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Rceanisodamine hydrochloride injection liquid stable in quality and preparation method of raceanisodamine hydrochloride injection liquid

A technology for anisodamine and injection, which is applied in the field of racemic anisodamine hydrochloride injection and its preparation, and can solve problems such as unstable production process, multiple impurities, and decreased content

Pending Publication Date: 2019-03-29
江西润泽药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the existing conventional preparation methods are often prone to contain more impurities due to factors such as the instability of the production process. Its content decreases, causing certain problems in the quality of the product

Method used

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  • Rceanisodamine hydrochloride injection liquid stable in quality and preparation method of raceanisodamine hydrochloride injection liquid
  • Rceanisodamine hydrochloride injection liquid stable in quality and preparation method of raceanisodamine hydrochloride injection liquid

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preparation example Construction

[0015] The invention provides a preparation method of racemic anisodamine hydrochloride injection with stable quality, wherein the preparation method comprises:

[0016] 1) adding hydrochloric acid to water for injection and mixing to obtain a hydrochloric acid solution;

[0017] 2) adding racemic anisodamine and sodium chloride to the hydrochloric acid solution and mixing until the pH value is 5.0-5.3 to obtain racemic anisodamine hydrochloride solution;

[0018] 3) adding glucose solution and tobramycin to the above-prepared racemic anisodamine hydrochloride solution and mixing to obtain a mixed solution M1;

[0019] 4) After the mixed solution M1 is subjected to coarse filtration and fine filtration in sequence, racemic anisodamine hydrochloride injection with stable quality is obtained.

[0020] The present invention prepares by first mixing hydrochloric acid and water for injection, then adding racemic anisodamine and sodium chloride therein, and further adjusting the pH...

Embodiment 1

[0032] 1) adding hydrochloric acid to water for injection and mixing to obtain a hydrochloric acid solution (so that the concentration of the hydrochloric acid solution is 0.1mol / L);

[0033] 2) Add 8 g of racemic anisodamine and 3 g of sodium chloride to 1 L of hydrochloric acid solution, place it at a temperature of 50° C., stir at a stirring rate of 100 r / min for 20 min, mix and adjust the pH value to 5.0 to obtain racemic hydrochloric acid Anisodamine solution;

[0034] 3) Add 300 mL of glucose solution with a concentration of 5% by weight and 0.3 g of tobramycin to 1 L of the above-prepared racemic anisodamine hydrochloride solution and mix to prepare a mixed solution M1;

[0035] 4) After the mixed solution M1 was sequentially filtered through a filter device with a filter hole of 0.45 μm and finely filtered through a filter device with a filter hole of 0.22 μm, racemic anisodamine hydrochloride injection A1 with stable quality was obtained.

Embodiment 2

[0037] 1) adding hydrochloric acid to water for injection and mixing to obtain a hydrochloric acid solution (so that the concentration of the hydrochloric acid solution is 0.15mol / L);

[0038] 2) Add 15 g of racemic anisodamine and 10 g of sodium chloride to 1 L of hydrochloric acid solution, place it at a temperature of 70° C., stir for 50 min at a stirring rate of 300 r / min, mix and adjust the pH value to 5.3 to obtain racemized hydrochloric acid Anisodamine solution;

[0039] 3) Add 600mL of glucose solution with a concentration of 5% by weight and 1g of tobramycin to 1L of the above-prepared racemic anisodamine hydrochloride solution and mix to prepare a mixed solution M1;

[0040] 4) After the mixed solution M1 was sequentially filtered through a filter device with a filter hole of 0.45 μm and finely filtered through a filter device with a filter hole of 0.22 μm, racemic anisodamine hydrochloride injection A2 with stable quality was obtained.

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Abstract

The invention discloses raceanisodamine hydrochloride injection liquid stable in quality and a preparation method of the raceanisodamine hydrochloride injection liquid. The preparation method comprises the following steps of (1) adding hydrochloric acid to water for injection, and performing mixing so as to obtain a hydrochloric acid solution; (2) adding raceanisodamine and sodium chloride to thehydrochloric acid solution, and performing mixing until the pH value is 5.0-5.3 so as to obtain a raceanisodamine hydrochloride solution; (3) adding a glucose solution and tobramycin to the prepared raceanisodamine hydrochloride solution, and performing mixing so as to obtain mixed liquid M1; and (4) sequentially performing coarse filtration and fine filtration on the mixed liquid M1 so as to obtain the raceanisodamine hydrochloride injection liquid stable in quality. The effects that the product nature can be stable, the raceanisodamine hydrochloride injection liquid stable in quality still has favorable quality after long-term storage, and the impurity content of the prepared raceanisodamine hydrochloride injection liquid stable in quality is lower can be achieved.

Description

technical field [0001] The invention relates to the field of production of racemic anisodamine hydrochloride injection, in particular to racemic anisodamine hydrochloride injection with stable quality and a preparation method thereof. Background technique [0002] Racemic anisodamine hydrochloride injection is an anti-M-cholinergic drug, which can relax smooth muscle and relieve microvascular spasm, etc. It is often used in the treatment of such diseases in clinic. However, the existing conventional preparation methods are often prone to contain more impurities due to factors such as the instability of the production process. Its content declines, causing certain problems in the quality of the product. [0003] Therefore, it is an urgent task of the present invention to provide a kind of product that can make its properties stable, still have good quality after long-term storage, and the stable quality of racemic anisodamine hydrochloride injection and preparation method th...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/02A61K47/26A61K31/46A61K31/702A61P1/06A61P21/02
CPCA61K9/0019A61K9/08A61K31/46A61K31/702A61K47/02A61K47/26A61P1/06A61P21/02A61K2300/00
Inventor 廖年生邹明明胡贤德胡庭国
Owner 江西润泽药业有限公司
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