论文部分内容阅读
目的:验证凝胶法检查骨化三醇注射液细菌内毒素的方法,建立动态比浊法测定其细菌内毒素含量。方法:用不同厂家的鲎试剂对不同批号的样品分别进行干扰试验,按《中国药典》2000年版方法考察其可行性。结果:骨化三醇注射液在20倍以上稀释可消除干扰作用,凝胶法检查和动态比浊法测定均符合规定,结果准确可靠。结论:鲎试验法适用于骨化三醇注射液中细菌内毒素检测。
OBJECTIVE: To verify the method for detecting bacterial endotoxin in calcitriol injection by gel method and to establish a dynamic turbidimetric method to determine the bacterial endotoxin content. Methods: The interference test was carried out on the samples of different batches with different reagents from different manufacturers. The feasibility was tested according to the Chinese Pharmacopoeia 2000 edition. Results: Calcitriol injection diluted more than 20 times can eliminate the interference effect, gel test and dynamic nephelometry were in line with the provisions, the results are accurate and reliable. Conclusion: The test method is suitable for the detection of bacterial endotoxin in calcitriol injection.