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5'-nucleotidase quality control product

A technology of nucleotidase and quality control products, applied in the field of 5'-nucleotidase quality control products, can solve the problems of short validity period and achieve the effects of improving stability, avoiding damage, and protecting stability

Pending Publication Date: 2019-10-15
DIRUI MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is to provide a 5'-nucleotidase quality control product in order to solve the problem that the existing 5'-nucleotidase quality control product has a shorter validity period

Method used

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Examples

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preparation example Construction

[0035] The preparation of the 5'-nucleotidase quality control product of the present invention can be prepared according to the conventional process method in this field, without special restrictions, preferably:

[0036] Add matrix serum into a clean preparation container, then add buffer, preservative, protective agent 1, protective agent 2, and surfactant in sequence, and stir until completely dissolved; use a 0.22um filter membrane to filter once, and use Dilute HCL solution or 0.1% NaOH solution to adjust the pH value to 7.5-7.6 (20±0.5°C), add 5'-nucleotidase according to the concentration calculation, so that the concentration of the quality control product is 45-72U / L, according to 1ml / bottle specifications for packaging.

Embodiment 1

[0039] A long-acting and stable 5'-nucleotidase quality control product, the composition of which is as follows:

[0040]

[0041] The preparation process of this quality control product is:

[0042] Add the whole batch of matrix serum into a clean preparation container, then add the whole batch of buffer solution, preservative, protective agent 1, protective agent 2, and surfactant in sequence, and stir until completely dissolved; use 0.22um filter membrane once. Use dilute HCL solution or 0.1% NaOH solution to adjust the pH value to 7.5-7.6 (20±0.5°C), and add 5’-nucleotidase according to the concentration calculation, so that the concentration of the quality control product is 45-72U / L. Pack according to the specification of 1ml / bottle.

Embodiment 2

[0044] A long-acting and stable 5'-nucleotidase quality control product, the composition of which is as follows:

[0045]

[0046]

[0047] The preparation process of this quality control product is:

[0048] Add the whole batch of matrix serum into a clean preparation container, then add the whole batch of buffer solution, preservative, protective agent 1, protective agent 2, and surfactant in sequence, and stir until completely dissolved; use 0.22um filter membrane once. Use dilute HCL solution or 0.1% NaOH solution to adjust the pH value to 7.5-7.6 (20±0.5°C), and add 5’-nucleotidase according to the concentration calculation, so that the concentration of the quality control product is 45-72U / L. Pack according to the specification of 1ml / bottle.

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Abstract

The present invention provides a 5'-nucleotidase quality control product and belongs to the technical field of quality control products. The quality control product specifically comprises the following components: 10-100 mmol / L of a buffer solution, 0.1-1% of a preservative, 0.1-5% of a protective agent 1, 0.1-5% of a protective agent 2, 0.1-2 mL / L of a surfactant, 1 L of matrix serum and 45-72 U / L of 5'-nucleotidase; the buffer solution is one or more of a TAPSO buffer solution, a potassium dihydrogen phosphate-sodium hydroxide buffer solution, a barbital buffer solution, a MOPS buffer solution, a HEPES buffer solution, a PIPES buffer solution and a phosphate buffer solution; and the protective agent 1 and the protective agent 2 are different and respectively selected from one of glucose,lactose, maltose, maltodextrin and arginine. The 5'-nucleotidase quality control product has an expiration date reaching 24 months.

Description

technical field [0001] The invention belongs to the technical field of quality control products, in particular to a 5'-nucleotidase quality control product. Background technique [0002] The determination of 5'-nucleotidase (5'-NT) is mainly used in the diagnosis of hepatobiliary system diseases and the differential diagnosis of bone diseases. Elevated serum 5'-NT is mainly seen in hepatobiliary system diseases, such as obstructive jaundice, liver cancer, hepatitis, etc., and its level changes are consistent with alkaline phosphatase (ALP). However, in diseases of the skeletal system, such as tumor metastasis, osteitis deformans, rickets, hyperparathyroidism, etc., the ALP level is usually elevated, while the 5'-NT is normal. Therefore, the simultaneous determination of ALP and 5'-NT is helpful for the differential diagnosis of hepatobiliary and skeletal system diseases. [0003] The 5'-nucleotidase quality control substance for biochemistry refers to a quality control sub...

Claims

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Application Information

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IPC IPC(8): C12Q1/44
CPCC12Q1/44
Inventor 刘阳李慧婷潘晓恒夏冬梅孙成艳何浩会
Owner DIRUI MEDICAL TECH CO LTD
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