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目的:制定健胃胶囊的质量标准。方法:采用薄层色谱法对制剂中的栀子、香附、苍术、川芎进行TLC鉴别;采用高效液相色谱法测定复方制剂中的栀子苷含量,色谱柱为ZORBAX RX-C18(4.6 mm×250 mm,5μm),采用乙腈-水(10∶90)为流动相;检测波长为238 nm;柱温35℃,流速1.0 mL.min-1。结果:栀子苷在0.19~0.95μg范围内线性良好,r=0.9997,平均回收率100.4%,RSD为1.25%。结论:该法分离好,快速、简便,可作为该复方制剂的质量控制方法。
Objective: To establish the quality standards for Jianwei capsules. METHODS: TLC identification was performed on T. chinense, C. sinensis, C. atractylodis, and Chuanxiong by TLC. The content of geniposide in compound preparations was determined by high performance liquid chromatography. The column was ZORBAX RX-C18 (4.6 mm. × 250 mm, 5 μm), mobile phase using acetonitrile-water (10:90); detection wavelength at 238 nm; column temperature at 35°C, flow rate at 1.0 mL.min-1. RESULTS: The linearity of jasminoidin was in the range of 0.19-0.95 μg, r=0.9997, the average recovery was 100.4%, RSD was 1.25%. Conclusion: This method is good, fast, simple, and can be used as a quality control method for the compound preparation.