Pathogen inactivator composition for blood or blood component and its compounding process

A preparation method and technology of blood components, applied in the direction of chemistry, can solve the problems of limiting the development and production of methylene blue-multi-bag system, the instability of methylene blue, and the inaccuracy of single dose, so as to solve the problems of scientific preparation and addition Problems, the effect of ensuring stability

Active Publication Date: 2006-11-08
SHANGHAI BLOOD CENT +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Literature "Chinese Journal of Blood Transfusion" 2004 Volume 17 Supplement p185 "Application of Methylene Blue Solid Formulation in Plasma Virus Inactivation" Huang Yuwen and others reported that the existing technology is mainly liquid methylene blue operation, and its main disadvantages are: methylene blue It is not stable in liquid, and it is prone to chemical reactions when exposed to light; liquid methylene blue is not suitable for long-term storage and transportation; liquid methylene blue has re-diluted plasma; it limits the development and production of methylene blue-multi-bag system
At present, the main method of adding pathogen inactivating agents at home and abroad is to directly add low-concentration liquid pathogen inactivating agents. Liquid pathogen inactivating photosensitizers will quickly degrade at low concentrations and lose the pathogen inactivating effect; there are also solid pathogen inactivating agents. Active agents, there are inaccurate and uneven single doses, and it is difficult to solve the problem of sterility, pyrogen-free and insoluble particles of pathogen inactivators and added excipients

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] 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, filter while hot, and use for filtration The pore size of the microporous filter membrane is less than 0.22um. After filtering, the intermediate solution without particles is added to 100ml with finely filtered water for injection, and then set aside. Then add 10ul of the above-mentioned pathogen inactivator intermediate solution dropwise to each clean medicinal polyester film, dry it under a 100-level laminar flow hood, and after passing the inspection of content, sterility, pyrogen, and particles, the The solid blood or blood component pathogen inactivating agent composition used together with a carrier can be applied to a blood pathogen inactivating device. The specific prescription is shown in Table 1:

[0020] name

Prescription amount

...

Embodiment 2

[0025] 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, fully dissolve, heat to 45°C, and then add activated needles into the solution Use 0.8g of activated carbon, heat 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, and the intermediate solution without particles after filtration is added to 200ml with finely filtered 50% ethanol. ,spare. Then add 20ul of the above-mentioned pathogen inactivator intermediate solution dropwise to each piece of clean medicinal polyester film, dry it under a 100-level laminar flow hood, and after passing the inspection of content, sterility, pyrogen, and particles, etc., it is obtained The solid blood or blood component pathogen inactivating agent composition used together with a carrier can be applied to a blood pathogen inactivating device. See Table...

Embodiment 3

[0031] Preparation method is with embodiment 2, and concrete prescription sees table five:

[0032] Table five

[0033] 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

[0034] 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.

[0035] The pathogen i...

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PUM

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Abstract

The present invention relates to pathogen inactivator composition for blood or blood component for clinical transfusion and its compounding process. The blood pathogen inactivator consists of photosensitizer capable of inactivating blood or blood component and supplementary material for venoclysis in the weight of 2-10 times that of the photosensitizer. The pathogen inactivator in the pathogen inactivator composition is solid and has the stability of the pathogen inactivating photosensitizer maintained. The pathogen inactivator and relevant supplementary material is prepared through high temperature pyrogen eliminating and abacterial filtering, and may be used in the photochemical pathogen inactivation of blood or blood component.

Description

technical field [0001] The invention relates to the technical field of a blood or blood component pathogen inactivator for clinical blood transfusion and a preparation method thereof. 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 blood transfusion. [0003] The use of photochemical me...

Claims

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Application Information

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Patent Type & Authority Applications(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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