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
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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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