盐酸林可霉素注射液辅料对产品质量的影响探讨.pdf

Drugs and Clinic 药物与临床 盐酸林可霉素注射液辅料对产品质量的影响探讨 刘成红，罗晓茹，魏立平，吴艳，倪明 总后卫生部药品仪器检验所, 北京 100071 [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。 [关键词] 盐酸林可霉素注射液；药品质量；辅料　 [中图分类号] R917　　[文献标识码]　A　　[文章编号]　1672-2809(2014)10-0029-04 Effects of Excipients on the Quality of Lincomycin Hydrochloride Injection LIU Cheng-hong, LUO Xiao-ru, WEI Li-ping, WU Yan, NI Ming [Abstract] 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. [Key words] Lincomycin Hydrochloride Injection; Drug Quality; Excipients 盐酸林可霉素注射液为高效广谱林可胺类碱 1 苯甲醇的含量测定结果及其与药品质量的相关 性抗生素，对需氧革兰阳性菌有较高抗菌 性统计分析 活性，对革兰阴性菌有抑菌活性。根据国家评价性抽 苯甲醇检查系根据近年来本品在临床应用时 验涉及的50家企业调研表明，各厂家辅料添加种类及 发生的不良反应结合所用盐酸林可霉素注射液处方 数量差异较大，共涉及辅料约8种：苯甲醇、EDTA-二 中所用辅料的试验研究和相关分析而增订的检查项 钠、亚硫酸氢钠、焦亚硫酸钠、醋酸钠、枸橼酸钠、 目。依据《临床用药须知》所述，按照每支规格为 磷酸二氢钠、碳酸氢钠等。其中以苯甲醇、EDTA-二 2mL:0.6mg的盐酸林可霉素注射液加入100mL 0.9% 钠、亚硫酸氢钠、焦亚硫酸钠最为常用，辅料添加种 氯化钠注射液的临床给药法，凡是含有超过9.45mg/ 类最多的处方达4种，辅料添加处方量差异较大，从0 mL苯甲醇的盐酸林可霉素注射液在加入到2%普通 至20.