柴胡薄层鉴别常用法在新制剂研发中的应用

General TLC Identification Method of Bupleuri Radix and Applications in New Traditional Chinese Medicine Preparation Research

目的探讨中药制剂中柴胡的薄层鉴别方法。方法梳理《中国药典》2015年版一部收载的成方制剂质量标准中柴胡的薄层鉴别方法,归纳,借鉴,在三种含柴胡的医疗机构制剂研发质量标准研究中进行实践。结果药典成方制剂中柴胡薄层鉴别方法多具共性。多采用正丁醇萃取,氨试液洗涤制备供试品溶液,用柴胡对照药材作为对照,以对二甲氨基苯甲醛的硫酸乙醇溶液为显色剂,加热显色,在日光和(或)紫外光灯365 nm下检视,观察斑点的对应情况。基于此法,为三种新制剂成功的建立了柴胡的薄层鉴别标准。结论此方法是成方制剂中柴胡薄层鉴别的常规方法,可在含柴胡的新制剂研发中首选应用。

OBJECTIVE To explore thin-layer chromatography(TLC)identification method of Bupleuri Radix in Traditional Chinese medicine preparation.METHODS The TLC identification methods of Bupleuri Radix in the quality standards of prescription preparations included in Chinese Pharmacopoeia 2015 edition were combed.The general identification methods were generalized,then practiced in quality standard research of three kinds of Traditional Chinese medicine preparations in medical institutions.RESULTS The TLC identification methods of Bupleuri Radix in prescription preparations possessed a lot commonality.Most of the sample solutions were prepared with n-butanol extraction,then washed by ammonia solution.Bupleuri Radix control medicinal herb was used as reference,ethanol sulfate solution of 4-Dimethylaminobenzaldehyde was used as developer,the thin layer chromatography which sprayed with developer was heated until the spots are clearly colored.The corresponding spots were examined in daylight and(or)ultraviolet light at 254 nm.Based on this method,the TLC identification standards of Bupleuri Radix were established successfully for three new Traditional Chinese medicine preparations.CONCLUSION The method is the conventional TLC identification method of Bupleuri Radix in prescription preparations,It could be preferred applied in new Traditional Chinese medicine preparation research,which prescription include Bupleuri Radix.