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Lyophilized heparanase preparation, heparanase cup as well as preparation method and application of lyophilized heparanase preparation and heparanase cup

The technology of freeze-dried preparation and heparinase cup is applied in the field of freeze-dried preparation of heparinase to achieve the effects of preventing blood coagulation, prolonging the validity period of the product and being convenient to use.

Inactive Publication Date: 2018-06-12
深圳优迪生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, current heparinase preparations still need to be improved

Method used

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  • Lyophilized heparanase preparation, heparanase cup as well as preparation method and application of lyophilized heparanase preparation and heparanase cup
  • Lyophilized heparanase preparation, heparanase cup as well as preparation method and application of lyophilized heparanase preparation and heparanase cup
  • Lyophilized heparanase preparation, heparanase cup as well as preparation method and application of lyophilized heparanase preparation and heparanase cup

Examples

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preparation example Construction

[0064] The present invention also provides a preparation method of a heparinase cup, which comprises freeze-drying and sealing the above-mentioned heparinase freeze-drying composition or the above-mentioned heparinase freeze-drying liquid to prepare liver Vegetable cup. On this basis, it is used in conjunction with a thromboelastogram ordinary cup (kaolin graph reagent) for the detection of blood samples.

[0065] According to an embodiment of the present invention, the freeze-drying process includes prefreezing treatment, sublimation treatment and drying treatment, wherein the prefreezing treatment is carried out at a temperature of -40 degrees Celsius to -70 degrees Celsius for 5 to 20 minutes ; The sublimation treatment is carried out at a temperature of -40 degrees Celsius to 20 degrees Celsius for 10 to 60 minutes; the drying treatment is carried out at a temperature of 20 to 30 degrees Celsius for 15 to 30 hours. Through pre-freezing treatment, the main properties of th...

Embodiment 1

[0083] The heparanase freeze-dried solution was prepared according to the steps in Preparation Examples 1-3, and then freeze-dried and sealed to obtain a heparinase cup.

preparation example 1

[0085] (1) Weigh 0.005g of heparinase I, 5.0g of mannitol, 3.0g of bovine serum albumin, 1.5g of calcium chloride and 0.07g of Proclin300, dissolve them in 100mL of purified water, stir to fully dissolve, and prepare heparin Enzyme freeze-dried solution, adjust the pH to 7.20 with 1mol / L hydrochloric acid.

[0086] (2) Freeze-drying the heparanase freeze-dried solution prepared in step (1) to obtain a freeze-dried powder. Specifically include the following steps:

[0087] 1) Pre-freezing: pre-freeze the lyophilized liquid prepared in step (2) at -40°C, and the pre-freezing time is 10 minutes;

[0088] 2) Sublimation: sublimate the pre-frozen material in step 1) at -20°C, and the sublimation time is 20 minutes;

[0089] 3) Drying: the sublimated substance in step 2) is dried at a drying temperature of 20° C. and a drying time of 20 h.

[0090] (3) Sealing and packaging the freeze-dried powder prepared in step (2) by using a fully automatic blister packaging machine to prepar...

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Abstract

The invention relates to the technical field of in vitro diagnostic reagents, and particularly relates to a lyophilized heparanase preparation, a heparanase cup as well as a preparation method and application of the lyophilized heparanase preparation and the heparanase cup. A redissolved enzyme activity yield of the lyophilized heparanase preparation provided by the invention is at least 75 percent. The heparanase cup provided by the invention comprises a cup body and the lyophilized heparanase preparation, wherein an accommodating space is defined in the cup body; the lyophilized heparanase preparation is arranged in the accommodating space. The invention also provides a method for preparing the lyophilized heparanase preparation. The method comprises the following steps: sequentially performing pre-freezing treatment, sublimation treatment and drying treatment on aqueous solutions prepared from heparinase, a protective agent, buffer salt and a preservative in a predetermined proportion so as to obtain the lyophilized heparanase preparation. The lyophilized heparanase preparation and the heparanase cup are used in a detection process of blood samples, and the detection sensitivityis high; moreover, the activity and the stability of the heparinase in a lyophilization process can be obviously improved.

Description

technical field [0001] The invention relates to the technical field of in vitro diagnostic reagents, in particular to a heparinase freeze-dried preparation, a heparinase cup, a preparation method and application thereof. Background technique [0002] Heparinase is a kind of enzyme that can specifically cleave the glycosidic bonds of heparin and heparin-like main chains. Heparinase is widely used, such as removing residual heparin in blood, preventing coagulation, producing low molecular weight heparin, and studying the structure of heparin. In addition, heparanase can be used in biochemical assays of blood samples such as thromboelastography. [0003] However, current heparinase preparations still need to be improved. Contents of the invention [0004] The present invention aims to solve one of the technical problems in the related art at least to a certain extent. For this reason, an object of the present invention is to propose a kind of heparanase lyophilized preparat...

Claims

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Application Information

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IPC IPC(8): C12Q1/56C12Q1/34
CPCC12Q1/34C12Q1/56G01N2333/924
Inventor 艾峰孙莹孙军
Owner 深圳优迪生物技术有限公司
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