Haemophilus influenzae type b conjugate vaccine and application thereof
A Haemophilus influenzae and conjugate vaccine technology, applied in the field of Haemophilus influenzae type b conjugate vaccine, can solve problems such as low recovery rate of polysaccharide protein conjugates, and achieve the effects of improving recovery rate, increasing stability and avoiding potential changes
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Embodiment 1
[0053] The following examples are used to illustrate the present invention, but are not intended to limit the scope of the present invention. Preparation of Example 1b type Haemophilus influenzae conjugate vaccine stock solution
[0054] 1) Prepare the refined polysaccharide of Haemophilus influenzae type b by adopting the process steps of strain culture, fermentation and refined polysaccharide preparation stipulated in the "Haemophilus influenzae type b conjugate vaccine" regulations in the third part of the Pharmacopoeia of the People's Republic of China (2010 edition) . The production strain of Haemophilus influenzae type b (MH200201, independently isolated by Beijing Minhai Biotechnology Co., Ltd.) was used, the strain was rejuvenated, cultivated, and fermented, and the fermentation broth was sterilized by formaldehyde and the culture was harvested;
[0055] 2) The collected culture was centrifuged to remove the bacteria, cetyltrimethylammonium bromide (CTAB) was added to p...
Embodiment 2
[0060] Embodiment 2 Preparation of stock solution of Haemophilus influenzae type b conjugate vaccine
[0061] The method steps are the same as in Example 1, except that the concentration of the TRIS-HCl buffer used is 0.05 mol / L.
[0062] Table 2 The assay results of the same batch of conjugates with different purification media
[0063]
Embodiment 3b
[0064] The preparation of embodiment 3b type Haemophilus influenzae conjugate vaccine stock solution
[0065] The method steps are the same as in Example 1, except that 0.1 mol / L TRIS-HCl buffer solution is used for equilibration.
[0066] Table 3 The assay results of the same batch of conjugates with different purification media
[0067]
[0068] The results show that: the same conjugate uses TRIS-HCl buffer as the mobile phase, and the recovery rate is much higher than that of using 0.2mol / L sodium chloride solution as the mobile phase, and the recovery rate of the former is more than twice that of the latter.
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