[关键词]
[摘要]
目的 建立参芪麝蓉丸的质量评价方法。方法 采用HPLC法测定4个类别10种指标成分的量;采用桨法测定溶出度,并计算累积溶出率。结果 原儿茶醛、松果菊苷、毛蕊异黄酮葡萄糖苷、毛蕊花糖苷、迷迭香酸、丹酚酸B、毛蕊异黄酮、芒柄花素、隐丹参酮、丹参酮IIA分别在4.14~62.1、303.8~455.8、10.0~150.0、28.2~422.4、19.0~570.0、253.2~7 596.0、6.86~205.8、46.4~1 392.0、54.0~1 620.0、10.6~318.0 μg呈良好线性关系。f2相似因子法表明3个不同批次参芪麝蓉丸中10种指标成分的溶出规律具有相似性。结论 所建立的方法准确可靠,可用于参芪麝蓉丸的质量评价。
[Key word]
[Abstract]
Objective To establish a quality evaluation method of Shenqi Sherong Pill. Methods Four types with 10 marker components were determined by HPLC. The dissolution tests were carried out with oaring method, and the accumulative release percentage was calculated. Results The linear ranges of protocatechuic aldehyde, echinacoside, calycosin-7-glucoside, acteoside, rosmarinic acid, salvianolic acid B, calycosin, formononetin, cryptotanshinone, and tanshinone IIA were 4.14-62.1, 303.8-455.8, 1.0-150.0, 28.2-422.4, 19.0-570.0, 253.2-7 596.0, 6.86-205.8, 46.4-1 392.0, 54.0-1 620.0, and 10.6-318.0 μg. The f2 similarity factor method indicated that the dissolution of Shenqi Sherong Pill with different lot numbers had similarity in the same media. Conclusion The method is sensitive, stable, practical, and suitable for the quality evaluation of Shenqi Sherong Pills.
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[基金项目]
上海教育委员会重点学科资助项目(J50302)