注射用布罗佐喷钠的细菌内毒素检查法可行性研究

目的：探讨应用细菌内毒素检查法控制Ⅰ类新药注射用布罗佐喷钠的热原物质的可行性。方法：应用2个厂家的鲎试剂和1批注射用布罗佐喷钠制剂进行干扰预试验，摸索出最大不干扰浓度；再分别对3批注射用布罗佐喷钠制剂进行正式干扰试验，根据供试品梯度稀释溶液对鲎试剂和细菌内毒素反应的干扰情况，确定细菌内毒素检查法的适用性；并根据限值应用适宜灵敏度的鲎试剂对3批制剂进行细菌内毒素检查。结果： 3个批次的制剂在有效浓度（3.125 mg·mL^-1）的9.5倍时对鲎试剂与内毒素的反应即无干扰作用，细菌内毒素检查结果均符合规定。结论：可应用细菌内毒素检查法检查注射用布罗佐喷钠的热原，该方法可快速、准确对制剂产品进行安全性质量控制。

Feasibility Study of Bacterial Endotoxin Test for Brozopine for Injection

Objective: To explore the feasibility of using bacterial endotoxin test to control the pyrogen of class I new drug Brozopine for injection. Methods: Tachypleus amebocyte lysate (TAL) from 2 manufacturers and 1 batche of Brozopine for injection were used for interference pilot test and the maximum non-interference concentration was found out. Then a formal interference test with the 3 batches of Brozopine for injection was conducted and the applicability of bacterial endotoxin test was determined according to the interference condition of the gradient dilution solution of the test articles to TAL and bacterial endotoxin. Furthermore, the bacterial endotoxin test of 3 batches of formulation was carried out using appropriate TAL according to the limit. Resuults: 3 batches of formulation showed no interference with TAL and endotoxin at 9.5 times of the effective concentration (3.125 mg·mL^-1). The results of bacterial endotoxin test were in line with the provision. Conclusion: The bacterial endotoxin test can be used to examine the pyrogen of Brozopine for injection. The method can be used quickly and accurately for the safety and quality control of the preparation products.