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Adrenocorticotropic hormone quality control material and preparation method thereof

A technology of adrenal cortex and quality control products, applied in the field of quality control, can solve the problems of ACTH poor stability, waste, and increase customer costs, and achieve the effect of reducing matrix effect, improving stability, and improving stability

Pending Publication Date: 2021-03-23
郑州标源生物科技有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the disadvantage of these quality control products is that ACTH has poor stability, usually can only be used once, and needs to be tested immediately, and cannot be sub-packaged and frozen, which has caused many restrictions for customers
Moreover, the current quality control product is a compound type, and the volume of each bottle is not less than 2mL. ACTH needs to be tested immediately after reconstitution. If the quality control product is only used for ACTH detection, it will cause a lot of waste and increase the number of customers. cost
Reconstitution is required every time ACTH quality control is performed, which increases the customer's operational work
At the same time, for the manufacturer, because the stability of ACTH is extremely poor, it is necessary to control the time from the completion of each preparation to the freeze-drying of sub-packaging, otherwise it is easy to cause differences in the concentration of ACTH between batches and batches

Method used

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  • Adrenocorticotropic hormone quality control material and preparation method thereof
  • Adrenocorticotropic hormone quality control material and preparation method thereof
  • Adrenocorticotropic hormone quality control material and preparation method thereof

Examples

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Embodiment 1

[0047] The preparation of embodiment 1 corticotropin quality control product

[0048] One, the quality control product formula of the present embodiment:

[0049]

[0050] 2. Preparation method:

[0051] The first step is to select commercial human plasma and test its HBsAg, hepatitis C antibody, syphilis antibody, and HIV antibody to ensure that they are all negative.

[0052] In the second step, select human plasma negative for HBsAg, hepatitis C antibody, syphilis antibody, and HIV antibody to be inactivated in a water bath at 56° C. for 3 hours.

[0053] In the third step, adjust the plasma pH in the second step to 6.5, then add aprotinin, sodium azide, Proclin300, gentamicin sulfate, EDTA-2Na, trehalose, and mix well;

[0054] The fourth step is to measure the background value of corticotropin and store it temporarily at 2-8°C;

[0055] In the fifth step, according to the background value determined in the fourth step, corticotropin active materials are added, and t...

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Abstract

The invention relates to the technical field of quality control, particularly to an adrenocorticotropic hormone quality control product and a preparation method thereof. The quality control product comprises the following raw materials and auxiliary materials: 0.01-0.1% of aprotinin, 0.1-1.0% of a preservative, 0.1-1.0% of EDTA-2Na, 1-10% of carbohydrates, 10-500 pg / mL of adrenocorticotropic hormone and the balance of inactivated plasma. By adopting a plasma inactivation process and an added formula, the stability of the adrenocorticotropic hormone quality control product can be improved.

Description

technical field [0001] The invention relates to the technical field of quality control, in particular to a corticotropin quality control product and a preparation method thereof. Background technique [0002] Adrenocorticotropic hormone (Adrenocorticotrophic Hormone, ACTH) is a hormone secreted by the anterior lobe of the pituitary. It is a polypeptide hormone composed of 39 amino acids. Axis is crucial. The corticotropic hormone cells of the pituitary gland secrete and release ACTH after being stimulated by corticotropic releasing hormone (CRH) released by the hypothalamus. ACTH acts on the adrenal cortex to promote the synthesis and secretion of glucocorticoids (especially cortisol). High concentrations of glucocorticoids in the blood can inhibit the secretion of CRH and ACTH through a negative feedback mechanism. ACTH in peripheral blood only exists in a small amount of pg / mL, and it is often detected clinically by immunoassay, and the double-antibody sandwich method u...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/531G01N33/74
CPCG01N33/531G01N33/74G01N2333/695G01N2496/05G01N2496/45
Inventor 杨建乐赵晓转王亚洲王新明刘功成
Owner 郑州标源生物科技有限公司
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