Colchicine double-layer osmotic pump controlled release tablets and preparation method thereof

An osmotic pump controlled-release, colchicine technology, which is used in pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc. It can solve the problems of multiple administrations, and achieve the effect of reducing the number of administrations, stabilizing the drug release rate, and ensuring the therapeutic effect.

Inactive Publication Date: 2009-07-22
普尔药物科技开发(深圳)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The existing colchicine oral and external preparations have the following defects: (1) the osmotic pump technology is used to obtain constant drug release in vitro, but limited by the

Method used

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  • Colchicine double-layer osmotic pump controlled release tablets and preparation method thereof
  • Colchicine double-layer osmotic pump controlled release tablets and preparation method thereof
  • Colchicine double-layer osmotic pump controlled release tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0149]

[0150] Coating film formula: cellulose acetate (CA-398-3) 16g

[0151] Polyethylene glycol (PEG-6000) 4g

[0152] Acetone 850mL

[0153] Ethanol (absolute ethanol) 150mL

[0154] The weight gain of the coating film is: 15 mg. The diameter of the drug release hole: 0.8 mm.

[0155] Preparation:

[0156] a. Mix colchicine, suspending agent, osmotically active substance and other pharmaceutical excipients according to the method of equal increment to make a mixture;

[0157] b. the mixture is mixed with PVPK-30 ethanol solution to make a soft material, the amount of the added ethanol solution is kneaded into agglomerates with the obtained soft material, and it is scattered as soon as it is waved; then granulated with a 22 mesh sieve to obtain a wet Granules, dry the wet granules at 40°C for 5 hours to obtain dry granules; then use a 20-mesh sieve to sieve the granules to obtain drug-containing layer granules;

[0158] c. Add expa...

Embodiment 2

[0163]

[0164]

[0165] Coating film formula: hydroxypropyl methylcellulose 19.4g

[0166] Polyethylene glycol (PEG-6000) 0.6g

[0167] Acetone 850mL

[0168] Ethanol (absolute ethanol) 150mL

[0169] The weight gain of the coating film is: 18mg. The pore diameter of the drug release hole: 2mm.

[0170] Preparation method: replace the film-forming material in the coating film with hydroxypropyl methylcellulose, and the rest of the preparation method is the same as in Example 1.

Embodiment 3

[0172]

[0173] Coating film formula: hydroxypropyl methylcellulose 19.4g

[0174] Polyethylene glycol (PEG-6000) 0.6g

[0175] Acetone 850mL

[0176] Ethanol (absolute ethanol) 150mL

[0177] The weight gain of the coating film is: 18 mg. The diameter of the drug release hole: 1.2 mm.

[0178] Preparation method: replace the film-forming material in the coating film with hydroxypropyl methylcellulose, and the rest of the preparation method is the same as in Example 1.

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Abstract

The invention discloses a colchicine double-layer osmotic pump controlled-release tablet and a method for preparing the same. The controlled-release tablet comprises a double-layer tablet core consisting of a drug containing layer and a pushing layer, and a layer of coating membrane which is coated on the outer surface of the double-layer tablet core and belongs to a semipermeable coating membrane, and the coating membrane is provided with a drug release hole on the surface of the drug containing layer, wherein in the tablet core, the drug containing layer contains the colchicine of which the weight percentage against the weight percentage of the double-layer tablet core is between 0.1 and 1.0 percent and a suspending agent, osmotic pressure active matters and pharmaceutic adjuvants; the pushing layer contains an expanding agent, a permeation enhancer, a retarder and a binder, a wetting agent, a lubricant and a bulking agent; and the weight gain of the coating membrane against the weight of the tablet core is between 10 and 20 percent, and the aperture of the drug release hole on the surface of the drug containing layer of the coating membrane is between 0.2 and 2 millimeters. The colchicine double-layer osmotic pump controlled-release tablet has the characteristics of stable drug release rate after being taken and easy control of the accumulation release degree during special time, can effectively reduce taking frequency so as to improve the compliance of patients and has better safety and effectiveness.

Description

technical field [0001] The invention relates to a medicine containing colchicine and a preparation method thereof, in particular to a colchicine osmotic pump controlled-release preparation and a preparation method thereof. Background technique [0002] Colchicine is a tropolone alkaloid, which was first isolated from the corm of Colchicum autumnale L., a plant of the Liliaceae family in Europe. Its appearance is light yellow crystalline powder, and the color becomes dark when exposed to light. Slightly soluble in water, easily soluble in ethanol or chloroform. Colchicine has significant biological activity, mainly anti-inflammatory, anti-tumor, anti-fibrosis and other pharmacological effects. Recurrent pericarditis, Bechet's disease, etc. also have good curative effect. Among them, colchicine is a specific drug for the treatment of acute attacks of gout. It was used to treat the attacks of gout as early as 1763, and it is still the main drug for treatment. [0003] Colch...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K9/36A61K31/167A61K47/12A61K47/34A61P19/06A61P29/00A61P35/00
Inventor 王文苹刘姹杨大坚陈新滋
Owner 普尔药物科技开发(深圳)有限公司
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