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Colchicine bilayer sustained-release tablet and preparing method thereof

A technology for colchicine and sustained-release tablets, which is applied in the field of colchicine double-layer sustained-release tablets and its preparation, can solve the problems that the cumulative release rate cannot meet the requirements of the Pharmacopoeia, and cannot better solve the problems of multiple administrations, etc. Achieve uniform and effective blood drug concentration, reduce the number of medications, and reduce the effects of toxic and side effects

Inactive Publication Date: 2010-06-16
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] But above-mentioned colchicine preparation also has the shortcoming of following aspect: comprise wherein (1) colchicine osmotic pump sheet, it adopts osmotic pump technology to obtain in vitro constant-speed drug release, but is limited by the solubility and dosage of colchicine itself , its cumulative release can not meet the pharmacopoeia requirements
(2) Failure to better solve the multiple administration of this product

Method used

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  • Colchicine bilayer sustained-release tablet and preparing method thereof
  • Colchicine bilayer sustained-release tablet and preparing method thereof
  • Colchicine bilayer sustained-release tablet and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] prescription

[0064] Immediate Release Layer Colchicine 0.05g

[0065] Calcium carbonate 27.5g

[0066] Starch 20g

[0067] Sodium carboxymethyl starch 2.45g

[0068] Magnesium Stearate Appropriate amount

[0069] 75% ethanol about 15ml

[0070] Sustained release layer Colchicine 0.2g

[0071] Hydroxypropyl Methyl Cellulose 20g

[0072] PEO700 60g

[0073] Microcrystalline Cellulose 15g

[0074] Lactose 4.8g

[0075] 95% ethanol about 35ml

[0076] Magnesium Stearate Appropriate amount

[0077]

[0078] Made into 1000 pieces

Embodiment 2

[0079] Example 2: Prescription

[0080] Immediate Release Layer Colchicine 0.1g

[0081] Calcium carbonate 19.6g

[0082] Starch 19.6g

[0083] Sodium carboxymethyl starch 0.8g

[0084] Magnesium Stearate Appropriate amount

[0085] 75% ethanol about 15ml

[0086] Sustained release layer Colchicine 0.4g

[0087] Hydroxypropyl methylcellulose 38.5g

[0088] PEO700 49.5g

[0089] Microcrystalline Cellulose 11.0g

[0090] Lactose 11.0g

[0091] 95% ethanol about 35ml

[0092] Magnesium Stearate Appropriate amount

[0093]

[0094] Made into 1000 pieces

Embodiment 3

[0095] Example 3: Prescription

[0096] Immediate Release Layer Colchicine 0.15g

[0097] Calcium carbonate 10.5g

[0098] Starch 18g

[0099] Sodium carboxymethyl starch 1.35g

[0100] Magnesium Stearate Appropriate amount

[0101] 75% ethanol about 15ml

[0102] Sustained release layer Colchicine 0.357g

[0103] Hydroxypropyl Methyl Cellulose 54g

[0104] PEO700 42g

[0105] Microcrystalline Cellulose 9.6g

[0106] Lactose 14.043g

[0107] 95% ethanol about 35ml

[0108] Magnesium Stearate Appropriate amount

[0109]

[0110] Made into 1000 pieces

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PUM

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Abstract

The invention discloses a colchicine bilayer sustained-release tablet which comprises a quick release layer and a sustained-release layer, wherein the quick release layer mainly consists of colchicine, a disintegrant, a filler, a lubricant and an adhesive; the sustained-release tablet mainly consists of colchicine, a sustained-release matrix, a retarding agent, a filler and an adhesive; the weight ratio of the colchicine in the quick release layer to the colchicine in the sustained-release layer is (0.25-0.42) : 1; and the weight ratio of the quick release layer to the sustained-release layer is 1: 2 to 1: 4. The invention also discloses a method for preparing the colchicine bilayer sustained-release tablet. The colchicine bilayer sustained-release tablet releases the drugs through the quick release layer to quickly achieve the effective blood drug concentration, slowly releases the drugs through the sustained-release layer to exert and sustain the stable and uniform effective blood drug concentration, reduces the drug taking times and lightens the toxic or side function.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing colchicine and a preparation method thereof, in particular to a colchicine immediate-release and sustained-release double-layer 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 m...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/165A61P35/00
Inventor 何元田刘姹杨大坚陈新滋
Owner 普尔药物科技开发(深圳)有限公司
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