一种甲状旁腺激素突变体、含甲状旁腺激素突变体的液体质控品及其应用

By introducing specific amino acid substitutions and forming intramolecular disulfide bonds in PTH molecules, the problem of easy degradation of PTH molecules in quality control materials is solved, achieving a balance between stability and immunoreactivity. It is suitable for multiple detection platforms and meets clinical quality control needs.

CN122404531APending Publication Date: 2026-07-17JIANGSU LANGDAO BIOTECHNOLOGY CO LTD

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
JIANGSU LANGDAO BIOTECHNOLOGY CO LTD
Filing Date
2026-06-18
Publication Date
2026-07-17

AI Technical Summary

Technical Problem

Existing PTH molecules are easily degraded by enzymes, oxidized, and aggregated in quality control materials, resulting in insufficient stability and affecting the accuracy and consistency of detection. Traditional chemical modification methods cannot simultaneously ensure stability and immunoreactivity.

Method used

By introducing specific amino acid substitutions into PTH molecules through site-directed mutagenesis, intramolecular disulfide bonds are formed, blocking enzymatic and oxidative pathways while retaining immunoreactivity characteristics, thus preparing liquid quality control products.

Benefits of technology

It achieves a balance between long-term stability and immunoreactivity of PTH molecules, is suitable for multiple detection platforms, meets clinical quality control needs, and is easy to industrialize.

✦ Generated by Eureka AI based on patent content.

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Abstract

本发明涉及甲状旁腺激素,特别涉及一种甲状旁腺激素突变体、含甲状旁腺激素突变体的液体质控品及其应用;一种甲状旁腺激素突变体,其特征在于,所述甲状旁腺激素突变体基于野生型人甲状旁腺激素氨基酸序列改造得到,具体突变包括:H9C、M18L、R25A、K26A、K27A、S48C;所述甲状旁腺激素突变体的氨基酸序列如SEQ ID NO.1所示。采用固相多肽合成工艺,易于规模化生产,成本可控。本方案通过精准定点突变实现PTH分子稳定化,在最小结构扰动下获得性能全面提升的改良分子,突破传统质控品稳定性瓶颈,为临床PTH检测提供高可靠液体质控品。
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