紫元胶囊的质量标准研究

Study on quality standard of Ziyuan Capsules

目的：建立紫元胶囊的质量标准。方法对处方中枸杞子、山药、茯苓进行显微鉴别；采用薄层色谱法对紫河车和枸杞子进行定性鉴别；采用高效液相色谱法测定制剂中甜菜碱的含量。色谱柱为Zorbax-NH2柱（4.6 mm×250 mm,5μm）,流动相为乙腈-0.1%四氢呋喃（85：15）,流速为1.0 mL/min,检测波长为192 nm,柱温为25益。结果显微鉴别特征明显易察见,重现性佳；薄层色谱鉴别结果斑点清晰,阴性对照无干扰；高效液相色谱法中,甜菜碱浓度在0.02922～0.46752 mg/mL与峰面积呈良好的线性关系,r=1.0,平均回收率为101.44%,RSD为1.85%（n=9）。结论建立的质量标准可靠、准确,可用于紫元胶囊的质量控制。

Objective To establish the quality standard of Ziyuan Capsules. Methods Fructus lycii, Chinese yam, Poria cocos in the prescription were identified under microscope; Dried human placenta and Fructus lycii were identified by thin layer chromatography （TLC）; the content of betaine was determined by high performance liquid chromatography （HPLC）. HPLC system was with Zorbax-NH2 （4.6 mm×250 mm,5μm） column, the mobile phase was acetonitrile-0.1%tetrahydrofuran （85：15）, the flowing rate was 1.0 mL/min, UV detecting wavelength was at 192 nm and the column tem-perature was 25℃. Results The microscopic characteristics were obvious and easy to be observed, the repeatability was good. TLC spots were clear and well separated without negative interference. Good linear relationship （r= 1.0） for be-taine at 0.02922-0.46752 mg/mL was obtained. The average recovery of betaine was 101.44%,RSD was 1.85%（n=9）. Conclusion The quality standard is reliable and accurate, can be used for the quality control of Ziyuan Capsules.