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过去10年灭活灰质炎疫苗的生产方法已经几次改进,最后是用原代猴肾细胞微载体培养所制备的一种浓缩、纯化的三价灰质炎疫苗。同样生产方法已用于由原代狗肾细胞制备灭活的组织培养狂犬病疫苗。这两种疫苗采用了基本相同检定方法;可以说这两种疫苗的制备已发展成一种“统一方法”。本文简扼报告了这二种疫苗的试生产和检定方法及用于人的效果。疫苗制备: 肾脏的胰酶消化:猴肾细胞用于灰质炎病毒,狗肾细胞用于狂犬病病毒。肾脏以灌注法消化。(参见“国外医学生物制品分册”1979(2):31——译者)采用灌注消化法已使猴的需用只数明显减少。消化狗肾细胞的细胞产量为3000～4000×16~6个/每只狗。细胞和病毒的培养:微载体培养技术,一般不更替培养液细胞即可增加10倍。细胞培养后,通过装有不锈钢滤网的管子,以除去培养液而保留带有细胞的球体。细胞培养物经过洗涤以排除血清,接种适当病毒。灰质炎病毒于种后三天收获。狂犬病病毒可多次收获,间隔4～5天。与Povitsky瓶内制备单层细胞比较,采用微载体培养技术,已导致生产灰质炎疫苗所需的人力和猴数降低。浓缩和纯化:为除去剩余的血清蛋白和细胞成份,将过滤澄清后的病毒悬液,经空
The production of inactivated vaccine has progressed several times over the past 10 years, culminating in a concentrated, purified, trivalent vaccine prepared using primary monkey kidney cell microcarrier culture. The same method of production has been used to prepare inactivated tissue culture rabies vaccine from primary dog kidney cells. The two vaccines use basically the same assay; it can be argued that the preparation of both vaccines has evolved into a “uniform approach.” This article briefly reports the pilot production and test methods for these two vaccines and their effects on humans. Vaccine preparation: Trypsin digestion of the kidneys: monkey kidney cells for the plague virus and dog kidney cells for the rabies virus. The kidneys are digested by perfusion. (See “Foreign Medical Biological Products Volume” 1979 (2): 31-- Translator) The use of perfusion digestion has reduced the number of monkeys required significantly. Digestion of dog kidney cell cell yield of 3000 ~ 4000 × 16 ~ 6 / dog. Cell and virus culture: microcarrier culture technology, generally do not replace the culture fluid cells can increase 10 times. After the cells were cultured, the cells with the cells were retained by passing through a tube equipped with a stainless steel mesh to remove the culture fluid. Cell cultures are washed to exclude serum and inoculated with the appropriate virus. The plague virus is harvested three days after the seed. Rabies virus can be harvested several times, an interval of 4 to 5 days. Compared with the preparation of monolayer cells in Povitsky bottles, the use of microcarrier culture techniques has led to a reduction in the manpower and number of monkeys required for the production of the vaccine. Concentration and purification: In order to remove the remaining serum proteins and cellular components, the clarified virus suspension will be filtered, emptied