Reagent compositions and methods of preparing lyophilized reagents

By using a combination of rabbit plasma, trehalose, and PBS buffer, along with liquid nitrogen droplet freeze-drying technology, the problems of inaccurate results and poor stability of freeze-dried products caused by improper selection of plasma source in coagulase assays were solved, achieving high formation rate, good resolubility, and preservation of coagulase activity in freeze-dried products.

CN122405792APending Publication Date: 2026-07-17WENZHOU MICRODOME MICROBIAL TECH CO LTD
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Patent Information

Application Number
CN202610845794.4
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-06-12
Publication Date
2026-07-17

AI Technical Summary

Technical Problem

In existing technologies, improper selection of plasma sources leads to inaccurate coagulase test results, poor stability, and problems such as appearance collapse, low molding rate, poor resolubility, and severe loss of coagulase activity in freeze-dried products during the freeze-drying process.

Method used

A combination of rabbit plasma, trehalose, and PBS buffer was used to form a regular lyophilized product through mixing, sterile filtration, and liquid nitrogen droplet lyophilization under light-protected conditions. Trehalose replaced water molecules to form hydrogen bonds with plasma proteins, mannitol formed a crystal framework, and PBS buffer maintained pH stability.

Benefits of technology

It improves the sensitivity and stability of coagulase assays, increases the formation rate and resolubility of lyophilized products, reduces the loss of coagulase activity, and extends shelf life.

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Abstract

本发明公开了一种试剂组合物及冻干试剂的制备方法,试剂组合物包含兔血浆、海藻糖、甘露醇和PBS缓冲液。通过选用兔血浆作为凝固酶试验的反应底物,改善了不同物种血浆在试验中敏感性不足、特异性差及凝块判读困难的问题。通过海藻糖在冻干过程中替代水分子与血浆蛋白形成氢键以维持蛋白构象、减少冰晶损伤,甘露醇形成结晶骨架以赋予冻干物规整形态和机械强度,改善了直接冻干导致的冻干物塌陷、成型率低和凝固酶活性损失的问题,提高了冻干试剂的稳定性。通过PBS缓冲液与兔血浆的配合,混合液pH维持在血浆蛋白稳定的范围,避免了额外添加pH调节剂,简化了配制工艺。
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