基于市售柴胡饮片质量考察的质量控制标准提升及真伪鉴别研究

Study on improvement of quality control standard and true and false identification based on quality investigation of commercial Bupleuri Radix pieces

目的:提升柴胡饮片质量控制标准,研究真伪柴胡饮片的鉴别方法。方法:按照2015年版《中华人民共和国药典》(以下简称《中国药典》)一部中的方法对柴胡饮片性状、水分、总灰分、酸不溶灰分、浸出物含量进行检测,采用以《中国药典》法为基础改进的高效薄层鉴别法对柴胡饮片进行TLC及真伪鉴别,建立柴胡饮片HPLC指纹图谱,改进《中国药典》含量测定法,对柴胡皂苷a、b1、b2、c、d的含量进行测定。结果:15批柴胡及伪品饮片的水分、总灰分、浸出物、柴胡皂苷含量均符合《中国药典》标准,酸不溶灰分中仅1批不符合《中国药典》规定。柴胡正品及伪品在外观性状、TLC及指纹图谱等方面存在明显差异。结论:提升的柴胡饮片质量控制标准及真伪鉴别研究可进一步有效控制柴胡饮片质量,保障临床疗效。

Objective:To improve the quality control standard and to establish the true and false identification method of Bupleuri Radix pieces.Methods:According to the method in the 2015 edition of Pharmacopoeia of the People’s Republic of China(hereinafter referred to as Chinese Pharmacopoeia),the characteristics,water content,total ash,acid-insoluble ash and extract content of Bupleuri Radix pieces were tested.High-performance thin-layer chromatography(HPTLC)identification method based on the Chinese Pharmacopoeia method was used to identify the true and false of Bupleuri Radix pieces,HPLC characteristic fingerprint of Bupleuri Radix pieces was established and the content of saikosaponin a,b1,b2,c,d was determined by a modified Chinese Pharmacopoeia content determination method.Results:The water content,total ash,extract content and saikosaponin content of 15 batches of Bupleuri Radix and false pieces were in compliance with the Chinese Pharmacopoeia standards.The acidinsoluble ash except one batch of Bupleuri Radix pieces was in compliance with the Chinese Pharmacopoeia.There are significant differences in the characteristics,TLC and HPLC fingerprint between Bupleuri Radix pieces and fake pieces.Conclusions:The improved quality control standard and true and false identification could be used to furtherly and effectively control the quality of Bupleuri Radix pieces,which can guarantee its clinical efficacy.