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Bromhexine hydrochloride compound and medicine composition thereof

A bromhexine hydrochloride compound technology, applied in the field of medicine, can solve the problems of unfavorable drug long-term storage, poor stability of bromhexine hydrochloride, and rapid reduction of active ingredient content, so as to improve drug safety, good stability, and not easy to change Effect

Active Publication Date: 2012-11-14
江西璟瑞药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The bromhexine hydrochloride obtained by the current method has poor stability, and the content of active ingredients in long-term storage decreases rapidly, which is not conducive to the long-term preservation of medicines

Method used

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  • Bromhexine hydrochloride compound and medicine composition thereof
  • Bromhexine hydrochloride compound and medicine composition thereof
  • Bromhexine hydrochloride compound and medicine composition thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] The preparation of the bromhexine hydrochloride composition is as follows: take 100 g of the bromhexine hydrochloride crude product, add a volume ratio of 8.5:1.5 ethanol:n-butanol solution whose volume is 10 times the weight of the bromhexine hydrochloride crude product, and stir at 40° C. Dissolve; after the bromhexine hydrochloride crude product is dissolved, add 0.3 times of activated carbon for decolorization for 30 minutes, filter; stop heating the filtrate, cool the filtrate to 23°C at a speed of 1.2°C / min, keep the temperature and add dropwise the volume of the bromhexine hydrochloride crude product The water: acetonitrile solution with a volume ratio of 3 times the weight of 4:6, the dropwise addition is at a constant speed of 8 minutes under the stirring speed of 14rmp; min, lower the temperature to 8°C, let stand for 17 hours, filter, wash twice with a 6:4 ethanol: n-butanol solution, each time the volume is 0.4 times the weight of the crude bromhexine hydroch...

Embodiment 2

[0035] The preparation of the bromhexine hydrochloride composition is as follows: take 100 g of the bromhexine hydrochloride crude product, add a volume ratio of 8.5:1.5 ethanol:n-butanol solution whose volume is 10 times the weight of the bromhexine hydrochloride crude product, and stir at 40° C. Dissolve; after the bromhexine hydrochloride crude product is dissolved, add 0.3 times of activated carbon for decolorization for 30 minutes, filter; stop heating the filtrate, cool the filtrate to 20°C at a speed of 1.2°C / min, keep the temperature and add dropwise the volume of the bromhexine hydrochloride crude product 3 times the weight of water: acetonitrile solution with a volume ratio of 4:6, the dropwise addition is at a constant speed of 8 minutes at a stirring speed of 15rmp; after dropping, stir and cool down, and the stirring and cooling is at a speed of 2.3°C / min, lower the temperature to 5°C, let stand for 18 hours, filter, wash twice with a 6:4 ethanol: n-butanol soluti...

Embodiment 3

[0038] The preparation of the bromhexine hydrochloride composition is as follows: take 100 g of the bromhexine hydrochloride crude product, add a volume ratio of 8.5:1.5 ethanol:n-butanol solution whose volume is 10 times the weight of the bromhexine hydrochloride crude product, and stir at 40° C. Dissolve; after the bromhexine hydrochloride crude product is dissolved, add 0.3 times of activated carbon for decolorization for 30 minutes, filter; stop heating the filtrate, cool the filtrate to 25°C at a speed of 1.2°C / min, keep the temperature and add dropwise the volume of the bromhexine hydrochloride crude product Water: acetonitrile solution with a volume ratio of 3 times the weight of 4:6, the dropwise addition is at a constant speed of 8 minutes under the stirring speed of 12rmp; min, lower the temperature to 10°C, let stand for 16 hours, filter, wash twice with a 6:4 ethanol:n-butanol solution, each time the volume is 0.4 times the weight of the crude product of bromhexine ...

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PUM

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Abstract

The invention relates to a bromhexine hydrochloride compound and a medicine composition thereof. The bromhexine hydrochloride is measured by the powder X-ray diffraction measurement method; and the characteristic diffraction peaks of the X-ray powder diffraction atlas represented by a diffraction angle of 2(theta)+ / -0.2 degrees are displayed at 6.78 degrees, 10.39 degrees, 13.40 degrees, 13.90 degrees, 16.75 degrees, 17.11 degrees, 17.74 degrees, 18.38 degrees, 27.80 degrees, 28.81 degrees, 30.06 degrees, 31.53 degrees and 35.78 degrees.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a bromhexine hydrochloride composition. Background technique [0002] Bromhexine hydrochloride, also known as bromhexyl ammonium, benzylcyclohexyl ammonium bromide, bisupin, and bisputum, is a semi-synthetic hydrochloride of orchidine derivatives, which was first synthesized by Keck in 1963. Bromhexine hydrochloride is white or off-white crystalline powder; odorless and tasteless. This product is slightly soluble in ethanol or chloroform, very slightly soluble in water. Melting point The melting point of this product is 239-243°C, and it decomposes at the same time when melting. [0003] Bromhexine hydrochloride can directly act on bronchial glands, promote the release of lysosomes of mucus-secreting cells, and differentiate and crack the sticky sugar fibers in sputum; it can also inhibit the synthesis of acid glycoproteins in mucous glands and goblet cells, Make it secrete low-viscosi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C211/52C07C209/84A61K31/137A61P11/12A61P11/10
Inventor 夏智红
Owner 江西璟瑞药业有限公司
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