滋肾健脑口服液质量标准的提高  

Improvement of the Quality Standard for Zishen Jiannao Oral Liquid

作　　者：邱婧 彭玲娜 李瑞莲 王银红 Qiu Jing;Peng Lingna;Li Ruilian;Wang Yinhong(Hunan Institute for Drug Control(Hunan Pharmaceutical Excipients Testing and Inspection Center),Changsha 410001,China;Hunan Engineering&Technology Research Center for Pharmaceutical Quality Evaluation)

机构地区：[1]湖南省药品检验研究院(湖南药用辅料检验检测中心),长沙410001 [2]湖南省药品质量评价工程技术研究中心

出　　处：《中国药师》2019年第11期2090-2093,共4页China Pharmacist

基　　金：国家药典委员会国家药品标准提高行动计划项目(编号:34)

摘　　要：目的:提高滋肾健脑口服液的质量标准。方法:通过简化前处理及调整色谱条件优化何首乌、白芍、黄芪及甘草的TLC鉴别方法;采用HPLC法对制剂中女贞子所含的特女贞苷含量进行测定以完善其质量标准,色谱柱为Wondasil C18-WR(250 mm×4.6 mm,5μm),流动相为甲醇-水(35∶65),流速为1.0 ml·min^-1,检测波长为224 nm,柱温为35℃,进样量为10μl。结果:优化后的TLC法,供试品制备方法简单,薄层色谱斑点清晰,阴性无干扰。特女贞苷在11.462~1194.0μg·ml^-1范围内线性关系良好(r=0.9999),平均回收率为99.89%(RSD=0.50%,n=6)。结论:提高后的质量标准方法简便可行,专属性强,重复性好,能更加有效地控制滋肾健脑口服液的质量。Objective:To improve the quality standard for Zishen Jiannao oral liquid.Methods:The TLC identification methods of Polygoni Multiflori Radix,Paeoniae Radix Alba,Astragali Radix and Glycyrrhizae Radix Et Rhizoma were optimized by simplifying preprocessing and adjusting the spectrum conditions.The content of specnuezhenide in the preparation was determined by HPLC.The determination was performed on a Wondasil C18-WR(250 mm×4.6 mm,5μm)column with the mobile phase consisting of methanol-water(35∶65)at a flow of 1.0 ml·min^-1,the detection wavelength was 224 nm,the column temperature was 35℃,and the sample size was 10μl.Results:The optimized TLC methods had the advantages of simple preparation,clear TLC spots and no negative interference.A good linear relationship was obtained between the peak areas and the concentrations of specnuezhenide within the range from 11.462 to 1194.0μg·ml^-1(r=0.9999).The average recovery was 99.89%(RSD=0.50%,n=6).Conclusion:The methods of improved standard are simple,specific and reproducible,which can control the quality of Zishen Jiannao oral liquid more effectively.

关 键 词：滋肾健脑口服液 质量标准 薄层色谱法 高效液相色谱法 特女贞苷 

分 类 号：TQ460.7[化学工程—制药化工]