芩地颗粒剂质量标准研究

Study on the Quality Standard of QinDi Granules

目的建立芩地颗粒剂成品检验的质量标准。方法采用薄层色谱法(TLC)对芩地颗粒剂进行薄层色谱鉴别;用高效液相色谱法(HPLC)测定芩地颗粒剂中黄芩苷的含量。结果用TLC方法检查重复性良好;含量测定用高效液相色谱法,黄芩苷含量不得小于2.0%;颗粒剂含水量用干燥失重法,含水量不得大于14%。结论各项检验方法简便、准确、可靠,可作为该制剂的质量控制方法。

Objective To establish the quality standard of QinDi Granules. Methods Baicalin in QinDi Granules was qualitatively identified by thin layer chromatographic method . An HPLC method was also developed for the determination of Baicalin in QinDi Granules. Results TLC check showed good reproducibility. Baicalin content was no less than 2.0% ;Pellet agent moisture content was determined by wet dry weight, and water content was no more than 14%. Conclusion Various test methods are simple, accurate, and reliable and can be used for the quality control of this preparation.