4种市售拉米夫定片主要质量指标的比较

The quality comparison of lamivudine tablets supplied by four manufactories

目的:对临床上使用的4个厂家生产的拉米夫定片(100 mg/片)进行主要质量指标的比较。方法:采用高效液相色谱法C18色谱柱测定拉米夫定片的主药含量、溶出度、有关物质,采用高效液相色谱法环糊精手性柱测定其右旋体。结果:4种片剂的主药含量均>90%,分别为97.74%,96.31%,93.74%和92.21%,以国产品种"银丁"最高。在pH 6.8磷酸盐缓冲液和去离子水中,10 min内4种片剂均完全溶出;在0.1 N盐酸和pH 4.5醋酸盐缓冲液中,包括"银丁"在内的3个产品在10 min内完全溶出,只有1个产品分别在15和30 min完全溶出。4种市售拉米夫定片剂中的有关物质及右旋体均符合美国药典34版中对该药原料的相关限度要求(0.6%和0.3%),其中"银丁"最低,分别为0.063%和0.023%。结论:4种市售拉米夫定片剂的主要质量指标均符合规定,但在含量、有关物质及右旋体等指标上有一定差异,国产品种"银丁"质量控制相对更为严格。

Objective：To compare the qualities of 4 kinds of lamivudine tablets（100mg） supplied by different manufactories.Methods：The content of lamivudine,related substances and dissolution were determined by HPLC with C18 column,and lamivudine enantiomer was determined by HPLC with cyclodextrin chiral column.Results：The contents of all lamivudine tablets were more than 90%,i.e.97.74%,96.31%,93.74% and 92.21%,respectively,among which the domestic product＂Yinding＂ had the highest content.Complete dissolution was observed in pH 6.8 phosphate buffer and distilled water within 10 min for all of the 4 lamivudine tablets.In 0.1 N HCl and pH 4.5 acetate buffer,complete dissolution was reached in 10 min for 3 products including ＂Yingding＂,but for another product,the dissolution was not complete until 15 min and 30 min,respectively.The contents of related substances and enantiomer of all the tablets were lower than the limits specified in the drug monograph of USP 34 edition（0.6% and 0.3%）,and the lowest contents were found for Yinding,which were 0.063% and 0.023%,respectively.Conclusion：The main quality items of lamivudine tablets produced by different companies all comply with the quality standard,but there exists variation.It seems that the quality was more strictly controlled by the manufacture of domestic product ＂Yingding＂.