摘要
目的:对国内7家不同生产企业的102批珍珠明目滴眼液的质量进行对比研究,评价该品种的质量现状。方法:采用法定标准检验方法对102批样品进行检验,并采用探索性研究方法对制剂原辅料、生产工艺、渗透压、乙醇量、抑菌剂和抑菌效力、微量元素及有害元素、多肽、总蛋白量、氨基酸、包装材料及贮存条件等进行考察。结果:102批样品按法定标准检验均合格;探索性研究显示该品种渗透压项目控制较宽。结论:该品种质量符合现行标准要求,质量标准有待提高。
Objective： To evaluate the quality situation of Zhengzhu Mingmu Eye Drops from 7 manufactories. Methods： A total of 102 batches of samples were detected by standard methods. The exploratory research method was adopted process, osmotic pressure, the content of ethanol, bacteriostat and bacteriostatic efficacy, trace elements and harmful element, polypeptide, total content of protein, amino acid, packing material, and storage condition were determined and analyzed. Results： Totally 102 batches of samples were eligible according to standard methods. However, the results of exploratory researches indicated that osmotic pressure evaluation of this preparation was poor. Conclusion： The quality of this preparation conform to the regulations. The present standard methods need to be improved.
出处
《中国药事》
CAS
2016年第5期482-485,共4页
Chinese Pharmaceutical Affairs
关键词
珍珠明目滴眼液
中成药质量检验
探索性研究
标准提高
Zhenzhu Mingmu eye drops
proprietary Chinese medicine quality testing
exploratory research
improve standard
