应用甲醛—赖氨酸解毒结合中空纤维超滤提高精制白喉类毒素纯度

Improvement of the Purity of Diphtheria Toxoid by Detoxification Using Formalin-lysine and Ultrafiltration Using Hollow Fiber Colum

精制白喉毒素单纯用甲醛解毒,解毒过程Lf/ml损失平均为14.81％,Lf/mg PN下降平均为13％;采用甲醛-赖氨酸解毒,解毒过程Lf/ml无损失,Lf/mg PN反而上升,平均为6.74％,纯度平均为2216Lf/mg PN。该制品经截留分子量为3万的中空纤维柱超滤后,纯度提高15.21％,平均为2540Lf/mg PN。HPLC仪分析结果表明,超滤后的特异类毒素成分由原来的78.26％增加至91.36％,非特异成分由原来的21.74％降低至8.64％。特异类毒素成分的分子量约为6.45万。

During the course of detoxification of purified diphtheria toxin by using formalin alone, the average of loss rates of Lf/ml and Lf/mg PN were 14.81% and 13%, respectively. However, when dextoxified by formaln and lysine, no Lf/ml was lost. On the contrary, Lf/mg PN was increased at a average rate of 6.74%, and the average of purity of the product reached 2216 Lf/ mg PN. After the product had been ultrafiltrated by hollow fiber column with an cut-off molecular weight 30 000, its purity was increased at a rate of 15. 21%, and reached 2540 Lf/mgPN in average. The results detected by HPLC showed that the rate of specific component of the vaccine rose from 78. 26% to 91.36%, and the rate of nonspecific component descended from 21.74% to 8. 64%, and the molecular weight of specific component was about 64 500.