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Pharmaceutical composition containing quinoline derivative or salt of quinoline derivative

A composition and drug technology, which is applied in the directions of drug combinations, active ingredients of heterocyclic compounds, and medical preparations of non-active ingredients, etc., can solve the problems of large production difficulties of preparations, uneven mixing of materials, and injuries to the respiratory system of operators.

Active Publication Date: 2016-11-23
JIANGSU HENGRUI MEDICINE CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the amount of silicic acid compounds is large, and the density of silicic acid compounds is extremely small, so they are easy to fly during production, causing damage to the respiratory system of operators.
At the same time, during the mixing process, due to the large difference between its density and other excipients, it may cause the risk of uneven mixing of materials, which will cause difficulties in the industrialized production of preparations

Method used

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  • Pharmaceutical composition containing quinoline derivative or salt of quinoline derivative
  • Pharmaceutical composition containing quinoline derivative or salt of quinoline derivative
  • Pharmaceutical composition containing quinoline derivative or salt of quinoline derivative

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～3

[0040] The methanesulfonate of 4-[3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy]-7-methoxy-6-quinolinecarboxamide (hereinafter referred to as compound A), arginine acid, D-mannitol, microcrystalline cellulose, hydroxypropyl cellulose, and low-substituted hydroxypropyl cellulose, according to the proportions in Table 1, were wet-granulated using a high-speed shear granulator, and purified water was used as moistening agent. Wet agent, carry out wet granulation and drying treatment on wet and soft materials, then carry out dry granulation on dry granules (water content less than 2%), add prescription amount of talcum powder, and use rotary blender for mixing. The obtained blended granules are filled into capsules to prepare capsules.

[0041] Table 1

[0042] Element

[0043] Unit: mass%

Embodiment 4～6

[0045] The methanesulfonate of 4-[3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy]-7-methoxy-6-quinolinecarboxamide (hereinafter referred to as compound A), meglu Amine, D-mannitol, microcrystalline cellulose, hydroxypropyl cellulose, and low-substituted hydroxypropyl cellulose, according to the proportions in Table 1, were wet-granulated using a high-speed shear granulator, and purified water was used as moistening agent. Wet agent, carry out wet granulation and drying treatment on wet and soft materials, then carry out dry granulation on dry granules (water content less than 2%), add prescription amount of talcum powder, and use rotary blender for mixing. The obtained blended granules are filled into capsules to prepare capsules.

[0046] Table 2

[0047] Element

[0048] Unit: mass%

Embodiment 7～16

[0049] Embodiment 7~16, comparative example 1~2

[0050]The mesylate of 4-[3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy]-7-methoxy-6-quinolinecarboxamide (hereinafter referred to as compound A), arginine Acid or meglumine, potassium bicarbonate or potassium carbonate, D-mannitol, microcrystalline cellulose, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, according to the ratio in Table 1, high-speed shear granulation The machine performs wet granulation, uses purified water as a wetting agent, performs wet granulation and drying treatment on wet and soft materials, and then performs dry granulation on dry granules (moisture is less than 2%), adds prescribed amount of talcum powder, and uses rotary blender for mixing. The obtained blended granules are filled into capsules to prepare capsules. And adopt the same method to prepare the capsules of Comparative Examples 1-2 that do not contain arginine, meglumine, potassium carbonate and potassium bicarbonat...

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PUM

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Abstract

The invention relates to pharmaceutical composition containing a quinoline derivative or salt of the quinoline derivative, in particular to pharmaceutical composition containing 4-[3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy]-7-methoxy-6-quinolinecarboxamide or pharmacologically acceptable salt and basic amino acid or meglumine and / or at least one compound selected from potassium carbonate and potassium bicarbonate. The pharmaceutical composition has the characteristics of being high in dissolving-out rate and good in stability.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a quinoline derivative 4-[3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy]-7-methoxy-6-quinoline carboxamide or a pharmaceutical composition of its salt, the composition has the characteristics of rapid dissolution and good stability. Background technique [0002] WO2002032872 discloses a quinoline derivative 4-[3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy]-7-methoxy-6-quinolinecarboxamide, which is known to have inhibitory Other pro-angiogenic and carcinogenic signaling pathway-related RTKs for tumor proliferation can also selectively inhibit the kinase activity of vascular endothelial growth factor (VEGF) receptors, and can be used clinically for the treatment of various tumors such as thyroid cancer, lung cancer, and melanoma. [0003] However, when preparing 4-[3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy]-7-methoxy-6-quinolinecarboxamide or a pharmaceu...

Claims

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Application Information

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IPC IPC(8): A61K47/18A61K31/47A61K9/48A61K47/04A61P35/00
CPCA61K31/47A61K47/02A61K9/1611A61K9/48
Inventor 王聪刘凯吴玉霞陈爱玲
Owner JIANGSU HENGRUI MEDICINE CO LTD
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