中药饮片标准汤剂质量评价案例.doc

中药饮片标准汤剂质量评价案例 　　[摘要]中药饮片标准汤剂是标化中药不同用药形式的参照物，为解决中药配方颗粒等不同中药现代剂型存在的质量不均一、质量标准不明确等问题提供了新的方向。目前，中药单味药标准汤剂在理念、方法和操作层次均缺乏研究。国家也急需这方面的资料，以提高中药制剂的一致性和稳定性。该文将以金银花为例，阐述中药饮片标准汤剂的制备和质量评价方法。收集有代表性的12批合格的金银花药材，建立金银花汤剂指纹图谱，采用UPLCQTOFMS对主要色谱峰进行结构确认，明确煎液中主要成分为有机酸和环烯醚萜类；标准煎液出膏率为（34.2±2.9）%、转移率为（78.6±8.4）%， 变化范围在均值的75%～125%。该文建立了金银花标准煎液的质量评价方法，为所有源于中药水煎剂的终端产品的质量控制方法的制定提供参考 [关键词] 标准汤剂/煎液； 金银花； 质量评价； 指纹图谱； 质谱鉴定； 出膏率； 转移率 [Abstract] Decoction of single medicinal herb is a reference for the standardization of different dosage form of Chinese medicine and it provides a new direction for solving the problems existing in the quality of Chinese medicinal granules such no uniform dosage forms and no clear quality standard. There are few reports on the idea， method and preparation of single herb standard decoction. Our country is in urgent need of that information in order to improve the consistency and stability of traditional Chinese medicine products. Here， Lonicerae Japinicae Flos was selected as an example to elucidate the preparation and quality evaluation of Chinese single herbal medicine decoction. Twelve batches of representative Lonicerae Japinicae Flos were collected， UPLC fingerprints were established， and the chemical structures of main peaks were identified with UPLCQTOFMS and standard compounds. The main components in the decoction are organic acids and iridoids. The extract rate of the standard decoction was （34.2±2.9）% and the transfer rate is （78.6±8.4）% in the form of chlorogenic acid， within the range of 75%125% of mean. This paper established a method for the quality evaluation of standard decoction of Lonicerae Japinicae Flos and provided reference for the quality control method of terminal products from decoction of Lonicerae Japinicae Flos. [Key words] decoction of single medicinal herb； Lonicerae Japinicae Flos； quality evaluation； fingerprint； mass spectrometry； extract rate； transfer rate 中?汤剂/煎液是一种传统的临床广泛使用的用药形式。但饮片质量的参差不齐，严重影响了煎剂的临床疗效。为了满足临床用药的便利性、一致性的需求