双黄妇乐栓的制备及含量测定

Preparation and Content Determination of Shuanghuang Fule Suppository

目的优化妇乐栓的制备工艺,并建立其含量测定方法。方法采用正交设计,以外观性状、重量差异、融变时限为指标,考察不同聚乙二醇比例、加入温度、搅拌速度、搅拌时间和注模温度等因素对栓剂制备工艺的影响;采用HPLC测定双黄妇乐栓中盐酸小檗碱的含量。结果 PEG-400∶PGE-6000∶S-40=6∶3∶1,加入温度50℃,搅拌时间40 min,搅拌速度150 r·min^(-1),注模温度60℃为双黄妇乐栓的最佳制备工艺,在该工艺下制备的3批双黄妇乐栓中盐酸小檗碱含量分别为2.10,2.14,2.15 mg。结论优选后的处方比例合理,制备工艺稳定易行,含量测定方法可靠。

OBJECTIVE To optimize the preparation process of Fule suppository and establish its assay method. METHODS Orthogonal design, the appearance, weight difference, disintegration, dissolution, content as index, the effects of different concentration of alcohol, polyethylene glycol ratio, temperature, stirring speed, influence of suppository preparation the process time and casting temperature and stirring. The content of berberine hydrochloride in Shuanghuang Fule suppository was determined by HPLC. RESULTS The best preparation condition was PEG-400∶PGE-6000∶S-40=6∶3∶1, temperature of 50 ℃, stirring time of 40 min, stirring speed of 150 r·min？1, injection temperature of 60 ℃. The berberine hydrochloride content of Shuanghuang Fule suppository were 2.10, 2.14, 2.15 mg. CONCLUSION The optimal proportion of the prescription is reasonable, the preparation process is stable and easy to operate, and the content determination method is reliable.