Method for preparing adjuvant-free haemophilus influenza type b conjugate vaccine lyophilized agent

Abstract

The invention discloses a method for preparing an adjuvant-free haemophilus influenza type b conjugate vaccine lyophilized agent. The method comprises forming the formula, preparing the mixture and performing a freeze-drying process. According to the technical scheme in the invention, in the process of performing vacuum sublimation freezing-drying to remove free water in the freeze-drying process, the temperature of the bottled material is controlled to eliminate aggregation of CRM197 proteins below the eutectic point of free water and bound water; in the process of performing vacuum heating desorption drying to remove the free water, the temperature of the bottled material is controlled to eliminate degradation of a Hib capsule structure below the degradation point, so that an adjuvant does not need to be added into a haemophilus influenza type b conjugate vaccine lyophilized agent. The problems and defects such as protein aggregation, structure degradation, adjuvant needs and the like in the prior art are overcome, so that the haemophilus influenza type b conjugate vaccine lyophilized agent achieves the aims of eliminating the protein aggregation and structure degradation and avoiding the adjuvant.

Description

technical field [0001] The invention relates to a preparation method of a vaccine freeze-dried preparation, in particular to a freeze-dried preparation of an adjuvant-free Haemophilus influenzae type b conjugate vaccine for making a freeze-dried preparation of Haemophilus influenzae type b conjugate vaccine Preparation. Background technique [0002] Haemophilus influenzae type b conjugate vaccine, scientific name Haemophilus influenzae type b capsular oligosaccharide and CRM197 protein conjugate, also known as Hib-CRM197 protein conjugate, is a vaccine used to prevent influenza type b in children; type b Haemophilus influenzae conjugate vaccine has two dosage forms: freeze-dried preparation and liquid preparation. The two dosage forms are consistent in quality indicators such as polysaccharide content, molecular size and distribution; among them, the freeze-dried preparation has high stability and does not need to add preservatives , and can extend the shelf life and validi...

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Problems solved by technology

[0003] Haemophilus influenzae type b conjugate vaccine freeze-dried agent, referred to as type b freeze-dried vaccine; the quality of type b freeze-dried vaccine depends on the freeze-drying process curve, referred to as the freeze-drying process; the freeze-drying process of the prior art makes the prepared type b Aggregation of CRM197 protein in lyophilized vaccines and degradation of Hib capsular structures (ribose-ribitol phosphate polymers), see image 3 and compare figure 1 , so that the biolo

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