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Preparation process of pralidoxime chloride for injection
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A technology for chlorinated phosphonium chloride and preparation process, applied in the field of medical drugs, can solve problems such as content drop and substance increase, and achieve the effects of reducing related substances, reducing the chance of substance contact, and reducing speed
Active Publication Date: 2012-10-31
JINZHOU AHON PHARM CO LTD
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[0012] The present invention aims to reduce the amount of related substances in pralidoxime chlorid preparation and solve the problem that related
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Embodiment 1
[0070] 1. Preparation of sterile powder by recrystallization of pralidoxime chloride
[0071] Take 1000g of pralidoxime chloride, add 2000ml of water for injection, add 50g of activated carbon for injection, stir to dissolve, heat until the temperature of the liquid is 50°C, keep warm and reflux for 20 minutes to decolorize, first decarburize by coarse filtration, and then use 0.22μm to sterilize Filter for sterile filtration.
[0072] In a sterile environment in a clean area, recrystallize the above solution, control the temperature of the liquid at 5°C-10°C, continue to stir, slowly add 4000ml of acetone, keep the temperature at 5°C-10°C, stop stirring, and let it stand for 24 hours to crystallize , The resulting crystals were filtered, washed, drained and dried. After the determination of water content, content and sterility inspection, it is packaged and ready for use. A sterile pralidoxime chloride powder with low related substances was obtained.
[0073] 2. Packing of...
Embodiment 2
[0078] 1. Preparation of sterile powder by recrystallization of pralidoxime chloride
[0079] Take 1000g of pralidoxime chloride, add 2500ml of water for injection, add 60g of activated carbon for injection, stir and dissolve, heat until the temperature of the liquid is 60°C, keep warm and reflux for 15 minutes to decolorize, first decarburize by coarse filtration, and then use 0.22μm to sterilize Filter for sterile filtration.
[0080] In a sterile environment in a clean area, recrystallize the above solution, control the temperature of the liquid at 5°C-10°C, continue to stir, slowly add 4500ml of acetone, keep the temperature at 5°C-10°C, stop stirring, and let it stand for 24 hours to crystallize , The resulting crystals were filtered, washed, drained and dried. After the determination of water content, content and sterility inspection, it is packaged and ready for use. A sterile pralidoxime chloride powder with low related substances was obtained.
[0081] 2. Packing o...
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Abstract
The invention discloses a preparation process of pralidoxime chloride for injection and belongs to the field of medical and pharmaceutical substances. According to research, pH and content of pralidoxime chloride injection which is performed with high-temperature sterilization or stored for a long time are reduced, and content of related substances is obviously increased and is higher than the national standard, so that research on preparation of a pralidoxime chloride preparation is conducted, and the subpackaging preparation process for preparing sterilized powder in a recrystallization method is invented. The preparation obtained through the preparation process is stable in the aspects of content of the preparation and the related substances and low in toxicity and the content of the related substances. Safety and effectivity of the pralidoxime chloride are ensured, and product quality can be guaranteed easily.
Description
technical field [0001] The invention relates to a preparation process of pralidoxime chloride for injection, which belongs to the field of medical drugs. Background technique [0002] 1. Pradoxime Chloride Injection belongs to the national essential medicine. It is a colorless or slightly yellow clear liquid. It can revive the activity of cholinesterase inhibited by acute organophosphate insecticides to different degrees. It is used to rescue various Poisoning by organophosphate insecticides. However, the poisoning effect on malathion, trichlorfon, dichlorvos, dimethoate, dimefox, mipafox and schradan is poor; it is insecticidal to carbamate The cholinesterase inhibited by the agent has no revival effect. [0003] 2. The original implementation standard of pralidoxime chloride injection was the fifth volume of the second part of the standard issued by the Ministry of the People's Republic of China, and the relevant substances and bacterial endotoxin inspection items were n...
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