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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 main quality indexes of lamivudine tablets (100 mg / tablet) produced in 4 factories. Methods: The main drug content, dissolution and related substances of lamivudine tablets were determined by high performance liquid chromatography C18 column, and the dextromethorphan was determined by high performance liquid chromatography with cyclodextrin chiral column. Results: The main drug contents of the four kinds of tablets were all> 90%, which were 97.74%, 96.31%, 93.74% and 92.21%, respectively. All four tablets were completely dissolved within 10 min in pH 6.8 phosphate buffer and deionized water; 3 products including “Silver” in 0.1 N HCl and pH 4.5 acetate buffer Completely dissolved within 10 min, only 1 product completely dissolved in 15 and 30 min. The four commercially available lamivudine tablets related substances and dexamethasone all meet the requirements of the United States Pharmacopeia 34 edition (0.6% and 0.3%) for the drug’s raw materials, of which “silver” is the lowest, 0.063% and 0.023% respectively. CONCLUSION: The main quality indexes of 4 commercially available lamivudine tablets are in accordance with the regulations, but there are some differences in the content, related substances and dexamethasone, and the quality control of the domestic product “Yin Ding” is relatively more strict.