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Medicinal tropisetron hydrochloride composition dry suspension for treating nausea and emesis

A technology of tropisetron hydrochloride and dry suspension, applied in the field of medicine, can solve the problems of difficult preparation of preparations, unsatisfactory hygroscopicity of impurity content crystal form, influence on stability, etc., and achieves good fluidity and safe and reliable clinical application. , good stability

Inactive Publication Date: 2015-12-30
QINGDAO HUAZHICAO PHARMA 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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  • Medicinal tropisetron hydrochloride composition dry suspension for treating nausea and emesis
  • Medicinal tropisetron hydrochloride composition dry suspension for treating nausea and emesis
  • Medicinal tropisetron hydrochloride composition dry suspension for treating nausea and emesis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1: Preparation of Tropisetron Hydrochloride Crystals

[0027] (1) Take tropisetron hydrochloride crude drug and add it to deionized water, the volume dosage of deionized water is 5 times of the mass of tropisetron hydrochloride;

[0028] (2) Stir until completely dissolved, and adjust the pH to 6-9;

[0029] (3) Add activated carbon for decolorization and filter to obtain a clear solution;

[0030] (4) Move the clarified solution into a pressure vessel, add 2°C isopropanol dropwise under the condition that the pressure in the pressure vessel is controlled at 2.0Mpa and stirred, the stirring speed is controlled at 35rmp, and the volume of isopropanol is de 3 times the volume of ionized water;

[0031] (5) Release the pressure after the dropwise addition, cool the solution to -5°C at a rate of 10°C / min, let it stand for 2 hours, filter, wash with ethanol, and dry under reduced pressure to obtain tropisetron hydrochloride crystals.

[0032] The prepared tropis...

Embodiment 2

[0033] Example 2: Preparation of Tropisetron Hydrochloride Dry Suspension

[0034] Prescription: in parts by weight as shown in Table 1

[0035] Table 1 Tropisetron Hydrochloride Composition Prescription

[0036]

[0037] Preparation:

[0038] 1) Weighing: Weigh the raw and auxiliary materials according to the prescription process;

[0039] 2) Pre-mixing and crushing: add the prescribed amount of tropisetron hydrochloride and lactose in equal amounts and mix them evenly, and crush them through a 100-mesh sieve after mixing;

[0040] 3) Total mixing: add the premixed and pulverized tropisetron hydrochloride, lactose and prescribed amount of mannitol, crospovidone, hypromellose, gum arabic, sucralose, and micronized silica gel to the three-dimensional mixer In the middle, the mixing speed is 12r / min, and the mixer is turned on for 60 minutes;

[0041] 4) Subpackage: Add the granules to the granule packaging machine for subpackage, and control the difference in the filli...

Embodiment 3

[0042] Example 3: Preparation of Tropisetron Hydrochloride Dry Suspension

[0043] Prescription: in parts by weight as shown in Table 2

[0044] Table 2 Tropisetron Hydrochloride Composition Prescription

[0045]

[0046] Preparation:

[0047] 1) Weighing: Weigh the raw and auxiliary materials according to the prescription process;

[0048] 2) Pre-mixing and crushing: add the prescribed amount of tropisetron hydrochloride and lactose in equal amounts and mix them evenly, and crush them through a 100-mesh sieve after mixing;

[0049] 3) Total mixing: add the premixed and pulverized tropisetron hydrochloride, lactose and prescribed amount of mannitol, crospovidone, hypromellose, gum arabic, sucralose, and micronized silica gel to the three-dimensional mixer In the middle, the mixing speed is 12r / min, and the mixer is turned on for 60 minutes;

[0050] 4) Subpackage: Add the granules to the granule packaging machine for subpackage, and control the difference in the filli...

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Abstract

The invention discloses a medicinal tropisetron hydrochloride composition dry suspension for treating nausea and emesis and belongs to the technical field of medicine. The composition is prepared from tropisetron hydrochloride, lactose, mannitol, PVPP, HPMC, Arabic gum, sucralose and aerosol. The tropisetron hydrochloride is a novel crystal-form compound. As shown in Figure 1 of X-ray powder diffraction diagram obtained by means of Cu-K alpha ray measurement, the tropisetron hydrochloride is different from tropisetron hydrochloride reported in the prior art. Tests find that the novel crystal-form compound is high in purity, good in fluidity and stability, low in impurity content, not prone to absorb moisture and safe and reliable in clinical application. The dry suspension prepared through the novel crystal-form compound is good in stability and quite suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicines and relates to a dry suspension of 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 ...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/46C07D451/12A61P1/08
Inventor 刘学键
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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