注射用头孢拉定在25℃时的稳定性研究

目的考察注射用头孢拉定在25℃时的稳定性,为其贮存条件的选择提供依据。方法选择3个厂家3个批号的注射用头孢拉定样品在25℃下贮存3个月,依据《中国药典》2010年版二部注射用头孢拉定项下规定,考察其性状、溶液澄清度和颜色、水分、pH值、有关物质和含量的变化情况。结果注射用头孢拉定在25℃下贮存3个月,性状、水分、pH值、有关物质和含量均符合《中国药典》2010年版的规定;其中,一个厂家一个批次的样品溶液颜色在放置2个月后,颜色超过规定的黄绿色8号标准比色液。结论不同厂家生产的注射用头孢拉定其稳定性不同,大部分厂家的药品可在25℃下贮存3个月。

Study on the stability of Cefradine for Injection at 25 ℃

Objective To provide the basis for selecting storage conditions ,the stability of Cefradine for Injection at 25 ℃ was stud-ied .Methods Three batches of Cefradine for Injection samples from three manufacturers were stored at 25 ℃ for 3 months ,and the physicochemical properties ,solution clarity and color ,moisture ,pH ,the related substances and the content of cefradine were determined according to Chinese Pharmacopoeia(2010 edition) .Results The physicochemical properties ,moisture ,pH ,the related substances and the content of cefradine met the requirements of Chinese Pharmacopoeia(2010 edition) under 25 ℃ storage for 3 months ,but the color for a batch of samples placed for 2 months later was yellow and more than the prescribed standards for the 8th standard colorimetric solution .Conclusion The stability of Cefradine for Injection of the different manufacturers was differ-ent ,and some of them could be stored for three months at 25 ℃ .