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四方胃片质量标准研究
引用本文:于永洲.四方胃片质量标准研究[J].中国药房,2010(47):4491-4493.
作者姓名:于永洲
作者单位:广州市药品检验所,广州市510160
摘    要:目的:建立四方胃片的质量控制方法。方法:采用薄层色谱法对制剂中的延胡索和浙贝母进行定性鉴别,采用高效液相色谱法测定四方胃片中盐酸小檗碱的含量。结果:定性鉴别专属性强;盐酸小檗碱进样量在0.06~1.8μg范围内与峰面积积分值呈良好线性关系(r=0.9999),平均回收率为97.1%,RSD=1.6%(n=6)。结论:所建标准能有效控制该制剂的质量。

关 键 词:四方胃片  盐酸小檗碱  薄层色谱法  高效液相色谱法  质量标准

Quality Standard Study for Sifangwei Tablets
YU Yong-zhou.Quality Standard Study for Sifangwei Tablets[J].China Pharmacy,2010(47):4491-4493.
Authors:YU Yong-zhou
Institution:YU Yong-zhou(Guangzhou Institute for Drug Control, Guangzhou 510160, China)
Abstract:OBJECTIVE: To establish the quality control of Sifangwei tablets. METHODS: Corydalis yanhusuo and Fritillaria thunbergii were identified by TLC and the contents of berberine hydrochloride were determined by HPLC. RESULTS:The quanitative identification was specific. The linear range of berberine hydrochloride was 0.06~1.8 μg(r=0.999 9) with an average recovery of 97.1%,RSD=1.6%(n=6). CONCLUSION: The standard is reliable for quality control of Sifangwei tablets.
Keywords:Sifangwei tablets  Berberine hydrochloride  TLC  HPLC  Qualiby standard
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