Limulus test of long-chain fat emulsion injection determination of bacterial endotoxin in research methodology.docVIP

 PAGE \* MERGEFORMAT 6 Limulus test of long-chain fat emulsion injection determination of bacterial endotoxin in research methodology [Abstract] Objective: To determine the long-chain fat emulsion injection of bacterial endotoxin check the feasibility of the limulus test. Methods: After the test interference test, the sample gel Limulus test for detection of bacterial endotoxin. Results: Three approved long-chain fat emulsion injection diluted to 2 times the detection of bacterial endotoxin no interference, the samples of the bacterial endotoxin content of less than 0.5EU · ml-1. Conclusion: The long-chain fat injection method to check endotoxin solution feasible. [Keywords:] long-chain fat emulsion injection, bacterial endotoxins, LAL testing, interference testing Bacterial endotoxin is a very important medicines safety indicators, infusion led to the original excessive heat is the main reason for infusion reactions [1], in recent years, more and more countries in the world to bacterial endotoxin test method instead of rabbit pyrogen Check drugs and biological products pyrogenic substances are increasingly common. long-chain fat emulsion injection commonly used in clinical oral or enteral nutritional intake can not be less than or fasting patients, the parenteral nutritional supplements fat. lt;”China Pharmacopoeiagt;gt; not yet received the 2005 edition contains the species. To this end, domestic long-chain fat emulsion on the injection of bacterial endotoxin were checked. 1 Drugs and reagents Long-chain fat emulsion injection, Hunan Nan Kelun Pharmaceutical Co., Ltd., 250ml: 5g fat and 3g phospholipids, batch number: E080401E080402E080403, bacterial endotoxin standard (Pharmaceutical and Biological Products, batch number: 150 601 200 860, each 160EU, bacterial endotoxin water (Pok Hong Zhanjiang Marine Biological Products Co., Ltd., batch number: 080529, TAL reagent (Zhanjiang safely Andean Biological Products Co., Ltd., λ = 0.25EU · ml-1, bat