光纤传感过程分析法评价不同厂家氨茶碱片的体外溶出度

目的:采用光纤传感过程分析法评价不同厂家氨茶碱片的体外溶出度,以考察不同厂家样品的质量差异。方法:采用对照品法,对5个厂家的片剂在4种溶出介质(水、pH1.2盐酸溶液、pH4.5醋酸盐缓冲液和pH6.8磷酸盐缓冲液)中的溶出行为进行测定,并以相似因子法进行比较。结果:氨茶碱片在不同溶剂中的溶出行为不一致,只有B厂样品在4种介质中均具有较好的溶出度;以B厂样品为参比制剂,其他4个厂样品与其比较的相似因子值均小于50%。结论:光纤传感过程分析法能够准确、方便地提供药物的溶出数据、反映药物的溶出行为,为全面考察药物的内在质量提供了良好的检测手段;不同厂家氨茶碱片质量有明显差异。

Evaluation of the Dissolution in Vitro of Aminophylline Tablets from Different Manufacturers by FODT

OBJECTIVE：To evaluate the dissolution in vitro of Aminophylline tablets from different manufacturers by fiber-optic dissolution test（FODT）,and to investigate the difference of samples from different manufacturers in quality.METHODS：By using substance control method,the dissolutions of Aminophylline tablets from 5 manufacturers were determined in the 4 kinds of mediums（water,hydrochloric acid（pH 1.2）,acetic acid buffer solution（pH 4.5）,phosphate buffer solution（pH 6.8））,compared with similarity factor method.RESULTS：The dissolutions of Aminophylline tablets were different in different mediums.Aminophylline tablets from manufacturer B well released in 4 mediums;using the tablet of manufacturer B as control,the similarity of tablets from other 4 manufacturers were all lower than 50%.CONCLUSION：FODT is capable of monitoring the drug dissolution and reflecting dissolution behavior accurately.The method provides an effective way to investigate the inner quality of drug completely.The product from different manufacturers were different in quality.