用皂土法制造型特异性肉毒诊断血清

用皂土为载体与类毒素结合方法及破伤风类毒素抗原抗体絮状反应方法去除A、B、C、D、E、F型肉毒抗血清原料中的异型和异种抗毒素(破伤风抗毒素)。制备的A、B、C、D、E、F型肉毒诊断血清每1m l均能中和相应型的肉毒毒素10000LD50以上,而中和异型肉毒毒素或破伤风毒素均低于5 LD50;A、B、C、D、E、F各型混合后的混合型血清每1m l能中和各型肉毒毒素亦大于10000 LD50,中和破伤风毒素低于5 LD50,即效价和特异性符合规程要求。

Preparation of diagnostic sera for botulinum toxin by way of bentonite

The preparation was conducted by using different botulinum toxoid coupling to bentonite, to get rid off the cross-reaction components in a certain type of diagnostric antisera such as type C without D, type E without F. The flocculation test was performed by the interaction of tetanus toxoid with botulinum antisera, to eliminate the anti-tetanus toxin components. By these methods, the prepared diagnostic sera for botulinum toxin type A, B, C, D, E, F can neutralize more than 10000 LD_(50)/ml of same type botulinum toxin, on the other hand, they neutralize less than 5 LD_(50)/ml of other types of botulinum toxin or tetanus toxin. The diagnostic sera for mixed types can neutralize more than 10000 LD_(50)/ml botulinum toxin of type A, B, C, D, E, F, and neutralize less than 5 LD_(50)/ml tetanus toxin. Both potency and identity of the prepared diagnostic sera are in accordance with requirements for biological products.