兽用化学药品注射剂灭菌工艺探讨

Discuss on Sterilization Process of Injection in Veterinary Chemical Pharmaceuticals

注射剂是我国兽药普遍使用的一类剂型,其制剂工艺多源于传统工艺,无菌保障意识薄弱,研发的广度和深度方面存在不足,势必导致产品质量下降和临床疗效降低,引发用药隐患。针对兽用化学药品注射剂中问题突出的灭菌工艺,从工艺选择、工艺验证、指示剂使用、数据评判和影响因素等方面进行探讨,并提出建议,以供研发者和生产者参考。

Injection is a commonly used dosage form in veterinary medicine in China.However,due to the pharmaceutical process is mostly derived from the traditional technology,it is weak in sterility assurance consciousness and insufficient in the breadth and depth of research and development,which results in the decline of the quality of the products and the decrease of clinical efficacy,and then leads to the potential risks of drug uses.The problems of sterilization process of injection in veterinary chemical pharmaceuticals are discussed including the choice of sterilization process,validation of process,indicator used,data evaluation,and influence factors,etc.Some suggestions are recommended in reference.