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目的对注射用阿昔洛韦进行细菌内毒素检查研究,建立检查注射用阿昔洛韦中细菌内毒素的试验方法。方法采用《中国药典》2005年版(二部)附录ⅪE细菌内毒素检查方法。结果注射用阿昔洛韦用TAL试剂检测无干扰因素的影响。结论用细菌内毒素检查法(凝胶法)检查注射用阿昔洛韦中细菌内毒素是可行的。可用细菌内毒素检查法代替家兔热原检查法来控制该制剂热原。
Objective To study the bacterial endotoxin test of aciclovir for injection and to establish a test method for the detection of bacterial endotoxin in aciclovir for injection. Methods “Chinese Pharmacopoeia” 2005 edition (two) Appendix ⅪE bacterial endotoxin test method. Results Acyclovir for injection was tested with TAL reagent for the effect of no interference. Conclusion Bacterial endotoxin test (gel method) to check the bacterial endotoxin in acyclovir injection is feasible. Bacterial endotoxin test method can be used instead of rabbit pyrogen test to control the preparation of pyrogen.