连葛降糖片质量标准

Study on the Standard for Quality Control of Liangejiangtang Tablet

目的建立连葛降糖片的质量标准。方法采用TLC法定性鉴别连葛降糖片中黄连、葛根、桑叶；采用HPLC法以C18（250mm×4.6mm，5μm）为固定相；流动相：乙腈-0.033mol·L^-1磷酸二氢钾溶液（30：70）；流速：1.0ml／min；检测波长：265nm，测定制剂中盐酸小檗碱的含量；采用HPLC法以C18（150mm×4.6mm，5μm）为固定相，流动相为乙腈-0.1％磷酸溶液（11：89）；流速：1．0ml／min；检测波长250nm；测定制剂中葛根素的含量。结果薄层色谱斑点清晰，专属性强；盐酸小檗碱在0.1014-2.0280μg范围内线性关系良好（r=0.9999），平均回收率为98．4％，RSD为1．08％（n=6）；葛根素在0．0844-1．688μg范围内线性关系良好（r=0．9998），平均回收率为98．7％，RSD为1．10％（n=6）。结论所建立的HPLC和TLC法可作为连葛降糖片的质量控制标准。

Aim To establish a standard for quality control of Liangejiangtang tablet. Methods TLC method was used for qualitative analysis of the materials of the prescription, including Rhizome coptidis, Radix puerapiae and Foliuin mori. The HPLC method was adopted to establish a method for determination of Berberine Hydrochloride contents in the tablet. The HPLC method was adopted and a C18（250mm×4.6mm,5μm） was used as the stationary phase column. The mobile phase was methanol-0.033mol·L^-1 Potassium dihydrogen phosphate solution （30： 70） at a flow rate of 1.0 mL/min. The detection wavelength was 265nm. The HPLC method was adopted to establish a method for determination of Puerain contents in the tablet. A C18（150mm×4.6mm,5μm） was used as the stationary phase column. The mobile phase was methanol-0.1% Phosphoric Acid solution （11：89） at a flow rate of 1.0ml/min. The detection wavelength was 250nm. Results In TLC,the spots were discernible and apparent with strong proprietary display features. The linearity of Berberine Hydrochloride was excellent over the range of 0.1014-2.0280μg （r =0.9999）. The average recovery was 98.4%, RSD = 1.08% （n=6）. The linearity of Puerain was excellent over the range of 0.0844 - 1.688μg（ r =0.9998）. The average recovery was 98.7%, RSD = 1.10% （ n =6）. Conclusion HPLC and TLC can be used as the standard for quality control of Liangejiangtang tablet.