A kind of preparation method of penehyclidine hydrochloride injection

A technology of penehyclidine hydrochloride and injection, which is applied in the field of medical drugs, can solve the problems of cumbersome operation, unfavorable large-scale production of injections, stability and uniformity of product quality, etc., and achieve good product quality and stability and simple operation , The effect of guaranteeing product quality

Active Publication Date: 2022-05-06
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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  • A kind of preparation method of penehyclidine hydrochloride injection
  • A kind of preparation method of penehyclidine hydrochloride injection
  • A kind of preparation method of penehyclidine hydrochloride injection

Examples

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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 30 g of penehyclidine hydrochloride raw material in the prescribed amount with an appropriate amount of water for injection, add water for injection to the full amount of 30 L (prescription specification 1 mg: 1 mL), to obtain penehyclidine hydrochloride liquid medicine;

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

[0039] S3, the pH-adjusted penhyclidine hydrochloride medicinal solution is filtered in series for 20 minutes through 3 μm and 1 μm filter elements (material is PES);

[0040] S4, connecting the penhyclidine hydrochloride medicinal solution with stable pH into the medicinal solution pipeline to filter until potting;

[0041] S5, subjecting the potted penhyclidine hydrochloride medicinal solution to high-te...

Embodiment 2

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

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

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

[0047] S3, the pH-adjusted penhyclidine hydrochloride medicinal solution is filtered in series for 10 minutes through 3 μm and 1 μm filter elements (material is PES);

[0048] S4, connecting the penhyclidine hydrochloride medicinal solution with stable pH into the medicinal solution pipeline to filter until potting;

[0049] S5, subjecting the potted penhyclidine hydrochloride medicinal solution to high-te...

Embodiment 3

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

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

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

[0055] S3, the pH-adjusted penhyclidine hydrochloride medicinal solution is filtered in series for 30 minutes through 3 μm and 1 μm filter elements (the material is PES);

[0056] S4, connecting the penhyclidine hydrochloride medicinal solution with stable pH into the medicinal solution pipeline to filter until potting;

[0057] S5, subjecting the potted penhyclidine hydrochloride medicinal solution to hi...

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Abstract

The invention relates to a preparation method of penehyclidine hydrochloride injection, which belongs to the field of medical drugs. The preparation method comprises: adjusting the pH of the penehyclidine hydrochloride drug solution, filtering once until the pH value is stable, filtering twice until it is potted, and then sterilizing at high temperature to obtain the product. The preparation method of penehyclidine hydrochloride injection provided by the present invention adjusts the pH of the penehyclidine hydrochloride liquid to 4.5-5.0, and then circulates and filters the liquid through a series of filter elements to ensure the uniformity of the liquid Stable, the thus prepared penhyclidine hydrochloride injection has better stability and is more suitable for industrial production. Moreover, when the penhyclidine hydrochloride injection prepared by the present invention is placed for a long time, its pH and content can be stably maintained within the acceptable range.

Description

technical field [0001] The invention belongs to the field of medical drugs, and in particular relates to a preparation method of a medicinal liquid for injection, 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. It selectively acts on M1 and M3 receptors, but has weak or insignificant effect on M2 receptors, 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 aspe...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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