十味骨康口服液的稳定性研究

摘要

目的 考察十味骨康口服液的稳定性和有效期。方法 进行影响因素试验、加速试验和长期试验，考察项目有性状、鉴别、装量、相对密度、PH值和微生物限度检查。结果 影响因素试验、加速试验和长期试验的各考察项目均符合规定（性状：本品为棕褐色液体；气微，味甜、微苦；放置后有少量沉淀。鉴别：供试品色谱中，在与对照药材淫羊藿、白芍、补骨脂色谱相应的位置上，显相同颜色的斑点，阴性对照无干扰。装量：均不小于10.0 ml/支。相对密度：均不低于1.02。PH值：PH为3.5～5.5。微生物限度：细菌数＜10个/ml，霉菌和酵母菌数＜ 10个/ml，没有检出大肠埃希菌和活螨）。结论 十味骨康口服液稳定性良好，有效期为两年。%Objective To investigate the stability and expiration date of Shiweigukang oral solution. Methods Influencing factors test, acceleration test, and long-term test were conducted to investigate properities, identification, filling volume, PH value, relative density, and microbial limits.Results EverT examination index on influencing factors test, acceleration test, and long-term test met the standards. This oral solution was blown in color and slightly bitter, and had little sediment. Shiweigukang showed the spots with the same color as those of epimedium, white paeony root, and malaytea scurfpea fruit on the color spectrum. The filling volume was not less than 10 ml/bottle; the relative density was not smaller than 1.02; PH value was 3.5 to 5.5; bacterial count was less than 10/ml; and mould and saccharomycetes count was less 10/ml. No E. Coliand mites were found. Conclusions Shiweigukang oral solution has good stability and an expiration date of two years.