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Terylene film absorbed with inactivator to blood pathogen, and its preparation method

A blood component and inactivator technology, applied in chemistry and other fields, can solve the problem of inaccurate and uneven single dose of solid pathogen inactivator, and it is difficult to solve the problem of sterility and non-pyrogen of pathogen inactivator, and achieve Solve the problems of scientific preparation and addition, good stability and accurate dosage

Active Publication Date: 2009-11-18
SHANGHAI BLOOD CENT +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, the method of adding pathogen inactivating agent at home and abroad is to directly add low-concentration liquid pathogen inactivating agent or solid pathogen inactivating agent. The liquid pathogen inactivating photosensitizer will degrade quickly at low concentrations and lose the pathogen inactivating effect. The solid pathogen inactivator has inaccurate and uneven single dose, and it is difficult to solve the problem of sterility, no pyrogen and no insoluble particles of the pathogen inactivator and the added excipients

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] The prescription is shown in Table 1:

[0033] Table I

[0034] name

Prescription amount

The role of the product in the prescription

Methylene blue (anhydrous)

230mg

Main drug

glucose

1.7g

excipient

polyester film

10000 pieces (∮=5,5mm)

carrier

Polymer cover

10000 sets

Complex carrier

Water for Injection

Appropriate amount

Solvents and Cleaners

Medicinal ethanol

Appropriate amount

Solvents and Cleaners

[0035] Preparation method: Add the prescribed amount of methylene blue and glucose into 50ml of water for injection, fully dissolve, heat to 70°C, then add 0.12g of activated charcoal for needles into the solution, keep stirring for 30 minutes, and filter while hot , The pore size of the microporous filter membrane used for filtration is less than 0.22um, and the finely filtered intermediate solution without particles is added to 100ml of constant volume wi...

Embodiment 2

[0043] The prescription is shown in Table 3:

[0044] Table three

[0045] name

Prescription amount

The role of the product in the prescription

Methylene blue (anhydrous)

830mg

Pathogen inactivator

glucose

4.0g

excipient

Mannitol

4.0g

excipient

polyester film

10000 pieces (∮=8mm)

carrier

Polymer cover

10000 sets

Complex carrier

Water for Injection

Appropriate amount

Solvents and Cleaners

Medicinal ethanol

Appropriate amount

Solvents and Cleaners

[0046] Preparation method: Add the prescribed amount of methylene blue and glucose into a 200ml volumetric flask, add 100ml of 50% medicinal ethanol, fully dissolve, heat to 45°C, and then add 0.8g of activated carbon for needles into the solution, Insulate and stir for 30 minutes, filter while it is hot, the pore size of the microporous filter membrane used for filtration is less than 0.22um, the filtered i...

Embodiment 3

[0052] The prescription is shown in Table 5:

[0053] Table five

[0054] name

Prescription amount

The role of the product in the prescription

Methylene blue (anhydrous)

1750mg

Main drug

Hydroxyethyl starch

11.2g

excipient

polyester film

10000 pieces (∮=11mm)

carrier

Polymer cover

10000 sets

Complex carrier

Water for Injection

Appropriate amount

Solvents and Cleaners

Medicinal ethanol

Appropriate amount

Solvents and Cleaners

[0055] Preparation method is the same as embodiment 2

[0056] The content of the polyester film adsorbed methylene blue composition prepared in this example was detected to be 168.2ug / tablet, and the sterility and pyrogen tests were qualified, and the particle test was in compliance with the provisions of appendix ixC of the Second Pharmacopoeia in 2005, and met the requirements for injection.

[0057] The pathogen inactivation verificati...

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PUM

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Abstract

The invention relates to the technical field of blood pathogen inactivating agent composition and preparation method used for photochemical pathogen inactivation of blood or blood components for clinical transfusion. The polyester film adsorbed with a blood component pathogen inactivating agent according to the present invention, wherein the inactivating agent is a composition composed of a photosensitizer for inactivating blood or blood component pathogens and an auxiliary material that can be infused intravenously, and the polyester film is a drug. polyester film used. The polyester film composition adsorbed with the blood component pathogen inactivator of the present invention can be stored for more than 2 years, and its content is reduced by no more than 3%; the dosage of the pathogen inactivator of the single-chip composition is accurate, and can reach 95-95% of the marked amount. 105%; sterile, no pyrogen, no insoluble particles, meet the requirements for intravenous injection, thus solving the scientific preparation and addition of pathogen inactivation agents for photochemical pathogen inactivation of plasma or blood components.

Description

technical field [0001] The invention relates to the technical field of blood pathogen inactivating agent composition and preparation method used for photochemical pathogen inactivation of blood or blood components for clinical transfusion. Background technique [0002] Blood transfusion is an important means of support in modern medicine. Whole blood transfused clinically is a broad connective tissue composed of plasma and various blood cells. Whole blood can be separated into red blood cells, platelets, granulocytes, plasma and cold blood by physical methods. Precipitation and other blood components, and the blood transfusion method of using blood components for different diseases is called component blood transfusion. Compared with whole blood transfusion, component blood transfusion has the advantages of remarkable clinical effect, low incidence of adverse reactions, easy storage and saving blood resources, etc., so it is widely used and becomes the main form of clinical ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L2/16A61L101/44
Inventor 黄宇闻莫琴谢如锋钱开诚
Owner SHANGHAI BLOOD CENT
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