脑膜炎球菌多糖疫苗培养基的标准化研究

目的用干粉原料完全替代以消化液为主要原料的培养基配方,实现脑膜炎球菌多糖疫苗培养基的标准化生产。方法用筛选改良的酪蛋白酸水解物干粉替代50%盐酸酪蛋白水解液,以改良酵母浸出粉替代酵母透析液和酵母浸出粉,适当调整培养基配方,改进并稳定培养基制备工艺,确定适宜质量指标,并对各项质量指标数据进行分析。结果改进后的脑膜炎球菌多糖疫苗干粉培养基有效地降低了批间差异,各项质量指标均符合脑膜炎球菌培养要求,培养基的各项质量指标更加稳定可控,在生产中得到了良好、稳定的生长结果。结论用干粉原料完全替代脑膜炎球菌多糖疫苗培养基中的消化液和酵母透析液是成功的,同时改良的干粉培养基进一步明确了配方标准,使原料准备、制备工艺、质量指标控制更加标准化,有效提高了培养基质量,有利于规模化生产,促进了脑膜炎球菌多糖疫苗生产用培养基的标准化工作。

The standardization of meningococcas polysaccharide vaccine medium

Objective To explore the possibility of replacement of the digestive liquid medium by power medium to realize the standardization preparation of meningococcas polysaccharide vaccine medium.Methods The 50% HCI hydrolysate of casein was replaced with powder medium of caseinic acid hydrolysis product,the yeast dialysate and yeast extractive powders were replaced by the improved yeast extractive powder.The formula and quality specifications of medium for preparing meningococcas polysaccharide vaccine were analyzed.Results The results showed that the powder medium have the advantages of accurate,stable,good repeatability and good culture results.Conclusion Using the power medium to prepare the meningococal polysaccharide vaccine is successful.It is beneficial to improve the quality of medium and the production on a large scale.