Novel guaiacol bromine composition and preparation method thereof

A composition, the technology of bromhexine hydrochloride, which is applied in the direction of drug combination, pharmaceutical formulation, drug delivery, etc., can solve the problem that the growth of bromhexine hydrochloride impurities cannot be well controlled, and achieve good prospects, simple and stable production steps good sex effect

Inactive Publication Date: 2020-05-12
北京柏雅联合药物研究所有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0016] The study found that the marketed preparations, Huifeitong, could not well control the growth of bromhexine hydrochloride impurities in the composition, especially impurity E and impurity B

Method used

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  • Novel guaiacol bromine composition and preparation method thereof
  • Novel guaiacol bromine composition and preparation method thereof
  • Novel guaiacol bromine composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-3

[0060] Examples 1-3 The formula of the guaiacol bromoxin composition is shown in Table 1 below, and its preparation method is basically the same, the only difference is that the pH of each composition is different.

Embodiment 1-3

[0061] Embodiment 1-3 concrete preparation method is as follows:

[0062] (1) Boil purified water for later use, take part of the purified water and cool it to 60-70°C, add bromhexine hydrochloride, citric acid, disodium edetate, guaiacol glyceryl ether, sucralose, sodium benzoate and stir dissolve. (2) Add povidone K90 and sorbitol into the above solution, stir and dissolve, and cool. (3) Add Allura Red and orange essence and stir until fully dissolved. After the volume is fixed to the prescription amount, a pH regulator (such as sodium hydroxide) is added to adjust to the required pH value and stirred evenly. (4) Filtration.

[0063] Table 1

[0064]

[0065]

[0066] Note: In Table 1, " / " means not added.

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Abstract

The invention relates to a novel guaiacol bromine composition and a preparation method thereof. According to the invention, edetic acid (edetate) is found to be able to well control growth of a bromhexine hydrochloride impurity E and impurity B, so the stability of bromhexine hydrochloride is remarkably improved. Compared with a conventional product with a similar kind, the novel guaiacol brominecomposition prepared by using the preparation method provided by the invention has the advantage that the high-temperature, accelerated and long-term stability results are obviously improved. The preparation method provided by the invention can be used for industrial large-scale production and has good prospect.

Description

technical field [0001] The invention relates to a guaiacol bromide composition and a preparation method thereof. Background technique [0002] Bromhexine hydrochloride: Chemical name: N-methyl-N-cyclohexyl-2-amino-3,5-dibromobenzylamine hydrochloride Structural formula: [0003] [0004] This product is an expectorant, which can directly act on bronchial glands, promote the release of lysosomes of mucus secreting cells, and make the mucopolysaccharide fibers in sputum differentiate and crack; it can also inhibit the production of acid glycoprotein in mucus glands and goblet cells. Synthesized to make it secrete low-viscosity small molecule glycoproteins, thereby reducing the viscosity of sputum and making it easier to cough up. In addition, it can also stimulate the gastric mucosa to reflexively increase the secretion of the respiratory glands and dilute the sputum. It is used for acute and chronic bronchitis, asthma, bronchiectasis, and emphysema, especially for those ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/137A61K9/08A61K31/09A61K47/18A61P11/10A61P11/14
CPCA61K9/08A61K31/09A61K31/137A61K47/183A61P11/10A61P11/14A61K2300/00
Inventor 王大光任霞陈曼
Owner 北京柏雅联合药物研究所有限公司
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