论文部分内容阅读
目的:验证盐酸氢吗啡酮注射液无菌检查的方法。方法:采用中国药典2005年版无菌检查法中的薄膜过滤法(附录ⅪH)。结果:盐酸氢吗啡酮注射液对生孢梭菌存在抑制作用,以金黄色葡萄球菌为阳性对照菌,至少需要0．1％的蛋白胨水溶液600 ml冲洗。结论:经方法学验证,该方法准确可靠,可作为盐酸氢吗啡酮注射液的无菌检查方法。
Objective: To verify the method of sterile test of hydromorphone hydrochloride injection. Methods: The Chinese Pharmacopoeia 2005 edition of the sterile test membrane filtration method (Appendix Ⅺ H). Results: Hydromorphone Hydrochloride Injection had inhibitory effect on Clostridium sporogenes. Staphylococcus aureus as a positive control, at least 0.1% peptone solution 600 ml rinse. Conclusion: The method is validated by the method, which is accurate and reliable. It can be used as a sterile test method of hydromorphone hydrochloride injection.