基于市售侧柏炭饮片质量问题探讨其“炒炭存性”的质控标准

Analysis of Quality Control Standard of “Carbonizing Retains Characteristics” Based on Quality Investigation of Commercial Platycladi Cacumen Carbonisata Pieces

目的:对市售侧柏炭质量进行考察,探讨侧柏叶"炒炭存性"的控制标准。方法:采用2015年版《中国药典》(一部)中方法对市售侧柏炭饮片的性状、水分、醇溶性浸出物含量进行检测,同时进行槲皮素的薄层色谱法(TLC)鉴别和有效成分槲皮苷、槲皮素的含量测定。结果:12批市售不同产地侧柏炭饮片中有9批炒炭程度较2015年版《中国药典》的标准重。建议对2015年版《中国药典》中TLC鉴别的展开条件进行修订,以避免展开剂分层;炒炭程度不同对侧柏炭所含槲皮苷和槲皮素含量的影响各异;同时检出槲皮苷和槲皮素可作为侧柏炭质量控制指标之一。结论:市售侧柏炭饮片大多存在炒炭程度过重的质量问题;建立的侧柏叶"炒炭存性"质控标准可用于有效保障侧柏炭饮片的质量。

Objective: To investigate the quality of Platycladi Cacumen carbonisata pieces in the market,then to explore control standard of "carbonizing retains characteristics"of Platycladi Cacumen. Method: The properties,water content and alcohol extract content of commercial Platycladi Cacumen carbonisata pieces were determined by the method in the 2015 edition of Chinese Pharmacopoeia. Thin layer chromatography( TLC)identification of quercetin and contents of quercetin and quercitin were determined. Result: The carbonizing degree of 9 batches of Platycladi Cacumen carbonisata pieces were heavier than which is specified in the 2015 edition of Chinese Pharmacopoeia. The conditions of TLC identification in the 2015 edition of Chinese Pharmacopoeia should be revised to avoid stratification;the carbonizing degree could affect the contents of quercetin and quercitin in Platycladi Cacumen carbonisata pieces;the simultaneous detection of quercetin and quercitin can be used as one of the quality control indexes of this carbonisata pieces. Conclusion: Most of commercial Platycladi Cacumen carbonisata pieces have the quality problem of excessive carbonizing degree,the established quality control standard of "carbonizing retains characteristics"can be used to effectively ensure the quality of Platycladi Cacumen carbonisata pieces.