提高胃炎灵片剂质量标准的研究  

Study on the Improvement of Quality Standard of Weiyanling Tablets

作　　者：陈宗文 葛任新 李月娥 卢明诗 

机构地区：[1]广东省高州市中医院,广东高州525200

出　　处：《中国执业药师》2015年第1期18-22,共5页China Licensed Pharmacist

摘　　要：目的：提高完善胃炎灵片剂的质量标准。方法：参照国家最新药品标准在原有质量标准的基础上,新增采用薄层色谱（TLC）对处方中的党参、黄芪、木香、白芍进行定性鉴别,同时新增紫外分光光度法对黄连中盐酸小檗碱进行含量测定。结果：薄层色谱斑点清晰集中,专属性强;紫外分光光度法测得盐酸小檗碱的含量在0~5.0μg/m L范围内与吸光度有良好的线性关系,其线性方程A=0.063 8C＋0.001 4,r=0.999 8,平均回收率为99.78%,RSD为0.27%（n=6）。结论：该方法简便,重复性好,可全面有效控制胃炎灵片的质量。Objective： To improve the quality standards of weiyanling tablets . Methods： According to the latest national drug standards , thin-layer chromatography （ TLC ） method was added for the qualitative identification of codonopsis radix , astragali radix , aucklandiae radix and radix paeoniae alba based on the original quality standards . While the content of berberine hydrochloride was determined by ultraviolet spectrophotometry （ UV ） . Results： The characteristic spots were clear with good specificity using TCL . A good linear relationship between the content of berberine hydrochloride and absorbance , determined by UV , was within the range of 0 ~ 5 . 0 μg/mL , the linear equation was A = 0 . 063 8C ＋ 0 . 001 4 （ r = 0 . 999 8 ） , and the average recovery was 99 . 78%, RSD was 0 . 27% （ n = 6 ） . Conclusion： The method is simple with good reproducibility , and can be used for the quality control of weiyanling tablets effectively .

关 键 词：胃炎灵 盐酸小檗碱 薄层色谱法 紫外分光光度法 

分 类 号：R286.0[医药卫生—中药学]