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紫元胶囊的质量标准研究 被引量:4

Study on quality standard of Ziyuan Capsules
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摘要 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.
出处 《中国医药导报》 CAS 2015年第18期89-91,95,F0004,共5页 China Medical Herald
基金 全军医疗机构制剂标准提高科研专项课题面上项目(13ZJZ15-2)
关键词 紫元胶囊 质量标准 显微鉴别 薄层色谱法 高效液相色谱法 甜菜碱 Ziyuan Capsules Quality standard Microscopic identification TLC HPLC Betaine
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