滋肾通关胶囊质量标准的建立

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 C18（200mm×4．6mm，5μm）；流动相：乙腈（A）-33mmol·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0．0057～0．1086mg·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0．0081～0．2576mg·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。

Quality Standard of Zishen Tongguan Capsules

Objective： To establish a quality standard of zishen tongguan capsules. Method： Rhizoma Anemarrhenal, Cortex Phellodendri and Cinnamomum cassia Prcsl were identified by TLC. The content of mangiferin and berberine hydrochloride were determined by HPLC. A Kromasil C18 （200 mm× 4.6 mm, 5 μm） column was used with a mobile phase consisted of phase A （acetonitrile）- phase B （33 mmol · L^-1 KH2PO4 ） in gradient elution 0 min （12： 88）-8 min （12： 88）-16 rain （20： 80） -32 min （30： 70）-40 rain （35： 65）, the UV detection warelength was at 317 nm, the flow rate was 1.0 ml · min^-1 with columm temperature at 25℃. Result： The developed TLC spots were quite clear. The calibration curue of mangiferin was linear within 0. 005 7 -0. 108 6 mg · ml^-1. The established TLC and HPLC method 97.52% with RSD of 1.07% （n =6） . The calibration curue of berbefine hydrochloride was hnear within 0. 008 1 -0. 257 6 mg · ml^- 1 The established TLC and HPLC method 97.85 % with RSD of 1.04% （ n = 6） o Conclusion： The established TLC and HPLC; The method is reliable, accurate and specific, reproducible and suitable for the quality control of zishen tongguan capsules.