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

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...

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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 of the suppository is still unsatisfactory, and the drug release is slow; and Clindamyces vulgaris Phosphate suppository also has technical problems such as not being easy to clean and easily contaminating clothes; the contact surface between the active ingredient and the human body is small, resulting in insufficient absorption and failure to exert the best curative effect of the prescription.

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