胡蓝降糖缓释片质量标准研究  

Study on Quality Standards for Hu Lan Hypoglycemic Sustained Release Tablets

作　　者：李季文[1] 

机构地区：[1]甘肃省中医院,甘肃兰州730050

出　　处：《中国现代中药》2013年第10期883-886,共4页Modern Chinese Medicine

基　　金：甘肃省科技支撑计划(090NKCA103)

摘　　要：目的：建立胡蓝降糖缓释片的质量控制标准。方法：采用薄层色谱法对胡蓝降糖缓释片中绞股蓝进行定性鉴别，用高效液相色谱法对胡芦巴中薯蓣皂苷元进行含量测定。结果：本品定性鉴别薄层色谱特征明显，专属性强。采用迪马SEDEX75-蒸发光散射检测器，岛津YP—ODS色谱柱（150mm×4．6mm，5μm），甲醇-水（84：16）为流动相；检测波长203nm；流量1．0mL·min^-1；柱温40℃；漂移管温度85℃；气流体积流量2．5L·min^-1。塔板数以薯蓣皂苷元计，不低于2000。薯蓣皂苷元在0．842～8．42μg与其色谱峰面积呈良好线性关系，薯蓣皂苷元平均回收率为98．53％，胡蓝降糖缓释片在2，4，12h的释放量分别在18％-35％，35％～55％，80％以上，均符合规定。结论：该法简便、准确、专属性强，可作为胡蓝降糖缓释片的质量控制方法。Objective： To establish Hu Lan Hypoglycemic Sustained Release Tablets quality control standard. Methods： TLC qualitative identification method was used to gynostemma in Hu Lan Hypoglycemic Sustained Release Tablets. Using HPLC method for diosgeni determination. Results： This product has apparent feature and strong specificity in qualitative identification of thin layer chromatography. The Dimma SEDEX75-evaporative light scattering detector, island sea VP-ODS （150 mm×4.6 mm, 5 μm） chromatographic column, methanol and water （84：16） as mobile phase ; Detection wavelength is 203 nm, flow rate 1.0 mL· min^-1 , column temperature 40℃; drift tube temperature 85℃ ; airflow volume flow 2.5 L·min^-1. Plate hundreds of diosgeni meter, no less than 2 000. Diosgeni in 0. 842-8.42 μg range and its chromatographic peak area had good linear relationship, and the average recovery of diosgeni was 98.53%, each piece in 2, 4, 12 h release quantity respectively in 18%-35%, 35%-55%, 80% range, which conform to the provisions. Conclusion： The method is simple, accurate, strong specificity and can be used as Hu Lan Hypoglycemic Sustained Release Tablets quality control method.

关 键 词：胡蓝降糖缓释片 质量控制 薯蓣皂苷元 

分 类 号：R971.1[医药卫生—药品]