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
CN109528640APending Publication Date: 2019-03-29江西润泽药业有限公司
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
江西润泽药业有限公司
Publication Date
2019-03-29

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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.
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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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