Dexibuprofen oral liquid preparation and preparation method thereof

A technology of liquid preparations and solutions, which can be used in anti-inflammatory agents, pharmaceutical formulations, non-central analgesics, etc., and can solve problems such as short duration

Inactive Publication Date: 2014-12-03
SHANGHAI SCIENPHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Ibuprofen has a platelet inhibitory effect, but the duration is shorter than that of aspirin

Method used

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  • Dexibuprofen oral liquid preparation and preparation method thereof
  • Dexibuprofen oral liquid preparation and preparation method thereof
  • Dexibuprofen oral liquid preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] This example is the preparation of Dexibuprofen Oral Solution

[0027] Every 10L Dexibuprofen Oral Liquid Preparation (1000 sticks of quality)

[0028]

[0029] Take menthol and add glycerin, stir until fully dissolved, set aside. Take Dexibuprofen and arginine and add 1 / 2 to 3 / 4 of purified water to dissolve, add sucrose, sodium benzoate, orange flavor, pigment, fully stir, dissolve, add menthol glycerin solution, fully stir, filter, Add water to the prescribed amount, inspect the quality, pack, and you get it.

Embodiment 2

[0031] This example is the preparation of Dexibuprofen Syrup

[0032] Every 10L Dexibuprofen Oral Liquid Preparation (1000 sticks of quality)

[0033]

[0034] Take menthol and add glycerin, stir until fully dissolved, set aside. Take Dexibuprofen and Arginine and add a small amount of purified water to dissolve. Take sodium benzoate, orange essence, and pigment, stir until completely dissolved, add menthol glycerin solution, stir well, add simple syrup to the full amount, quality test, pack, and get ready.

Embodiment 3

[0036] The influence factor test of the oral liquid preparation of dexibuprofen described in embodiment 1,2.

[0037] According to the 2010 version of "Chinese Pharmacopoeia" two appendix XIX C raw material drug and drug preparation stability test guideline, the Dexibuprofen oral liquid preparation described in embodiment 1, 2 is carried out influence factor test. Because it is a liquid preparation, the influence factor test only carries out the high temperature test and the strong light irradiation test. High temperature test: Take Examples 1 and 2 and place them at 60°C for 10 days, take samples on the 5th and 10th days, and test according to the key stability inspection items. Strong light irradiation test: Take Examples 1 and 2 and place them in a light box equipped with fluorescent lamps, place them for 10 days under the condition of illuminance of 4500lx±500lx, take samples on the 5th and 10th days, and inspect the key items according to the stability to test. The test...

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PUM

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Abstract

Belonging to the field of pharmaceutical preparations, the invention relates to a dexibuprofen oral liquid preparation. The oral liquid preparation adopts dexibuprofen as the effective component, and is added with proper auxiliary materials like a pH regulator, a solubilizer, a flavoring agent, an antiseptic agent and a coloring agent. A solution preparation process or syrup preparation process is employed to prepare the clear and transparent liquid preparation. The dexibuprofen liquid preparation provided by the invention is dispersed in the medium in a molecular state, has the characteristics of quick absorption, rapid effect, convenient oral administration and easy fractionation dose, and can simultaneously satisfy clinical medication, patient compliance, industrial scale production and other requirements.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a dexibuprofen oral liquid preparation and a preparation method thereof. Background technique [0002] Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID). It is often used to relieve arthritis, menstrual pain, fever and other symptoms. It is also an analgesic, especially for pain caused by inflammation. Ibuprofen has a platelet inhibitory effect, but the duration is shorter than that of aspirin. Ibuprofen is one of the essential medicines designated by the World Health Organization. [0003] Dexibuprofen is the dextrorotatory form of ibuprofen. This product is white or off-white crystalline powder with a slightly peculiar odor and almost tasteless. The melting point is 49-53°C. Easily soluble in ethanol, acetone, chloroform, ether and aqueous sodium hydroxide solution, almost insoluble in water. Studies have found that the pharmacological activity of ibupr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/192A61P29/00
Inventor 江东波李巨鸿马小思
Owner SHANGHAI SCIENPHARM CO LTD
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