注射用替加环素无菌方法适用性实验的研究

Study of the applicability of sterility test method of Tigecycline for injection

目的建立注射用替加环素无菌的方法适用性。方法用100mL 0.1%的MgCl_2溶液冲洗后,再用700mL pH 7.0含0.1%吐温-80的0.1%无菌蛋白胨溶液冲洗,以消除替加环素样品的抑菌活性,进行注射用替加环素的细菌及真菌的无菌验证。结果采用上述方法进行验证,6种菌的供试品与阳性对照生长状况一致。结论注射用替加环素的无菌检验,需要用100mL 0.1%的MgCl_2溶液冲洗后,再用700mL pH7.0含0.1%吐温-80的0.1%无菌蛋白胨溶液冲洗。

Objective To develop and verify the applicability of sterility test on Tigecyeline for injection. Methods 0.1% MgCI2 solution（100mL） was selected as the first step of rinsing fluid,and the pH7.0 buffer（700mL） containing 0.1% tween-80 and 0.1% peptone as the second step of rinsing fluid,to eliminate the interference of Tigecycline＇s bacteriostatic activity and validate the sterility test method of Tigecyeline for Injection. Results With the method above,the growth states of the six validated bacteria for both the test solution and positive control were at the same level. Conclusion The sterility test of Tigecycline for injection,which including the rinsing with 0.1% MgCl2 solution（100mL） initially,and then with the pH7.0 buffer（700mL） containing 0.1% tween-80 and 0.1% peptone.