Colchicine framework controlled release tablets or capsules

A technology of colchicine and controlled-release tablets, which is applied in bone diseases, medical preparations of non-active ingredients, organic active ingredients, etc., can solve the problem of repeated administration and cumulative release that cannot reach the Pharmacopoeia Requirements and other issues to achieve the effect of improving the safety of medication, reducing the number of medications, 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

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Problems solved by technology

[0006] However, there are still some defects in the existing patented technology, such as: (1) adopting osmotic pump technology to obtain constant drug release in vitro, but limited by the s

Method used

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  • Colchicine framework controlled release tablets or capsules
  • Colchicine framework controlled release tablets or capsules
  • Colchicine framework controlled release tablets or capsules

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0125] 4. Preparation of Pilot Products

[0126] According to the optimized prescription, three batches of colchicine matrix tablets (batch numbers: 071001, 071002, and 071003) were prepared in our company, with 10,000 tablets in each batch. The results are shown in Table 10.

[0127] Table 10 Pilot test results

[0128]

[0129]The test results show that the product quality is stable and the process is feasible.

Embodiment 1

[0131]

[0132] The preparation method: a. mixing colchicine, hydrophilic polymer and other pharmaceutical excipients according to the method of equal increase to prepare a mixture;

[0133] b. Mix the mixture with ethanol solution to make a soft material, the amount of the added ethanol solution is to make the soft material knead into agglomerates and disperse when waved; then granulate through a 22 mesh sieve to obtain wet granules, and 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 granules;

[0134] c. Add the granules obtained in step b to magnesium stearate and mix evenly; the die of the tablet press is shallow concave (Φ=0.8mm); carry out tablet compression and press molding; tablet core hardness 50-70N, tablet weight 150mg ±2%.

Embodiment 2

[0136]

[0137] The preparation method: a. mixing colchicine, hydrophilic polymer and other pharmaceutical excipients according to the method of equal increase to prepare a mixture;

[0138] b. Mix the mixture with ethanol solution to make a soft material, the amount of the added ethanol solution is to make the soft material knead into agglomerates and disperse when waved; then granulate through a 22 mesh sieve to obtain wet granules, and 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 granules;

[0139] c. Add magnesium stearate to the granules obtained in step b and mix evenly, and pack into capsules.

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Abstract

The invention discloses a colchicine framework controlled-release tablet or capsule, which comprises colchicines and framework materials having controlled-release function, wherein the framework materials contain hydrophilic polymers of which the weight against the weight of the tablet is at least 20 percent and other pharmaceutic adjuvants; and the tablet or capsule comprises the following components in percentage by weight: 0.01 to 1.0 percent of colchicine, 20 to 85 percent of hydrophilic polymer, 1 to 30 percent of retarder, 20 to 60 percent of bulking agent, and 0.1 to 2 percent of lubricant. Release degree test results show that more than 90 percent of drugs are continuously released in vitro in 12 hours; and compared with the common tablet, the tablet or capsule has the advantages of obviously reducing daily taking frequency, lowering toxic and side effects of the drugs and improving the compliance and curative effect of patients.

Description

technical field [0001] The invention relates to a pharmaceutical preparation containing colchicine, more specifically, to a colchicine matrix controlled-release tablet or capsule preparation. Background technique [0002] Colchicine is a well-known drug that can be used in the treatment of gout and anti-cancer fields. Colchicine can inhibit the infiltration and phagocytosis of granulocytes during gout attacks, and has selective anti-inflammatory effects on acute gouty arthritis. It is the most effective drug for the treatment of acute gout; in terms of anti-cancer, it can treat leukemia, breast cancer, etc. by inhibiting cell mitosis. In recent years, it has been discovered in the academic field that colchicine can also be used to treat liver cirrhosis. Colchicine has serious side effects, mainly including gastrointestinal reactions, liver damage, kidney damage, bone marrow toxicity, hair loss, mental depression, anorexia, numbness of hands and feet, etc. Hemorrhagic gastro...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K9/52A61K31/167A61K47/34A61K47/38A61P19/06A61P35/00A61K47/10
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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