Liquid ready-to-use activated partial thromboplastin time detection reagent

A technology of thromboplastin time and detection reagents, which is applied in the field of biomedical diagnosis, can solve the problems of poor stability of liquid preparations, and achieve the effects of good stability, reduced errors, and high sensitivity

Inactive Publication Date: 2017-11-17
NINGBO ACCUTECH BIOSCI LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, compared with lyophilized powder formulations, the stability of liquid formulations is relatively poor

Method used

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  • Liquid ready-to-use activated partial thromboplastin time detection reagent
  • Liquid ready-to-use activated partial thromboplastin time detection reagent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Embodiment 1 APTT reagent preparation

[0020] 1. Preparation of Synthetic Phospholipids

[0021] Take by weighing an appropriate amount of acylserine, phosphatidylcholine, phosphatidylglycerol, and cholesterol, dissolve them in chloroform in different proportions (accounting for the mass percentage of synthetic phospholipids), see Table 1, mix well, blow dry with nitrogen, and vacuum Vacuum off residual chloroform. A certain amount of water was added and stirred at room temperature for 2 hours to prepare a phospholipid liposome solution. Store at -20°C for later use.

[0022] Table 1

[0023]

[0024] 2. APTT reagent preparation

[0025] Prepare 50mM / L Tris buffer, dissolve ellagic acid in the buffer, the final concentration is 0.1mmol / L, add phenol to make the final concentration 0.35%, adjust the pH of the solution to 7.5, add the prepared phospholipid solution, Mix well, and the final concentration of phospholipids is 60 μM / L.

[0026] 3. Screening o...

Embodiment 2

[0031] The screening of embodiment 2 stabilizers

[0032] Select the corresponding component of phospholipid 5, prepare the APTT reagent containing different stabilizer components according to the method of Example 1 (the mass volume percentage of each component of the stabilizer in the APTT reagent is as shown in Table 3), add sodium azide respectively, The final concentration of sodium azide was 0.05%.

[0033] table 3

[0034] APTT reagent

BSA

PEG6000

Hydroxyanisole

Mannitol

Glycine

Trehalose

Stabilizer 1

1％

1％

0.02％

5％

5％

5％

Stabilizer 2

1％

0.02％

5％

5％

5％

Stabilizer 3

1％

0.02％

5％

5％

5％

Stabilizer 4

1％

1％

0.02％

5％

5％

Stabilizer 5

1％

1％

0.02％

5％

5％

Stabilizer 6

1％

1％

0.02％

5％

5％

Stabilizer 7

1％

1％

0.02％

5％

Stabilizer 8

1％

0.02％

5％

...

Embodiment 3

[0039] The stability test of embodiment 3APTT reagent

[0040]Weigh an appropriate amount of acylserine, phosphatidylcholine, and cholesterol, dissolve them in chloroform at a mass ratio of 10:40:45:5, mix well, blow dry with nitrogen, and then vacuum dry the residual chloroform. A certain amount of water was added and stirred at room temperature for 2 hours to prepare a 10 mM phospholipid solution. Prepare the 50mM / L Tris buffer solution containing 20mM / L sodium chloride, dissolve ellagic acid in the buffer solution, and the final concentration is 0.1mmol / L, add phenol, so that the final concentration is 0.35% (mass volume percentage) , adjust the pH of the solution to 7.5, add phospholipid solution to make its final concentration 60 μM / L, add stabilizers and preservatives, so that the reagent contains 1% BSA by mass volume, 1% PEG6000, 5% mannitol, and 5% trehalose and 0.05% sodium azide, mixed to obtain APTT reagent.

[0041] The APTT reagent was incubated at 4°C and 37°C...

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PUM

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Abstract

The invention discloses a liquid ready-to-use detection reagent for activated partial thromboplastin time, which comprises a buffer, a synthetic phospholipid, an activator, a stabilizer and phenol, and the synthetic phospholipid is composed of phosphatidylserine, phosphatidylcholine, phospholipid Ethanolamine and cholesterol composition, the activator is ellagic acid. The detection reagent of the invention has good stability, small difference between batches, easy quality control during production, and high sensitivity.

Description

technical field [0001] The invention belongs to the technical field of biomedical diagnosis, and in particular relates to a liquid ready-to-use activated partial thromboplastin time APTT detection reagent and a corresponding kit. Background technique [0002] The blood coagulation system is regulated by multiple factors, and the activation of the blood coagulation system is mainly divided into intrinsic and extrinsic pathways. The reduction or absence of blood coagulation factors can cause blood coagulation system diseases, such as bleeding, thrombosis and other diseases. There are many reasons for the reduction or absence of coagulation factors, including congenital factors and acquired factors. In clinical practice, it is often necessary to monitor the function of the coagulation system of the patient. For example, the coagulation function of the patient must be tested before surgery, so as to prevent massive bleeding or thrombus in advance. During anticoagulant and thro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/86
CPCG01N33/86
Inventor 赖增祖叶欣杨奎东徐健
Owner NINGBO ACCUTECH BIOSCI LTD
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