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目的:应用动态浊度法研究注射用阿莫西林钠溶液放置时间和不同pH对细菌内毒素检查法的影响。方法:按2005年版《中国药典》细菌内毒素检查法相关规定进行试验。结果:该样品溶液在放置4h后对细菌内毒素检查结果有产生假阴性的趋势;在pH升至12时,有产生假阳性的趋势。结论:注射用阿莫西林钠溶液配制后需尽快测定,pH保持在稳定范围内,细菌内毒素检查结果才真实可靠。
Objective: To study the influence of amoxicillin sodium solution injection time and different pH on bacterial endotoxin test by dynamic nephelometry. Methods: According to the relevant provisions of the 2005 edition of “Chinese Pharmacopoeia” bacterial endotoxin test method for testing. Results: After 4 hours of storage, the sample solution showed a tendency of false negative for the result of bacterial endotoxin test. At the pH of 12, there was a tendency of false positive. CONCLUSIONS: As soon as possible after the preparation of amoxicillin sodium solution for injection, the pH should be kept within a stable range and the bacterial endotoxin test result is reliable.