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Method for detecting anaphylactoid reaction of Shengmai liquid preparation

A liquid preparation and detection method technology, which is applied in biological testing, material inspection products, etc., can solve the problems of low sensitivity, high sample requirements, cumbersome experimental process, etc., and achieve the effects of high sensitivity, reduced incidence, and guaranteed quality

Inactive Publication Date: 2012-07-18
JIANGSU SUZHONG PHARM GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among them, the animal experiment method has a long detection cycle and low sensitivity, and the ELISA method is relatively high in cost, cumbersome in the experimental process, and has high requirements for samples.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] 1. Preparation of basophils

[0034] 1) Preparation of Percoll suspension: take Percoll 90ml, add HBSS 9ml, 0.25mol / l HEPES 1ml, pH 7.3, 1mol / l HCl 0.4ml to adjust to pH7.4;

[0035] 2) Preparation of Percoll density gradient tube: Prepare solutions of different densities according to the ratio in the table below

[0036] density

Percoll / HBSS (ml / ml)

1.070

24∶20

1.079

27∶15.9

1.088

23∶10

[0037] 3) The order of adding the layered solution: first add 4ml 1.088g / ml Percoll solution to the bottom layer, add 4ml 1.079g / ml Percoll solution to the second layer, and add 3ml 1.070g / ml Percoll solution to the top layer to make 3 Density gradient tubes for separating basophils;

[0038] 4) Use 0.1mol / l EDTA, pH 7.7 to anticoagulate fresh blood, add an equal volume of fresh anticoagulated blood to the Percoll density gradient layering solution, and centrifuge at 1200rpm for 25min at room temperature;

[0039] 5) ...

Embodiment 2

[0046] 1. Preparation of basophils

[0047] 1) Preparation of Percoll suspension: take Percoll 90ml, add HBSS 9ml, 0.25mol / l HEPES 1ml, pH 7.3, 1mol / l HCl 0.4ml to adjust to pH7.4;

[0048] 2) Preparation of Percoll density gradient tube: Prepare solutions of different densities according to the ratio in the table below

[0049] density

Percoll / HBSS (ml / ml)

1.070

24∶20

1.079

27∶15.9

[0050] 1.088

23∶10

[0051] 3) The order of adding the layered solution: first add 4ml 1.088g / ml Percoll solution to the bottom layer, add 4ml 1.079g / ml Percoll solution to the second layer, and add 3ml 1.070g / ml Percoll solution to the top layer to make 3 Density gradient tubes for separating basophils;

[0052] 4) Use 0.1mol / l EDTA, pH 7.7 to anticoagulate fresh blood, add an equal volume of fresh anticoagulated blood to the Percoll density gradient layering solution, and centrifuge at 1200rpm for 25min at room temperatu...

Embodiment 3

[0060] 1. Preparation of basophils

[0061] 1) Preparation of Percoll suspension: take Percoll 90ml, add HBSS 9ml, 0.25mol / l HEPES 1ml, pH 7.3, 1mol / l HCl 0.4ml to adjust to pH7.4;

[0062] 2) Preparation of Percoll density gradient tube: Prepare solutions of different densities according to the ratio in the table below

[0063] density

Percoll / HBSS (ml / ml)

1.070

24∶20

1.079

27∶15.9

1.088

23∶10

[0064] 3) The order of adding the layered solution: first add 4ml 1.088g / ml Percoll solution to the bottom layer, add 4ml 1.079g / ml Percoll solution to the second layer, and add 3ml 1.070g / ml Percoll solution to the top layer to make 3 Density gradient tubes for separating basophils;

[0065] 4) Use 0.1mol / l EDTA, pH 7.7 to anticoagulate fresh blood, add an equal volume of fresh anticoagulated blood to the Percoll density gradient layering solution, and centrifuge at 1200rpm for 25min at room temperature;

[0066] 5) ...

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PUM

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Abstract

The invention discloses a method for detecting an anaphylactoid reaction of a Shengmai liquid preparation. According to the method, the quality of a finished Shengmai liquid preparation product is detected by inducing the activation amount of basophilic granulocyte through the Shengmai liquid preparation, and the method is a quick detection method for industrial scale production safety evaluation of the Shengmai liquid preparation, so that the quality of the finished Shengmai liquid preparation product is ensured, and the occurrence rate of the anaphylactoid reaction in the clinical application process is reduced.

Description

technical field [0001] The invention relates to a detection method for hypersensitivity reactions of Shengmai liquid preparations, in particular to a detection method for measuring basophil degranulation induced by Shengmai liquid preparations. Background technique [0002] Allergic reactions include acute allergic reactions and non-acute allergic reactions, wherein acute allergic reactions are divided into type I allergic reactions and anaphylactoid reactions, and the vast majority of acute allergic reactions are anaphylactoid reactions. [0003] Among the adverse reactions of Shengmai liquid preparations during clinical use, the incidence of anaphylactoid reactions is the highest. The current commonly used methods for detecting hypersensitivity reactions mainly include animal experiments and ELISA. Among them, the animal experiment method has a long detection cycle and low sensitivity, and the ELISA method has relatively high cost, cumbersome experimental process and high...

Claims

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Application Information

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IPC IPC(8): G01N33/53
Inventor 欧阳强易宏伟戴德玲
Owner JIANGSU SUZHONG PHARM GRP CO LTD
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