Industrial production method of penehyclidine hydrochloride injection

A technology for penehyclidine hydrochloride and a production method, which are applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, antidote, etc., can solve the problem of increased damage rate of ampere bottles or vials of washing times, corrosion of stainless steel equipment, and many processes. and other problems, to achieve the effect of clinical efficacy guarantee, safety guarantee, and strong operability.

Active Publication Date: 2013-09-04
CHENGDU ZIHAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The steps of this method are complicated, there are many processes in actual production, and the operability is poor. It is not known whether this method is suitable for industrialized large-scale production
[0006] The CN102525910 patent reports solving the problem that the pH rises and the content changes due to long-term stability by placing penehyclidine hydrochloride dissolved in water and directly embedding it in ampoules or vials treated with acids of different concentrations in advance. This method is practical. In production, tens of thousands or even millions of ampoules or vials need to be cleaned with acid in advance, which cannot guarantee thorough cleaning; on the other hand, the acid solution corrodes stainless steel equipment, and the washing acid increases the number of washings, resulting in the Increased bottle breakage

Method used

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  • Industrial production method of penehyclidine hydrochloride injection
  • Industrial production method of penehyclidine hydrochloride injection
  • Industrial production method of penehyclidine hydrochloride injection

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Experimental program
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Effect test

Embodiment 1

[0023] The preparation of embodiment 1 penhyclidine hydrochloride injection

[0024] prescription:

[0025] Penhyclidine hydrochloride: 100.0g

[0026] Water for injection: add to 100000ml

[0027] Preparation process: Weigh 100.0 g of penehyclidine hydrochloride, add 100,000 ml of water for injection to dissolve, add 0.01% (calculated according to the total volume w / v of the preparation) of activated carbon, stir for 10 minutes, and decarburize with a 5um titanium rod for 15 minutes. Adjust the pH to 4.00 with 0.05mol / L hydrochloric acid solution, and the measured pH is 3.99 and the content is 99.6% through the intermediate quality control test. The medicinal liquid is finely filtered with a 0.22um filter membrane, and then filled and sealed in cleaned low-borosilicate ampoules and medium-borosilicate ampoules, sterilized by damp heat at 121°C for 15 minutes, and inspected by light to obtain finished products. The test results of the finished product are shown in Table 1 b...

Embodiment 2

[0030] The preparation of embodiment 2 penhyclidine hydrochloride injection

[0031] prescription:

[0032] Penhyclidine hydrochloride: 100.0g

[0033] Water for injection: add to 100000ml

[0034] Preparation process: Weigh 100.0 g of penehyclidine hydrochloride, add 100,000 ml of water for injection to dissolve, add 0.01% (calculated according to the total volume w / v of the preparation) of activated carbon, stir for 10 minutes, and decarburize with a 5um titanium rod for 15 minutes. Use 0.05mol / L hydrochloric acid solution to adjust the pH=4.30, and the measured pH is 4.31 and the content is 101.5% through the intermediate quality control test. The medicinal solution is finely filtered with a 0.22um filter membrane, filled and sealed in cleaned low-borosilicate ampoules and medium-borosilicate ampoules, sterilized by damp heat at 121°C for 15 minutes, and inspected by light to obtain a finished product. The test results of the finished product are shown in Table 2 below: ...

Embodiment 3

[0037] The preparation of embodiment 3 penhyclidine hydrochloride injection

[0038] prescription:

[0039] Penhyclidine hydrochloride: 100.0g

[0040] Water for injection: add to 100000ml

[0041] Preparation process: Weigh 100.0 g of penehyclidine hydrochloride, add 100,000 ml of water for injection to dissolve, add 0.01% (calculated according to the total volume w / v of the preparation) of activated carbon, stir for 10 minutes, and decarburize with a 5um titanium rod for 15 minutes. The pH was adjusted to 4.59 with 0.05mol / L hydrochloric acid solution, and the measured pH was 4.58 through intermediate quality control detection, and the content was 100.2%. The medicinal solution is finely filtered with a 0.22um filter membrane, filled and sealed in cleaned low-borosilicate ampoules and medium-borosilicate ampoules, sterilized by damp heat at 121°C for 15 minutes, and inspected by light to obtain a finished product. The test results of the finished product are shown in Tabl...

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Abstract

The invention provides an industrial production method of penehyclidine hydrochloride injection, wherein the penehyclidine hydrochloride injection is prepared by steps of adjusting pH to be not less than 4.0 and less than 4.6 by using an acid, filling and sterilizing. The industrial production method of penehyclidine hydrochloride injection provided by the invention is strong in industrialization operability; and the obtained injection is good in stability, and capable of effectively avoiding the quality changes of pH, related substances, content, related indexes and the like after being stored for a long time without the need of special storage conditions, thus bringing an effective guarantee for the safety and the clinical efficacy of the product.

Description

technical field [0001] The invention relates to an industrial production method of penehyclidine hydrochloride injection. Background technique [0002] Penehyclidine hydrochloride is 3-(2-hydroxy-2-cyclopentyl-2-phenylethoxy)quinuclidane hydrochloride, the molecular formula is: C 20 h 29 NO 2 .HCl [0003] [0004] The compound is a potent anticholinergic drug designed and developed by the Chinese Academy of Military Medical Sciences, with selective M 1 , M 3 and N 1 , N 2 Receptor antagonism, showing a strong anticholinergic effect on the central and peripheral, but on M 2 The receptor has no obvious effect, which can avoid the tachycardia caused by atropine lack of M receptor subtype selectivity and block the presynaptic membrane M 2 Receptor regulation function, so long-acting and less side effects, in 1999, Chengdu Lisite Pharmaceutical Co., Ltd. exclusively marketed penehyclidine hydrochloride injection under the trade name of Changtuoning, which has been wid...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/439A61P39/02A61P25/28A61P25/02
Inventor 鲍锐余建红叶兵刘忠荣
Owner CHENGDU ZIHAO PHARMA
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