Method for determining content of high molecule weight substance in injection

A technology of high molecular weight and substance content, applied in the direction of measuring device, material separation, analysis material, etc., to achieve the effect of less interference, saving first aid time, and high sensitivity
CN1808116AActive Publication Date: 2006-07-26MUDANJIANG YOUBO PHARMA CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
MUDANJIANG YOUBO PHARMA CO LTD
Publication Date
2006-07-26

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Abstract

The invention provides a method for measuring the content of high molecular weight matter in an injection. Particularly provides a method which measures content of high molecular weight matter in Shuxuetong injection with high efficiency liquid chromatography, taking human insulin as reference, measures the content of which molecular weight greater then human insulin as high molecular weight matter content. The inventive method has the advantages of being quick, accurate and of have high sensibility.
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Description

technical field

[0001] The invention relates to a method for determining the content of high-molecular-weight substances in injections, in particular to high-performance liquid chromatography for determining the content of high-molecular-weight substances in injections. Background technique

[0002] For injection products containing high molecular weight substances, from the perspective of safety, patients need to undergo skin tests when applying them. However, the skin test can only predict the immediate type I allergic reaction, and the positive coincidence rate is only 30%. Even if the skin test is negative, it cannot explain that no allergic reaction will occur in the future. There are also II and III allergic reactions that may occur clinically. , Type IV allergy, which cannot be predicted by the skin test.

[0003] Therefore, in order to ensure the safety and effectiveness of clinical medication, the content of high-molecular-weight substances in injection products is...

Claims

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