红景天标准汤剂制备及质量标准研究

Study on Preparation and Quality Evaluation of Rhodiola crenulata Standard Decoction

目的:制备红景天标准汤剂,并建立其质量标准,为红景天配方颗粒的质量控制提供参考依据。方法:按照标准汤剂的制备要求,制备十五批不同产地红景天标准汤剂。以红景天苷作为定量检测指标,计算其出膏率及转移率,采用高效液相色谱法建立标准汤剂指纹图谱,用《中药色谱指纹图谱相似度评价系统(2012版)》软件进行指纹图谱分析。结果:红景天标准汤剂平均出膏率为24.82%;红景天苷平均转移率为48.45%,红景天标准汤剂指纹图谱共有11个共有峰,指认出红景天苷、酪醇2种成分。十五批红景天标准汤剂相似度均大于0.90。结论:红景天标准汤剂制备规范,建立的指纹图谱方法简便有效,为红景天标准汤剂质量控制提供了较全面的信息。

Objective To prepare Rhodiola crenulata standard decoction and establish the quality standard,and provide reference for quality control of Rhodiola crenulata formula granules.Methods Fifteen batches of Rhodiola crenulata s tandard decoction were prepared according to the standardization method.With salidroside as the detection index,the transfer rate and extractum rate were calculated and the HPLC chromatograms was established.Similarity evaluation system for chromatographic fingerprint of TCM(2012)was used to analyze and compare the fingerprint.Results The average extractum rates of Rhodiola crenulata standard decoction were 24.82%,and average transfer rates were 48.45%,eleven common peaks were determined and two were identified.The similarity evaluations were carried out on 15 batches of Rhodiola crenulata standard decoction,and their similarities were all greater than 0.90.Conclusion The preparation method of Rhodiola crenulata standard decoction is standart,the established fingerprint method is simple and effective,and provides comprehensive information for the quality control of Rhodiola crenulata sformula granules.