Preparation method of penehyclidine hydrochloride powder injection for injecting
A technology of penehyclidine hydrochloride and powder injections, which is applied in the field of medical drugs, can solve the problems of pH value and related substances rising and content falling, and achieve the stability of related substances and content, reduce the chance of contact, and reduce the speed of reaction Effect
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Embodiment 1
[0066] A. Take 100g of penehyclidine hydrochloride, add 600ml of anhydrous ethanol-anhydrous ether (1:2), heat to 78°C to dissolve, add 0.2g of activated carbon to stir, first decarburize with coarse filtration, and then use 0.22 The microporous membrane of μm is filtered to obtain a clear liquid;
[0067] B. Under a sterile environment, recrystallize the clear liquid in step B, filter under reduced pressure, wash with 300ml of absolute ethanol-anhydrous ether (1:2), drain, dry at 105°C, and pulverize to obtain pentyl hydrochloride Diethylquilidine sterile powder, ready for use after packaging;
[0068] C, the preparation of penehyclidine hydrochloride powder injection for injection
[0069] a. Glass bottle treatment: Clean the glass bottle with ultrasonic waves, rinse it with pure water, then rinse it with water for injection, and sterilize it with tunnel-type dry heat at 320°C for 5 minutes to obtain a clean, sterile, dry, heat-free glass bottle;
[0070] b. Treatment of r...
Embodiment 2
[0073] A. Take 100g of penehyclidine hydrochloride, add 700ml of anhydrous ethanol-anhydrous ether (1:2), heat to 75°C to dissolve, add 0.3g of activated carbon to stir, first decarburize by coarse filtration, and then use 0.22 The microporous membrane of μm is filtered to obtain a clear liquid;
[0074] B. Under a sterile environment, recrystallize the clear liquid in step B, filter under reduced pressure, wash with 300ml of absolute ethanol-anhydrous ether (1:2), drain, dry at 105°C, and pulverize to obtain pentyl hydrochloride Diethylquilidine sterile powder, ready for use after packaging;
[0075] C, the preparation of penehyclidine hydrochloride powder injection for injection
[0076] a. Glass bottle treatment: Clean the glass bottle with ultrasonic waves, rinse it with pure water, then rinse it with water for injection, and sterilize it at 180°C for 1.5 hours to obtain a clean, sterile, dry, heat-free glass bottle;
[0077] b. Treatment of rubber stoppers: wash the rub...
Embodiment 3
[0080] A. Take 100g of penehyclidine hydrochloride, add 100ml of anhydrous ethanol-anhydrous ether (1:10), heat to 40°C to dissolve, add 0.2g of activated carbon for injection and stir, first decarburize by coarse filtration, and then use 0.22 The microporous membrane of μm is filtered to obtain a clear liquid;
[0081] B. Under a sterile environment, recrystallize the clear liquid in step B, filter under reduced pressure, wash with 400ml of absolute ethanol-anhydrous ether (1:10), drain, dry at 105°C, and pulverize to obtain pentyl hydrochloride Diethylquilidine sterile powder, ready for use after packaging;
[0082] C, the preparation of penehyclidine hydrochloride powder injection for injection
[0083] a. Glass bottle treatment: Clean the glass bottle with ultrasonic waves, rinse it with pure water, then rinse it with water for injection, and sterilize it with tunnel-type dry heat at 320°C for 5 minutes to obtain a clean, sterile, dry, heat-free glass bottle;
[0084] b....
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