侧柏叶标准汤剂制备及质量标准研究

Study on Preparation and Quality Evaluation of Cacumen Platycladi Standard Decoction

目的:参照《中药配方颗粒质量控制与标准制定技术要求》,对15批侧柏叶饮片进行标准汤剂制备,建立特征图谱,并测定其槲皮苷含量,提供一种可靠的评价侧柏叶标准汤剂质量的方法。方法:以槲皮苷为含量指标成分,分别对15批不同产地的侧柏叶饮片标准汤剂进行测定,计算转移率和出膏率,建立高效液相特征图谱方法,同时采用液质联用技术对共有峰进行指认。结果:15批侧柏叶标准汤剂出膏范围为10.51%~20.35%,平均值为16.08%;槲皮苷含量范围为0.69%~1.12%,平均值为0.91%;槲皮苷转移率的分布范围为51.11%~67.16%,平均值为57.67%。特征图谱呈现13个特征峰,其中10个共有峰被指认,与对照特征图谱相比,侧柏叶标准汤剂的相似度均大于0.90。结论:侧柏叶饮片标准汤剂制备规范,槲皮苷含量测定与特征图谱方法可靠、准确性和重现性好,可评价侧柏叶标准汤剂的质量,也可以评价侧柏叶配方颗粒的质量。

Objective:According to the technical requirements for quality control and standard formulation of traditional Chinese Medicine Formula Granules, 15 batches of standard decoction of Cacumen Platycladi are prepared. Determine the contents of quercitrin and establish the characteristic spectrum, to provide a reliable method for the quality control of Cacumen Platycladi standard decoction. Methods:The transfer rate and extract rate of the 15 batches of Cacumen Platycladi standard decoction from different producing areas were calculated with the content of quercitrin as the index;The characteristic spectrum was established and the common peaks were identified by LC-MS. Results:The extract range of the 15 batches of Cacumen Platycladi standard decoction was 10.51%~20.35%,with an average of 16.08%;The content of quercitrin ranged from 0.69% to 1.12%,the average value was 0.91%;The transfer rate of the content of quercitrin ranged from 51.11% to 67.16%,the average was 57.67%. The characteristic spectrum showed 13 characteristic peaks and identified 10 common peaks. The similarity of the 15 batches of Cacumen Platycladi standard decoction was all above 0.90. Conclusion:The preparation of Cacumen Platycladi standard decoction conformed to the standard. The method for the determination of quercitrin and characteristic spectrum are reliable.It can be used for the quality evaluation of Cacumen Platycladi standard decoction, and also provide a reference basis for the quality control of Cacumen Platycladi formula granules.