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Pharmaceutical tropisetron hydrochloride composition dry suspension for treating nausea and vomiting both caused by chemotherapy

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

Inactive Publication Date: 2015-12-30
杨献美
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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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  • Pharmaceutical tropisetron hydrochloride composition dry suspension for treating nausea and vomiting both caused by chemotherapy
  • Pharmaceutical tropisetron hydrochloride composition dry suspension for treating nausea and vomiting both caused by chemotherapy
  • Pharmaceutical tropisetron hydrochloride composition dry suspension for treating nausea and vomiting both caused by chemotherapy

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1: Preparation of Tropisetron Hydrochloride Crystals

[0025] (1) Dissolve tropisetron hydrochloride in a mixed solvent of methanol and propyl acetate, the required amount of solvent per gram of tropisetron hydrochloride is 120 ml, and the volume ratio of methanol and propyl acetate is 5:3;

[0026] (2) After heating to 35°C to dissolve, add seed crystals after cooling to room temperature;

[0027] (3) Cool to below -5°C, stir and crystallize, the crystallization temperature is -10°C, filter, dry, collect crystals to obtain tropisetron hydrochloride crystals.

[0028] The prepared tropisetron hydrochloride crystal uses Cu-Kα ray to measure the X-ray powder diffraction pattern obtained as figure 1 shown.

Embodiment 2

[0029] Example 2: Preparation of Tropisetron Hydrochloride Dry Suspension

[0030] Prescription: in parts by weight

[0031]

[0032] Preparation:

[0033] (1) Weighing: Weighing according to the process prescription;

[0034] (2) Treatment of raw and auxiliary materials: Mix the prescribed amount of tropisetron hydrochloride and the prescribed amount of glucose in equal increments, mix evenly, and then pulverize through a 100-mesh sieve to obtain a mixture of raw and auxiliary materials;

[0035] (3) Mixing: Put the pre-mixed raw and auxiliary material mixture and instant sorbitol, xanthan gum, and love blue into the three-dimensional motion mixer, set the pre-mixing speed to 15 rpm, and the mixing time to 60 minutes;

[0036] (4) Packaging: Calculate the theoretical loading range according to the content of the materials obtained from the total blending, and then carry out sub-packaging.

Embodiment 3

[0037] Example 3: Preparation of Tropisetron Hydrochloride Dry Suspension

[0038] Prescription: in parts by weight

[0039]

[0040] Preparation:

[0041] (1) Weighing: Weighing according to the process prescription;

[0042] (2) Treatment of raw and auxiliary materials: Mix the prescribed amount of tropisetron hydrochloride and the prescribed amount of glucose in equal increments, mix evenly, and then pulverize through a 100-mesh sieve to obtain a mixture of raw and auxiliary materials;

[0043] (3) Mixing: Put the pre-mixed raw and auxiliary material mixture and instant sorbitol, xanthan gum, and love blue into the three-dimensional motion mixer, set the pre-mixing speed to 15 rpm, and the mixing time to 60 minutes;

[0044] (4) Packaging: Calculate the theoretical loading range according to the content of the materials obtained from the total blending, and then carry out sub-packaging.

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PUM

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Abstract

The invention belongs to the technical field of medicine, and relates to a pharmaceutical tropisetron hydrochloride composition dry suspension for treating nausea and vomiting both caused by chemotherapy. The composition comprises tropisetron hydrochloride, instant sorbitol, glucose, xanthan gum and aishenglan. The tropisetron hydrochloride is a new crystal-form compound, an X-ray powder diffraction map obtained from Cu-K alpha ray measurement is shown as a map 1, and the tropisetron hydrochloride is different from tropisetron hydrochloride reported in the prior. Experiments show that the new crystal-form compound is high in purity, mobility and stability, low in impurity content, less prone to moisture absorption and safe and reliable in clinical application, and the dry suspension made from the crystal-form compound is high in stability and quite suitable for clinical application.

Description

Technical field [0001] The invention is a pharmaceutical technology field, which involves a sliced suspension of nausea and vomiting drug hydrochloride hydrochloride hydrochloride caused by chemotherapy. Background technique [0002] Tyl Hydrochloride is a selective peripheral neuron and a central nervous system 5-hydroxylidin receptor antagonist. It can choose to block the vomiting reflex center.The 5-hydroxylidin receptor of the club in the final region of the central nervous nerve can prevent and treat nausea and vomiting caused by chemotherapy, and does not cause adverse reactions in the external system. [0003] In existing technologies, there are many studies for the crystal type of tot alkyl hydrochloride, but the impurities, stability, and crystalline humidity are still unsatisfactory.It's difficult. [0004] After a large number of experimental studies of the present invention, a hydrochloric acidocarcin compound that is different from existing technology has been made.L...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/46C07D451/12A61P1/08
Inventor 杨献美
Owner 杨献美
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