乙型肝炎卡介苗联合疫苗的制备

Study on the Preparation of Hepatitis B-BCG Combined Vaccine

在常规制备乙型肝炎疫苗和卡介苗技术基础上制备联合疫苗,建立了联合疫苗制备及冻干工艺,对冻干工艺的稳定性及其对抗原的影响进行了研究,采用动物实验进行免疫效果比较、安全性、局部毒性、过敏试验。结果表明冻干对两种抗原无影响;两种抗原具有良好的相容性;联合疫苗与同批卡介苗相比,效力无显著性差异(P>0.05);联合疫苗组与同批乙肝疫苗组全程免疫相比,统计学无显著性差异(P>0.05);安全性试验联合疫苗组与卡介苗组反应一致,均未见结核性病变。联合疫苗组与卡介苗组病变性质和病理演变过程相似,HBsAg并不增强卡介苗引起的炎症反应;未见全身过敏反应。连续9批成品检定全部合格,证明冻干工艺稳定,技术可行。

To prepare the Hepatitis B-BCG combined vaccine, the hepatitis B surface antigen（ HBsAg）was prepared by genetic engineering technique and BCG was produced using routine biological technique, then the final product of the hepatitis B-BCG combined vaccine was processed by freeze-drying. The stability and efficacy on freeze-dry antigen were also studied. The immune response, safety, partial toxicity, and allergy were tested using different animals. Results found that the freeze-drying technique had no effect on antigen; also no significant difference in the relative efficacy among the combined vaccine or BCG（P〉0. 05） ; The Hepatitis B vaccine was the same （P〉0. 05）; The safety in hepatitis B-BCG combined vaccine group was accorded with that in BCG group, and the tuberculosis was not seen. The process in pathological changes of hepatitis B-BCG combined vaccine group and BCG group was similar. HBsAg did not strengthen the inflammation reaction caused by BCG. addition the allergy was not found in experment.