摘要
目的:建立糖肾康胶囊的质量标准。方法:采用薄层色谱法(TLC)对制剂中丹参、知母和黄芪进行定性鉴别,采用高效液相色谱法测定制剂中淫羊藿苷的含量,色谱柱为Diamonsil C18(200 mm×4. 6 mm,5μm),流动相为乙腈-水(27∶73),流速为1. 0 ml/min,检测波长为270 nm,柱温为30℃,进样量为10μl。结果:丹参、知母和黄芪的TLC图斑点清晰,分离度好,阴性对照无干扰。淫羊藿苷进样量线性范围为0. 093～0. 464μg(r=0. 999 9);精密度、稳定性、重复性试验的RSD均小于2. 0%;平均加样回收率为99. 18%,RSD为1. 20%(n=9)。结论:所建标准可用于糖肾康胶囊的质量控制。
To establish the quality standard of tangshenkang capsule.Methods:TLC was used for qualitative identif-cation of Salvia miltiorthiza,Anemarhena asphodeloides and Astragalus membranaceus in the preparation.HPLC method was usedto determine the content of icarin.The determination was perfomed on Diamonsil Cig column with mobile phase consisting of ace-tonitrile-water(27:73)at the flow rate of 1.0 ml/min.The detection wavelength was set at 270 nm,and the column tempera-ture was 30C.The sample size was 10 ul.Results:TCL spots of Salvia miltiorhiza,Anemarrhena asphodeloides and Astragalusmembranaceus were clear and well separated without interference from negative control.The linear range of icarin ranged 0.093~0.464 pug(r=0.999 9);the RSDs of precision,stability and repeatability tests were no more than 2.0%.The average recoverywas99.18%(RSD was 1.20%,n=9).Conclusions:The established standard can be used for the quality control of tangshen-kang capsule.
作者
黄涛
Huang Tao(Tianjin Childrens Hospital,Tianjin 300134)
出处
《天津药学》
2019年第1期12-15,共4页
Tianjin Pharmacy
