胃炎保康丸的质量控制研究  

Research on the quality control of Weiyan Baokang pills

作　　者：范在举 李敏 FAN Zaiju;LI Min(Preparation Center,Hospital of Traditional Chinese Medicine of Liaocheng City,Shandong,Liaocheng 252000,China)

机构地区：[1]山东省聊城市中医医院制剂中心,山东聊城252000

出　　处：《中国医药科学》2025年第5期49-52,158,共5页China Medicine And Pharmacy

基　　金：山东省聊城市重点研发计划政策引导类项目(2022YDSF67)。

摘　　要：目的通过对胃炎保康丸主要成分的质量控制研究验证其制备工艺的合理性,并为进一步的中药制剂类药学研究提供数据支持。方法采用薄层色谱法(TLC)对胃炎保康丸中延胡索、白芷、厚朴进行定性鉴别;采用高效液相色谱法(HPLC)对胃炎保康丸中厚朴所含厚朴酚、和厚朴酚进行含量测定,使用InertSustain C_(18)(5μm,4.6 mm×250 mm)色谱柱,流动相为A(水)∶B(甲醇)=28∶72,波长采用294 nm,柱温为23℃。结果TLC鉴别斑点清晰,阴性样品无干扰,重现性良好;含量测定中厚朴酚浓度在0.0080~0.0400 mg/ml线性关系良好,和厚朴酚浓度在0.0018~0.0180 mg/ml线性关系良好,平均回收率为99.57%,从而建立了胃炎保康丸中延胡索、白芷、厚朴的TLC鉴别方法及测定厚朴酚、和厚朴酚含量的HPLC方法。结论该质量控制方法稳定可靠,准确性好,精密度高,验证了胃炎保康丸制备工艺的稳定性和可行性,为中药制剂质量控制研究提供有力数据支撑。Objective To verify the rationality of its preparation technology through the research on the quality control of main components of Weiyan Baokang pills,and provide data support for further pharmaceutical research on traditional Chinese medicine(TCM)preparation.Methods Corydalis Rhizoma,Angelicae dahuricae Radix and Magnoliae officinalis Cortex in Weiyan Baokang pills were qualitatively identified by thin layer chromatography(TLC).High performance liquid chromatography(HPLC)was used to determine the contents of magnolol and honokiol in Magnoliae officinalis Cortex in Weiyan Baokang pills.InertSustain C18(5μm,4.6 mm×250 mm)column was used,the mobile phase was A(water)∶B(methanol)=28∶72,the wavelength was 294 nm,and the column temperature was 23℃.Results TLC identification spots were clear,and negative samples had no interference,with good reproducibility.In the content determination,the concentration of magnolol showed a good linear relationship from 0.0080 to 0.0400 mg/ml,and the concentration of honokiol showed a good linear relationship from 0.0018 to 0.0180 mg/ml.The average recovery rate was 99.57%.Therefore,a TLC identification method for Corydalis Rhizoma,Angelicae dahuricae Radix and Magnoliae officinalis Cortex in Weiyan Baokang pills and an HPLC method for the determination of magnolol and honokiol were established.Conclusion The quality control method is stable,reliable,accurate and highly precisive,which verifies the stability and feasibility of the preparation technology of Weiyan Baokang pills and provides strong data support for the research on the quality control of TCM preparations.

关 键 词：胃炎保康丸 薄层鉴别 含量测定 厚朴酚 和厚朴酚 质量控制 

分 类 号：R286.0[医药卫生—中药学]