Study on Quality Standard for Zishen Tongguan Capsules / 中国中医药信息杂志

ABSTRACT

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.