硝苯地平片剂溶出度的考察

目的考察不同生产企业生产的硝苯地平片剂的体外溶出度。方法分别以0.1 mol.L-1盐酸溶液、人工胃液(不含胃蛋白酶)、pH 4.5醋酸钠缓冲液、pH 6.8磷酸盐缓冲液和蒸馏水为溶出介质,采用紫外分光光度法检查;以质量分数为0.25%十二烷基硫酸钠为溶出介质,采用HPLC法检查,比较不同厂家硝苯地平片剂的体外溶出度。用相似因子法评价硝苯地平片剂在0.1 mol.L-1盐酸溶液、人工胃液(不含胃蛋白酶)、pH 4.5醋酸钠缓冲液、pH 6.8磷酸盐缓冲液和蒸馏水中的溶出行为。结果在质量分数为0.25%十二烷基硫酸钠溶液中,硝苯地平的溶出度在60 min均大于65%,而在其他溶出介质中的溶出度均达不到《英国药典》及《美国药典》中规定的标准。相似因子f2均在50~100之间。结论溶出介质的pH值对硝苯地平的溶出度没有影响。从整体来看,国产硝苯地平片剂的体外溶出行为与国外制剂相比有很大差距。

Investigation on dissolution of nifedipine tablets

Objective To study the dissolution of nifedipine from different factories.Methods 0.1 mol·L-1 HCl,simulated gastric fluid(without pepsin),pH 4.5 sodium acetate buffer,pH 6.8 phosphate buffer and water were used as dissolution media.The dissolution of nifedipine tablets in vitro was determined by the UV spectrophotometric method.0.25% sodium dodecyl sulfate was used as dissolution medium and the dissolution of nifedipine tablets in vitro was determined by high performance liquid chromatogram method.The data were analyzed by the statistical method-similar factor method,which obtained from the dissolution of nifedipine tablets in 0.1 mol·L-1 HCl,simulated gastric fluid(without pepsin),pH 4.5 sodium acetate buffer,pH 6.8 phosphate buffer and water method of similar factor.Results The dissolutions of nifedipine tablets in 0.25% SDS were all more than 65% at 60 minutes while they were lower than the standard of British Pharmacopoeia(BP) and U.S.Pharmacopoeia(USP) in their media.The similar factors f2 were between 50 and 100.Conclusions pH has no influence on the dissolution of nifedipine tablets.There is a large difference between domestic-made preparations and foreign preparations in the aspect of excipient and preparation technology.