Liquid prothrombin time determination kit and preparation method thereof

Abstract

The invention belongs to the field of in-vitro detection kits, and particularly relates to a liquid prothrombin time determination kit and a preparation method thereof. The liquid prothrombin time determination kit comprises thromboplastin, a stabilizer, a surfactant, salt ions and a buffer solution. The kit has the beneficial effects that the sensitivity of a reagent is controllable through combined use of thromboplastin from multiple sources, and the problem of inter-batch difference is solved; the surfactant is added, so that the uniformity of the reagent is improved, and the accuracy of the reagent is further improved; by optimizing the formulas of the protective agent and the preservative, the stability of the reagent is improved, so that a reagent can be prepared into a liquid reagent without freeze-drying, the reagent preparation and production process is simplified, the reagent can be used after being produced and opened, and the use and operation process of a terminal customeris simplified.

Description

technical field [0001] The invention belongs to the field of in vitro detection kits, in particular to a liquid type prothrombin time measurement kit and a preparation method thereof. Background technique [0002] The principle of prothrombin time (PT) determination is based on the coagulation theory of the "waterfall theory" exogenous coagulation pathway, and the laboratory usually uses the Quick method. The mechanism of coagulation is that after tissue thromboplastin is added to the plasma to be tested, its protein part forms a complex with coagulation factor VII in plasma, and activates coagulation factors X and Xa in plasma, which pass through the phospholipid surface provided by tissue thromboplastin. Calcium ions and factor V form prothrombin activator, which turns prothrombin into thrombin, and then catalyzes the coagulation reaction. [0003] Plasma prothrombin time (PT) is sensitive, rapid and practical, and it is the preferred indicator for monitoring oral anticoa...

AI Technical Summary

Problems solved by technology

[0005] At present, most commercially available prothrombin time assay kits are in the freeze-dried dosage form. Although the validity period is relatively long, the production process is complicated because the freeze-dried powder reagent needs a freeze-drying process, and the cost is high. In addition, in use Redissolve

The process from production to use, including sub-packaging, freeze-drying, reconstitution and other steps may bring different degrees of reagent bottle-to-bottle differences, resulting in significant batch-to-batch differences

Images