玻璃安瓿与盐酸利多卡因注射液质量的相关性研究  

On the Relation between Glass Ampoule and the Quality of Lidocaine Hydrochloride Injection

作　　者：姚羽 徐向炜 陈文璐 

机构地区：[1]山西省食品药品检验所,太原030001

出　　处：《中国药事》2017年第6期637-641,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:研究玻璃安瓿与盐酸利多卡因注射液质量的相关性。方法:通过扫描电镜观察、分析盐酸利多卡因注射液中的可见异物,测定玻璃安瓿的线热膨胀系数及三氧化二硼含量,并观察不同灭菌温度下玻璃安瓿内表面玻璃屑的脱落情况。结果:玻璃安瓿的线热膨胀系数、三氧化二硼含量及制剂灭菌温度均影响玻璃安瓿的质量。结论:玻璃安瓿对制剂质量具有一定影响,企业应选用优质包材。Objective： To analyze the relation between glass ampoule and the quality of Iidocaine hydrochloride injection. Methods： The visible particles in lidocaine hydrochloride injection were observed and analyzed by SEM. The coefficient of mean linear thermal expansion and the content of diboron trioxide of glass ampoule were measured. The dropped glass particles after sterilization under different temperatures were also observed. Results： The coefficient of mean linear thermal expansion, the content of boron oxide and the sterilization temperature could affect the quality of glass ampoule. Conclusion： Glass ampoule could affect the quality of the preparations. Therefore, pharmaceutical companies should select and use high quality packaging materials.

关 键 词：玻璃安瓿 盐酸利多卡因注射液 相关性 线热膨胀系数 三氧化二硼 可见异物 

分 类 号：R944.1[医药卫生—药剂学]