^(18)F-FDG注射液的无菌检查及方法学验证

Sterility test for ^(18)F-FDG injection and methodology validation

目的:探讨^(18)F标记的2-去氧-2-[氟-18]氟-D-葡萄糖(^(18)F-FDG)注射液的无菌检查法,并验证其准确性和可靠性。方法:按照《中国药典》2015年版四部1101无菌检查法项下要求,对^(18)F-FDG注射液无菌检查方法进行研究。结果:样品无菌检查均合格,含供试品溶液的6株阳性对照菌生长良好。结论:通过验证试验的直接接种法进行无菌检查的方法可行,所得结果可靠,适合该药品的无菌检查。

Objective:To investigate the sterility test for 18F-FDG injection and validate its accuracy and reliability.Methods:The sterility test for 18F-FDG injection was investigated in accordance with the requirements under the 1101 Sterility Test described in Chinese Pharmacopoeia(2015 Edition,Volume IV).Results:The results of sterility tests for all samples met the requirements.Six strains of positive control bacteria grew well in the solution containing the test product.Conclusion:The validated and tested direct inoculation method is feasible to do the sterility test and produces reliable results,indicating that it is applicable to the test of sterility for the product.