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Fudosteine oral liquid and preparation method thereof

A technology of fudosteine ​​oral liquid and stetan oral liquid, which is applied in the field of biomedicine, can solve the problems of increasing production cost, increasing the workload of preparation products, product quality, etc., to reduce conversion, improve dimensional stability, and good stability Effect

Active Publication Date: 2020-12-11
AC PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method needs to introduce acid salts in the raw material drug stage, which increases the production cost, and may introduce toxic impurities with sulfonate groups due to the selection of the process route in the raw material drug production stage, which increases the workload and impact on the development of preparation products. Quality of products

Method used

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  • Fudosteine oral liquid and preparation method thereof
  • Fudosteine oral liquid and preparation method thereof
  • Fudosteine oral liquid and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] The present embodiment provides a kind of 500mL fudosteine ​​oral liquid, described fudosteine ​​oral liquid comprises 8% fudosteine, 3.6% zinc sulfate, acid-base regulator (1M citric acid 5.9mL, 1M citric acid sodium 4.1mL), 0.05% sodium benzoate, 10% trehalose, 0.01% lemon essence, 0.1% tartrazine and water; wherein the mol ratio of fudosteine ​​and zinc sulfate is 2:1, the pH value of the oral solution is 4.0. Its preparation method is as follows:

[0051] (1) Mix zinc sulfate with 200mL water and stir until dissolved;

[0052] (2) Mix the solution obtained in step (1) with fudosteine, stir until dissolved, and add an acid-base regulator to adjust the pH value of the solution to 4.0;

[0053] (3) The solution obtained in step (2) was subjected to a chelation reaction at 50°C for 60 minutes, cooled, and then the remaining components were added to it. After mixing evenly, water was added to a total volume of 500 mL to obtain the fudosteine Oral solution.

Embodiment 2-7

[0055] This embodiment provides six kinds of 500mL fudosteine ​​oral liquid, and its difference with embodiment 1 is that the molar ratio of fudosteine ​​and zinc sulfate is different, as shown in the following table:

[0056]

[0057] Its preparation method is identical with embodiment 1.

Embodiment 8-12

[0059] The present embodiment provides five kinds of 500mL fudosteine ​​oral liquid, and its difference with embodiment 1 is only that the mass percentage content of fudosteine ​​is different, and wherein the mol ratio of fudosteine ​​and zinc sulfate is 2:1, As shown in the table below:

[0060]

[0061] Its preparation method is identical with embodiment 1.

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Abstract

The invention relates to a fudosteine oral liquid and a preparation method thereof. The fudosteine oral liquid comprises fudosteine, a metal ion compound, an acid-base regulator and a solvent, whereinthe fudosteine and metal ions form a chelate through chelation. The preparation method comprises the following steps: (1) mixing the metal ion compound with part of the solvent, and stirring until the metal ion compound is dissolved; (2) mixing the solution obtained in the step (1) with the fudosteine, stirring until the solution is dissolved, and adding the acid-base regulator to regulate the pHvalue of the solution; and (3) carrying out chelation reaction on the solution obtained in the step (2), cooling, and adding the solvent to the target quantity, thereby obtaining the fudosteine oralliquid. The oral liquid has the advantages of favorable stability and lower isomer impurity content, and solves the problem that the isomer impurity content in the fudosteine oral liquid increases quickly as the time goes on in the prior art.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and in particular relates to a fudosteine ​​oral liquid and a preparation method thereof, in particular to a fudosteine ​​oral liquid with low impurity content and good stability and a preparation method thereof. Background technique [0002] Fudosteine ​​(Fudosteine) contains a closed sulfhydryl group in its structure, which is metabolized into an active free sulfhydryl derivative in the body to play a physiologically active role. It has a strong expectorant effect on cough, chronic bronchitis, bronchiectasis, pneumoconiosis, emphysema, non-stereotype acid-fast bacteria disease and other diseases. There are two configurations of fudosteine, which are chiral enantiomers. Chiral drug enantiomers often have different pharmacological activities and toxicity, and often have different metabolic effects in the body. Therefore, most chiral drugs must be used clinically in the form of optically pure...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/198A61K47/52A61K47/12A61K47/02A61P11/14A61P11/00A61P31/04
CPCA61K9/0095A61K31/198A61K47/52A61K47/12A61K47/02A61P11/14A61P11/00A61P31/04
Inventor 刘锋谭晓峰罗雪仪苏文瑜金迪华梁文伟
Owner AC PHARMA CO LTD
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