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Medicinal tropisetron hydrochloride composition capsule for treating nausea and vomiting

A technology for tropisetron hydrochloride and a composition, 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, safe and reliable clinical application, and dissolution. high degree of effect

Inactive Publication Date: 2015-12-09
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 capsule for treating nausea and vomiting
  • Medicinal tropisetron hydrochloride composition capsule for treating nausea and vomiting
  • Medicinal tropisetron hydrochloride composition capsule for treating nausea and vomiting

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1: Preparation of Tropisetron Hydrochloride Crystals

[0028] Take tropisetron hydrochloride crude drug, add in the mixed solvent A of water, acetone, N-methylacetamide whose volume is 8 times of the weight of tropisetron hydrochloride at 30 ℃, water, acetone, N-methylacetamide Volume ratio is 4:1:0.5, obtains solution; Apply the constant magnetic field that magnetic field intensity is 0.7T then on the horizontal direction of the liquid level of gained solution, and drop volume is torr hydrochloride in solution under the condition of this constant magnetic field. Mixed solvent B of ethanol, isobutanol, and diethyl ether that is 5 times the weight of anisetron, and the volume ratio of ethanol, isobutanol, and diethyl ether is 2:4:3; hours, filtered, washed, and vacuum-dried to obtain the tropisetron hydrochloride crystals.

[0029] The prepared tropisetron hydrochloride crystals use Cu-Kα ray to measure the X-ray powder diffraction pattern obtained as figure ...

Embodiment 2

[0030] Example 2: Preparation of Tropisetron Hydrochloride Capsules

[0031] Prescription: in parts by weight as shown in Table 1

[0032] Table 1 Tropisetron Hydrochloride Composition Prescription

[0033]

[0034] Preparation:

[0035] 1) Weighing according to the process prescription;

[0036] 2) Processing of raw and auxiliary materials: sieve the prescribed amount of tropisetron hydrochloride and mannitol through 100 mesh;

[0037] 3) Pre-mixing: mix the prescribed amount of tropisetron hydrochloride and mannitol in equal increments;

[0038] 4) Prepare povidone K30 ethanol solution: put the prescribed amount of 95% ethanol in a stainless steel bucket, add the prescribed amount of povidone K30 while stirring, and stir until completely dissolved for later use;

[0039] 5) Mixing and granulation: Add the prescribed amount of tropisetron hydrochloride, mannitol, sodium sulfite, and sodium starch glycolate into the wet mixing granulator, turn on the stirring motor an...

Embodiment 3

[0044] Example 3: Preparation of Tropisetron Hydrochloride Capsules

[0045] Prescription: in parts by weight as shown in Table 2

[0046] Table 2 Tropisetron Hydrochloride Composition Prescription

[0047]

[0048] Preparation:

[0049] 1) Weighing according to the process prescription;

[0050] 2) Processing of raw and auxiliary materials: sieve the prescribed amount of tropisetron hydrochloride and mannitol through 100 mesh;

[0051] 3) Pre-mixing: mix the prescribed amount of tropisetron hydrochloride and mannitol in equal increments;

[0052] 4) Prepare povidone K30 ethanol solution: put the prescribed amount of 95% ethanol in a stainless steel bucket, add the prescribed amount of povidone K30 while stirring, and stir until completely dissolved for later use;

[0053] 5) Mixing and granulation: Add the prescribed amount of tropisetron hydrochloride, mannitol, sodium sulfite, and sodium starch glycolate into the wet mixing granulator, turn on the stirring motor an...

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Abstract

The invention discloses a medicinal tropisetron hydrochloride composition capsule for treating nausea and vomiting, which belongs to the technical field of medicines. The composition is prepared from tropisetron hydrochloride, mannitol, sodium sulfite, carboxymethyl starch sodium, povidone K30, 95 percent ethanol and talc powder, wherein the tropisetron hydrochloride is a new crystalline compound; an X-ray powder diffraction pattern, which is obtained by measurement of Cu-Kalpha rays, of the new crystalline compound, is as shown in figure 1, and the new crystalline compound is tropisetron hydrochloride different from the tropisetron hydrochloride reported in the prior art; tests prove that the new crystalline compound has the advantages of high purity, good flowability, good stability, low content of impurities, low possibility of moisture absorption, and safety and reliability in clinical application; the capsule prepared from the new crystalline compound is high in dissolution rate, good in stability and very suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a tropisetron hydrochloride composition capsule 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 prepara...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/46A61K47/36A61P1/08
Inventor 刘学键
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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