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Piroxicam beta-cyclodextrin inclusion compounds and preparation method of tablets thereof

A technology of cyclodextrin inclusion complex and piroxicam, which is applied in the directions of non-active ingredient medical preparations, active ingredients-containing medical preparations, anti-inflammatory agents, etc., can solve the problems of high production cost, poor flow performance and great difficulty and other problems, to achieve the effects of easy industrialized large-scale production, good liquidity, and simple production and operation.

Inactive Publication Date: 2010-07-07
GUANGZHOU OUHUA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The most common is to adopt a single freeze-drying preparation process. This preparation process mainly has two disadvantages: 1. The operation is complicated, the production cost is high, and it is very difficult to carry out industrial production; 2. The clathrate obtained is Powdery structure, poor fluidity, it is difficult to control the weight difference or loading difference of the product when using the clathrate to produce oral solid preparations
That is to say, it is difficult to guarantee the product quality of oral solid preparations using the clathrate

Method used

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  • Piroxicam beta-cyclodextrin inclusion compounds and preparation method of tablets thereof
  • Piroxicam beta-cyclodextrin inclusion compounds and preparation method of tablets thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1 - Spray drying and vacuum drying were combined to prepare piroxicam β-cyclodextrin inclusion compound (molar ratio 1: 2.0-2.5).

[0024] Add 25g of β-cyclodextrin into a flask filled with 78ml of purified water, heat to 75°C, stir until dissolved, and adjust the pH value to 10.0 with 0.1M sodium hydroxide solution to obtain an aqueous solution of β-cyclodextrin. Take 3g of piroxicam and put it into a beaker, add 11.25ml of ethanol (concentration is 95%), stir to disperse evenly, and obtain a viscous solution. The viscous solution was added into an aqueous solution of β-cyclodextrin, and stirred at a constant temperature of 75° C. for 3 hours. Keep the temperature of the solution not lower than 70°C, and carry out spray drying, and the drying time is 20 minutes. The parameters of the spray dryer are as follows: the air flow of the blower (Blower) is 0.75m 3 / min, the atomizing pressure (Atomizing) is 15×10kPa, the inlet temperature (Inlet Temp) is greater tha...

Embodiment 2

[0031] Example 2 - Preparation of piroxicam β-cyclodextrin inclusion complex (molar ratio 1:2.0-2.5) by combining spray drying and vacuum drying.

[0032] Add 137g of β-cyclodextrin into a flask filled with 429ml of purified water, heat to 70°C, stir until dissolved, and adjust the pH value to 10.0 with 0.1M sodium hydroxide solution to obtain an aqueous solution of β-cyclodextrin. Take 16.5g of piroxicam and put it into a beaker, add 62ml of ethanol (concentration is 95%), stir to disperse evenly, and obtain a viscous solution. The viscous solution was added into an aqueous solution of β-cyclodextrin, and stirred at a constant temperature of 75° C. for 3 hours. Keep the temperature of the solution not lower than 75°C, and carry out spray drying, and the drying time is 31 minutes. The parameters of the spray dryer are as follows: The air flow of the blower (Blower) is 0.75m 3 / min, the atomizing pressure (Atomizing) is 15×10kPa, the inlet temperature (Inlet Temp) is greater ...

Embodiment 3

[0033] Example 3 - Preparation of tablets comprising piroxicam β-cyclodextrin inclusion compound

[0034] According to the following raw and auxiliary materials in each tablet prescription, tablets (1000 tablets in total) containing piroxicam β-cyclodextrin inclusion compound (prepared by Example 1) were prepared by direct compression method.

[0035] prescription:

[0036] Piroxicam β-cyclodextrin inclusion complex 200mg

[0037] Starch 187mg

[0038] Povidone (K30) 6.2mg

[0039] Talc 6mg

[0040] Sodium carboxymethyl starch 6.6mg

[0041] Magnesium Stearate 2mg

[0042]

[0043] Total 407.8mg (equivalent to piroxicam 20mg)

[0044] crafting process:

[0045] Pass 1000 times of the raw and auxiliary materials of the above prescription amount through a 100-mesh sieve, and fully mix until uniform (about 50 minutes). Dry tableting, that is, 1000 tablets.

[0046] The extruded tablet is according to " Chinese Pharmacopoeia " 2...

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Abstract

The invention relates to piroxicam beta-cyclodextrin inclusion compounds and a preparation method of tablets thereof. The preparation method comprises the following steps of: after keeping an alkaline aqueous solution (the pH value is 8.0-11.0) of a component at the temperature of 70-80 DEG C for 1-3 hours, spraying and drying the alkaline aqueous solution at the temperature of 70-80 DEG C and drying in vacuum. Compared with the product obtained by using the method in the prior art, the appearance of the obtained product and the properties of the technology using the product for producing preparations are obviously improved, and the product provides superior conditions for preparing oral-administration preparations.

Description

technical field [0001] The invention relates to a piroxicam β-cyclodextrin inclusion compound and a preparation method thereof. Background technique [0002] Piroxicam is a non-steroidal anti-inflammatory and analgesic drug developed by Pfizer in the early 1970s. Piroxicam is mainly used to treat rheumatoid arthritis and rheumatoid arthritis. It has obvious analgesic, anti-inflammatory and detumescence effects, and the recent effective rate is about 85%. The protein binding rate of piroxicam is greater than 90%, and the elimination half-life is about 45 hours, so it can be administered once a day. The dosage for treating rheumatoid arthritis is usually 20-40mg (once a day). Common adverse reactions are gastrointestinal symptoms. When the dose is greater than 20 mg, gastrointestinal mucosal damage or even ulcers may occur. Due to its slow oral absorption, piroxicam is less suitable for acute pain management. [0003] Piroxicam is insoluble in water (pH5, solubility is 0.0...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/48A61K9/20A61K31/5415A61P29/00A61K47/69
Inventor 不公告发明人
Owner GUANGZHOU OUHUA PHARMA
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