肾衰康口服液质量标准研究  

Studies on Quality Standard of Shenshuaikang Oral Liquid

作　　者：石丽霞[1] 张红岩[2] 张振家[1] 

机构地区：[1]吉林医药学院附属医院药剂科,吉林吉林132013 [2]吉林省中医中药研究院,吉林长春130021

出　　处：《特产研究》2008年第1期31-33,共3页Special Wild Economic Animal and Plant Research

基　　金：吉林省中医药管理局中医药科技项目(BZZ06-02)

摘　　要：目的建立肾衰康口服液的质量标准。方法采用薄层色谱法(TLC法)对黄芪进行定性鉴别;采用高效液相色谱法(HPLC法),用ODS C_18柱,以甲醇-0.1%磷酸(83:17)为流动相,检测波长为254nm测定肾衰康口服液中大黄酸(Rhein)的含量。结果薄层色谱斑点清晰,阴性对照无干扰;Rhein在0.12～0.60μg范围内进样量与峰面积积分值呈良好的线性关系,回归方程为y=2104 301.7x+881.4,r=0.9998。平均加样回收率为98.98%,RSD为1.26%(n=5)。结论建立的质量标准方法可靠,结果稳定,重现性好,为肾衰康口服液质量控制标准提供了依据。Objective To establish a quality standard of Shenshuaikang oral liquid. Methods Radix astragali were identified by the TLC , and Rhcin in Shenshuaikang oral liquid was determined by HPLC. An ODS C18 column was used. The mobile phase was methanol-0.1%phosphoric acid （83 ： 17）. Detecting wavelength was 254nm. Results The TLC spots were developed fairly clear, and the blank test showed no interference; A good linearity was showed at the concentration range of 0.12 - 0.60μg of Rhcin,the linear regression equation was y=2 104 301.7x ＋ 881.4, r =0.999 8,and the average recovery rate was 98.98%, RSD was 1.26%,（n=5）. Conclusion This method is reliable, the results are stable with a good repeatability and can be used for quality controling standard of Shenshuaikang oral liquid.

关 键 词：肾衰康口服液 质量标准 薄层色谱法 黄芪 高效液相色谱法 大黄酸 

分 类 号：R284.2[医药卫生—中药学]