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Medicine tropisetron hydrochloride composition for treating nausea and emesis

A technology of tropisetron hydrochloride and its composition, which is applied in the field of medicine, and can solve problems such as difficulties in preparing preparations, unsatisfactory hygroscopicity of impurity content crystal forms, and affecting stability, etc.

Inactive Publication Date: 2015-12-23
QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In the prior art, there have been many studies on the crystal form of tropisetron hydrochloride, but the impurity content, stability and hygroscopicity of the crystal form are still not ideal, which affects its own stability and also brings problems to the preparation of the preparation. here comes the difficulty

Method used

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  • Medicine tropisetron hydrochloride composition for treating nausea and emesis
  • Medicine tropisetron hydrochloride composition for treating nausea and emesis
  • Medicine tropisetron hydrochloride composition for treating nausea and emesis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Example 1: Preparation of Tropisetron Hydrochloride Crystals

[0023] (1) Grind the crude tropisetron hydrochloride, pass it through a 90-mesh sieve, add it to 45% N-methylacetamide aqueous solution, and raise the temperature to 30°C while stirring; mix the crude tropisetron hydrochloride with 45% The weight ratio of the N-methylacetamide aqueous solution is 1:10; the stirring speed is 180 rpm; adding activated carbon, stirring for 50 minutes and sterile filtering;

[0024] (2) Add ethanol while stirring, and lower the temperature to -15°C; the stirring speed is 240 rpm; the weight of ethanol is 7 times the weight of the mixed solution of tropisetron hydrochloride and 45% N-methylacetamide aqueous solution , the adding rate is 95 ml / min; the cooling rate is 10°C / hour;

[0025] (3) After adding the mixed solvent, the obtained crystals were left to stand for crystallization; filtered, washed, and vacuum-dried for 6 hours to obtain the tropisetron hydrochloride compound...

Embodiment 2

[0027] Example 2: Preparation of tropisetron hydrochloride composition

[0028] The composition comprises: 1 part by weight of tropisetron hydrochloride crystal prepared by the present invention, and 0.1 part by weight of anhydrous sodium carbonate.

[0029] The preparation method is:

[0030] (1) Weigh tropisetron hydrochloride crystals and anhydrous sodium carbonate in proportion and mix them thoroughly;

[0031] (2) Dispense into sterilized vials and stopper them.

Embodiment 3

[0032] Example 3: Preparation of tropisetron hydrochloride composition

[0033] The composition is: 1 part by weight of tropisetron hydrochloride crystal prepared by the present invention, and 0.15 part by weight of anhydrous sodium carbonate.

[0034] The preparation method is:

[0035] (1) Weigh tropisetron hydrochloride crystals and anhydrous sodium carbonate in proportion and mix them thoroughly;

[0036] (2) Dispense into sterilized vials and stopper them.

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Abstract

The invention relates to a medicine tropisetron hydrochloride composition for treating nausea and emesis and belongs to the technical field of medicines. The composition is prepared from tropisetron hydrochloride and anhydrous sodium carbonate, wherein the tropisetron hydrochloride is of a crystal and an X-ray powder diffraction pattern obtained by Cu-K alpha ray measurement is shown as a figure 1. A new crystal form of the tropisetron hydrochloride provided by the invention is different from a crystal form structure in the prior art; experimental verification is carried out to surprisedly find out that the compound with the new crystal form has high purity, good mobility, good stability and low impurity content, does not easily absorb moisture, and is safe and reliable in clinical application; a powder injection prepared from the compound with the new crystal form has good stability; the medicine tropisetron hydrochloride composition has good stability after being matched with a solvent, and the content of insoluble micro-particles is extremely low, so that the composition is very suitable for the clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a tropisetron hydrochloride composition for treating nausea and vomiting. Background technique [0002] Tropisetron hydrochloride is a selective peripheral neuron and central nervous system 5-hydroxytryptamine receptor antagonist, which can selectively block the vomiting reflex center, the excitation of peripheral neuron presynaptic 5-hydroxytryptamine receptors, and act on afferent The 5-hydroxytryptamine receptor active in the vagus nerve in the postrema area of ​​the central nervous system can prevent and treat nausea and vomiting caused by chemotherapy without causing extrapyramidal adverse reactions. [0003] In the prior art, there have been many studies on the crystal form of tropisetron hydrochloride, but the impurity content, stability and hygroscopicity of the crystal form are still not ideal, which affects its own stability and also brings problems to the preparation of ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/46A61K47/04A61P1/08C07D451/12
Inventor 刘学键
Owner QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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