注射用罗红霉素的制备及安全性评价
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方金玲，王艳娇，何仲贵
(沈阳药科大学 药学院，辽宁 沈阳 110016)
摘要：目的 制备注射用罗红霉素，并对制剂的安全性进行评价。方法 采用与酸成盐增加其水溶性的方法制备注射用罗红霉素，即室温下，罗红霉素与L-门冬氨酸按摩尔比1:1反应生成水溶性盐，再将罗红霉素水溶性盐经冷冻干燥制备其冻干粉针；采用静脉血管刺激性试验、体外溶血试验及过敏试验对制剂进行安全性考察。结果 罗红霉素与L-门冬氨酸成盐后溶解度大大提高，制备的冻干粉针复溶后澄明度良好；注射用罗红霉素无血管刺激性、无溶血现象、无过敏反应。结论 该制备工艺简单易行，制备的制剂可以安全用药，为临床用药提供了实验依据。
关键词：药剂学；水溶性盐；冷冻干燥；罗红霉素；制剂安全性
中图分类号：R94 文献标识码：A
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Preparation of roxithromycin for injection and its animal test on safty
FANG Jin-Ling, WANG Yan-jiao, HE Zhong-gui
(School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China)
Abstract: Objectives To prepare roxithromycin for injection and investigate its safety. Methods The solution of roxithromycin soluble salt was freeze-dried after roxithromycin reacted to L-aspartic acid with mole ratio of 1:1 under room temperature. Irritative, anaphylaxis and haemolyticus tests were performed to evaluate the injectable safety of roxithromycin for injection. Results The clarity was good after roxithromycin redissolved in water; the preparation had no hemolysis phenomenon, no significant irritation effect on vessels and no allergic response. Conclusions The technics of preparing roxithromycin for injection is simple. The animal tests on safety provide a reliable basis for clinical application of roxithromycin for injection.
Key words: pharmaceutics; water-soluble salt; lyophillization; roxithromycin; drug safty
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