摘要
我国治疗用Ａ型肉毒毒素采用酸等电点沉淀，磷酸盐提取，核糖核酸酶处理，ＤＥＡＥＡ５０离子交换层析，硫酸铵浓缩及自然结晶等程序从Ａ型肉毒梭菌培养物中提取，并经稀释、冻干而成。它毒力强、纯度高、性能稳定，宜于长期保存。经生化、免疫学测定，毒素系神经毒素和血凝素的复合体，纯度为２５～３．０×１０７ＬＤ５０（小鼠，下同）／ｍｇｐｒ，ＯＤ２６０／ＯＤ２８０≤０．５５不仅达到了美国ＦＤＡ对注射用Ａ型肉毒毒素的质量要求，而且在冻干损失，稳定性方面还优于美国制品。
Procedures for preparing type A botulinum crystalline toxin were described.These included acid precipitation of crude toxin of the culture of C.botulinum A,extraction of the precipitate with phosphate buffer,RNase treatment,DEAE A50 ionexchange chromatography and dialysis against saturated solution of (NH 4) 2SO 4 to form crystalline naturally,then diluted and lyophilized.It has high toxicity,high purity,good stability and easy to store for long time.Biochemistry and immunology tests indicate that the toxin is the compound of neurotoxin and hemoagglutinin,the purity is 2.5 3.0×10 7LD 50 (mouse)/mg pr,OD 260 /OD 280 ≤0.55. Not only meet FDA requirement for BOTOX,but also do better in lyophilizing lost and stability than the same product of U.S.A
出处
《微生物学免疫学进展》
1999年第3期41-47,共7页
Progress In Microbiology and Immunology
