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Adrenocorticotropic hormone solution and application thereof

A technology of adrenal cortex and hormones, applied in the direction of material inspection products, coatings, instruments, etc., can solve problems such as high requirements for instruments and equipment, increase product production costs, and affect test results, etc., to reduce preparation costs and facilitate operation and preparation 、Overcome the complex effect of freeze-drying process

Active Publication Date: 2018-02-16
SICHUAN MACCURA BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the freeze-drying process of ACTH freeze-dried powder is complicated, and requires high staff, equipment, etc. Uncontrollable factors such as staff, equipment, and reconstitution will increase the quality of ACTH quality control or calibrator products. Differences between batches and bottles affect the test results and increase the production cost of the product to a certain extent

Method used

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  • Adrenocorticotropic hormone solution and application thereof
  • Adrenocorticotropic hormone solution and application thereof
  • Adrenocorticotropic hormone solution and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] The preparation of embodiment 1 adrenocorticotropic hormone solution

[0022] The corticotropic hormone solution of the present invention comprises the following steps:

[0023] (1) Dissolve 2-morpholineethanesulfonic acid in water, then add NaCl, after complete dissolution, add NaOH or hydrochloric acid to adjust the pH value to 5.4-5.6;

[0024] (2) Add trehalose, casein, 4-aminoantipyrine, surfactant, glycerol, and biological preservatives to the solution in step (1) in sequence, and then add NaOH or hydrochloric acid to adjust the pH value to 5.5-6.7 ; pH preferably 5.9-6.1.

[0025] (3) Adding corticotropin antigen to the solution in step (2).

[0026] The dosage and source of specific ingredients are shown in Table 1. Purified water is used as the dosing solvent, and the other material can only be put in after the former material is completely dissolved.

[0027] Table 1

[0028]

[0029]

Embodiment 2

[0030] Performance evaluation of embodiment 2 corticotropic hormone solution

[0031] Stability tests were carried out using five different formulations of groups A, B, C, D, and E in Table 2. Wherein group B is the optimal ratio of each component of the corticotropic hormone solution of the present invention, group C is the higher concentration ratio of each component of the corticotropic hormone solution of the present invention, and group D is the corticotropic hormone solution of the present invention The concentration ratio of each component is lower, and the ratio and pH value of the other components in group E are the same as those in group B except that 4-aminoantipyrine is not added.

[0032] Table 2

[0033]

A

B

C

D

E

Phosphate buffer

20mM

/

/

/

/

2-Morpholineethanesulfonic acid

/

20mM

100mM

10mM

20mM

NaCl

0.90％

0.90％

0.90％

0.90％

0.90％

Trehalose

1...

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Abstract

The invention relates to an adrenocorticotropic hormone solution and application thereof. The solution is prepared from adrenocorticotropic hormone antigen, 2-morpholinoethanesulfonic acid, NaCl, trehalose, casein, 4-aminoantipyrine and water. The invention provides a preparation method of the adrenocorticotropic hormone solution and the application of the adrenocorticotropic hormone solution. Thepreparation method of the solution is simple and cost-saving, and a technological process is controllable; a finished product has good stability and can be maintained for 7-14 days at the temperatureof 37 DEG C, and the titer retention rate is still greater than 85%; after the finished product is stored for 12 months at the temperature of 2-8 DEG C, the titer retention rate is greater than 90%;the adrenocorticotropic hormone solution can be used as a calibration product or a quality control product of adrenocorticotropic hormone for performing in vitro quantitative detection on the adrenocorticotropic hormone in human plasma, thus having good clinical application prospect.

Description

technical field [0001] The invention relates to an in vitro diagnostic reagent calibrator or quality control product, in particular to a liquid adrenocorticotropic hormone calibrator or quality control product with a simple preparation method and stable potency and an application thereof. Background technique [0002] Adrenocorticotropic hormone (ACTH) is a peptide hormone composed of 39 amino acids with a molecular weight of about 4.5kD. ACTH is produced in the pituitary gland and acts on the adrenal cortex to promote the proliferation of adrenal cortical tissue and the production and secretion of corticosteroids. Clinically, ACTH detection is valuable for the differential diagnosis of adrenal hypofunction and hypersecretion. Therefore, in vitro diagnostic reagents for the determination of ACTH have emerged. [0003] In vitro diagnostic reagents for the determination of ACTH need to be equipped with ACTH quality control or calibrator. However, the liquid ACTH quality cont...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/74G01N33/536G01N33/577G01N33/543G01N33/532
CPCG01N33/532G01N33/536G01N33/54326G01N33/577G01N33/74G01N2333/5751G01N2446/80
Inventor 黄燕玲赵浩瀚郭鹏徐雨
Owner SICHUAN MACCURA BIOTECH CO LTD
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