注射用盐酸头孢替安与卤化丁基橡胶塞的相容性研究

Study on the Compatibility between Cefotiam Hydrochloride for Injection and Halogenated Butyl Rubber Stoppers

目的探讨影响卤化丁基橡胶塞与注射用盐酸头孢替安相容性的因素,建立评价注射用盐酸头孢替安与药用卤化丁基橡胶塞相容性的碱性紫外吸光度法。方法用UV检查法,测试卤化丁基橡胶塞碱性提取液的紫外吸光度,考察碱性紫外吸光度与盐酸头孢替安相容性药液澄清度和颜色的关系。结果盐酸头孢替安药液澄清度与卤化丁基橡胶塞碱性紫外吸光度呈正相关性,当卤化丁基橡胶塞的碱性紫外吸光度小于0.1时,头孢替安相容性药液澄清度小于0.5号标准浊度液。结论碱性紫外吸光度法能有效的评价注射用盐酸头孢替安与卤化丁基橡胶塞的相容性。

Objective To the explore influence factors of the compatibility between halogenated butyl rubber stopper and cefotiam hydrochloride for injection, and to establish an alkaline uv absorbance method for the evaluation of the compatibility between halogenated butyl rubber stopper and cefotiam hydrochloride for injection. Method The UV absorbance of the alkaline extraction liquid of halogenated butyl rubber stoppers was measured by ultraviolet spectrophotometry. The relation between alkaline UV absorbance and the liquid clarity of cefotiam hydrochloride for injection was investigated. Results The relation between alkaline UV absorbance of halogenated butyl rubber stoppers and the liquid clarity of cefotiam hydrochloride for injection was a positive correlation. While the alkaline UV absorbance of the halogenated butyl rubber stoppers is less than 0.1, the liquid clarity of cefotiam hydrochloride for injection is less than 0.5 standard turbidity solution. Conclusion The alkaline UV absorbance method can effectively evaluate the compatibility between halogenated butyl rubber stopper and cefotiam hydrochloride for injection.