葛根素滴丸的成型工艺研究及体外溶出度测定

Research on the molding process of puerarin dropping pill and the determination of its dissolution rate in vitro

采用紫外光谱法,测量葛根素滴丸中葛根素的含量,并利用L9(34)正交表,以圆整度、质量差异、载药率为评价指标,优选出葛根素滴丸的最佳成型工艺并验证,考察了滴丸的体外溶出度。结果表明,葛根素滴丸的最佳成型工艺为药浴温度80℃,制冷温度6℃,药物与基质的质量比为1∶7,滴距为12cm。以水为介质,30min时体外溶出可达94%,符合药典标准。

The puerarin content of drugs in the dropping pills was determined with ultraviolet spectrum method in its maximum absorption wavelength in the study.The optimum molding process conditions of puerarin dropping pills was investigated by L 9(3 4)orthogonal tests with roundness of pills,weight variation,the loading rate of drug,disintegration time as the evaluation indexes,which is the liquid temperature of 80℃,the condensation temperature of 6℃,the weight of the drugs to the substrate ratio of 1∶7,dropping distance of 12 cm.With water as the dissolution medium,the dissolution in vitro of the dropping pills under optimum conditions was investigated that the drug dissolution from dropping pills could up to about 94%in 30 min,indicating that is accord with pharmacopoeia standard.