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Pharmaceutical composition containing cilostazol and preparation method thereof

A technology of cilostazol and composition, which is applied in the field of pharmaceutical composition containing cilostazol and its preparation, can solve the problems of low-cost cilostazol preparation bioavailability, etc., and achieve low production cost and excellent preparation process. Simple, easy-to-operate effects

Pending Publication Date: 2021-12-10
SUZHOU SIXTH PHARMA PLANT OF JIANGSU WUZHONG PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Therefore, the technical problem to be solved in the present invention is to overcome the defect that the bioavailability of cilostazol preparations cannot be improved by simple methods and low cost in the prior art, thereby providing a pharmaceutical composition containing cilostazol and its Preparation

Method used

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  • Pharmaceutical composition containing cilostazol and preparation method thereof
  • Pharmaceutical composition containing cilostazol and preparation method thereof
  • Pharmaceutical composition containing cilostazol and preparation method thereof

Examples

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Embodiment 1

[0049] The present embodiment provides a kind of pharmaceutical composition containing cilostazol, which is cilostazol tablet, and each tablet contains cilostazol 50mg, and 1000 tablets are made according to the following prescription: granule composition 53.3g (made by cilostazol Hexazol 50g, hypromellose 1.8g, SDS1.5g), microcrystalline cellulose 27g, corn starch 23.7g, carmellose calcium (internal addition) 5g, carmellose calcium (external addition) 5g, Magnesium stearate 1g. The preparation method sequentially comprises: a preparation step of the granule composition, a mixing step, a soft material preparation step, a granulation step, a drying step, a granulation step, a total mixing step, and a tabletting step.

[0050] Wherein, the preparation step of the granule composition is to weigh and mix cilostazol, SDS, and hypromellose according to the prescription quantity, and pulverize them with a jet mill until the particle diameter D(90) is 40 μm to obtain the granule compo...

Embodiment 2

[0052] This embodiment provides a pharmaceutical composition containing cilostazol, its prescription and preparation method are basically the same as in Example 1, the only difference is that in the preparation method of the granular composition, cilostazol, SDS, hydroxypropyl The mixture of methylcellulose was co-pulverized with a jet mill until the particle diameter D(90) was 20 μm to obtain a granular composition.

Embodiment 3

[0054] This embodiment provides a pharmaceutical composition containing cilostazol, its prescription and preparation method are basically the same as in Example 1, the only difference is that in the preparation method of the granular composition, cilostazol, SDS, hydroxypropyl The mixture of methyl cellulose was co-pulverized with a jet mill until the particle diameter D(90) was 10 μm to obtain a granular composition.

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Abstract

The invention relates to the field of pharmacy, and particularly provides a cilostazol-containing pharmaceutical composition and a preparation method thereof. The cilostazol-containing pharmaceutical composition comprises a particle composition, the particle composition comprises cilostazol, an adhesive and a surfactant, the particle size D90 of the particle composition is smaller than or equal to 40 micrometers. The inventor finds that the dissolution rate of a cilostazol-containing pharmaceutical preparation, such as a tablet, can be obviously improved by adopting a particle composition comprising an adhesive and a surfactant and controlling the particle size D90 of the particle composition to be less than or equal to 40 microns. Particularly, when the particle size D90 of the particle composition is controlled to be 10-40 microns, the dissolution rate is further improved, and more particularly, when the particle size D90 is controlled to be 10-20 microns, the dissolution rate is optimal.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a pharmaceutical composition containing cilostazol and a preparation method thereof. Background technique [0002] Cilostazol, also known as 6-[4-(1-cyclohexyl-1H-pentazol-5-yl)butoxy]-3,4-dihydro-2(1H)-quinolone, is a Phosphodiesterase inhibitors can inhibit the activity of platelet and vascular smooth muscle phosphodiesterase, increase the concentration of cAMP, and have the effect of anti-platelet aggregation and vasodilation; in addition, it can inhibit the platelet aggregation caused by TXA2, but it does not affect the activity of platelets. Arachidonic acid metabolism increases limb blood flow, improves peripheral blood flow dynamics, and inhibits thrombus formation. Therefore, cilostazol is widely used to improve or treat diseases such as atherosclerosis, Takayasu arteritis, and thrombovascular vasculitis. [0003] The cilostazol preparations currently on the market mainly includ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/16A61K31/4709A61K47/38A61K47/36A61K47/26A61K47/32A61P7/02A61P9/10A61P9/14
CPCA61K9/2059A61K9/2054A61K9/2018A61K9/1652A61K9/1635A61K31/4709A61P7/02A61P9/10A61P9/14
Inventor 李瑜王丹梅王淑啸邓银来卢俞愉胡开方
Owner SUZHOU SIXTH PHARMA PLANT OF JIANGSU WUZHONG PHARMA GROUP
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