A detection kit for urinary kallidin residual protein and a preparation method and application thereof

By developing a detection kit containing capture and detection antibodies, combined with the ELISA method, the issues of simplicity and accuracy in detecting residual proteins in urokinase have been resolved. This enables highly sensitive and specific quantitative analysis, suitable for the quality control of urokinase active pharmaceutical ingredient.

CN122084888BActive Publication Date: 2026-07-24NANJING AIDEA PHARM TECH CO LTD +2
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Patent Information

Application Number
CN202610561279.3
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2026-04-27
Publication Date
2026-07-24
Estimated Expiration
2046-04-27

AI Technical Summary

Technical Problem

Existing technologies lack simple and accurate methods for detecting residual proteins in urokinase, especially for quantitative analysis in urokinase active pharmaceutical ingredients. Furthermore, existing methods are costly and complex to operate, making them difficult to meet routine quality control requirements.

Method used

Develop a detection kit comprising a capture antibody and a detection antibody, and prepare a highly specific and sensitive detection method by combining an anti-Urokinase residual protein polyclonal antibody and a biotin-labeled anti-Urokinase residual protein polyclonal antibody with an enzyme-linked immunosorbent assay (ELISA).

Benefits of technology

This method achieves highly sensitive and specific quantitative detection of residual proteins in urokinase. It is simple, suitable for routine quality control, and has a detection limit of about 4 ng/ml. It does not require expensive instruments and is easy to operate.

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Abstract

The application discloses a kind of ecallantide residual protein detection kit and its preparation method and application, the detection kit includes capture antibody and detection antibody, the capture antibody includes anti-ecallantide residual protein polyclonal antibody, the detection antibody includes biotin-labelled anti-ecallantide residual protein polyclonal antibody, the anti-ecallantide residual protein polyclonal antibody is obtained after multiple immunization of animal with ecallantide residual protein as immunogen, and the ecallantide residual protein is further purified after removing ecallantide using anti-ecallantide monoclonal antibody affinity column adsorption from human prekallikrein crude preparation.The application fills the detection blank of urinary protein drug residual protein, is strong in specificity, antibody coverage reaches more than 70%, method limit of quantification is about 4ng / ml, for the detection limit of ecallantide residual protein, high detection sensitivity, without expensive instrument, simple operation.
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