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Dasatinib tablet and preparation process thereof

A technology of nicillin tablets and ethyl cellulose, which is applied in the field of preparation of drug dasatinib tablets, can solve problems such as blood drug concentration fluctuations and influence on curative effect, and achieve the effects of drug stability, preparation cost reduction, and product stability

Active Publication Date: 2014-02-05
哈药集团股份有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The existing dasatinib preparations, including dasatinib tablets, are once-a-day dosage forms. Due to the characteristics of oral absorption of dasatinib, fluctuations in blood drug concentration often occur after taking it, which affects the curative effect

Method used

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  • Dasatinib tablet and preparation process thereof
  • Dasatinib tablet and preparation process thereof
  • Dasatinib tablet and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Make 1000 dasatinib tablets

[0057] Recipe composition:

[0058]

[0059] Preparation:

[0060] 1) mix

[0061] Weigh hydroxypropyl methylcellulose, lactose monohydrate and 1 / 2 amount of ethyl cellulose according to the prescription amount, and mix them evenly; then add dasatinib raw materials and mix for 10 minutes, and the remaining ethyl cellulose is Base cellulose and polyethylene glycol 4000, microcrystalline cellulose were mixed with the above mixture for 20 minutes, set aside.

[0062] 2) Granulation

[0063] Use ethanol as a soft material, pass through a 20-mesh sieve to granulate, dry at 50-60°C for 1.5 hours; pass through a 20-mesh sieve for granulation, add the prescribed amount of croscarmellose sodium, mix for 10 minutes, and mix well , add the prescribed amount of magnesium stearate, mix for 5 minutes, and set aside.

[0064] 3) Tablet

[0065] Put the mixed material into the hopper of the tablet press, and adjust the tablet weight. The limit req...

Embodiment 2

[0067] Prepare 1000 dasatinib tablets

[0068]Recipe composition:

[0069]

[0070] Preparation:

[0071] 1) mix

[0072] Weigh hydroxypropyl methylcellulose, lactose monohydrate and 1 / 2 amount of ethyl cellulose according to the prescription amount, and mix them evenly; then add dasatinib raw materials and mix for 10 minutes, and the remaining ethyl cellulose is Base cellulose and polyethylene glycol 4000, microcrystalline cellulose were mixed with the above mixture for 20 minutes, set aside.

[0073] 2) Granulation

[0074] Use ethanol as a soft material, pass through a 20-mesh sieve to granulate, dry at 50-60°C for 1.5 hours; pass through a 20-mesh sieve for granulation, add the prescribed amount of croscarmellose sodium, mix for 10 minutes, and mix well , add the prescribed amount of magnesium stearate, mix for 5 minutes, and set aside.

[0075] 3) Tablet

[0076] Put the mixed material into the hopper of the tablet press, and adjust the tablet weight. The limit r...

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Abstract

The invention relates to a preparation process of medicinal preparations, particularly relates to a preparation process of a medicine Dasatinib tablet suitable for chronic myeloid leukemia drug-resistant or non-tolerant to therapeutic schedules containing imatinib mesylate.

Description

technical field [0001] The present invention relates to a preparation of a pharmaceutical preparation, in particular to a drug dasatinib tablet suitable for chronic myeloid leukemia that is resistant or intolerant to treatment regimens including imatinib mesylate preparation. Background technique [0002] Philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase (Ph+CP-CML) is a slowly progressive blood and bone marrow disease associated with genetic abnormalities. Signal transduction mediated by tyrosine kinases is directly related to tumorigenesis and development. Tyrosine kinase inhibitor (TK1) is a hotspot in the development of anticancer drugs. Including single-target and multi-target. The signaling pathways of tumor cells are intertwined, and it is difficult for single-target TK1 to ideally block the development of tumor cells and treat specific tumors. Multi-target TK1 acts on multiple targets, with high efficiency, good safety, and significan...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/506A61K47/34A61P35/02
Inventor 袁淑杰杨新春王丽娜张道旭王忠杨祎楠李郑武高晶宋紫玉户巧芬
Owner 哈药集团股份有限公司
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