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Calibration product of osteocalcin detection reagent and preparation method thereof

A technology for detecting reagents and calibrator, which is applied in the field of calibrator of osteocalcin detection reagent and its preparation, can solve problems such as shortened shelf life, pollution, and difficulty in serum consistency, and achieve unstable storage, reduce production costs, and store long-term effect

Active Publication Date: 2019-03-19
DIRUI MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The main reason is that its composition is complex, its content and its mechanism of action are still unclear, especially some substances such as polypeptide growth factors, hormones and lipoproteins have not been fully understood, which will have a certain impact on the experiment; secondly, serum is mass-produced , there will be some differences between batches, and the storage period of serum also needs to be considered, which is likely to cause bacterial contamination and shorten the shelf life. Therefore, it is difficult to ensure the consistency of each batch of serum, so that the standardization of the experiment is limited. Restrictions; and the price of imported serum is relatively high, so there are many factors to be considered when choosing serum as a matrix component, which has greatly restricted the practical application
On the other hand, serum is easily contaminated by bacteria, which will bring certain risks to the stability of the validity period of the calibrator, and the price of high-quality serum is relatively high, which will increase the cost of the final calibrator

Method used

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  • Calibration product of osteocalcin detection reagent and preparation method thereof
  • Calibration product of osteocalcin detection reagent and preparation method thereof
  • Calibration product of osteocalcin detection reagent and preparation method thereof

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preparation example Construction

[0051] The invention provides a method for preparing a calibrator of an osteocalcin detection reagent, the method comprising:

[0052] (a), prepare buffer solution;

[0053] (b), adding the lyoprotectant and calcitonin of different concentrations to the buffer solution obtained in step (a);

[0054] (c), freeze-drying the buffer mixture obtained in step (b), thereby obtaining the calibrator;

[0055] In step (b), the order of adding the lyoprotectant and the antigen calcitonin is not particularly limited, and can be added simultaneously or sequentially;

[0056] Buffer of the present invention is one or more in disodium hydrogen phosphate-citric acid, MOPSO or barbiturate-hydrochloric acid buffer, preferably pH6.5-7.5, concentration is the MOPSO buffer of 10mM-20mM, Most preferred is MOPSO buffer at pH 7.5 at a concentration of 10 mM.

[0057] The freeze-drying protectant of the present invention is a mixture composed of amino acid protectant, protein protectant, sugar prot...

Embodiment 1

[0076] The preparation of embodiment 1 calibrator

[0077] Prepare 100 mL of MOPSO buffer solution with a pH of 7.5 and a concentration of 10 mM, add 1 g of glycine, 5 g of bovine serum albumin, 2 g of mannitol, 2 g of trehalose, 0.2 g of ProClin300, filter through a 0.22 μm filter membrane, and pour into the prepared calibration The concentrations of osteocalcin added to the product matrix were 0, 1.5, 8.4, 25.8, 60.5, 124.6, 290.8 ng / mL.

[0078] Weigh the prepared calibration product at 1g±0.005g / bottle, put it in a freeze dryer at room temperature, drop the temperature to -50°C, keep it for 4 hours, then raise the temperature to -40°C, keep it for 8 hours, after the main drying stage is completed, The temperature was raised to 30° C. and maintained for 3 hours.

[0079] The prepared calibrator uses international or domestic reference materials to trace the value of the calibrator

[0080] Add 1g±0.005g of pure water to the prepared lyophilized calibrator, and redissolve ...

Embodiment 2

[0082] The preparation of embodiment 2 calibrator

[0083] Prepare 100mL of barbiturate-HCl buffer solution with pH 7.5 and a concentration of 10mM, add 1g of glutamic acid, 5g of bovine serum albumin, 2g of sorbitol, 2g of sucrose, 0.2g of sodium azide, and a 0.22μm filter membrane After filtration, the concentrations of osteocalcin added to the prepared calibrator matrix were 0, 1.5, 8.4, 25.8, 60.5, 124.6, 290.8 ng / mL.

[0084] Weigh the prepared calibration product at 1g±0.005g / bottle, put it in a freeze dryer at room temperature, drop the temperature to -40°C, keep it for 4 hours, then raise the temperature to -30°C, keep it for 8 hours, after the main drying stage is completed, The temperature was raised to 25°C and maintained for 3 hours.

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Abstract

The invention belongs to the field of medicine in-vitro diagnosis, and particularly relates to a calibration product of an osteocalcin detection reagent and a preparation method thereof. Due to addingof a composite protection substance composed of an excipient, a surfactant, a stabilizer and a preservative, the calibration product is high in stability and can be stable for one month at room temperature, can be stable at 20 DEG C for one year; the preparation method can trace to international or national reference substance, so that accuracy of clinical result. The calibration product is suitable for industrial large-scale production, the problem that existing calibration products are unstable in preservation is solved, and production cost is lowered.

Description

technical field [0001] The invention belongs to the field of medical in vitro diagnosis, and in particular relates to a calibrator of an osteocalcin detection reagent and a preparation method thereof. Background technique [0002] Osteocalcin is the most important specific non-collagen protein in the bone matrix, synthesized and secreted by osteoblasts in bones and teeth, and its binding to bone calcium depends on vitamin K. Osteocalcin molecule contains 49 amino acids with a molecular weight of about 5800D. In bone synthesis, osteoblasts produce osteocalcin, which depends on vitamin K, and vitamin D3 can promote the production of osteocalcin. The use of vitamin K antagonists can reduce the content of this protein in bone, but it does not affect its proline content, nor does it affect the mechanical strength of bone. After the production of osteocalcin, part of it enters the bone matrix, and the other part is released into the peripheral blood. Therefore, the content of o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N1/28
CPCG01N1/28G01N33/68G01N2001/2893
Inventor 汪一名李娟赵妍
Owner DIRUI MEDICAL TECH CO LTD
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