摘要
目的:研究复方葡甘聚糖减肥片的质量标准。方法:将原料及片剂样品用60%乙醇超声洗涤再用2.0mol/L硫酸将葡甘聚糖水解成葡萄糖和甘露糖后用1-苯基-3-甲基-5吡唑啉酮(PMP)衍生化,采用反相高效液相色谱法分段梯度洗脱,检测波长250nm,通过内标法对单糖定量进行了方法学的研究,同时测定原料及片剂中葡甘聚糖的含量。结果:甘露糖和葡萄糖在浓度0.05～0.5mmol/L之间线性关系良好(r=0.9943,0.9998),平均回收率分别为100.67%和98.34%,RSD分别为2.74%和3.22%(n=5),葡甘聚糖中单糖组成为Glc∶Man=2∶3,原料中葡甘聚糖含量为88.2%,片剂中葡甘聚糖平均含量为354mg/片。测定葡甘聚糖的溶出度符合均一性要求。结论:所建立的质量标准简便可行、重复性好,可以用来评价复方葡甘聚糖减肥片的质量。
AIM：To establish the quality control standard of Compound Glucomannan Weight-reducing Tablet. METHODS：Material and tablets went through ultrasonic cleaning by 60% alcohol and then hydrolyzed to glucose and mannose with 2.0 mol/L sulfuric acid,derivatized with PMP,separated by RP-HPLC using a stage gradient elution,and wavelength was at 250 nm. The monosaccharide were studied under the help of internal standard; while the glucomannan content in Konjac refined powder and tablets was determined. RESULTS： Linearities of glucose and mannose were good （ r = 0.994 3,0. 999 8 ） in the range of 0.05 - 0.5 mmol/L. The average recoveries of this method were 100.67% and 98.34% ,RSD were 2.74% and 3.22% （ n =5 ） respectively. Ratio of glucose to mannose in glucomannan was 2 ： 3, glucomannan content in Konjac refined powder was 88.2%, glucomannan content in tablet was 354 mg/p, dissolution used for glucomannan conformed to homogeneity. CONCLUSION： The established quality standard is simple, feasible and reproducible, and can be used for quality control of Compound Glucomannan Weight-reducing Tablet.
出处
《中成药》
CAS
CSCD
北大核心
2009年第12期1868-1870,共3页
Chinese Traditional Patent Medicine
关键词
复方葡甘聚糖减肥片
质量标准
葡甘聚糖
葡萄糖
甘露糖
Compound Glucomannan Weight-reducing Tablet
quality control
glucomannan
glucose
mannose
