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Preparation process of penehyclidine hydrochloride powder for injection

A penhyclidine hydrochloride, preparation technology, applied in the field of medical drugs, can solve the problems of content drop, pH value and related substances increase, and achieve the effects of reducing contact opportunities, related substances and content stability, and ensuring pH value

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

[0008] 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 Process

Method used

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  • Preparation process of penehyclidine hydrochloride powder for injection
  • Preparation process of penehyclidine hydrochloride powder for injection
  • Preparation process of penehyclidine hydrochloride powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] A, the preparation of penehyclidine hydrochloride aseptic solution

[0068] Weigh 0.1g of penehyclidine hydrochloride and 10g of mannitol, add 80ml of water for injection, add hydrochloric acid solution to adjust the pH value to 5.42, add water to 100ml, add 0.1g of activated carbon for needles, stir evenly, keep warm at 60°C for adsorption, first Decarburize by coarse filtration, and then filter with a 0.22 μm microporous membrane until clear to obtain the penhyclidine hydrochloride liquid.

[0069] B, freeze-drying of penehyclidine hydrochloride aseptic solution

[0070] a. Glass bottle treatment: Clean the glass bottle with ultrasonic waves, rinse it with pure water, then rinse it with water for injection, dry and sterilize it within 4 hours, and get a clean, sterile, dry, heat-free glass bottle; sterilization conditions And the method is: tunnel dry heat sterilization at 320°C for 5min.

[0071] b. Treatment of rubber stoppers: wash the rubber stoppers with dilute...

Embodiment 2

[0075] A, the preparation of penehyclidine hydrochloride aseptic solution

[0076] Weigh 0.1g of penehyclidine hydrochloride and 15g of mannitol, add 80ml of water for injection, add hydrochloric acid solution to adjust the pH value to 5.36, add water to 100ml, add 0.1g of activated carbon for needles, stir evenly, keep warm at 65°C for adsorption, first Decarburize by coarse filtration, and then filter with a 0.22 μm microporous membrane until clear to obtain the penhyclidine hydrochloride liquid.

[0077] B, freeze-drying of penehyclidine hydrochloride aseptic solution

[0078] a. Glass bottle treatment: Clean the glass bottle with ultrasonic waves, rinse it with pure water, then rinse it with water for injection, dry and sterilize it within 4 hours, and get a clean, sterile, dry, heat-free glass bottle; sterilization conditions And the method is: dry heat sterilization at 180°C for 1.5h.

[0079] b. Treatment of rubber stoppers: wash the rubber stoppers with dilute hydroc...

Embodiment 3

[0083] A, the preparation of penehyclidine hydrochloride aseptic solution

[0084] Weigh 0.1g of penehyclidine hydrochloride and 20g of xylitol, add 80ml of water for injection, add hydrochloric acid solution to adjust the pH value to 8.0, add water to 100ml, add 0.1g of activated carbon for needles, stir evenly, and keep it at 70°C for adsorption. Decarbonize by coarse filtration first, and then filter with a 0.22 μm microporous membrane until it becomes clear to obtain the penhyclidine hydrochloride medicinal solution.

[0085] B, freeze-drying of penehyclidine hydrochloride aseptic solution

[0086] a. Glass bottle treatment: Clean the glass bottle with ultrasonic waves, rinse it with pure water, then rinse it with water for injection, dry and sterilize it within 4 hours, and get a clean, sterile, dry, heat-free glass bottle; sterilization conditions And the method is: tunnel dry heat sterilization at 320°C for 5min.

[0087] b. Treatment of rubber stoppers: wash the rubb...

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Abstract

The invention discloses a preparation process of penehyclidine hydrochloride powder for injection, and belongs to the field of medical products. The process comprises the following steps: weighing penehyclidine hydrochloride and excipient; dissolving with injection water; regulating the pH value with hydrochloric acid solution; adding injection water to full dose; measuring the pH and content; filtering the liquid medicine through a 0.22mu m filter membrane, and subpackaging into aseptic penicillin bottles; and carrying out freeze drying; closing a butyl rubber stopper, and rolling an aluminum cap. The preparation prepared by the method has more stable pH value, related substances and content, and lower toxicity, so that the safety and efficiency of the penehyclidine hydrochloride and product quality are easier to be ensured.

Description

technical field [0001] The invention relates to a preparation process of penehyclidine hydrochloride for injection, in particular to a preparation process 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 bronch...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/439A61P25/28A61P25/02A61P39/02
Inventor 黄绍渊张浩
Owner JINZHOU AHON PHARM CO LTD
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