盐酸林可霉素注射液辅料对产品质量的影响探讨  

Effects of Excipients on the Quality of Lincomycin Hydrochloride Injection

作　　者：刘成红[1] 罗晓茹[1] 魏立平[1] 吴艳[1] 倪明[1] 

机构地区：[1]总后卫生部药品仪器检验所,北京100071

出　　处：《药品评价》2014年第10期29-32,共4页Drug Evaluation

摘　　要：目的:探讨辅料对盐酸林可霉素注射液产品质量的影响。方法:对50家生产企业223批次国家药品评价抽验样品进行检验,并对辅料与表征产品质量的多个指标进行相关性统计分析。结果:添加苯甲醇不利于药品的稳定,EDTA-二钠、亚硫酸氢钠、焦亚硫酸钠、枸橼酸钠有利于药品的稳定,醋酸钠、磷酸二氢钠、碳酸氢钠对药品质量无显著影响。结论:部分不合理处方应在科学评价的基础上,进行修改。Objective： To explore the effects of excipients on the quality of the lincomycin hydrochloride injection. Methods： 223 batches of national drug evaluation testing samples that produced by 50 production enterprises were examined, and correlation between a number of indicators of quality and excipients was analyzed statistically. Results： The addition of benzyl alcohol was not conducive to the stability of lincomycin, while EDTA-2Na, bisulfite sodium, sodium metabisulfite and sodium citrate was conducive to the stability of the drug and sodium acetate, sodium dihydrogen phosphate, sodium bicarbonate had no significant effect on the quality of lincomycin. Conclusion： Some unreasonable prescription should be modified on the basis of the scientific evaluation.

关 键 词：盐酸林可霉素注射液 药品质量 辅料 

分 类 号：R927[医药卫生—药学]