20AA复方氨基酸注射液细菌内毒素检查法的研究

Study on Bacterial Endotoxin Test Method for 20AA Compound Amino Acid Injection

目的研究20AA复方氨基酸注射液对细菌内毒素检查试验的干扰情况,建立其细菌内毒素的限量检查方法。方法参照《中国药典》2005年版二部附录细菌内毒素凝胶限量检查法进行实验,以不同生产厂家、不同批号的鲎试剂对多批供试品进行干扰试验。结果20AA复方氨基酸注射液经4倍稀释后对检测无干扰作用。结论该制剂可用细菌内毒素检查法替代家兔热原检查法控制产品质量,其内毒素限值为含内毒素量应<1.2EU·ml-1。

Aim To study the interference of 20AA compound amino acid injection in bacterial endotoxin tests, and to establish a testing method of the endotoxin limit for the preparation. Methods The bacterial endotoxin test was performed according to the bacterial endotoxin determination method in China Pharmacopoeia 2005, using different tachypleus amebocyte lysate （TAL） made by different manufacturers. Results Diluted by four times the concentration, the 20AA compound amino acid injection did not interfere in the result of the test. Conclusion The gelclot test of bacterial endotoxin could rabbit pyrogen method replace the quality for control of 20AA compound amino acid injection , in which the bacterial endotoxin limit should be less than 1.2EU·ml^-1.