黑柴胡质量标准

Quality Standards of Bupleuri Smithii Radix

目的:修订和提高黑柴胡药材的质量标准。方法:采用生药学研究考察不同黑柴胡药材的横切面显微特征和粉末特征,依据2010年版《中国药典》附录药品标准研究方法对10批黑柴胡药材的水分、总灰分、酸不溶性灰分和浸出物进行检查,并测定活性成分含量。结果:修订了黑柴胡药材的性状特征和显微特征;建立了TLC鉴别黑柴胡的方法;黑柴胡的水分限度≤10.0%,总灰分≤9.0%,酸不溶性灰分≤3.1%,浸出物的含量≥15%,柴胡皂苷a和d的总质量分数≥0.2%。结论:完善了黑柴胡药材的质量标准,可作为该药材的修订内容。

Objective：To revise and improve quality standards of Bupleuri Smithii Radix.Method：Cross-section microscopic characteristics and powder characteristics of Bupleuri Smithii Radix were investigated by pharmacognosy study.According to drug standard methods in appendix of 2010 edition of ‘Chinese Pharmacopoeia’,moisture,total ash,acid-insoluble ash,alcohol-soluble extractives and contents of bioactive constituents in ten batches of Bupleuri Smithii Radix were determined.Result：Properties and microscopic characteristics of Bupleuri Smithii Radix were revised,and its TLC identification method was established ; Moisture limit of Bupleuri Smithii Radix was ≤ 10.0％,total ash limit was ≤ 9.0％,acid insoluble ash limit was ≤ 3.1％,alcohol-soluble extractive limit was ≥ 15％,total mass fraction limit of saikosaponin-a and saikosaponin-d was ≥0.2％.Conclusion：Quality standards of Bupleuri Smithii Radix was improved,it could be used revision of this Chinese materia medica.