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本文对吸附精制百白破混合制剂的不同配方进行了实验,结果表明,新一代吸附精制百白破混合制剂最佳配方为:精制百日咳菌苗18μgPN/ml、精制白喉类毒素为30Lf/ml、精制破伤风类毒素为10Lf/ml。由该配方组成的吸附精制百白破混合制剂,其中百日咳菌苗的毒性试验BWDU/ml、LPU/ml、HSU/ml三种指标均符合制检规程要求。其效力单位(IU/ml)超过规程要求一倍以上,精制白喉和破伤风类毒素的安全试验均符合规程要求,白类效力试验≥80-100%,破类效力试验≥0.5-4.5IU/ml。上述结果说明本文提出的配方作为新一代精制百白破混合制剂的配方是适宜和实用的。
In this paper, we studied the different formulations of the adsorbed and purified Bupleurum mixture with different formulations. The results showed that the optimal formula of a new generation of Bp and B and C mixture was 18μgPN / ml of purified pertussis vaccine, 30Lf / ml of purified diphtheria toxoid, The refined tetanus toxoid is 10 Lf / ml. By the formula composed of adsorbed purified penehyclidine mixed preparations, which pertussis vaccine toxicity test BWDU / ml, LPU / ml, HSU / ml three indicators are in line with the inspection program requirements. Its efficacy unit (IU / ml) more than twice the requirements of the regulations, refined diphtheria and tetanus toxoid safety tests are in line with the rules and requirements, white class efficacy test ≥ 80-100%, broken class efficacy test ≥ 0.5-4 .5IU / ml. The above results indicate that the formulation proposed in this paper is suitable and practical as a formulation of a new generation of PentaBlack mixed preparation.