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目的通过比较甲醛处理前后重组乙型肝炎病毒表面抗原(HBsAg)和疫苗(汉逊酵母)成品各项检测指标及稳定性的变化,评估甲醛在重组乙型肝炎疫苗工艺中的作用,为重组乙型肝炎疫苗工艺中是否可取消甲醛处理步骤提供参考。方法采用扫描电镜观察、HPLC检测和疫苗体内效力评价指标半数有效剂量(ED_(50))、乙肝疫苗常规检测项目比较甲醛处理前后HBsAg及疫苗成品的变化情况,通过稳定性考察确定甲醛对疫苗稳定性和有效期的影响。结果 HBsAg经甲醛处理后产生轻微聚合,但疫苗成品ED_(50)和其他各项检测指标均无明显变化,动物异常毒性合格。甲醛处理和未处理疫苗成品的稳定性考察结果相同。结论重组乙型肝炎疫苗生产工艺中甲醛处理步骤对疫苗成品检测指标及稳定性无影响,可考虑取消,从而提高乙肝疫苗的质量和安全性。
Objective To evaluate the effect of formaldehyde on recombinant hepatitis B vaccine by comparing the detection indexes and stability of recombinant hepatitis B virus surface antigen (HBsAg) and vaccine (Hansenula) before and after formaldehyde treatment. Hepatitis B vaccination process whether to cancel the formaldehyde treatment steps for reference. Methods The scanning electron microscopy (SEM), HPLC and half dose of ED50 (ED 50) were used to test the efficacy of the vaccine against hepatitis B vaccine (HB50). The changes of HBsAg and vaccine products before and after formaldehyde treatment were compared. Sex and validity of the impact. Results HBsAg was slightly polymerized by formaldehyde treatment. However, there was no significant change in the ED 50 of the vaccine product and other test indicators, and the animal was abnormally toxic. The stability of formaldehyde-treated and untreated vaccine products was the same. Conclusion The formaldehyde treatment step in the recombinant hepatitis B vaccine production process has no effect on the detection index and stability of the vaccine product, so it can be considered to be canceled so as to improve the quality and safety of the hepatitis B vaccine.