Study on bacterial endotoxin detection of egg yolk lecithin of Chinese Pharmacopoeia 2020 Edition / 中国药理学通报

ABSTRACT

Abstract; Aim To solve the problems in the appliea- tion of egg yolk leeithin endotoxin test method, and and to establish the baeterial endotoxin examination method for egg yolk lecithin (for injeetion). Methods The ethanol solution of Tween 80 ( the volume ratio of tween 80 to anhydrous ethanol was 2. 5 • 2. 7, mixed for 4 min) was used to prepare lecithin solution of egg yolk at 0. 1 kg • L 1 , and 10 test water was added to 1 mL lecithin solution of egg yolk (500 EU • mL 1 standard solution of endotoxin IOjxL was added for pos¬itive control). After diluted 20 times with endotoxin test water, the standard curve range was 10 ~0. 01 EU • mL 1 by kinetic-turbidimetrie assay. Methodology of endotoxin test was studied using limulus lysate from two manufacturers and eight hatches of samples. Results The recoveries of eight hatches of samples all met the requirement of interference test between 50% and 200% stipulated in the pharmacopoeia, which solved the problems of the current endotoxin test method in practical application. Conclusions The bacterial en¬dotoxin test method of egg yolk lecithin with good dura-bility is established to provide the basis for the revision of pharmacopoeia.