Preparation method of penehyclidine hydrochloride injection

A technology of penehyclidine hydrochloride and injection, which is applied in the field of medical drugs, and can solve problems such as cumbersome operation, unfavorable large-scale production of injections, stability and uniformity of product quality, etc., to ensure product quality, product quality and stability Good, simple operation effect

Active Publication Date: 2021-04-30
WUHAN DOCAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the actual production process, this method of carrying out acidification pretreatment of commercially available medicinal ampoules or glass vials is cumbersome to operate. There are risks of stability and uniformity in quality, which is not conducive to the industrialized production of injections

Method used

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  • Preparation method of penehyclidine hydrochloride injection
  • Preparation method of penehyclidine hydrochloride injection
  • Preparation method of penehyclidine hydrochloride injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] The preparation method of the penhyclidine hydrochloride injection provided by the present embodiment comprises the following steps:

[0037] S1, after dissolving the penehyclidine hydrochloride raw material 30g of prescription quantity with an appropriate amount of water for injection, add water for injection to full dose 30L (prescription specification 1mg: 1mL), obtain penehyclidine hydrochloride liquid medicine;

[0038] S2, using 0.05mol / L hydrochloric acid aqueous solution to adjust the pH of the above-mentioned penhyclidine hydrochloride liquid to 4.77;

[0039] S3, the penhyclidine hydrochloride medicinal solution after pH adjustment is passed through 3 μm and 1 μm filter element (material is PES) serial circulation filtration 20min;

[0040] S4, the penhyclidine hydrochloride medicinal liquid after the pH stabilization is inserted in the medicinal liquid pipeline and filtered to potting;

[0041] S5, subjecting the potted penehyclidine hydrochloride medicinal ...

Embodiment 2

[0044]The preparation method of the penhyclidine hydrochloride injection provided by the present embodiment comprises the following steps:

[0045] S1, after dissolving the penehyclidine hydrochloride raw material 30g of prescription quantity with an appropriate amount of water for injection, add water for injection to full dose 30L (prescription specification 1mg: 1mL), obtain penehyclidine hydrochloride liquid medicine;

[0046] S2, using 0.05mol / L hydrochloric acid aqueous solution to adjust the pH of the above-mentioned penhyclidine hydrochloride liquid to 4.77;

[0047] S3, the penhyclidine hydrochloride medicinal solution after pH adjustment is passed through 3 μm and 1 μm filter element (material is PES) serial circulation filtration 10min;

[0048] S4, the penhyclidine hydrochloride medicinal liquid after the pH stabilization is inserted in the medicinal liquid pipeline and filtered to potting;

[0049] S5, subjecting the potted penehyclidine hydrochloride medicinal s...

Embodiment 3

[0052] The preparation method of the penhyclidine hydrochloride injection provided by the present embodiment comprises the following steps:

[0053] S1, after dissolving the penehyclidine hydrochloride raw material 30g of the prescription amount with an appropriate amount of water for injection, add water for injection to a full dose of 30L (prescription specification 1mg: 1mL), to obtain penehyclidine hydrochloride liquid medicine.

[0054] S2, using 0.05 mol / L hydrochloric acid aqueous solution to adjust the pH of the above-mentioned penhyclidine hydrochloride liquid to 4.77.

[0055] S3, the penhyclidine hydrochloride medicinal solution after pH adjustment is passed through 3 μm and 1 μm filter element (material is PES) serial circulation filtration 30min;

[0056] S4, the penhyclidine hydrochloride medicinal liquid after the pH stabilization is inserted in the medicinal liquid pipeline and filtered to potting;

[0057] S5, subjecting the potted penehyclidine hydrochloride...

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Abstract

The invention relates to a preparation method of penehyclidine hydrochloride injection, and belongs to the field of medical drugs. The preparation method comprises the following steps: adjusting the pH value of penehyclidine hydrochloride liquid medicine, filtering for the first time until the pH value is stable, filtering for the second time until the pH value is stable, filling and sealing, and sterilizing at high temperature to obtain the penehyclidine hydrochloride injection. According to the preparation method of the penehyclidine hydrochloride injection, provided by the invention, the pH of the penehyclidine hydrochloride liquid medicine is adjusted to 4.5-5.0, and then the liquid medicine is subjected to circulating filtration treatment through the filter elements connected in series, so that the uniformity and stability of the liquid medicine are guaranteed, and the prepared penehyclidine hydrochloride injection has better stability and is more suitable for industrial production. Moreover, when the penehyclidine hydrochloride injection prepared by the invention is placed for a long time, the pH and the content of the penehyclidine hydrochloride injection can be stably kept within a qualified range.

Description

technical field [0001] The invention belongs to the field of medical drugs, and in particular relates to a preparation method of an injection liquid, more specifically, a preparation method of a selective anticholinergic drug penhyclidine hydrochloride injection. Background technique [0002] Penehyclidine hydrochloride is a new type of new drug with independent intellectual property rights independently developed by Chinese researchers in the 20th century. It is a new type of selective anticholinergic drug with selective choline receptor antagonism. Selectively acts on M1 and M3 receptors, while the effect on M2 receptors is weak or not obvious, does not act on cardiac M2 receptors, does not increase myocardial oxygen consumption, and can inhibit heart rate variability and reduce the occurrence of arrhythmia in patients Rate. Compared with the commonly used anticholinergic drug atropine at home and abroad, penhyclidine hydrochloride has advantages in many aspects, such as ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/439A61P9/06A61P43/00A61J3/00
CPCA61K31/439A61K9/08A61K9/0019A61P9/06A61P43/00A61J3/00
Inventor 尹万顺李剑盛章喜瞿启诚李付红贺雅丽艾俊全谢诗李浩
Owner WUHAN DOCAN PHARMA
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