CAJ | 학술논문

目的：比较硫酸氢氯吡格雷片在研药与原研药在四种溶出介质中的溶出曲线，计算f2相似因子，从而提高在研硫酸氢氯吡格雷片内在质量。方法分别测定2种片剂在pH 1.2盐酸缓冲液、pH 6.8磷酸盐缓冲液、pH 4.5磷酸盐缓冲液和水中的溶出曲线，通过f2相似因子确定相似性。结果在四种溶出介质中的f2相似因子分别为71.4、51.8、86.8、60.1。结论在研药与原研药在四种溶出介质中的溶出曲线相似。
목적：비교류산경록필격뢰편재연약여원연약재사충용출개질중적용출곡선，계산f2상사인자，종이제고재연류산경록필격뢰편내재질량。방법분별측정2충편제재pH 1.2염산완충액、pH 6.8린산염완충액、pH 4.5린산염완충액화수중적용출곡선，통과f2상사인자학정상사성。결과재사충용출개질중적f2상사인자분별위71.4、51.8、86.8、60.1。결론재연약여원연약재사충용출개질중적용출곡선상사。
Pbjective To improve the quality of generics of Clopidogrel Bisulfate Tablets,the stripping curves of brand name drug and generics of Clopidogrel Bisulfate Tablets in four different mediums were compared,then calculate the f2 fac-tor. Methods The stripping curves of the two tablets in pH 1. 2 hydrochloric acid—potassium chloride buffer solution,pH 6. 8 phosphate buffer,pH 4. 5 phosphate buffer and water were tested respectively,the similarity was investigated according to the f2 factor. ResuIts The f2 factors between two tablets in four different mediums were 71. 4,51. 8,86. 8 and 60. 1,re-spectively. ConcIusion There were significant similarity between the stripping curves of brand name drug and generics in four different mediums.