A kind of pharmaceutical composition for treating tumor and its preparation method and application

A composition and drug technology, applied in the field of drug preparation, can solve the problems of raw and auxiliary materials fluidity, high particle size requirements, unfavorable personnel protection, dissolution effects, etc., and achieves narrow particle size distribution range, good therapeutic effect, and improved particle properties. Effect

Active Publication Date: 2020-04-21
TOT BIOPHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the preparation method of this drug is to directly mix and fill capsules. This process has high requirements on the fluidity and particle size of raw materials and auxiliary materials. Too fine raw materials make the filling process more difficult. protection against

Method used

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  • A kind of pharmaceutical composition for treating tumor and its preparation method and application
  • A kind of pharmaceutical composition for treating tumor and its preparation method and application
  • A kind of pharmaceutical composition for treating tumor and its preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] In this embodiment, the formulation of the pharmaceutical composition is as follows:

[0049]

[0050] The fluidized bed one-step granulation process is adopted. Part of the starch is added internally, and part of it is made into starch slurry and mixed with hypromellose solution as a spray liquid. The steps are as follows:

[0051] (1) 50g starch is dispersed with purified water to make starch slurry, the mass percent concentration of the starch slurry is 13%, and hypromellose and purified water are weighed to form hypromellose Solution (concentration is 10%), starch slurry and hypromellose solution are mixed to obtain spray liquid;

[0052] (2) After mixing the remaining starch with vorinostat and low-substituted hypromellose, place it in a fluidized bed, preheat the material at 40-50°C, and spray the spray liquid obtained in step (1), Granulation and drying are carried out simultaneously, and sieved to make dry granules;

[0053] (3) Add magnesium stearate to th...

Embodiment 2

[0057] In this embodiment, the formulation of the pharmaceutical composition is as follows:

[0058] Element Unit dose / mg percentage / % Volinota 100 31.25 starch 199.2 62.25 hypromellose 6.4 2.0 Low-substituted hydroxypropyl cellulose 12.8 4.0 Magnesium stearate 1.6 0.5

[0059] The fluidized bed one-step granulation process is adopted. Part of the starch is added internally, and part of it is made into starch slurry and mixed with hypromellose solution as a spray liquid. The steps are as follows:

[0060] (1) 30g starch is dispersed with purified water to make starch slurry, the mass percent concentration of the starch slurry is 10%, and hypromellose and purified water are weighed to form hypromellose Solution (concentration is 10%), starch slurry and hypromellose solution are mixed to obtain spray liquid;

[0061] (2) After mixing the remaining starch with vorinostat and low-substituted hypromellose, place it in a fluidize...

Embodiment 3

[0066] In this embodiment, the formulation of the pharmaceutical composition is as follows:

[0067] Element Unit dose / mg percentage / % Volinota 100 31.25 starch 196 61.2％ hypromellose 9.6 3.0 Low-substituted hydroxypropyl cellulose 12.8 4.0 Magnesium stearate 1.6 0.5

[0068] A pharmaceutical composition prepared by a fluidized bed one-step granulation process, a part of the starch is added as a dry powder, and a part of the starch is made into a starch slurry and mixed with a hypromellose solution as a spray liquid. The steps are as follows:

[0069] (1) 25g starch is dispersed with purified water to make starch slurry, the mass percent concentration of the starch slurry is 6%, and hypromellose and purified water are weighed to form hypromellose Solution (concentration is 8%), starch slurry and hypromellose solution are mixed to obtain spray liquid;

[0070] (2) After mixing the remaining starch with vorinostat and low-sub...

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Abstract

The invention provides a pharmaceutical composition for treating tumor and a preparation method and application thereof. The pharmaceutical composition comprises vorinostat and pharmaceutically acceptable adjuvant materials, wherein the pharmaceutically acceptable adjuvant materials comprise a filling agent, a binder, a disintegrating agent and a lubricating agent. The pharmaceutical composition and the preparation method thereof have the advantages that the pharmaceutically acceptable adjuvant materials are used to coordinate with the vorinostat so as to achieve even and stable particle granularity, and a fast dissolution feature is achieved to increase the antitumor effect of the vorinostat; during preparation, a fluidized bed top spray granulation method is used to allow the particle granularity to be even and stable, especially part of the filling agent is specifically used to prepare filling agent slurry which is mixed with a binder solution to serve as spraying liquid, the other part of the filling agent is mixed with other materials in a dry powder form to serve as fluidized bed materials, the particle granularity is well controlled through the spraying using the spraying liquid, particle properties are improved, stability is increased, preparation dissolution degree is increased, the preparation process is simple and controllable, and staff can be well protected.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and relates to a medicine composition for treating tumors, a preparation method and application thereof. Background technique [0002] Tumor is second only to cardiovascular and cerebrovascular diseases and seriously threatens the second killer of human life and health. At present, the incidence of malignant tumors in my country is increasing at a rate of 2.5% per year, and the mortality rate is increasing by about 1.3% per year. Chemotherapy has become one of the important means of comprehensive treatment of malignant tumors. Vorinostat (SAHA), chemical name "N-hydroxy-N'-phenylsuberamide", is a histone deacetylase inhibitor, which can inhibit the activity of histone deacetylase (HDAC) activity, and then promote the acetylation of histones, and ultimately inhibit the growth of cancer cells, induce cancer cell differentiation and apoptosis. Treatment of cutaneous T-cell lymphoma (C...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/16A61K47/38A61K47/36A61K47/12A61P35/00
CPCA61K9/2013A61K9/2054A61K9/2059A61K9/2095A61K31/16
Inventor 曹恒杰陈小宝
Owner TOT BIOPHARM CO LTD
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