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目的:建立滋肾通关胶囊的质量标准。方法:采用TLC法鉴别处方中的知母、黄柏、肉桂。用HPLC法测定知母中的芒果苷和黄柏中的小檗碱的含量。色谱柱:Kromasil C_(18)(200 mm×4.6mm,5μm);流动相:乙腈(A)-33 mmol·L~(-1)磷酸二氢钾缓冲液(B),采用梯度洗脱;检测波长:317nm;柱温:25℃;流速:1ml·min-1。结果:TLC鉴别色谱特征斑点明显。芒果苷进样量在0.005 7～0.108 6mg·ml~(-1)范围内线性关系良好。平均加样回收率为97.52%,RSD=1.07%(n=6)。盐酸小檗碱进样量在0.008 1～0.257 6mg·ml~(-1)范围内线性关系良好。平均加样回收率97.85%,RSD=1.04%(n=6)。结论:所建立的TLC和HPLC法,专属性强,重复性好,可用于滋肾通关胶囊的质量控制。
Objective: To establish the quality standard of Zishen Tongguan capsule. Methods: Identification of Anemarrhena asphodeloides, Treats, Cinnamon by TLC method. The contents of berberine and cortex phellodendri in Rhizoma et Radix were determined by HPLC. The mobile phase consisted of acetonitrile (A) -33 mmol·L -1 potassium dihydrogen phosphate buffer (B) and gradient elution. The mobile phase consisted of Kromasil C 18 (200 mm × 4.6 mm, 5 μm) Detection wavelength: 317 nm; Column temperature: 25 ° C .; Flow rate: 1 ml · min-1. Results: TLC identification of chromatographic features obvious spots. Mangiferin injection volume in the range of 0.005 7 ~ 0.108 6mg · ml ~ (-1) within a good linear relationship. The average recovery rate was 97.52%, RSD = 1.07% (n = 6). Berberine hydrochloride injection volume in the range of 0.008 1 ~ 0.257 6mg · ml ~ (-1) within a good linear relationship. The average recovery was 97.85%, RSD = 1.04% (n = 6). Conclusion: The established TLC and HPLC methods are highly specific and reproducible and can be used for the quality control of Zishen Tongguan Capsules.