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Vomit-stopping drug, namely, tropisetron hydrochloride composition tablets

A technology for tropisetron hydrochloride and a composition, which is applied in the field of medicine, can solve the problems of unsatisfactory hygroscopicity of impurity content crystal form, difficult preparation of preparations, influence on stability, etc., and achieves safe and reliable clinical application, good fluidity, and dissolution. high degree of effect

Inactive Publication Date: 2015-12-02
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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  • Vomit-stopping drug, namely, tropisetron hydrochloride composition tablets
  • Vomit-stopping drug, namely, tropisetron hydrochloride composition tablets
  • Vomit-stopping drug, namely, tropisetron hydrochloride composition tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Example 1: Preparation of Tropisetron Hydrochloride Crystals

[0030] (1) Grind the crude product of tropisetron hydrochloride, pass it through a 80-mesh sieve, then add it into methanol whose volume is 11 times the weight of tropisetron hydrochloride, and stir at 130 rpm for 10 minutes;

[0031] (2) Add acetone whose volume is 6 times the weight of tropisetron hydrochloride under stirring at 90 rpm, and raise the temperature to 45°C at the same time;

[0032] (3) After adding the solution, let it stand for 2 hours, and add dropwise isobutanol at -5°C, whose volume is 8 times the weight of tropisetron hydrochloride, under the condition of stirring at 240 rpm, and finish adding dropwise at a uniform speed within 1.5 hours;

[0033] (4) After the dropwise addition was completed, the temperature was lowered to -10°C, and stirring was continued at a stirring rate of 110 rpm for 2 hours, and crystals were precipitated after standing for 2 hours, filtered, washed, and vacuu...

Embodiment 2

[0035] Example 2: Preparation of Tropisetron Hydrochloride Tablets

[0036] Prescription: 0.5 parts by weight of tropisetron hydrochloride crystal form compound obtained in Example 1, 10 parts by weight of starch, 4 parts by weight of magnesium aluminum silicate, 2.5 parts by weight of crospovidone, 0.25 parts by weight of povidone K300. , 0.08 parts by weight of sodium dodecylbenzenesulfonate, 2.5 parts by weight of purified water, 0.35 parts by weight of magnesium stearate;

[0037] Preparation:

[0038] (1) Weighing: Weighing according to the process prescription;

[0039] (2) Treatment of raw and auxiliary materials: Mix the prescribed amount of tropisetron hydrochloride and the prescribed amount of magnesium aluminum silicate in equal increments, mix evenly, and pulverize through a 100-mesh sieve to obtain a mixture of raw and auxiliary materials;

[0040] (3) Preparation of adhesive: Take the prescribed amount of purified water and place it in a stainless steel bucke...

Embodiment 3

[0046] Example 3: Preparation of Tropisetron Hydrochloride Tablets

[0047] Prescription: 0.5 parts by weight of tropisetron hydrochloride crystal compound obtained in Example 1, 12 parts by weight of starch, 4.2 parts by weight of magnesium aluminum silicate, 3 parts by weight of crospovidone, and 300.3 parts by weight of povidone K , 0.1 parts by weight of sodium dodecylbenzenesulfonate, 3 parts by weight of purified water, 0.4 parts by weight of magnesium stearate;

[0048] Preparation:

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

[0050] (2) Treatment of raw and auxiliary materials: Mix the prescribed amount of tropisetron hydrochloride and the prescribed amount of magnesium aluminum silicate in equal increments, mix evenly, and pulverize through a 100-mesh sieve to obtain a mixture of raw and auxiliary materials;

[0051] (3) Preparation of adhesive: Take the prescribed amount of purified water and put it in a stainless steel bucket, add the...

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Abstract

The invention discloses a vomit-stopping drug, namely, tropisetron hydrochloride composition tablets, and belongs to the technical field of medicines. The composition is prepared from the following materials: tropisetron hydrochloride, starch, magnesium aluminum silicate, polyvinylpolypyrrolidone, povidone K30, sodium dodecyl benzene sulfonate, purified water and magnesium stearate. Tropisetron hydrochloride is a new crystal compound and different from that reported in the prior art. The X-ray powder diffraction pattern obtained through measurement using Cu-K-alpha rays is shown in the figure 1. Experiments show that the new crystal compound is high in purity, good in fluidity and stability, low in impurity content, not liable to absorb moisture, and safe and reliable in clinical application; the tablets prepared using the new crystal compound is high in dissolution rate, good in stability and quite suitable for clinical applications.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to an antiemetic drug tropisetron hydrochloride composition tablet. 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 the prep...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/46A61K9/20C07D451/12A61P1/08
Inventor 刘学键
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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