不同厂家复方氨酚烷胺胶囊中两种成分在4种溶出介质中的溶出曲线比较

Comparison of Compound Paracetamot and Amantadine Lydrochloide Capsules Dissolution Curves in 4 Different Dissolution Media

目的比较9个厂家在4种溶出介质中的溶出曲线,为制定完善的药品标准提供依据。方法9个厂家在水、0.1mol·L^-1盐酸溶液、pH 4.5醋酸盐缓冲液和pH 6.8磷酸盐缓冲液4种溶出介质中的溶出度,采用高效液相色谱法,测定对乙酰氨基酚和咖啡因的溶出量,绘制溶出曲线。结果9个厂家的咖啡因和对乙酰氨基酚在水、pH 4.5醋酸盐缓冲液和pH 6.8磷酸盐缓冲液中差异大,且是否制粒的厂家溶出曲线差异大,0.1mol·L^-1盐酸溶液中溶出曲线较一致。结论不同辅料和是否制粒对复方氨酚烷胺胶囊溶出度有影响。

OBJECTIVE To compare the Compound Paracetamot and Amantadine Lydrochloide Capsules of 9 manufacturers in 4 kinds of dissolution medium,providing the basis for the development of drug standard.METHODS The dissolution curves of Compound Paracetamot and Amantadine Lydrochloide Capsules in water,0.1 mol·L^-1 HCl(pH 4.5)acetate buffer and phosphate buffer(pH 6.8)was determined by HPLC.RESULTS The acetaminophen and caffeine dissolution curves of 9 manufactures was different in water,pH 4.5 acetate buffer and pH 6.8 phosphate buffer,however consistent in 0.1 mol·L^-1 hydrochloric acid.CONCLUSION The dissolution curves of the Compound Paracetamot and Amantadine Lydrochloide Capsules was effected by the excipients of different manufactures.