宫颈康泡腾片的制备及质量控制

目的:制备宫颈康泡腾片并建立其质量控制方法。方法:将绿萼梅等6味中药进行提取和纯化后的浸膏粉与冰片、碳酸氢钠、酒石酸等混合制备阴道泡腾片;采用薄层色谱法对绿萼梅、黄柏、冰片进行定性鉴别;用薄层扫描法测定黄柏中盐酸小檗碱的含量。结果:薄层图谱斑点清晰,阴性对照无干扰;盐酸小檗碱进样量在0 .174μg～1. 044μg 范围内线性关系良好(r=0. 9995) ,回收率为98. 01 %～100 .80 % ,RSD<2 %。结论:本方法易于操作,制剂质量稳定、可控。

Preparation and Quality Control of Gongjinkang Effervescent Tablets

OBJECTIVE:To prepare Gongjinkang Effervescent Tablets and to establish a method of quality control for this tablets.METHODS:The Gongjinkang Effervescent Tablets was prepared with mixture of purified powdered extract from6kinds of traditional Chinese medicine such as Flos Mume and Borneol,Sodium bicarbonate,tartaric acid,etc.;the Flos Mume,Phellodendron and borneol were identified by the TLC;the content of berberine hydrochloride was determined by TLC-scanning.RESULTS:The TLC chraomatogram spots were clear and no interference was found in the negative reference;the linear range of berberine hydrochloride on calibration curve was0.174μg～1.044μg(r=0.9995),the average recovery was98.01%～100.80%and RSD<2%.CONCLUSIONS:This preparation method was easy to operate;the quality was stable and controllable.