注射用盐酸甲砜霉素甘氨酸酯细菌内毒素检查法研究

摘要

Objective To establish bacterial endotoxin test method of thiamphenicol glycinate hydrochloride (TGH) for injection. Methods Methodological research was accomplished according to Bacterial Endotoxin Test listed in the second part of Chinese Pharmacopoeia 2010. Results TGH diluted to 1.66 mg/mL was of no interference to bacterial endotoxin test. Conclusion Pyrogen test of TGH can be replaced by bacterial endotoxin test.%目的：建立注射用盐酸甲砜霉素甘氨酸酯细菌内毒素检查法。方法参照《中国药典》2010年版二部细菌内毒素检查法进行方法学研究。结果注射用盐酸甲砜霉素甘氨酸酯稀释至1.66 mg/mL后对细菌内毒素检查无干扰。结论细菌内毒素检查法替代热原检查法可行。