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Preparation method of penehyclidine hydrochloride powder injection for injecting

A technology of penehyclidine hydrochloride and powder injection, which is applied in the preparation of penehyclidine hydrochloride powder injection and the field of preparation of penehyclidine hydrochloride for injection, and can solve the problems of content decrease, pH value and related substance increase, etc. To achieve the effects of reducing the chance of contact, stabilizing related substances and content, and reducing the speed of reaction

Active Publication Date: 2012-07-18
JINZHOU AHON PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The present invention aims to solve the problem that the existing penhyclidine hydrochloride injection is subjected to high-temperature sterilization or long-term storage, and its pH value and related substances increase and the content decreases, and provides a penhyclidine hydrochloride powder for injection. Preparation

Method used

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  • Preparation method of penehyclidine hydrochloride powder injection for injecting
  • Preparation method of penehyclidine hydrochloride powder injection for injecting
  • Preparation method of penehyclidine hydrochloride powder injection for injecting

Examples

Experimental program
Comparison scheme
Effect test

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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Abstract

The invention discloses a preparation method of a penehyclidine hydrochloride powder injection for injecting, which belongs to the field of medicinal supplies. The method comprises the following process steps of: dissolving a penehyclidine hydrochloride bulk pharmaceutical into a solution of absolute ethanol-absolute ether, adding an appropriate amount of active carbon for decolorizing, rough filtering for decarbonizing, and filtering with a microporous filtering film of 0.22 mum to obtain an aseptic and clear solution; in an aseptic environment, crystallizing the aseptic and clear solution of the penehyclidine hydrochloride, filtering an obtained crystal, washing, draining and drying; and detecting moisture and content, detecting aseptic state, charging into a sterilized penicillin bottle, covering with a butyl rubber plug, and rolling an aluminum cover to obtain the penehyclidine hydrochloride powder injection. Due to the adoption of the preparation method, a preparation is more stable on the aspects of pH value, relevant substances and content, the toxicity is lower, and the safety and effectiveness of the penehyclidine hydrochloride and the quality of a product are ensured more easily.

Description

technical field [0001] The invention relates to a preparation method of penehyclidine hydrochloride for injection, in particular to a preparation method of penehyclidine hydrochloride powder injection, and belongs to the field of medical drugs. Background technique [0002] Penehyclidine hydrochloride is a new type of selective anticholinergic drug, which can enter the brain through the blood-brain barrier. It can block the stimulant effect of acetylcholine on muscarinic receptors and nicotinic receptors in the brain; therefore, it can better antagonize the symptoms of central poisoning caused by organophosphate poisoning, such as convulsions, central respiratory and circulatory failure, and restlessness . At the same time, it also has a strong ability to block the stimulatory effect of acetylcholine on M receptors in the periphery; therefore, it can better antagonize the muscarinic poisoning symptoms caused by organophosphorus poison (pesticide) poisoning, such as bronchia...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/439A61P39/02
Inventor 黄绍渊张浩
Owner JINZHOU AHON PHARM CO LTD
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