门冬氨酸阿奇霉素注射液稳定性的考察
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文章编号：(2004)02-0018-03,门冬氨酸阿奇霉素注射液稳定性的考察
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高 斐1 ,王东凯1,刘 莱1 ,徐松林1 ,郝 海2
(1. 沈阳药科大学药学院， 辽宁 沈阳 110016； 2.沈阳沃森药物研究所， 辽宁 沈阳 110016)
摘要： 目的 对门冬氨酸阿奇霉素注射液的稳定性进行考察。方法 门冬氨酸阿奇霉素注射液在高温、低温、光照等影响因素及室温条件下放置10 d，上市包装40℃、相对湿度75%条件下放置3个月，考察其外观、pH值、溶液的澄清度与颜色、降解产物及含量。结果 门冬氨酸阿奇霉素注射液的各项指标均无明显变化。结论 表明本品稳定性较好。
关键词： 药剂学；影响因素；稳定性考察；门冬氨酸阿奇霉素；注射液
中图分类号：R944.11 文献标识码：A
Study on stabililty of azithromycin aspartate injection
GAO Fei1 , WANG Dong-kai1 , LIU Lai1 , XU Song-lin1 , HAO Hai2
(1.School of Pharmcy, Shenyang Pharmaceutic University, Shenyang, 110016. 2.Shenyang Watson Medicine Company, Shenyang, 110016)
Abstract：Objective To study the stability of azithromycin aspartate injection. Methods Samples were stored under the conditions of high and low temperature, strong light and room temperature for 10 d ,respectively; other samples in market package were stored at 40℃, RH75% for 3 months; then their appearance, value of pH, color and clarity, degradation and content of azithromycin were investigated. Result Every parameter of the injection remains unchanged. Conclusion Azithromycin aspartate injection is stable.
Key words: pharmaceutics; factors; stability study; azithromycin aspartate; injection
Key Words: pharmaceutics; dosage form; review; ophthalmic drug delivery; bioavailability
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