition of the Chinese Pharmacopoeia 2010 published the quality standards for metronidazole suppositories, and the 11th volu...

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Problems solved by technology

[0006] Xu Ziyou (Xu Ziyou, Chen Jiyue, Li Qiaoyun, etc. Experimental Research on Metronidazole Gelatin Sponge Vaginal Suppositories [J], Chinese Hospital Pharmaceutical Impurities, 1994, 14 (9): 387-388) disclosed a combination of metronidazole, gelatin, formaldehyde Sponge suppositories made of solution and distilled water; Common suppositories made of semi-synthetic fatty acid glycerides or glycerin gelatin; the water solubility of metronidazole in the above suppositories is poor, and its absorption in the vagina is not ideal, which affects its curative effect; , easy to contaminate clothes, the contact surface between the active drug and the human body is small, resulting in insufficient absorption, and the best curative effect of the prescription is not exerted; the drug has a fast onset of action, and the effective administration time is short and other technical problems

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