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Storage stabilizer for human serum immunoglobulin solution preparations

A storage stabilizer and immunoglobulin technology, which is applied in the direction of medical preparations and pharmaceutical formulas containing active ingredients, and can solve the problem of high degree of polymerization of immunoglobulins

Active Publication Date: 2017-11-14
广东卫伦生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But at high temperature, high concentration or long storage time, the degree of immunoglobulin aggregation is still high

Method used

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  • Storage stabilizer for human serum immunoglobulin solution preparations
  • Storage stabilizer for human serum immunoglobulin solution preparations
  • Storage stabilizer for human serum immunoglobulin solution preparations

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0011] Take human serum immunoglobulin chromatography solution (purity 99.2%, concentration 0.37mmol / L) after virus inactivation, concentrate by ultrafiltration to prepare immunoglobulin solution with a concentration of 10wt%, take 1L sample, add glucose to 230mmol / L L, adjust the pH to 4.1 as a blank control sample, take another 3 L, add glutathione to 6mmol / L, maltose to 300mmol / L, proline to 50mmol / L, adjust the pH to 4.1, divide into sample 1 and sample 2 , Sample 3 each 1L. The molecular size distribution of the product was investigated under storage conditions at room temperature.

[0012] The molecular size distribution is checked by high-performance liquid chromatography: a hydrophilic silica gel high-efficiency size-exclusion chromatography column (SEC, exclusion limit 300kD, particle size 10μm), column diameter 7.5mm, length 60cm; with 1% isopropanol, pH value 7.0, 0.2mol / L phosphate buffer (take 200ml of 0.5mol / L sodium dihydrogen phosphate, 420ml of 0.5mol / L disod...

Embodiment 2

[0016] Take human serum immunoglobulin chromatographic solution (purity 99.5%, concentration 0.25mmol / L) after virus inactivation, concentrate by ultrafiltration to prepare an immunoglobulin solution with a concentration of 10wt%, take 1L sample, add glucose to 220mmol / L L, adjust the pH to 3.85 as a blank control sample, take another 3 L, add cysteine ​​to 4mmol / L, maltose to 500mmol / L, glycine to 130mmol / L, adjust the pH to 3.85, respectively for sample 1, sample 2, Sample 3. The molecular size distribution of the product was investigated under the storage condition of 37°C.

[0017] The molecular size distribution was checked by high performance liquid chromatography according to Example 1. The immunoglobulin monomer plus dimer content was measured at 3, 6, 9, 12 and 24 months of storage, and the results are shown in the table below.

[0018]

Embodiment 3

[0020] Take the immunoglobulin chromatography solution after virus inactivation (purity 98.7%, concentration 0.27mmol / L), concentrate by ultrafiltration to prepare an immunoglobulin solution with a concentration of 5wt%, take 1L sample, add glucose to 225mmol / L, Adjust pH to 6.9 as blank control sample, take another 3L, add glutathione to 8mmol / L, maltose to 250mmol / L, serine to 75mmol / L, adjust pH to 6.9, divide into sample 1, sample 2, sample 3 1L. The molecular size distribution of the product was investigated under the storage condition of 37°C.

[0021] The molecular size distribution was checked by high performance liquid chromatography according to Example 1. The immunoglobulin monomer plus dimer content was measured at 3, 6, 9, 12 and 24 months of storage, and the results are shown in the table below.

[0022]

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PUM

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Abstract

The invention discloses a stabilizer capable of reducing or avoiding the polymerization of human serum immunoglobulin solution preparations during storage. The immunoglobulin solution preparations contain a combination of L-cysteine ​​or its hydrochloride and glutathione. One or more sulfhydryl protecting agents, the concentration of which is 3-20mmol / L; one or more sugar stabilizers containing maltose or trehalose, the concentration of which is 150-600mmol / L; and containing proline or its salt, One or more amino acid stabilizers of glycine or its salts, serine or its salts, the concentration of which is 12-150mmol / L, by adding stabilizers, it can reduce the occurrence of immunoglobulin due to high temperature, high concentration or long storage time Polymerization, improve the effectiveness of the drug.

Description

technical field [0001] The invention relates to a pharmaceutical additive, in particular to a stabilizer used for storage of human serum immunoglobulin solution preparation for intravenous injection. Background technique [0002] Human serum immunoglobulin (IgG) preparations are mainly used for primary and secondary immunoglobulin deficiency, as well as other autoimmune diseases, such as idiopathic thrombocytopenic purpura, Kawasaki disease, etc. [0003] IgG is purified from human plasma, which is produced by B cells and plasma cells after contacting antigens. Its molecular weight is about 150KDa, and it consists of four peptide chains. Two identical light chains (L) and heavy chains (H) pass through Two disulfide bonds are covalently linked, and otherwise, non-covalently cross-linked to form a homogeneous and symmetrical Y-shaped dimer. The light chain is composed of two homology domains and the heavy chain is composed of four homology domains, these domains are character...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K45/08
Inventor 黄锦程陈成坤王文杰黄邦春周仁花吴艳亲
Owner 广东卫伦生物制药有限公司
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