ABSTRACT
OBJECTIVE: To investigate the situation of the key quality parameters of the main domestic and imported tetanus-based combined vaccines used in the basic immunization phase in our country. METHODS: The quality parameters of 50 batches of vaccine products which were manufactured respectively by domestic and foreign manufacturers were analyzed and compared. RESULTS: AND CONCLUSION: Domestic and imported tetanus-based combined vaccine products have different advantages and the quality and these products may be improved further in some respects. It is suggested that more domestic and foreign vaccine manufacturers improve the product quality based on the characteristics of their own products to provide safer and more effective vaccines that can also more convenient for use in the future.
ABSTRACT
OBJECTIVE: To get the present information of potency assay Methods of adsorbed tetanus vaccine, latest research and developmental trend. METHODS: Induction, summary and analyses were used, mainly according to the Chinese Pharmacopoeia, European Pharmacopoeia, British Pharmacopoeia, Japanese Pharmacopoeia, Indian Pharmacopoeia, the manual for quality control of diphtheria, tetanus, and pertussis vaccines, adopted Methods of FDA and literatures in the field. RESULTS and CONCLUSION: In the near future, complete in vitro potency assay Methods of adsorbed tetanus vaccine can be used instead of in vivo assay, so it is important and urgent that related research should be made in China.