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Method for preparing penehyclidine hydrochloride injection

A technology of penehyclidine hydrochloride and injection, which is applied in the field of medical drugs, can solve problems such as poor stability, decreased content, and increased pH value, and achieve the effects of easy product quality, stable content, and improved stability

Active Publication Date: 2013-01-23
JINZHOU AHON PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The present invention aims to solve the problem that the existing penehyclidine hydrochloride injection has poor stability in the commercially available ampoules and vials without any treatment, and the pH value rises and the content drops after long-term storage for 8 months, and provides A novel preparation method of penehyclidine hydrochloride injection, especially a method of pre-processing penehyclidine hydrochloride injection before potting

Method used

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  • Method for preparing penehyclidine hydrochloride injection
  • Method for preparing penehyclidine hydrochloride injection
  • Method for preparing penehyclidine hydrochloride injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0152] Example 1 (adjustment of pH & ampoule)

[0153] prescription:

[0154] Penehyclidine Hydrochloride 20g

[0155] Add water for injection to 20000ml

[0156] (Specification: 1ml: 1mg, 1ml per tube)

[0157] Preparation Process:

[0158] Weigh 20.0g of penehyclidine hydrochloride, add 16000ml of water for injection to dissolve, adjust pH=4.72 with 0.1mol / L hydrochloric acid solution, add water for injection to the full amount, measure pH=4.88, content=101.5%. The medicinal solution is filtered through a 0.22 μm filter membrane and filled into washed and dried ampoules. The samples obtained by potting were sterilized at 121° C. for 12 minutes. After passing the inspection, the sample of Example 1 is obtained.

Embodiment 2

[0159] Embodiment 2 (regulate pH & vial)

[0160] prescription:

[0161]Penehyclidine Hydrochloride 10g

[0162] Add water for injection to 20000ml

[0163] (Specification: 1ml: 0.5mg, 1ml per tube)

[0164] Preparation Process:

[0165] Weigh 10.0g of penehyclidine hydrochloride, add 16000ml of water for injection to dissolve, adjust pH=4.75 with 0.5mol / L hydrochloric acid aqueous solution, add water for injection to the full amount, measure pH=4.87, content=100.7%. The medicinal solution was filtered through a 0.22 μm filter membrane and then sealed in a cleaned and dried vial. The samples obtained by potting were sterilized at 121° C. for 12 minutes. The sample of Example 2 is obtained after passing the inspection.

Embodiment 3

[0166] Embodiment 3 (regulate pH & vial)

[0167] prescription:

[0168] Penehyclidine Hydrochloride 10g

[0169] Add water for injection to 20000ml

[0170] (Specification: 1ml: 0.5mg, 1ml per bottle)

[0171] Preparation Process:

[0172] Weigh 10.0g of penehyclidine hydrochloride, add 16000ml of water for injection to dissolve, adjust pH=4.65 with 0.3mol / L hydrochloric acid aqueous solution, add water for injection to the full amount, measure pH=4.87, content=100.7%. The medicinal solution was filtered through a 0.22 μm filter membrane and then sealed in a cleaned and dried vial. The samples obtained by potting were sterilized at 121° C. for 12 minutes. The sample of Example 2 is obtained after passing the inspection.

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Abstract

The invention discloses a method for preparing a penehyclidine hydrochloride injection and belongs to the field of medicines. The specific preparation process of the injection is as follows: (1) washing inner packaging materials with purified water and water for injection and then pasteurizing and drying the inner packaging materials for standby application; (2) weighing penehyclidine hydrochloride based on the prescription dose, adding a defined amount of water for injection to dissolve penehyclidine hydrochloride, regulating the pH value of the liquid medicine to 4.6-4.8 with a pH regulator, then adding water for injection to reach the total amount and stirring the liquid medicine uniformly; and (3) measuring the pH value and the content, filtering the liquid medicine after the pH valueand the content are qualified, filling and sealing the filtrate in the inner packaging materials for standby application and carrying out pasteurization, thus obtaining the penehyclidine hydrochloride injection. The method has the following beneficial effects: not only can the pH value and content of the penehyclidine hydrochloride injection product obtained by the method be more stable, but alsothe product quality is more easily ensured; and meanwhile, the final product is proved to be safe and effective by animal long-term toxicity tests and pharmacodynamics tests.

Description

technical field [0001] The invention relates to a preparation method of an injection liquid, in particular to a preparation method of a selective anticholinergic drug penhyclidine hydrochloride injection, belonging to the field of medical drugs. Background technique [0002] Penehyclidine hydrochloride injection is a new type of selective anticholinergic drug, which can bind to M and N choline receptors and selectively act on M 1 , M 3 , N 1 , N 2 receptor, to M 2 The receptor has no effect, and has the advantages that anticholinergic drugs such as atropine and scopolamine do not have, such as strong anticholinergic effect, long duration of action, protection of heart rate two-way regulation mechanism, improvement of microcirculation, and low toxicity and side effects. It has shown broad application prospects: treatment of organophosphorus pesticide poisoning, drug use before anesthesia, application in respiratory diseases, anti-shock, protective effect on cerebral ische...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/439A61P1/00A61P9/10A61P11/00A61P39/06A61P43/00
Inventor 黄绍渊张浩金红娣刘新春朱登军
Owner JINZHOU AHON PHARM CO LTD
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