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Medicine tropisetron hydrochloride composition for treating nausea and vomiting caused by chemotherapy

A technology for tropisetron hydrochloride and a composition, applied in the field of medicine, can solve the problems of affecting stability, unsatisfactory hygroscopicity of impurity content crystal form, difficult preparation of preparations and the like

Inactive Publication Date: 2015-10-28
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 vomiting caused by chemotherapy
  • Medicine tropisetron hydrochloride composition for treating nausea and vomiting caused by chemotherapy
  • Medicine tropisetron hydrochloride composition for treating nausea and vomiting caused by chemotherapy

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Example 1: Preparation of Tropisetron Hydrochloride Crystals

[0023] (1) Dissolve tropisetron hydrochloride in a mixed solvent of acetone and water, the required amount of solvent per gram of tropisetron hydrochloride is 80ml, and the volume ratio of acetone and water is 1:5;

[0024] (2) After heating to 35°C to dissolve, add seed crystals after cooling to room temperature;

[0025] (3) Cool to below 0°C, stir and crystallize, the crystallization temperature is -15°C, filter, dry, collect crystals to obtain tropisetron hydrochloride crystals.

[0026] The prepared tropisetron hydrochloride crystals use Cu-Kα ray to measure the X-ray powder diffraction pattern obtained as figure 1 Shown, its purity as determined by high performance liquid chromatography is 99.9%.

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 0.4 part by weight of sodium chloride.

[0029] The preparation method is:

[0030] (1) Weigh tropisetron hydrochloride crystals and sodium chloride 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 comprises: 1 part by weight of tropisetron hydrochloride crystal prepared by the invention, and 0.5 part by weight of sodium chloride.

[0034] The preparation method is:

[0035] (1) Weigh tropisetron hydrochloride crystals and sodium chloride 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 vomiting caused by chemotherapy and belongs to the technical field of medicines. The composition is composed of tropisetron hydrochloride and sodium chloride; the tropisetron hydrochloride is a crystal; an X-ray powder diffraction pattern obtained through Cu-K<alpha> ray measurement is shown in the figure 1 (shown in the description). The new crystal form of the tropisetron hydrochloride provided by the invention is different from that in the prior art, through experimental verification, that the new crystal form compound is high in purity, good in liquidity, good in stability, and low in impurity content, does not absorb moisture easily, and is safe and reliable in clinical application is pleasantly found, powder-injection prepared through the new crystal form compound is good in stability, and good in stability after being combined with a solvent, the content of insoluble particles is extremely low and the medicine tropisetron hydrochloride composition is very suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a composition of tropisetron hydrochloride, a drug for treating nausea and vomiting caused by chemotherapy. Background technique [0002] Tropisetron hydrochloride is a selective peripheral neuron and central nervous system 5 - HT receptor antagonist, which can selectively block the vomiting reflex center, the excitation of peripheral neuron presynaptic 5 - HT receptors, and act on afferent The serotonin receptors active in the vagus nerve in the area postrema 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 th...

Claims

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Application Information

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