精制白喉标准毒素及精制锡克试验毒素的制备与检定

Preparation and Characterization of Purified Diphtheria Toxin Standard and Purified Schick Test Toxin

采用纯度为2000Lf/mgPN以上的精制白喉毒素,加到甘油明胶缓冲液中,制成约1000MLD/ml的精制白喉标准毒素。放置4℃保存10年,其MLD/Lf仅下降13.6％,证明稳定性良好;而原制白喉标准毒素在同样条件下MLD/Lf竟下降94.6％,稳定性很差,其放置的前3年,MLD/Lf呈急剧直线下降,后7年则呈缓慢下降。用精制白喉标准毒素共生产精制锡克试验毒素10批,经检定,MRD/ml和MLD/ml皆符合我国规程要求;结合力,7批符合英国药典规定,另3批经20％稀释亦能达到上述要求。原制锡克试验毒素的结合力一般为精制的2～5倍。

Purified diphtheria toxin standard (1000MLD/ml) was prepared by adding the purified diphtheria toxin (2 116Lf/mgPN) in glycerin-gelatin buffer solution. Being stored at 4℃ for 10 years, the decline rate of MLD/Lf of the standard was only 13. 6%, but that of crude diphtheria toxin stan- dard was 94.6% under the same condition. The MLD/Lf of crude standard declined sharply durinig the first 3 years, but declined slowly during the following 7 years. 10 lots of Schick test toxin were prepared with purified diphtheria toxin standard and tested. The result showed that the MLD/ml and MRD/ml of all the 10 lots accorded with the Chinese Require- ments of Biologicals. The combining power of 7 of the 10 lots accorded with the requirements of British Pharmacopeia, and the other 3 lots could also accord with B. P. after 20% dilution. The combining power of the Schick test toxin prepared with crude toxin standard was 2~5 times as strong as that pre- pared with purified toxin standard.