双黄妇乐栓的制备及含量测定

沈炜; 夏晨柯; 姜丹蕾; 陈学奇<sup>*</sup>

引用本文:	沈炜,夏晨柯,姜丹蕾,陈学奇.双黄妇乐栓的制备及含量测定[J].中国现代应用药学,2016,33(12):1529-1532.
	SHEN Wei,XIA Chenke,JIANG Danlei,CHEN Xueqi.Preparation and Content Determination of Shuanghuang Fule Suppository[J].Chin J Mod Appl Pharm(中国现代应用药学),2016,33(12):1529-1532.

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双黄妇乐栓的制备及含量测定
沈炜¹, 夏晨柯², 姜丹蕾², 陈学奇³
1.浙江中医药大学附属第一医院, 杭州 310000;2.浙江中医药大学药学院, 杭州 310053;3.浙江中医药大学附属第三医院, 杭州 310003

摘要:

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。

关键词: 栓剂制备工艺优化

DOI：10.13748/j.cnki.issn1007-7693.2016.12.010

分类号:

基金项目:浙江省科技计划项目（2014C33123）；浙江省中医药科学计划项目（2015ZA114）

Preparation and Content Determination of Shuanghuang Fule Suppository

SHEN Wei¹, XIA Chenke², JIANG Danlei², CHEN Xueqi³

1.The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou 310000, China;2.College of Pharmaceutical Science, Zhejiang University of Traditional Chinese Medicine, Hangzhou 310053, China;3.The Thired Affiliated Hospital of Zhejiang Chinese Medical Univerdity, Hangzhou 310003, China

Abstract:

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.

Key words: suppository preparation process optimization