Ambroxol hydrochloride compound and medicine composition thereof

A kind of technology of ambroxol hydrochloride and compound, which is applied in a method and the field of pharmaceutical composition prepared by this compound, can solve the problems such as unqualified tablet weight uniformity and poor fluidity when pressed into tablets

Active Publication Date: 2013-03-13
SHENYANG XINMA PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Those of ordinary skill in the field of pharmaceutical preparations know that the consumption of lubricant is generally within 1%, but the existing ambroxol hydrochloride preparation and crystallization method obtains the poor fluidity of ambroxol hydrochloride crystalline form, if the consumption of magnesium stearate is within 1% %, the weight uniformity of the tablet will be unqualified due to the poor fluidity of the raw material

Method used

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  • Ambroxol hydrochloride compound and medicine composition thereof
  • Ambroxol hydrochloride compound and medicine composition thereof
  • Ambroxol hydrochloride compound and medicine composition thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Take the ambroxol crude product, add a non-polar solvent whose volume is 10 times the weight of ambroxol, heat it to 100-145°C to dissolve it, then drop it to 20-25°C, and add ambroxol to ambroxol under temperature control. Slowly feed HCl gas in the toluene or xylene solution of Sulfox, the weight that feeds HCl is 9% of ambroxol weight. After passing through the HCl gas, the mixture was heated to 50-80° C. and kept stirring at the temperature for 5-8 hours. Filtrate while hot, and the product obtained is dried under vacuum to obtain ambroxol hydrochloride. The yield is 98%

Embodiment 2

[0016] Take the ambroxol crude product, add a non-polar solvent whose volume is 13 times the weight of ambroxol, heat it to 110-130°C to dissolve it, and then drop it to 20-25°C. Slowly feed HCl gas in the toluene or xylene solution of Sulfox, the weight that feeds HCl is 15% of ambroxol weight. After passing through the HCl gas, the mixture was heated to 50-80° C. and kept stirring at the temperature for 5-8 hours. Filtrate while hot, and the product obtained is dried under vacuum to obtain ambroxol hydrochloride. The yield was 99%.

Embodiment 3

[0018] Take the crude product of ambroxol, add a non-polar solvent whose volume is 15 times the weight of ambroxol, heat it to 100-145°C to dissolve it, then drop it to 20-25°C, and add ambroxol to ambroxol under the condition of temperature control. Slowly feed HCl gas in the toluene or xylene solution of Sulfox, the weight that feeds HCl is 12% of ambroxol weight. After passing through the HCl gas, the mixture was heated to 50-80° C. and kept stirring at the temperature for 5-8 hours. Filtrate while hot, and the product obtained is dried under vacuum to obtain ambroxol hydrochloride. The yield was 99%.

[0019] Ambroxol hydrochloride obtained in the above examples is measured by powder X-ray diffraction assay, and the X-ray powder diffraction spectrum expressed at 2θ ± 0.2 ° diffraction angle is at 6.9 °, 7.2 °, 10.2 °, 12.5 °, 15.8 °, 20.2 ° , 29°, 32°, 35.2° showed characteristic diffraction peaks. See attached picture figure 2 .

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Abstract

The invention discloses an ambroxol hydrochloride crystal and a medicine composition prepared by the ambroxol hydrochloride crystal. The ambroxol hydrochloride crystal shows specific diffractive peaks in parts of 6.9 degrees, 7.2 degrees, 12.8 degrees, 15.6 degrees, 17.5 degrees, 20 degrees, 21 degrees, 22 degrees and 24 degrees in an X-ray powder diffraction pattern which is shown in form of 2 Theta +/-0.2 degrees. The prepared ambroxol hydrochloride crystal is high in yield and liquidity; and the amount of lubricant in original prescription is halved, so that the weight and uniformity of tablets can meet the specification.

Description

technical field [0001] The invention relates to an expectorant drug ambroxol hydrochloride compound, which is a new crystal form of ambroxol hydrochloride, and also relates to a method for preparing the compound and a pharmaceutical composition prepared from the compound. Background technique [0002] Ambroxol hydrochloride mainly acts on the secretory cells of the respiratory tract, regulates the secretion of mucus and serous substances, increases the secretion of serous substances, and can also crack the polysaccharide fibers of acidic glycoproteins in sputum, and inhibit the acidic proteins in mucous glands and goblet cells. The synthesis of sputum reduces the viscosity of sputum, making the sputum thin and easy to discharge. At the same time, the drug can also increase the movement frequency and intensity of airway cilia, promote the discharge of sputum and the self-purification of the airway. Ambroxol Hydrochloride (Ambroxol Hydrochloride) has the advantages of small a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C215/44C07C213/10A61K31/137A61P11/10
Inventor 刘畅徐雷黄牧童杨秀伟
Owner SHENYANG XINMA PHARMA
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