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
Examples
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
1750mg
Main drug
11.2g
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...
PUM
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Description
Claims
Application Information
- IPC
- A61L2/16; A61L101/44
- Inventors
- 黄宇闻; 莫琴