Pharmaceutical composition for treating hepatitis B, and preparation method and application thereof

A technology of hepatitis B and hepatitis B virus, applied in the field of biomedicine

Pending Publication Date: 2020-07-17
JIANGSU THERAVAC BIO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For example, vaccination with aluminum-containing adjuvant can cause some adverse reactions, such as erythema, subcutaneous nodules, contact hypersensitivity, granuloma, myofascitis, etc.

Method used

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  • Pharmaceutical composition for treating hepatitis B, and preparation method and application thereof
  • Pharmaceutical composition for treating hepatitis B, and preparation method and application thereof
  • Pharmaceutical composition for treating hepatitis B, and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] The preparation of each component of embodiment 1 therapeutic hepatitis B pharmaceutical composition

[0040] 1. Preparation of HBsAg stock solution:

[0041] The amino acid sequence of the HBsAg protein is shown in SEQ ID NO.1.

[0042] The HBsAg protein is prepared by HBsAg gene recombinant yeast cells, and the yeast cell types include Hansenula, Saccharomyces and Pichia, preferably Hansenula. 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 obtained by bacteria-breaking treatment, silica gel adsorption, column chromatography and TFF purification.

[0043] 2. Preparation of HBcAg stock solution:

[0044] The amino acid sequence of the HBcAg protein is shown in SEQ ID NO.2.

[0045] The HBcAg protein is prepared by HBcAg gene recombinant yeast cells, and the yeast cell types include Hansenula, Sacc...

Embodiment 2

[0050] The preparation of embodiment 2 therapeutic hepatitis B pharmaceutical composition

[0051] 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;

[0052] 2. 0.5% polysorbate 80 (Tween 80) solution: weigh 5.0 g of Tween 80 and dilute to 1000 ml with PBS buffer solution;

[0053] 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;

[0054] 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;

[0055] 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 c...

Embodiment 3

[0057] The screening test of embodiment 3 therapeutic hepatitis B pharmaceutical composition prescription

[0058] Among the three components of HBsAg, HBcAg and CpG, HBsAg was most affected by various factors and had the worst stability. Therefore, HBsAg is used as an index to screen prescriptions.

[0059] HBsAg mainly exists in the form of virus-like particles (hereinafter referred to as VLP), and the area of ​​the main peak detected by HPLC represents the amount of VLP in the solution. Therefore, a decrease in the area of ​​the main peak represents a decrease in the amount of HBsAg in the VLP form in solution.

[0060] 1) Screening of buffer system

[0061] Solution preparation:

[0062] 1.0.5% polysorbate 80 (Tween 80) solution is made by embodiment 2;

[0063] 2. Histidine buffer solution: histidine 1.55g, histidine hydrochloride 2.095g, add water to dissolve and dilute to 1000ml.

[0064] 3. HBsAg solution (PBS buffer solution): Take the HBsAg stock solution, add...

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Abstract

The invention relates to a pharmaceutical composition for treating hepatitis B. The pharmaceutical composition comprises a hepatitis B surface antigen or a fragment thereof, a hepatitis B core antigenor a fragment of the hepatitis B core antigen, oligodeoxynucleotide and polysorbate 80. The pharmaceutical composition does not contain sugar, has simple components, does not have adverse reactions caused by an aluminum adjuvant, has good antigen stability, shows good preservation effect in a long-term stability experiment, can meet production, storage and use requirements of vaccines, and is suitable for large-scale production and use of therapeutic hepatitis B vaccines.

Description

technical field [0001] The invention belongs to the field of biomedicine and relates to a pharmaceutical composition for treating hepatitis B. Background technique [0002] Hepatitis B virus (HBV) infection is one of the serious public health problems worldwide. HBV infection is an important cause of chronic hepatitis B, liver cirrhosis and hepatocellular carcinoma (Fattovich G.J. Hepatol. 2008; 48:335-352). The commonly used drugs for clinical treatment of chronic HBV infection mainly include nucleoside analogues and interferon. Nucleoside analogs cannot completely remove cccDNA in liver cells, and long-term use can easily lead to the emergence of drug-resistant mutants and rebound after drug withdrawal (Kwon H, LokAS. Nat Rev Gastroenterol Hepatol. 2011; 8: 275-284). Interferon is not suitable for asymptomatic HBV carriers. In chronic HBV patients, the incidence of HBeAg seroconversion after half a year of use is only 33%, and the side effects of interferon also limit it...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/29A61K39/39A61K47/26A61K47/02A61P1/16A61P31/20A61P35/00
CPCA61K39/12A61K39/39A61K47/26A61K47/02A61P1/16A61P31/20A61P35/00A61K2039/575A61K2039/572A61K2039/55561C12N2730/10134A61K9/08A61K9/0019A61K47/183A61K9/19C07K14/005C12N2730/10122A61P37/04A61K39/292
Inventor 李建强葛君任苏林黄红颖孙娇娇周童顾月陈晓晓周雪
Owner JIANGSU THERAVAC BIO PHARMA CO LTD
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