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Drug compound containing tuberculosis allergen CE

A technology for allergens and compositions, which can be used in compound screening/testing, pharmaceutical formulations, preparations for in vivo tests, etc., and can solve problems such as poor tuberculosis specificity, incomplete PPD components, and inaccurate tuberculosis infection rates. , to achieve the effect of strong immunogenicity, improved sensitivity, and improved microenvironment

Active Publication Date: 2017-07-18
HISUN BIORAY PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

(2) Human-type PPD: pure protein derivative (PPD) of the culture filtrate of virulent strains of Mycobacterium tuberculosis. Due to the strong infectivity of the production strain, the country requires that the preparation of the PPD should be carried out in the secondary pressure workshop. Therefore, The manufacturer in Miyun, Beijing has been out of production for many years. At present, there is no domestic manufacturer producing Mycobacterium tuberculosis PPD
However, after the production of human-type PPD was discontinued, BCG PPD was temporarily used to replace human-type PPD in clinical skin tests, but the components of the two PPDs were not exactly the same. Therefore, the value of BCG-PPD skin test in assisting the diagnosis of tuberculosis still needs further research
At present, only Chengdu Biological Products is produced in China, and the supply is in short supply.
(4) Mycobacterium tuberculosis recombinant 38KD protein: It is a skin test antigen developed by the Tuberculosis Research Institute of the 309th Hospital of the People's Liberation Army. It has obtained a new drug certificate and has been transferred to a company in Dongguan, Guangdong. It is currently under construction and put into production, and has not yet been used in clinical practice.
Therefore, the specificity of PPD skin test in diagnosing tuberculosis is poor, and the tuberculosis infection rate obtained by sampling survey of tuberculosis epidemiology with this method is inaccurate and cannot truly reflect the actual situation of tuberculosis infection in the population

Method used

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  • Drug compound containing tuberculosis allergen CE
  • Drug compound containing tuberculosis allergen CE
  • Drug compound containing tuberculosis allergen CE

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0084] Embodiment 1, the cloning of the coding gene of recombinant fusion protein CE and the expression and purification of recombinant fusion protein CE

[0085] 1. Design of fusion of two protein epitopes

[0086] Analyze the gene sequence and protein structure of Mycobacterium tuberculosis CFP10 and ESAT6, determine the fusion region, combination and sequence of the epitopes of the two proteins, and select the codon with high frequency as the best codon according to the codon usage frequency of Escherichia coli codons or preferred codons, remove some rare or low-utilization codons, and optimize by replacing the original codons with synonymous codons, so that the designed gene can be expressed at a high level in E. coli, increase protein production, and enable protein production more efficient and economical.

[0087] The sequence shown in SEQ ID No.1 was designed. In SEQ ID No.1, the 1st-6th position is restriction endonuclease Nde I digestion recognition site 5'-CATATG-3...

Embodiment 2

[0253] Example 2: Formulation pH Study

[0254] Solution pH is one of the important parameters affecting the physical and chemical stability of biopharmaceuticals. pH can adjust the charge distribution on the surface of the protein, thereby affecting the intramolecular and intermolecular forces of biopharmaceuticals, and directly affects the solubility of the protein. May have lower colloidal stability (Colloidal stability).

[0255] 1. Prescription design

[0256] The optimal pH is determined by investigating the influence of different pH values ​​on the stability of the preparation solution of this product. The pH range was designed to be 2.6-8.0 (20mM citrate-phosphate buffer system), and a prescription was designed every 0.2 pH, and a total of 28 prescriptions with different pH were prepared.

[0257] 2. Prescription configuration

[0258] 20mM pH 2.6 citric acid / citrate buffer and 20mM pH 8.0 phosphate buffer were respectively prepared, and then mixed in different pro...

Embodiment 3

[0274] Example 3: Screening of Prescription Structure Protectors and Formulation Confirmation Research

[0275] The commonly used structural protective agents for protein drugs include polyols (such as mannitol, glycerol), sugars (such as sucrose and trehalose), and amino acids (such as glycine, arginine). The protection mechanism of the above-mentioned structure protectors is called "preferential exclusion", that is, in aqueous solution, the protein preferentially excludes the protector molecules from the protein surface, and the addition of these protectors will increase the chemical potential energy of the protein. Due to the increased surface area of ​​protein denaturation and unfolding, and the increase in interaction with excipients, the chemical potential energy increases, and the activation energy for protein conformational denaturation increases, so that the balance between the natural conformation and the denatured conformation of the protein shifts to the natural con...

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PUM

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Abstract

The invention relates to a drug compound containing tuberculosis allergen CE, and a preparation method and application thereof. The compound includes tuberculosis allergen CE, a structure protective agent, a surface active agent, a buffering agent, and the like. The compound provided by the invention is high in detection sensitivity to tuberculosis, has high physical and chemical stability and has wide market application prospect.

Description

technical field [0001] The invention belongs to the field of biotechnology, and in particular relates to a pharmaceutical composition containing tuberculosis allergen CE, a preparation method and application thereof. Background technique [0002] Tuberculosis is still one of the major infectious diseases that endanger human health all over the world, and it is one of the important public health problems that need to be solved urgently. my country's tuberculosis epidemic and drug resistance are quite serious, and it is one of the 22 countries with a high burden of tuberculosis in the world. The number of tuberculosis patients ranks second in the world, second only to India. The preliminary results of the Fifth National Tuberculosis Epidemiological Sampling Survey in 2010 showed that there were 5-6 million tuberculosis patients, including 860,000 infectious tuberculosis patients; the number of cases and deaths of tuberculosis in the country ranked first among all legal infecti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K49/00
CPCA61K49/0006
Inventor 方伟杰王海彬郑洪健白骅
Owner HISUN BIORAY PHARMA CO LTD
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