重组乙型肝炎疫苗(CHO细胞)鉴别试验的方法研究

目的：建立重组乙型肝炎疫苗(CHO细胞)鉴别试验的方法。方法：取重组乙型肝炎疫苗(CHO细胞)以1：10比例加入lmol/L盐酸调节pH值,采用ELISA双抗体夹心法检测,同时设以氢氧化铝、未处理的重组乙型肝炎疫苗、狂犬疫苗、出血热疫苗,以及试剂盒的阴、阳性作为对照。结果：狂犬疫苗、出血热疫苗及氢氧化铝对照为阴性,直接检测重组乙型肝炎疫苗(CHO细胞)呈弱阳性,加入盐酸调节pH值后原倍样品呈弱阳性,10倍稀释后呈强阳性。采用该方法检测5批疫苗均呈强阳性。组内平行试验,组间重复试验。结论：将重组乙型肝炎疫苗(CHO细胞)调节pH值后10倍稀释,用ELISA双抗体夹心法检测呈阳性,而且稳定可靠,该方法可用于该疫苗的鉴别试验。

Study of the Method of Detecting Recombinant CHO Hepatitis B Vaccine

Objective:To explore a new efficient method of detecting Recombinant CHO hepatitis B vaccine (rHBsAg vaccine).Methods:rHBsAg (CHO) was mixed by hydrochloric acid of 1mol/L with 10:1 to a suitable pH,and detected by ELISA test with aluminium hydroxide,unsettled rHBsAg vaccine,Rabies vaccine,Haemorrhagic Fever vaccine and positove and regative control tests in test box as control.Results:Rabies vac- cine,Haemorrhagic Fever vaccine and aluminium hydroxide showed negative,unsetlled rHBsAg vaccine(CHO) and HCl mixed one showed slight- ly positive,HCl adjusted rHBSAg vaccine which was diluted in to a concentrition of 1/10 of its original one showed stong positive.Also,5 groups of rHBsAg vaccine got the same result.Control tests carried out in parallel inner group and between groups supported the above.Conclusion:rH- BsAg vaccine adjusted by HCl and diluted into a concentration of 1/10 of it can make a evident positive result available in ELISA test,which is a stable reactoin and a good method in rHBsAg vaccine detection.