Pharmaceutical preparation for treating hepatitis B, and preparation method and application thereof
A pharmaceutical preparation, technology for hepatitis B, applied in the field of biomedicine
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Embodiment 1
[0050] The preparation of each component of embodiment 1 therapeutic hepatitis B vaccine preparation
[0051] 1. Preparation of HBsAg stock solution:
[0052] The amino acid sequence of the HBsAg protein is shown in SEQ ID NO.1.
[0053] The HBsAg protein is prepared by HBsAg gene recombinant yeast cells, and the yeast cell types include Hansenula, Saccharomyces and Pichia, preferably Hansenula.
[0054] For the specific preparation steps, refer to the Chinese patent application CN108330145A, the HBsAg gene recombinant Hansenula cells are fermented and cultured, and the cells are harvested. The HBsAg stock solution was prepared by bacteria-breaking treatment, silica gel adsorption, column chromatography and TFF purification. The prepared HBsAg stock solution is required to have a purity greater than 95% and a protein content of not less than 200 μg / ml. The residues of host DNA, host protein and other chemical substances are in compliance with the Pharmacopoeia regulations...
Embodiment 2
[0063] The preparation of embodiment 2 therapeutic hepatitis B vaccine preparations
[0064] 1. PBS buffer solution: Na 2 HPO 4 12H 2 O 2.0g, NaH 2 PO 4 2H 2 O 2.4g, NaCl 9g, add water to dissolve and dilute to 1000ml, adjust the pH value to 7.20 with hydrochloric acid or sodium hydroxide;
[0065] 2. 0.5% polysorbate 80 (Tween 80) solution: weigh 5.0 g of Tween 80 and dilute to 1000 ml with PBS buffer solution;
[0066] 3. HBsAg solution: get the HBsAg stock solution (prepared in Example 1), add 0.5% Tween 80 solution, and dilute the concentration of Tween 80 to 0.05% with PBS buffer solution;
[0067] 4. HBcAg solution: take the HBcAg stock solution (prepared in Example 1), add 0.5% Tween 80 solution, and dilute the concentration of Tween 80 to 0.05% with PBS buffer solution;
[0068] 5. CpG solution: take CpG (prepared in Example 1) and dissolve and dilute it with PBS buffer solution to obtain a CpG stock solution, add 0.5% Tween 80 solution, and dilute the concent...
Embodiment 3
[0070] The screening test of embodiment 3 therapeutic hepatitis B vaccine preparation prescriptions
[0071] Among the three components of HBsAg, HBcAg and CpG, HBsAg was most affected by various factors and had the worst stability. Therefore, HBsAg was used as an index to screen the formulation prescription.
[0072] HBsAg mainly exists in the form of virus-like particles (hereinafter referred to as VLP), and the main peak area detected by HPLC represents the amount of VLP in the preparation. Therefore, a decrease in the area of the main peak represents a decrease in the amount of HBsAg in the VLP form in the formulation.
[0073] 1) Screening of buffer system
[0074] Solution preparation:
[0075] 1.0.5% polysorbate 80 (Tween 80) solution is made by embodiment 2;
[0076] 2. Histidine buffer solution: histidine 1.55g, histidine hydrochloride 2.095g, add water to dissolve and dilute to 1000ml.
[0077] 3. HBsAg solution (PBS buffer solution): Take the HBsAg stock so...
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