CAJ | 학술논문

目的：比较国产双嘧达莫片和原研制剂的溶出曲线相似性，为全面评价国产双嘧达莫片的质量提供参考与依据。方法：采用《中华人民共和国药典》（2010年版二部）标准，测定了国内6家企业生产的制剂以及原研制剂的溶出度及溶出曲线，并以国内制剂为受试制剂，原研制剂为参比制剂，采用差异因子f1和相似因子f2比较其溶出曲线的相似性。结果：按照《中国药典》2010年版标准，受试制剂与参比制剂的溶出度均符合规定；采用相似因子法评价，受试制剂批内溶出曲线差异较大，受试制剂与原研制剂相比也无相似性。结论：相似因子评价法能够有效地反映和控制产品的内在质量，指导厂家改进生产工艺，提高产品质量。
목적：비교국산쌍밀체막편화원연제제적용출곡선상사성，위전면평개국산쌍밀체막편적질량제공삼고여의거。방법：채용《중화인민공화국약전》（2010년판이부）표준，측정료국내6가기업생산적제제이급원연제제적용출도급용출곡선，병이국내제제위수시제제，원연제제위삼비제제，채용차이인자f1화상사인자f2비교기용출곡선적상사성。결과：안조《중국약전》2010년판표준，수시제제여삼비제제적용출도균부합규정；채용상사인자법평개，수시제제비내용출곡선차이교대，수시제제여원연제제상비야무상사성。결론：상사인자평개법능구유효지반영화공제산품적내재질량，지도엄가개진생산공예，제고산품질량。
Objective:To compare the similarity of dissolution curves of dipyridamole tablets from the original drug enterprise and do-mestic enterprises,and provide the basis for a comprehensive evaluation of the quality of domestic dipyridamole tablets.Methods:The disso-lusion and dissolution curves of the original drug enterprise and 6 domestic enterprises were ditermined on the basis of the“Chinese Pharma-copoeia”2010 edition,the similarity was compared by the calculation of f1 and f2 factors using the product from the original enterprise as the reference preparation,and the domestic products as the test preparation.Results:Accordance with the standard of the“Chinese Pharmaco-poeia” 2010 edition,the dissolution of the reference preparation and the test preparation comply with the requirements.Similarity factor was evaluated,the disslution curves of the same batch of test preparation exhibited obvious differences,and there was no similarity between the test preparation and the reference preparation by the methods of f1 and f2 factors.Conclusion:The similarity factor evaluation method can ef-fectively reflect and control the intrinsic quality of the product,instruct manufacturers to improve production processes and product quality.