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Bilirubin measuring freeze-drying calibration liquid and preparing method thereof

A technology of bilirubin and calibration solution, which is applied in the field of preparation of freeze-dried calibration solution for bilirubin determination, can solve the problems of turbidity, high residual moisture, easy to deteriorate quickly, etc., and achieve the effect of stable properties and good stability

Active Publication Date: 2011-06-15
NINGBO MEDICAL SYSTEM BIOTECHNOLOGY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The former is in a liquid state and can remain stable for a certain period of time at low temperatures, but it is easy to deteriorate quickly during transportation in summer
The freeze-dried product only has the level of natural stability of biological materials once freeze-dried, but the residual moisture is high, and once reconstituted, it will appear turbid and the potency will drop rapidly.

Method used

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  • Bilirubin measuring freeze-drying calibration liquid and preparing method thereof
  • Bilirubin measuring freeze-drying calibration liquid and preparing method thereof
  • Bilirubin measuring freeze-drying calibration liquid and preparing method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0025] Take 150ml of qualified healthy human serum, put the raw serum in a plastic bottle, put it in a refrigerator at -20°C for 12 hours, and then immediately put it at room temperature for 12 hours, and repeat the freezing and thawing process 7 times until most of the upper layer of the serum is clear. state. Use a pipette to carefully separate the upper layer without confusion; filter with dense filter paper, 0.45 μm filter membrane, and then 0.22 μm filter membrane to make it transparent and sterile lipoprotein-free serum. Take 96ml of the above serum (≈96g, the density of serum is close to the density of water) in a Erlenmeyer flask with a capacity of 200ml for later use.

[0026] Weigh 4mg of indirect reaction bilirubin, add 0.2mol / L Na 2 CO 3 Solution 1ml, mix well until no dry powder floats on the liquid surface, then add 1ml of methanol and shake well until completely dissolved and transparent; weigh 12mg of direct reaction bilirubin, add 2ml of water and mix until ...

Embodiment 2

[0037] Take 150ml of qualified healthy human serum, put the raw serum in a plastic bottle, put it in a refrigerator at -20°C for 12 hours, and then immediately put it at room temperature for 12 hours, and repeat the freezing and thawing process 7 times until most of the upper layer of the serum is clear. state. Use a straw to carefully separate the upper layer without confusion; filter with dense filter paper, 0.45 μm filter membrane, and 0.22 μm filter membrane respectively to make it a transparent sterile lipoprotein-free serum. Take 94ml (≈94g) of the above serum in a Erlenmeyer flask with a capacity of 200ml for later use.

[0038] Weigh 3mg of indirect reaction bilirubin, add 0.2mol / L Na 2 CO 3 Solution 1ml, mix well until no dry powder floats on the liquid surface, then add 1ml of methanol and shake well until completely dissolved and transparent; weigh 11mg of direct reaction bilirubin, add 4ml of water and mix until completely dissolved and transparent.

[0039] Add...

Embodiment 3

[0050] Take 150ml of qualified healthy human serum, put the raw serum in a plastic bottle, put it in a refrigerator at -20°C for 12 hours, and then immediately put it at room temperature for 12 hours, and repeat the freezing and thawing process 7 times until most of the upper layer of the serum is clear. state. Use a straw to carefully separate the upper layer without confusion; filter with dense filter paper, 0.45 μm filter membrane, and 0.22 μm filter membrane respectively to make it a transparent sterile lipoprotein-free serum. Take 96ml (≈96g) of the above serum in a Erlenmeyer flask with a capacity of 200ml for later use.

[0051] Weigh 5mg of indirect reaction bilirubin, add 0.2mol / L Na 2 CO 3 Solution 1ml, mix well until no dry powder floats on the liquid surface, then add 1ml of methanol and shake well until completely dissolved and transparent; weigh 13mg of direct reaction bilirubin, add 2ml of water and mix until completely dissolved and transparent.

[0052] Add...

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Abstract

The invention discloses a frozen calibrating liquid for determining bilirubin and the preparing method for the liquid. The raw materials of the liquid are: 92-98 portions of grease and pertain removed serum from a health person, 2-8 portions of indirect bilirubin, 8-20 portions of direct bilirubin, 1000-50000 portions of albumin from animal's serum, 10-100 antioxygen, 50-500 portions of complexing agent, 0.1-10 portions of preservative, 1000-50000 portions of excipient. All the portions are in term of weight. The frozen calibrating liquid for determining bilirubin is a steady and economy frozen calibrating liquid for determining bilirubin that is near to the existing form of bilirubin in human being's serum, consistent with the serum bilirubin in human body. The preparing method concentrates the frozen liquid, reduces half liquid volume of ordinary freezing process, the residual moisture in the prepared frozen calibrating liquid for determining bilirubin is low, and the performance issteady.

Description

technical field [0001] The invention relates to a bilirubin determination freeze-dried correction solution, and at the same time, the invention also relates to a preparation method of the bilirubin determination freeze-dry correction solution. Background technique [0002] The determination of bilirubin is one of the most commonly used liver function items in laboratory medicine. It is an important means and basis for diagnosing the existence of jaundice and its category in clinical practice, and is frequently used. Bilirubin has four components: namely, unconjugated bilirubin, monoglucuronide-conjugated bilirubin and double glucuronide-conjugated bilirubin, and bilirubin covalently bound to albumin is called delta-bilirubin. red pigment. Usually we call the total of the four components total bilirubin, and the latter three are called direct bilirubin. The first two of direct bilirubin are also called conjugated bilirubin. [0003] There are many methods for the determina...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/72
Inventor 宋克征邹炳德
Owner NINGBO MEDICAL SYSTEM BIOTECHNOLOGY CO LTD