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- W950096598 abstract "Objective To develop a pilot production procedure of adsorbed acelluar DTP-recumbinant hepatitis B (CHO cells) combined vaccine (DTaP-HBV). Methods The formula of DTaP-HBV was optimized, based on which a pilot production procedure was developed. Three batches of DTaP-HBV were prepared by the procedure and subjected to quality control and stability tests. Results The optimal formula of DTaP-1-IBV consisted of 18μg PN/ml hulk of acellular pertussis vaccine, 25Lf/ml purified diphtheria toxoid, 7 Lf/ml purified tetanus toxoid and 20μg/ml bulk of recombinant HB vaccine. The sodium chloride solution at a concentration of 0.85% was selected as diluent, which showed good adsorption effect, while no interference between antigens was observed. The method for formulation showed no significant effect on the potency of DTaP-HBV. All the 3 batches of prepared DTaPHBV showed good stability, and their quality indexes met the requirements in Chinese Pharmacopoeia (Volume Ⅲ, 2005 edition). Conclusion A pilot production procedure of DTaP-HBV was developed, and the prepared vaccine was safe, stable and effective." @default.
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- W950096598 date "2009-10-20" @default.
- W950096598 modified "2023-09-24" @default.
- W950096598 title "吸附无细胞百白破－重组乙型肝炎（CHO细胞）联合疫苗的中试工艺" @default.
- W950096598 hasPublicationYear "2009" @default.
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