冠心丸的质量标准  

Quality Standard for Guanxin Pills

作　　者：田金苗[1] 

机构地区：[1]辽宁省食品药品检验所,沈阳110023

出　　处：《中国药师》2013年第8期1147-1150,共4页China Pharmacist

摘　　要：目的:研究完善冠心丸的质量标准。方法:薄层色谱法鉴别制剂中的川芎、人参、三七。HPLC法测定制剂中丹酚酸B的含量,色谱柱为Waters C_(18)(250 mm×4.6 mm,5μm),流动相为甲醇-乙腈-甲酸-水(28.5:9.5:1:61),流速为1.0 ml·min^(-1),检测波长为286 nm,柱温为30℃,进样量为10μl。结果:鉴别阴性对照均无干扰;含量测定方法中丹酚酸B的线性范围分别为0.024 8～0.742 5μg(r=0.999 8),回收率分别为99.2%(RSD=0.34%,n=6)。结论:所建方法简单、可靠,可作为冠心丸的质量控制标准。Objective：To establish the quality standard for Guanxin pills.Method：The TLC methods were established for the identification of Rhizoma Chuanxiong,Radix Ginseng and Radix Notoginseng.An HPLC method was established for the determination of salvianolic acid B on a Waters C_（18）（250 mm×4.6 mm,5μm） analytical column with methanol-acetonitrile-formic acid-water（28.5： 9.5：1：61） as the mobile phase at the flow rate of 1.0 ml？min^（-1）,the detection wavelength was 286 nm,the column temperature was 30℃and the sample voulme was 10μl.Result：No interference of the negative controls was shown in the TLC identification.The linear range of salvianolic acid B was 0.024 8-0.742 5μg（r=0.9998）,and the average recovery was 99.2%（RSD=0.34%,n=6）. Conclusion：The method is convenient and reliable,and suitable for the quality assessment of Guanxin pills.

关 键 词：川芎 人参 三七 丹酚酸B 冠心丸 高效液相色谱法 

分 类 号：TQ460.72[医药卫生—药物分析学]