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目的:探讨高效液相色谱(HPLC)法测定天麻首乌片中大黄素含量的可靠性,并为天麻首乌片的质量评价提供理想依据。方法:采用高效液相色谱(HPLC)法对天麻首乌片中的大黄素进行含量测定。结果:在采用254nm波长的情况下,天麻首乌片组方中的其它成分成峰不会对大黄素峰造成干扰,绿原酸对照溶液在1.006~12.072μg/mL范围内线性关系良好[A=46447.2C-11328.4(r=0.9998)],精密度试验、稳定性试验、重复性试验和回收率试验均表现良好,最终测得湖南德海制药有限公司生产120621、120703、120718三个批次样品的大黄素含量分别为43.52mg/片、44.13mg/片、43.88mg/片。结论:采用高效液相色谱(HPLC)测定天麻首乌片中大黄素含量灵敏、准确、可靠,重现性非常好,可作为天麻首乌片质量控制的有效方法。
Objective: To investigate the reliability of HPLC method for the determination of emodin in Tianma Shouwu tablets, and to provide an ideal basis for the quality evaluation of Tianma Shouwu tablets. Methods: The content of emodin in Tianma Shouwu tablet was determined by high performance liquid chromatography (HPLC). Results: Under the condition of 254nm wavelength, the peaks of other components in the gastrodia tuber recipe group did not interfere with the emodin peak. The control solution of chlorogenic acid had good linearity in the range of 1.006 ~ 12.072μg / mL [A = 46447.2C-11328.4 (r = 0.9998)], the precision test, the stability test, the repeatability test and the recovery test all performed well. Finally, the three batches of 120621, 120703 and 120718 produced by Hunan Dehai Pharmaceutical Co., Emodin content of the sample were 43.52mg / tablet, 44.13mg / tablet, 43.88mg / tablet. Conclusion: The HPLC method was used to determine the emodin content of Tianma Shouwu tablet sensitive, accurate, reliable and reproducible. It can be used as an effective method for quality control of Tianma Shouwu tablet.