Method for measuring trace of albumin in pulse promoting injection

A technology of Shengmai injection and trace protein, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of undetectable trace protein, unsuitable intermediate determination, long detection cycle, etc., achieve stability and product quality, prevent Allergic reactions, high sensitivity effects

Active Publication Date: 2013-08-14
江苏苏中药业集团生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this type of test has at least two defects: 1. The detection period is too long, which is not suitable for the determination of intermediates; 2. The sensitivity is low, and it is impossible to detect trace proteins containing potential allergens in the product

Method used

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  • Method for measuring trace of albumin in pulse promoting injection
  • Method for measuring trace of albumin in pulse promoting injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] 1. Preparation of Shengmai Antigen: Take ginseng, Ophiopogon japonicus, and Schisandra chinensis as raw materials with a mass ratio of 10:32.1:15.6, slightly crush them, boil and reflux for 2 h, filter, and precipitate the filtrate with 60% ethanol, filter, and collect the precipitate , the precipitate was reconstituted with water and freeze-dried to obtain the Shengmai antigen. The BCA method was used to prepare the standard curve with bovine serum albumin (BSA) to determine the protein content in Shengmai antigen.

[0039] 2. Preparation of anti-Shengmai antigen antibody: Rabbits were immunized with Shengmai antigen to prepare rabbit anti-Shengmai antigen serum. The method is as follows, the antigen is prepared with complete Freund's adjuvant, and New Zealand rabbits are injected into the toes or subcutaneously at multiple points for initial immunization, and the dose is 1 mg / rat based on the protein contained. Three weeks later, the antigen was prepared with incomp...

Embodiment 2

[0044] 1. Preparation of Shengmai antigen: take raw materials ginseng, Ophiopogon japonicus, and schisandra with a mass ratio of 10:32.1:15.6, slightly crush them, boil and reflux for 4 h, filter, and precipitate the filtrate with 85% ethanol, filter, and collect the precipitate , the precipitate was reconstituted with water and freeze-dried to obtain the Shengmai antigen. The BCA method was used to prepare the standard curve with bovine serum albumin (BSA) to determine the protein content in Shengmai antigen.

[0045] 2. Preparation of anti-Shengmai antigen antibody: New Zealand rabbits were immunized with Shengmai antigen to prepare rabbit anti-Shengmai antigen serum. The method is as follows, the antigen is prepared with complete Freund's adjuvant, and New Zealand rabbits are injected into the toes or subcutaneously at multiple points for initial immunization, and the dose is 3 mg per rabbit based on the protein content. Two weeks later, the antigen was prepared with inco...

Embodiment 3

[0050] 1. Preparation of Shengmai antigen: take the raw materials ginseng, Ophiopogon japonicus, and Schisandra chinensis with a mass ratio of 10:32.1:15.6, slightly crush them, boil and reflux for 1 hour, filter, and precipitate the filtrate with 75% ethanol, filter, and collect the precipitate. The precipitate was reconstituted with water and freeze-dried to obtain Shengmai antigen. The BCA method was used to prepare the standard curve with bovine serum albumin (BSA) to determine the protein content in Shengmai antigen.

[0051] 2. Preparation of anti-Shengmai antigen antibody: New Zealand rabbits were immunized with Shengmai antigen to prepare rabbit anti-Shengmai antigen serum. The method is as follows, the antigen is prepared with complete Freund's adjuvant, and New Zealand rabbits are injected into the toes or subcutaneously at multiple points for initial immunization, and the dose is 5 mg / rat based on the protein contained. Three weeks later, the antigen was prepared ...

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Abstract

The invention discloses a method for measuring trace of albumin in a pulse promoting injection. The method comprises the following steps of: preparing an antigen with a water extraction alcohol precipitation method; preparing an anti-pulse-promoting antigen blood serum with a rabbit immunifaction, and further purifying to prepare an antibody; and measuring the content of the trace of albumin in the pulse promoting injection by utilizing an ELISA (Enzyme Linked Immuno Sorbent Assay). The invention solves the problem that the content of the trace of albumin in the pulse promoting injection can not be detected quickly and has important significance in improving the quality of a pulse promoting injection product and preventing the clinical anaphylactic response.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for measuring trace protein in Shengmai injection. Background technique [0002] Shengmai injection is a traditional Chinese medicine injection that has been clinically used for many years. It is mainly used to treat septic shock, cardiogenic shock and myocardial infarction. [0003] The clinical adverse reactions of Shengmai injection include: allergic rash, contact allergic dermatitis, abdominal distension, hypotension, tachycardia, etc., among which the incidence of anaphylaxis is the highest. There are many reasons for the allergic reaction of Shengmai injection, and macromolecular substances such as protein are the main allergens. At present, methods for detecting allergic reactions generally use animal experiments, such as experiments with guinea pigs and rats. However, this type of test has at least two defects: 1. The detection period is too long, which i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/543
Inventor 欧阳强林爱琴戴德玲王光凤
Owner 江苏苏中药业集团生物制药有限公司
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