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Mezloxicon liquid preparation using HPCD as solubilizing and stabilizing agent and its preparation method

A technology of meloxicam and liquid preparations, which is applied in the field of medicine, can solve the problems of hemolysis, toxicity irritation, strong hemolysis, toxicity irritation, etc., so as to avoid gastrointestinal side effects, meet clinical needs, and achieve effective fast effect

Inactive Publication Date: 2004-05-05
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Similar foreign products use surfactants as solubilizers to obtain a solution of meloxicam with a suitable concentration at a suitable pH, but in my country, there is no surfactant for injection, and the addition of surfactants—even if it is non-ionic Surfactants are also toxic and irritating to a certain extent, and may cause hemolysis, while cationic and anionic surfactants are more toxic, irritating and hemolytic, and are generally not used in injections and eye drops. The difficulty in the preparation of loxicam liquid preparations is how to obtain clear liquids of various doses of meloxicam that are suitable for clinical application and will not precipitate solids when stored at low or normal temperatures without the presence of surfactants.

Method used

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  • Mezloxicon liquid preparation using HPCD as solubilizing and stabilizing agent and its preparation method
  • Mezloxicon liquid preparation using HPCD as solubilizing and stabilizing agent and its preparation method
  • Mezloxicon liquid preparation using HPCD as solubilizing and stabilizing agent and its preparation method

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Embodiment 1

[0020] Embodiment 1: Preparation uses HPCD as the meloxicam injection of solubilizer and stabilizer

[0021] 100ml

[0022] Preparation: Add an appropriate concentration of HPCD aqueous solution to the suspension of the drug and propylene glycol, add 0.1M NaOH solution under heating and stirring at 60-80°C, add injectable sodium chloride after clarification, and finally adjust the pH to 6.5-8.5 with glycine, Make up to the specified volume with water for injection, continue heating for 15-20 minutes, filter with a 0.22-minute membrane filter, sterilize the filtrate with 100 flow-through steam, put it into ampoules in divided doses, and melt seal it to obtain the product.

[0023] 100ml

[0024] Preparation: Add an appropriate concentration of HPCD aqueous solution into the suspension of the drug and propylene glycol, add the prescribed amount of meglumine under heating and stirring at 60-80°C, add injectable sodium chloride after complete dissolution, an...

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Abstract

A liquid preparation of meloxican is prepared from the meloxicam or its medical salt and water-soluble cyclodextrin derivative HP-beta-CD used as solubilizer and stabilizer, proportionally mixing, adding cosolvent, pH regulator and water for injection, heating and membrane filtering. It has long storage time at low temp.

Description

Technical field: [0001] The invention relates to the technical field of medicine, in particular it is a meloxicam liquid preparation using HPCD as a solubilizer and a stabilizer and a preparation method thereof. Background technique: [0002] Meloxicam is a new generation of non-steroidal anti-inflammatory drugs developed by BOEDIRINGER INGELHEIM of Germany, and it is the first COX-2 inhibitor to be marketed. This product has significant and long-lasting anti-inflammatory effects and certain antipyretic and analgesic effects. Meloxicam, which is higher than the pharmacodynamic test dose, has no significant effect on the central nervous system, cardiovascular system, respiratory system, autonomic nervous system, etc. influences. Clinical trials have shown that the therapeutic effect of meloxicam on patients with osteoarthritis, rheumatoid arthritis, and sciatica is comparable to or even better than that of current NSAIDs, and the daily dose is better than that of piroxicam, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/541A61P29/00
Inventor 何仲贵杨丽英
Owner SHENYANG PHARMA UNIVERSITY
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