白虎汤颗粒的质量标准研究

目的：建立白虎汤颗粒的质量标准。方法：采用TLC定性鉴别该复方制剂中的知母、甘草，并采用HPLC-UV/ELSD对主要成分芒果苷和知母皂苷BⅡ的含量进行测定，进一步采用HPLC-UV/ELSD对10批白虎汤颗粒甲醇提取物进行检测，所得色谱图采用中药指纹图谱相似度评价软件进行分析。结果：知母、甘草TLC 图斑点清晰，阴性对照无干扰；芒果苷和知母皂苷BⅡ分别在14.02~84.12 μg·mL^-1（r=0.999 9）、101.2~809.6 μg·mL^-1（r=0.999 7）范围内线性关系良好，平均加样回收率（n=9）分别为99.5%（RSD=1.5%）、98.5%（RSD=2.3%）；10批白虎汤颗粒甲醇提取物的指纹图谱相似度（≥0.946）良好。结论：本研究所建立的方法简便可靠，重复性好，适用于白虎汤颗粒的质量控制。

Objective: To establish the quality standard for Baihu decotion granules. Methods: TLC was used to identify Anemarrhenae Rhizoma and Radix Glycyrrhizae. HPLC-DAD/ELSD was used to determine the contents of mangiferin and timosaponin BⅡ. Similarity evaluation software was used to analyse the similarities between the HPLC-UV/ELSD fingerprints of the 10 batches of Baihu decoction granules extracts. Results: The spots of Anemarrhenae Rhizoma and Radix Glycyrrhizae in TLC were clear, and the negative controlled substance did not show interference. The linear ranges of mangiferin and timosaponin BⅡ were 14. 02-84. 12 μg·mL^-1(r=0. 999 9) and 101. 2-809. 6 μg·mL^-1 (r=0. 999 7). The average sample recoveries (n=9) were 99. 50% (RSD=1. 46%) and 98. 46% (RSD=2. 27%). The fingerprint showed good similarities between 10 batches of Baihu decoction granules(≥0. 946). Conclusion: The methods are simple, reliable and repeatable, which can be used to control the quality of Baihu decoction granules.