三层共挤输液用袋包装复方氨基酸注射液细菌内毒素检查法研究

Study on bacteria endotoxin test for compound amino acid injection

目的对复方氨基酸注射液(17AA-H)直接接触药品的包装材料,由原玻璃输液瓶分装变更为三层共挤输液用袋分装,之后采用细菌内毒素检查的可行性进行研究,从而增加细菌内毒素检查项。方法参考17AA-H玻璃输液瓶分装产品细菌内毒素验证方法,用三层共挤输液用袋分装产品的16倍稀释液三批(批号分别为MOA001T、MOA002T、MOA003T)进行干扰试验。结果无干扰作用。结论 17AA-H包装材料发生变更后仍采用细菌内毒素检查法进行试验是可行的。

Objective The packaging materials of compound amino acid injection（17AA-H）direct contacting with drug was changed to three co-extruded packing bag. After the conducted research was used the bacterial endotoxin test,which increasing the bacterial endotoxin test items.Methods Refer to the bacterial endotoxin test method,the drug infusion bottle glass packaging products using three-layer co-extrusion infusion bag fitted with 16 times diluent three batch（lot number respectively MOA001T、MOA002T、MOA003T）,which interference experiment was carried out. Results The Packing method has no interference with the results. Conclusion The test that 17AA-H packaging materials still used after the change occurs in bacterial endotoxin was feasible.