Raceanisodamine hydrochloride injection composition

An anisodamine and composition technology, which is applied in the field of racemic anisodamine hydrochloride injection composition, can solve the problems of easy precipitation of small white spots, yellowish solution color, inability to determine the prescription and the like

Inactive Publication Date: 2014-10-01
TIANJIN JINYAO GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Due to the poor stability of racemic anisodamine hydrochloride in aqueous solution, the following problems are prone to occur during the production of high-temperature sterilization, transportation and storage of this product: first, racemic anisodamine hydrochloride is degraded after high-temperature sterilization, The relevant substances exceed the standard and / or the color of the solution turns yellow, resulting in unqualified related substances and color items. Secondly, it is easy to precipitate small white spots, white blocks, solution turbidity and other precipitates during long-term storage or winter low temperature conditions, resulting in visible foreign matter in the product. exceed the standard
[0007] The improvement of quality standards has put forward higher requirements for drug production. The original production method cannot meet the quality requirements. At the same time, because it is impossible to determine how to adjust the prescription and preparation method to make the content, related substances and other indicators qualified, many domestic manufacturers The manufacturer stops the production of the product

Method used

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  • Raceanisodamine hydrochloride injection composition
  • Raceanisodamine hydrochloride injection composition
  • Raceanisodamine hydrochloride injection composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example number

[0027] Sodium chloride (g)

[0028] Mix racemic anisodamine, part of hydrochloric acid, sodium chloride and water evenly, adjust the pH value with the rest of hydrochloric acid and water for injection, and set the volume to 1000ml, then filter through a terminal of 0.22μm and pot it. Sterilize by steam at 100°C for 30 minutes. Nitrogen protection can be used during preparation and potting.

Embodiment 2

[0030] Example number

[0031] The preparation method is the same as in Example 1.

Embodiment 3

[0033] Example number

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PUM

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Abstract

The invention discloses a raceanisodamine hydrochloride injection composition with a Ph value less than 4, which contains raceanisodamine hydrochloride, hydrochloric acid, sodium chloride and water, and a preparation method of the composition.

Description

technical field [0001] The invention relates to a racemic anisodamine hydrochloride injection composition with a pH value of 3-4.5. Background technique [0002] Racemic anisodamine hydrochloride is the hydrochloride salt of (±)-6-hydroxy-1H, 5H-tropane-3-ol tropic acid ester, which is an anti-M cholinergic drug independently developed in my country, mainly used to relieve the pain of smooth muscle Spasm, gastrointestinal colic, biliary spasm, acute microcirculation disturbance and organophosphate poisoning, etc. [0003] [0004] Due to the poor stability of racemic anisodamine hydrochloride in aqueous solution, the following problems are prone to occur during the production of high-temperature sterilization, transportation and storage of this product: first, racemic anisodamine hydrochloride is degraded after high-temperature sterilization, The relevant substances exceed the standard and / or the color of the solution turns yellow, resulting in unqualified related substan...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/04A61K31/46A61P21/02A61P1/06A61P9/00A61P39/02
Inventor 杨国存于润芳张岚付慧玲张媛媛林劼刘明志
Owner TIANJIN JINYAO GRP
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