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Preparation process of pralidoxime chloride powder injection for injection
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A technology of pralidoxime chloride and preparation process, which is applied in the field of medical drugs, and can solve the problems of pH value and related substances increasing and content decreasing
Active Publication Date: 2013-09-25
JINZHOU AHON PHARM CO LTD
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Problems solved by technology
[0013] The present invention aims to solve the problem that the pH value and related substances increase and the content of the existing pralidoxime chloride injection increases and the content decreases after high-temperature sterilization or long-term storage
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Embodiment 1
[0069] 1. Prescription of pralidoxime chloride for injection
[0070] The prescription of the freeze-dried preparation includes 0.1 g of pralidoxime chloride and 10 g of mannitol.
[0071] 2. Preparation of pralidoxime chloride sterile solution
[0072] Weigh the specified amount of pralidoxime chloride and mannitol, add 80ml of water for injection to dissolve, add water to 100ml, add 0.1g of activated carbon for injection, stir evenly, keep warm at 60°C for adsorption, then decarburize by coarse filtration, and then use 0.22μm Filter through a microporous membrane until clear.
[0073] 3. Freeze-drying of pralidoxime aseptic solution
[0074] Glass bottle treatment: clean the glass bottle with ultrasonic waves, rinse with pure water, and then rinse with 0.22 μm filtered water for injection, dry and sterilize within 4 hours (sterilization conditions: tunnel dry heat sterilization at 320°C for 5 minutes), and obtain Clean, sterile, dry, pyrogen-free glass bottle.
[0075] R...
Embodiment 2
[0079] 1. Prescription of pralidoxime chloride for injection
[0080] The prescription of the freeze-dried preparation includes 0.1 g of pralidoxime chloride and 15 g of mannitol.
[0081] 2. Preparation of pralidoxime chloride sterile solution
[0082] Weigh the specified amount of pralidoxime chloride and mannitol, add 80ml of water for injection to dissolve, add water to 100ml, add 0.1g of activated carbon for injection, stir evenly, keep warm at 65°C for adsorption, then decarbonize by coarse filtration, and then use 0.22μm Filter through a microporous membrane until clear.
[0083] 3. Freeze-drying of pralidoxime aseptic solution
[0084] Glass bottle treatment: Clean the glass bottle with ultrasonic waves, rinse with pure water, and then rinse with 0.22μm filtered water for injection, dry and sterilize within 4 hours (sterilization conditions: dry heat sterilization at 180°C for 1.5h), and get clean , sterile, dry, pyrogen-free glass bottle.
[0085] Rubber stopper t...
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Abstract
The invention discloses a preparation process of pralidoxime chloridepowder injection for injection and belongs to the field of medical and pharmaceutical substances. According to research, content of pralidoxime chloride injection which is performed with high-temperature sterilization is reduced, and content of related substances is obviously increased, so that research on preparation of a pralidoxime chloride preparation is conducted, and the process for preparing sterilized powder in a freezing drying method is invented. The preparation obtained through the preparation process is stable in pH value and 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 for injection, in particular to a preparation process of pralidoxime for injection powder injection, and 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, ...
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