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Injection liposome microball containing ketoprofen or ketoprofen ester and its preparing process

A technology of ketoprofen axetil and lipid microspheres, applied in the field of medicine, can solve the problems of gastrointestinal disorders, patients unable to take oral medicines, etc.

Inactive Publication Date: 2005-12-21
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, most NSAID preparations on the market are oral dosage forms or suppositories. Since it has been found that oral NSAIDs can easily cause side effects such as gastrointestinal disorders, and most patients cannot take drugs orally when treating postoperative pain or pain caused by cancer, it is necessary Development of intravenous dosage forms of NSAIDs

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Example 1: Mix 12 grams of lecithin, 25 grams of glycerin with 800 ml of water for injection preheated to 80°C, transfer to a high-speed tissue masher, stir for 3 minutes at 20,000 rpm, repeat 3 times until Lecithin is uniformly dispersed; in the above dispersion, add 500 mg of ketoprofen axetil (equivalent to ketoprofen) preheated to 80 ° C, 50 grams of soybean oil, and 50 grams of medium-chain triglycerides, and transfer to high-speed tissue pounding In the crusher, stir at 20,000 rpm for 3 minutes, repeat 3 times until evenly dispersed; take the above-mentioned colostrum and add water for injection preheated to 80°C to make the full amount 1000 ml, transfer it to a high-pressure homogenizer, and homogenize 6 times, take a sample for microscopic inspection until the oil droplet is below 0.5 micron; take the above emulsion and fill it in a 20 ml infusion bottle, fill it with nitrogen, and sterilize at 105°C for 45 minutes.

Embodiment 2

[0058] Example 2: Mix 12 grams of lecithin, 25 grams of glycerin with 800 ml of water for injection preheated to 80°C, transfer to a high-speed tissue masher, stir for 3 minutes at 20,000 rpm, repeat 3 times until Lecithin is evenly dispersed; in the above dispersion, add 500 mg of ketoprofen axetil (equivalent to ketoprofen) preheated to 80 ° C, 100 grams of soybean oil, and transfer it to a high-speed tissue grinder at a rate of 20,000 per minute. Turn and stir for 3 minutes, repeat 3 times until evenly dispersed; take the above-mentioned colostrum and add water for injection preheated to 80°C to make the full volume 1000 ml, transfer it to a high-pressure homogenizer, homogenize 6 times, and take a sample for microscopic examination. The oil droplet is below 0.5 micron; take the above emulsion and fill it in a 20ml infusion bottle, fill it with nitrogen, and sterilize it at 105°C for 45 minutes.

Embodiment 3

[0059] Example 3: Mix 12 grams of lecithin, 25 grams of glycerin with 800 milliliters of water for injection preheated to 80°C, transfer to a high-speed tissue masher, stir for 3 minutes at 20,000 rpm, repeat 3 times until Lecithin is evenly dispersed; in the above dispersion liquid, add 1000 mg of ketoprofen axetil (equivalent to ketoprofen) preheated to 80 ° C, 200 grams of soybean oil, and transfer it to a high-speed tissue masher at a speed of 20000 per minute. Turn and stir for 3 minutes, repeat 3 times until evenly dispersed; take the above-mentioned colostrum and add water for injection preheated to 80°C to make the full volume 1000 ml, transfer it to a high-pressure homogenizer, homogenize 6 times, and take a sample for microscopic examination. The oil droplet is below 0.5 micron; take the above emulsion and fill it in a 20ml infusion bottle, fill it with nitrogen, and sterilize it at 105°C for 45 minutes.

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Abstract

The present invention relates to a lipid microsphere injection containing ketoprofen or ketoprofen ester, its preparation process and prescription. It has good action for stopping pain, resisting inflammation and reducing fever. Said lipid microsphere includes ketoprofen or one ketoprofen ester, injection soybean oil, injection medium chain triglyceride, phospholipids, pure glycerin and injection water. Said invention can be used for preparing pain-stopping and inflammation-relieving medicine.

Description

Technical field: [0001] The invention relates to the technical field of medicine, in particular to a lipid microsphere for injection containing ketoprofen or ketoprofen axetil and a preparation process thereof. It is an analgesic and anti-inflammatory lipid microsphere injection, and the route of administration is intravenous administration. Background technique: [0002] Ketoprofen is a non-steroidal anti-inflammatory drug (NSAIDs) that is currently used worldwide. Clinical trials have proved that ketoprofen has a significant anti-inflammatory and analgesic effect on rheumatoid arthritis, spondylitis, trauma and postoperative. Ketoprofen has the advantages of high curative effect, low toxicity and small dose; at the same dose, its anti-inflammatory and analgesic effect is 150 times stronger than that of aspirin, and its antipyretic effect is 4 times that of indomethacin and 100 times that of aspirin, while its toxicity is 100 times that of aspirin. 1 / 20 of indomethacin. ...

Claims

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Application Information

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IPC IPC(8): A61K31/192
Inventor 唐星何海冰
Owner SHENYANG PHARMA UNIVERSITY
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