妇康宝口服液质量标准探讨

Study on quaity standard of Fukangbao oral solution

目的:控制妇康宝口服液的质量,指导工艺研究,对主药当归、川芎中所含的主要成分阿魏酸进行定性鉴别。方法:采用薄层色谱法,薄层板采用硅胶 G-3‰CMC-Na板(0．4 mm厚),展开剂为苯－冰乙酸－甲醇(30:1:3),在 365 nm紫外光灯下观察荧光斑点。结果:妇康宝口服液中无阿魏酸斑点。结论:原工艺方法(水蒸汽蒸馏法)不能提出阿魏酸,需改进生产工艺,用乙醇回流法提取。

Objective: A quality control method was established for Fukangbao oral solution. Methods: The main drugs of the preparation were Radix Angelicae Sinensis and Rhizoma ChuanXiong. The chief effective component Ferulic acid of these drugs has been identified by thin - layer chromatography. The thin layer plate was silica gel - 3 %e CMC - Na(0. 4 mm), The developer was Benzene -Acetic Acid Glacial - Methanol(30 : 1 : 3). The fluorescence spot has been examined under ultraviolet light (365 nm). Results: There was no Ferulic acid spot in Fukangbao oral solution . Conclusion: The old technique couldn' t extract Ferulic acid (water vapor distillation) . The technique should be improved and extracted with ethanol reflux.