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目的建立丹鹿健腰颗粒的质量控制标准。方法采用TLC法对丹鹿健腰颗粒中的丹参、夏天无及鹿衔草进行定性鉴别;应用HPLC法对丹鹿健腰颗粒中的丹酚酸B、原阿片碱进行定量测定。结果丹参、夏天无及鹿衔草的TLC鉴别方法专属性强,简单可行。丹酚酸B、原阿片碱分别在0.4~2.0、0.3~1.2μg范围内呈良好的线性关系,r均为0.9999;平均回收率(n=6)分别为99.3%(RSD为0.7%)、98.8%(RSD为1.2%)。结论本研究所建立的质量标准方法稳定、准确、重复性好,可用于丹鹿健腰颗粒的质量控制。
Objective To establish the quality control standard of Danlu Jianlv granules. Methods TLC method was used to qualitatively identify Salvia miltiorrhiza in summer and autumn in No. 1, and in summer. The HPLC method was used to determine the contents of salvianolic acid B and protopine in Danlu Jianlian granules. Results Salvia miltiorrhiza, TLC and identification method without summer grasshopper rank strong, simple and feasible. Salvianolic acid B and protopine showed good linearity in the range of 0.4-2.0 and 0.3-1.2 μg, respectively, with r of 0.9999 and mean recovery of 99.3% (RSD 0.7%), respectively (n = 6) 98.8% (RSD 1.2%). Conclusion The quality standard method established in this study is stable, accurate and reproducible. It can be used for the quality control of Danlu Jianlian granules.