滋肾通关胶囊质量标准研究

Study on Quality Standard for Zishen Tongguan Capsules

目的 建立滋肾通关胶囊的质量标准.方法 采用薄层色谱法对制剂中知母、黄柏进行定性鉴别.采用高效液相色谱法同时对制剂中新芒果苷、盐酸黄柏碱、芒果苷、盐酸小檗碱进行定量检测.结果 通过薄层鉴别分别检出知母中的芒果苷、黄柏中的盐酸黄柏碱.新芒果苷、盐酸黄柏碱、芒果苷、盐酸小檗碱分别在0.025 25～2.02 μg（r=0.999 7）、0.025 5～2.04 μg（r=0.999 7）、0.026～2.08 μg（r=0.999 7）、0.025 5～2.04 μg（r=0.999 6）范围内有良好的线性关系,平均加样回收率分别为99.99%、101.06%、103.05%、100.55%,RSD分别为2.69%、5.62%、2.49%、2.06%.结论 本方法准确、快速、稳定、可靠,重复性好,可用于该制剂的质量控制及评价.

Objective To establish a quality standard forZishen Tongguan Capsules.Methods Anemarrhneae Rhizoma and Phellodendri Chinensis Cortex were qualitatively identified by TLC method. The contents of neomangferin, phellodendrine hydrochloride, mangiferin and berberine hydrochloride inZishen Tongguan Capsules were quantitatively determined by HPLC method.Results The spots of qualitative identification method were clear without interference. Neomangferin in Anemarrhneae Rhizoma and phellodendrinehy drochloride in Phellodendri Chinensis Cortex were identified. Neomangferin, phellodendrinehy drochloride, mangiferin and berberine hydrochloride showed good linearity in the range of 0.025 25–2.02 μg (r=0.999 7), 0.025 5–2.04 μg (r=0.999 7), 0.026–2.08 μg (r=0.999 7), and 0.025 5–2.04 μg (r=0.999 6) respectively. The average recoveries of neomangferin, phellodendrinehy drochloride, mangiferin and berberine hydrochloride were 99.99%, 101.06%, 103.05%, and 100.55%, respectively. The RSD were 2.69%, 5.62%, 2.49%, and 2.06%, respectively.Conclusion The method is accurate and rapid, with good stability, reliability and reproducibility, which can be used for the quality control and evaluation of the preparation of Zishen Tongguan Capsules.