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目的该课题对肝康颗粒进行质量标准研究,为申报新药打下良好的基础。方法肝康颗粒由八味中药组成,已经应用于临床多年。起初质量标准研究的方法是用紫外分光光度仪检测总黄酮的含量。该研究对处方中黄芪、五指毛桃根、十大功劳采用TLC鉴别。HPLC测定大黄素和淫羊藿苷的含量,并考察含量测定方法的精密度、稳定性和重复性。结果黄芪、五指毛桃根、十大功劳采用TLC鉴别专属性较强。大黄素和淫羊藿苷的HPLC含量测定方法简单、快速、精密度、准确度高(r2=0.994),初步制订颗粒的大黄素和淫羊藿苷含量指标为不少于0.60mg/g和0.80mg/g。结论质量标准研究结果表明,肝康颗粒质量稳定可控,符合现代中药制剂的要求。
Objective To study the quality standards of Gankang granules and lay a good foundation for the declaration of new drugs. Method Gankang granules consists of eight herbs, which have been used in clinical practice for many years. At first, the method of quality standard research was to detect the content of total flavonoids by ultraviolet spectrophotometer. The study on the prescription Astragalus, Fingers peach root, the top ten merit TLC identification. HPLC determination of emodin and icariin content, and to examine the content determination of the precision, stability and reproducibility. Results Astragalus, Fingers peach root, top ten credit TLC identification of the more specific. The HPLC method for the determination of emodin and icariin was simple, rapid, precise and accurate (r2 = 0.994). The emodin and icariin content of the particles were not less than 0.60 mg / g and 0.80 mg / g. Conclusion The results of the quality standard research indicate that the quality of Gankang Granules is stable and controllable, which accords with the requirement of modern Chinese medicine preparation.