六味地黄丸(浓缩丸)质量标准研究

Quality Standard of Liuwei Dihuang Pill(Concentrated Pill)

目的:建立六味地黄丸(浓缩丸)的质量标准。方法:采用薄层色谱(TLC)法对方中熟地黄、山药、茯苓、泽泻进行定性鉴别;采用高效液相色谱法测定制剂中丹皮酚和马钱苷的含量。结果:TLC的斑点清晰、分离度较好,阴性无干扰;丹皮酚和马钱苷的进样量分别在0.1006～1.006μg(r=0.9999)、0.3096～2.322μg(r=0.9996)范围内与各自峰面积积分值呈良好的线性关系;平均回收率分别为98.2%、95.3%,RSD分别为2.3%(n=6)、0.42%(n=6)。结论:所建标准可用于六味地黄丸(浓缩丸)的质量控制。

OBJECTIVE： To establish the quality standard of Liuwei dihuang pill （concentrated pill） . METHODS： Radix Rehmanniae Preparata, Dioscorea opposita, Poria cocos and Alisma orientalis in Liuwei dihuang pill （concentrated pill） were identified by TLC and the contents of paeonolum and loganin were determined by HPLC.RESULTS： The TLC spots were clear and well - separated yet free of interference of negative sample.The linear ranges of paeonolum and laganin were 0.100 6-1.006μg （r = 0.9999） and 0.3096-2.322μg（r = 0.9996）, respectively, and their recovery rates were 98.2%（RSD = 2.3%, n = 6） and 95.3% （RSD = 0.42%, n = 6）, respectively. CONCLUSION ： The established standard is applicable for the quality control of Liuwei dihuang pill.