论文部分内容阅读
目的:评价现阶段市售样品硫酸阿米卡星注射液的生产质量。方法:根据市售样品的检验,对比2014年、2015年硫酸阿米卡星注射液检验结果,从样品颜色、PH值、有关物质等指标的差异分析其质量。结果:在检验合格率上,2015年为100.00%,略高于2014年的98.36%,整体上来说药品质量达标;2014年不同企业及同一企业不同批次药品的颜色、PH值等指标均有一定的差异性,而2015年这种现象基本消失;在有关物质检查上,2015年市售样品中的阿米卡星B、杂质A、杂质D的含量均低于2014年。结论:执行《中国药典》2010年版,市售硫酸阿米卡星注射液质量基本达标,但是仍有个别企业生产技术有待提高,固定生产工序及标准,确保质量稳定。
Objective: To evaluate the quality of the currently marketed amikacin sulfate injection. Methods: According to the test of commercially available samples, the quality of amikacin sulfate injection was compared with the results of 2014 and 2015 by the difference of the sample color, PH value and related substances. Results: The test pass rate was 100.00% in 2015, slightly higher than 98.36% in 2014. Overall, the quality of the drug products reached the standard. In 2014, the indexes of color and pH value of different batches of drugs in different batches of the same enterprise were However, the phenomenon disappeared in 2015. Amicarbin B, impurity A and impurity D in commercial samples in 2015 were all lower than that of 2014 in the related substances inspection. Conclusion: The implementation of the “Chinese Pharmacopoeia” 2010 edition, the market standard of amikacin sulfate quality of basic compliance, but there are still some enterprises to be improved production technology, fixed production processes and standards to ensure quality and stability.