A kind of lyophilized liquid formula and its application

A freeze-drying and formulating technology, applied in instruments, measuring devices, scientific instruments, etc., can solve the problems of difficulty in meeting the preservation requirements of the kit, use restrictions, and different preservation effects, and achieve good product appearance, improved molding rate, and good freezing. dry effect

Active Publication Date: 2019-02-01
广东云天抗体生物科技有限公司
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  • Abstract
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  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the storage methods of ELISA standard products include glycerol -20°C storage method and vacuum freeze-drying method. These two methods can prolong the stability of the protein, but it is difficult to meet the long-term storage requirements of the kit.
From practical experience, it is found that different proteins have different preservation effects on the lyophilized solution of the same formula
However, the storage time of general kits on the market is half a year, which limits the use

Method used

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  • A kind of lyophilized liquid formula and its application
  • A kind of lyophilized liquid formula and its application
  • A kind of lyophilized liquid formula and its application

Examples

Experimental program
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Embodiment 1

[0021] Preparation of lyophilized solution: 1% sodium caseinate, 5% mannitol, and 0.1% polypyrrolidone K30 (PVPK30) were dissolved in 0.01 mol / L phosphate buffer (PBS) with a pH of 7.4.

[0022] The formulas of all the other embodiments and comparative examples are shown in Table 1

[0023] Table 1

[0024]

[0025] The preparation of monkey cytokine IL-12 / 23 ELISA standard product comprises the following steps:

[0026] S1. Pre-cool freeze-drying related equipment, such as vials, racks, and trays, to 4°C;

[0027] S2. After the monkey cytokine IL-12 / 23 standard protein was dissolved in water, it was prepared into a mother liquor, and the mother liquor was diluted to the target concentration with the lyophilized solution of each embodiment or comparative example to obtain a standard concentration protein solution;

[0028] S3. Dispense the standard concentration protein solution obtained in S2. into S1. pre-cooled 3mL vials, fill each bottle with 1mL protein solution, and...

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Abstract

The invention discloses a freeze-drying solution formula and application thereof. The freeze-drying solution is prepared from the following components in percentage by mass: 0.5-5% of sodium caseinate, 1-10% of mannitol, 0.05-0.5% of polypyrrolidone K30 and the balance of phosphate buffer liquor with concentration of 0.01 mol / L. The freeze-drying solution formula is reasonably matched, is beneficial for film-forming of protein by cooperative effect of mannitol and polypyrrolidone K30, reduces a wall-hanging phenomenon which appears after the freeze-drying powder is freeze-dried, and improves a forming rate of the freeze-drying powder. The freeze-drying solution formula is freeze-dried, so that good forming effect can be obtained, and the product is good in appearance and is free of bad phenomena such as the wall-hanging phenomenon. The freeze-drying solution has very good freeze-drying effect on various cell factors, especially has very good freeze-drying effect on monkey cell factors. The monkey cell factor standard product prepared by the freeze-drying solution has the quality guarantee period which can reach two years.

Description

technical field [0001] The invention belongs to the field of preparation of biological in vitro diagnostic reagents. It specifically relates to a freeze-dried liquid formula and application thereof. Background technique [0002] Enzyme-linked immunosorbent assay (ELISA), as the internationally recognized gold standard for protein quantification, has the characteristics of high sensitivity and good specificity. Among them, the standard is a key to the composition of the ELISA kit, and the shelf life of the standard directly affects the shelf life of the kit. At present, the storage methods of ELISA standard products include glycerol -20°C storage method and vacuum freeze-drying method. These two methods can prolong the stability of the protein to a certain extent, but it is difficult to meet the long-term storage requirements of the kit. From practical experience, it is found that different proteins have different preservation effects on the same formula of lyophilized liqu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/531
CPCG01N33/531
Inventor 毕利军朱国峰张晓莉邓丽华冯欣怡
Owner 广东云天抗体生物科技有限公司
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