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Quality control method and quality control standard for the biological activity of osteopeptide for injection on rheumatoid arthritis

A biologically active and rheumatoid technology, applied in biochemical equipment and methods, microbial measurement/testing, biological material analysis, etc., can solve the problem of lack of quality control of biological activity

Active Publication Date: 2021-05-11
HEILONGJIANG ZBD PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no effective method to evaluate its biological activity, especially for the biological activity of osteopeptide "rheumatoid arthritis" indication, there is a lack of quality control

Method used

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  • Quality control method and quality control standard for the biological activity of osteopeptide for injection on rheumatoid arthritis
  • Quality control method and quality control standard for the biological activity of osteopeptide for injection on rheumatoid arthritis
  • Quality control method and quality control standard for the biological activity of osteopeptide for injection on rheumatoid arthritis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] This example provides a quality control method for the biological activity of ossotide for injection on rheumatoid arthritis, which includes:

[0045] MTT method was used to detect the inhibitory activity of osteopeptide for injection on synovial fibroblasts (MH7A) of rheumatoid arthritis:

[0046] 1. Preparation of reagents and liquid medicine

[0047] Thiazolium blue (MTT) solution: Accurately weigh 250 mg of MTT, dissolve in 50 mL of PBS (0.01 mol L-1, pH 7.4), filter and sterilize with a 0.22 μm microporous membrane, aliquot, and store in the dark at 4°C. Valid for two weeks.

[0048] Osteopeptide solution for injection: take 1 stick (10 mg) of osteopeptide freeze-dried powder for injection, add 500 μL of 1640 complete culture solution to dissolve, make 20 g L-1 osteopeptide mother solution for injection, and then dilute it with 1640 complete medium to working concentration. Each experiment is used now.

[0049] 2. Cell culture

[0050] MH7A cells were cultured...

Embodiment 2

[0069] This example provides a quality control method for the biological activity of ossotide for injection on rheumatoid arthritis, which includes:

[0070] The inhibitory activity of osteopeptide for injection on human mononuclear macrophages (THP-1) was detected by CCK-8 method:

[0071] 1. Preparation of reagents and liquid medicine

[0072] Osteopeptide solution for injection: take 1 stick (10 mg) of osteopeptide freeze-dried powder for injection, add 500 μL of 1640 complete culture medium to dissolve, make 20 mg·mL-1 osteopeptide mother solution for injection, and then dilute it with 1640 complete medium to working concentration. Each experiment is used now.

[0073] 2. Cell culture

[0074] THP-1 cells were cultured in 1640 complete culture medium (containing 10% fetal bovine serum, 100 U·mL-1 penicillin / streptomycin), placed in an incubator at 37°C, 5% CO2 and saturated humidity, and the right Cells in growth phase were counted for subsequent experiments.

[0075]...

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Abstract

The invention provides a quality control method and a quality control standard for the biological activity of osteopeptide for injection on rheumatoid arthritis, and relates to the field of drug quality control. It includes: using the MTT method to detect the inhibitory activity of osteopeptide for injection on synovial fibroblasts of rheumatoid arthritis; using the CCK-8 method to detect the inhibitory activity of osteopeptide for injection on monocyte-macrophages; and the dose-response The parallel line method was used to evaluate the biological potency and credible limit rate of osteopeptide for injection on rheumatoid arthritis synovial fibroblasts and monocyte-macrophages. The method has high repeatability, simple operation, rapid and accurate detection, which not only supplements the quality control method of osteopeptide for injection, but also can reflect the biological effect and quality of the drug more intuitively. The quality control standard of osteopeptide for injection formed by this method will help to ensure the safety, effectiveness and quality controllability of the drug more comprehensively and comprehensively.

Description

technical field [0001] The invention relates to the field of drug quality control, in particular to a quality control method and a quality control standard for the biological activity of osteopeptide for injection on rheumatoid arthritis. Background technique [0002] Rheumatoid arthritis (RA) is a common clinical chronic inflammatory autoimmune disease, characterized by polyarticular inflammation, synovial hyperplasia and bone erosion, manifested as symmetrical peripheral polyarthritis, and eventually leads to joint Destruction, functional disability. Abnormal proliferation of fibroblast-like synoviocytes in affected joints is a characteristic change of RA that distinguishes it from other joint inflammations. Studies have shown that osteopeptide can regulate bone metabolism, inhibit inflammatory erosion, and effectively relieve pain, stiffness and other symptoms. [0003] Osteopeptide for injection belongs to the class of polypeptide drugs. During the process from its pro...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C12Q1/02
CPCC12N2503/02G01N33/5008G01N33/5044G01N33/5055G01N2500/10
Inventor 方同华许照芹项彦华葛一蒙韩淑娴张倩
Owner HEILONGJIANG ZBD PHARMA
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