降脂丸质量控制研究

目的研究并建立降脂丸的质量控制方法。方法采用薄层色谱法(TLC)对制剂中山楂、葛根、丹参进行定性鉴别;采用HPLC法对制剂中2,3,5,4′-四羟基二苯乙烯-2-O-β-D-葡萄糖苷进行含量测定。结果所鉴别的药材TLC特征明显,在与对照药材色谱相应的位置上显相同颜色的斑点;在与对照品色谱相应的位置上显相同颜色的斑点,阴性对照无干扰。2,3,5,4′-四羟基二苯乙烯-2-O-β-D-葡萄糖苷检测量在0.19608~2.6144μg范围内与峰面积积分值呈良好的线性关系(r=0.9999),平均回收率为99.50%,RSD=1.20%(n=6)。结论所建方法可用于降脂丸的质量控制。

Study on Quality Standard of Jiangzhi Pills

Objective To establish a method for quality control of Jiangzhi Pills.Methods Fructus Crataegi,Radix Puerariae Lobatae and Radix et Rhizoma Salviae Miltiorrhizae were identified by TLC.The content of 2,3,5,4＇-terahydroxystilbene-2-O-β-D-glucoside in the preparation was determined by HPLC.Results The studies on the quality control showed that the characteristics for identification by TLC were distinct.The linear range of 2,3,5,4＇-terahydroxystilbene-2-O-β-D-glucoside was within 0.19608~2.6144μg（r=0.9999）.The average recovery was 99.50% and RSD was 1.20%（n=6）.Conclusion The methods can be used for identification and quantification of the preparation.