胃炎消胶囊制备工艺及质量标准研究  

Study on preparation technology and quality standard of Weiyanxiao capsule

作　　者：谢丽明 黄健梅 刘玉玲 Xie Li-ming;Huang Jian-mei;Liu Yu-ling(Department of Pharmacy,Kaiping Hospital of Traditional Chinese Medicine,jiangmen 529300,China)

机构地区：[1]开平市中医院药剂科,广东江门529300

出　　处：《北方药学》2024年第11期4-7,共4页Journal of North Pharmacy

基　　金：江门市卫生健康局科研立项项目(22A092)。

摘　　要：目的:建立胃炎消胶囊制备工艺及质量标准。方法:以L9(3~3)正交试验法,选取提取工艺中次数、加水量和时间为影响因素,以胃炎消胶囊中野黄芩苷和盐酸小檗碱为评价指标探究最佳制备工艺;采用TLC薄层鉴别分析鉴别胃炎消胶囊中三七及白芍药材,采用Alltima C18(250mm×4.6mm, 5μm)为色谱柱,流速为1.0 mL/min,乙腈-20mmol/L乙酸铵(用冰醋酸调pH值至4.0)为流动相的HPLC法同时测定野黄芩苷和盐酸小檗碱含量。结果:胃炎消胶囊制备的最佳工艺为提取时间1.5h,提取次数2次,加水量10倍;TLC薄层鉴别分析方法专属性良好;HPLC分析方法中野黄芩苷和盐酸小檗碱在浓度范围内线性关系良好,相关系数大于0.999,低、中、高3种浓度水平野黄芩苷和盐酸小檗碱回收率在96.59%~99.12%,重复性和精密度RSD分别为2.85%和2.64%。结论:优化后的胃炎消胶囊制备工艺稳定性良好,TLC及HPLC质量控制分析方法操作简单、准确度和精密度良好,可用于胃炎消胶囊的质量控制。To establish the preparation technology and quality standard of Weiyanxiao capsule.Methods:L9(33)orthogonal test was used to select the extraction times,water amount and time as the influencing factors,and the baicalin and berberine hydrochloride in Weiyanxiao capsules were used as evaluation indexes to explore the best preparation technology.Radix Notoginseng and Radix paeoniae paeoniae in Weiyanxiao capsules were identified by TLC thin layer analysis.The chromatographic column was Alltima C18(250mm×4.6mm,5μm)with the flow rate of 1.0mL/min.Simultaneous determination of baicalin and berberine hydrochloride by HPLC with acetonitrile 20mmol/L ammonium acetate(pH adjusted to 4.0 with glacial acetic acid)as mobile phase.Results:The optimum preparation process of Weiyanxiao capsule was extraction time 1.5h,extraction times 2 times,adding 10 times of water;TLC thin-layer identification analysis method has good specificity.In HPLC analysis,the linear relationship between baicalin and berberine hydrochloride was good in the concentration range,and the correlation coefficient was greater than 0.999.The recoveries of baicalin and berberine hydrochloride at low,medium and high concentrations were 96.59%~99.12%,and the RSD of repeatability and precision were 2.85%and 2.64%,respectively.Conclusion:The optimized preparation process of Weiyanxiao capsule has good stability,TLC and HPLC quality control analysis methods are simple,accurate and precise,and can be used for the quality control of Weiyanxiao capsule.

关 键 词：HPLC 胃炎消胶囊 野黄芩苷 盐酸小檗碱 制备工艺 质量标准 

分 类 号：R283[医药卫生—中药学]