Cilostazol oral solid medicine composition

A technology of cilostazol and a composition is applied in the field of oral solid pharmaceutical composition of cilostazol and its preparation field, and can solve the problems of large preparation volume, small drug-loading amount of solid dispersion, reducing patient compliance and the like

Inactive Publication Date: 2019-01-08
天津双硕医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0018] However, the drug loading of the solid dispersion thus prepared is small. When the drug specification is small, this technology can significantly increase the drug dissolution rate, but when the drug specification is large, such as tens of milligrams or even Hundreds of milligrams, d...

Method used

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  • Cilostazol oral solid medicine composition
  • Cilostazol oral solid medicine composition
  • Cilostazol oral solid medicine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 150

[0111] Embodiment 150mg specification cilostazol tablet preparation (unit: g)

[0112] prescription:

[0113] Raw materials

Dosage

Cilostazol

50g

Solutol HS 15

40g

polyvinyl alcohol

150g

microcrystalline cellulose

3.6g

Low-substituted hydroxypropyl cellulose

28g

colloidal silica

5.6g

Magnesium stearate

2.8g

N-Methylpyrrolidone

Appropriate amount

unit element tablet weight

280mg

Ordinary gastric soluble coating powder Opadry

Coating weight gain 5%

Co-made

1000 pieces

[0114] The pharmaceutical composition of described cilostazol is further prepared into tablet by the following steps:

[0115] 1) Take the cilostazol crude drug, pulverize it, pass through an 80-mesh sieve, and set aside;

[0116] 2) Take the prescription quantity step 1) successively to obtain the cilostazol raw material drug, Solutol HS 15, polyvinyl alcohol, dissolve in an appropr...

Embodiment 2

[0121] Example 2 Preparation of 100mg Specification Cilostazol Tablets (Unit: g)

[0122] prescription:

[0123]

[0124] .

[0125] The pharmaceutical composition of described cilostazol is further prepared into tablet by the following steps:

[0126] 1) Take the cilostazol crude drug, pulverize it, pass through an 80-mesh sieve, and set aside;

[0127] 2) Take the prescription quantity step 1) successively to obtain the cilostazol raw material drug, Solutol HS 15, polyvinyl alcohol, dissolve in an appropriate amount of N-methylpyrrolidone, stir, and set aside;

[0128] 3) Take the solution obtained in step 2), put it in a vacuum drying oven and dry it to obtain an improved solid dispersion of cilostazol; 4) Take the improved solid dispersion of cilostazol obtained in step 3), pulverize it, and pass through a 40-mesh sieve ,spare;

[0129] 5) Take the pulverized improved cilostazol solid dispersion obtained in step 4), add filler microcrystalline cellulose, disintegr...

Embodiment 3

[0132] Example 3 Preparation of 50 mg specification cilostazol hard capsules (unit: g)

[0133] prescription:

[0134] Raw materials

Dosage

Cilostazol

50g

Solutol HS 15

40g

polyvinyl alcohol

150g

microcrystalline cellulose

3.6g

Low-substituted hydroxypropyl cellulose

28g

colloidal silica

5.6g

Magnesium stearate

2.8g

N-Methylpyrrolidone

Appropriate amount

Unit capsule content weight

280mg

gelatin capsule shell

1000 capsules

Co-made

1000 capsules

[0135] The pharmaceutical composition of described cilostazol is further prepared into hard capsules through the following steps:

[0136] 1) Take the cilostazol crude drug, pulverize it, pass through an 80-mesh sieve, and set aside;

[0137] 2) Take the prescription quantity step 1) successively to obtain the cilostazol raw material drug, Solutol HS 15, polyvinyl alcohol, dissolve in an appropriate amou...

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PUM

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Abstract

The invention relates to a cilostazol oral solid medicine composition. Through research, the inventor obtains an improved cilostazo solid dispersion preparation process and an improved cilostazo soliddispersion with high water solubility as well. In addition, low substituted hydroxypropyl cellulose (of which the water content is less than 5%) of a low water content is selected as a disintegrant of a solid preparation, and the overall water content of the preparation is effectively reduced while a disintegration function is brought into play, so that disintegration caused by the situation thatmoisture in the preparation is absorbed by a raw material medicine can be inhibited. Finally, cilostazol is prepared into a common oral solid preparation. Tests show that the dissolution behavior ofa cilostazol oral solid preparation prepared by using the technique is remarkably improved, and furthermore, the bioavailability of the preparation can be also improved. Meanwhile, because of a low overall water content of auxiliary materials, degradation impurities caused by hydrolysis, of the raw material medicine, can be inhibited, the stability can be improved, and the preparation is simple inprocess, controllable in quality and applicable to industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an oral solid pharmaceutical composition of cilostazol, a preparation method and application thereof. Background technique [0002] Cardiovascular, cerebrovascular and vascular diseases are diseases with high morbidity, great harm, death, and high disability rate. Cardiovascular and cerebrovascular diseases are essentially vascular lesions, and the main cause of vascular lesions is atherosclerotic plaque in arteries And vascular abnormalities caused by atheromatous lipid plaques, which are the main causes of heart and cerebral ischemia and infarction; about the mechanism of atherosclerosis, there are lipid infiltration, smooth muscle hyperplasia, thrombosis, platelet aggregation and arterial intima injury theory, which shows that cardiovascular and cerebrovascular diseases are caused by many factors. important and meaningful. [0003] Cilostazol is a typical intrac...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/4709A61K47/38A61K9/36A61K9/48A61P9/10A61P7/02A61P9/00A61P29/00A61P9/12A61P11/06A61P9/14
CPCA61K9/146A61K9/2866A61K9/4808A61K31/4709A61P7/02A61P9/00A61P9/10A61P9/12A61P9/14A61P11/06A61P29/00
Inventor 不公告发明人
Owner 天津双硕医药科技有限公司
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