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Ibuprofen injection composite and preparation method thereof

A technology for injection and water for injection, which is applied in the direction of drug combination, pharmaceutical formula, drug delivery, etc. It can solve the problems of unfavorable long-term storage and clinical use, increase of related substances, and poor long-term stability, so as to improve stability and safety , good stability

Active Publication Date: 2012-02-01
CHENGDU EASTON BIOPHARMACEUTICALS CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It has been verified by experiments that after the ibuprofen injection is used in combination with glucose injection and sodium chloride injection, there will be different degrees of opalescence and the increase of visible foreign matter, and the injection is under the high temperature condition of 60 ℃, 10 Days later, the color of the sample properties changed significantly, related substances increased significantly, and the impurity of 4-isobutylacetophenone was greater than 0.1%. The injection was placed under normal temperature storage conditions for 6 months. Not only did the color of the sample properties change, but also Related substances increase significantly, and their long-term stability is poor, which is not conducive to their long-term storage and clinical use

Method used

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  • Ibuprofen injection composite and preparation method thereof
  • Ibuprofen injection composite and preparation method thereof
  • Ibuprofen injection composite and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Each 1000 injection preparations contains the following ingredients:

[0042] Ibuprofen 100g

[0043] Lysine 72g

[0044] Add water for injection to 1000ml

[0045] Weigh lysine according to the prescription amount, add 600-900ml water for injection, stir to dissolve it, then add the prescribed amount of ibuprofen, stir continuously to dissolve it, measure the pH value of the solution to be about 7.3, and use sodium hydroxide solution Adjust the pH value of the solution to 7.5-8.5, add water for injection to 1000ml, stir and mix evenly; add activated carbon for needles with a total volume of 0.1% (W / V), heat and stir at 40-60°C for 20 minutes, filter and remove Carbon for standby; the above solution is finely filtered with 0.22 μm and 0.45 μm microporous membranes until the filtrate is clear. After the semi-finished product is qualified, it is subpackaged and filled in 1000 1ml ampoules, so that the content of the main drug in each ampule is 100 mg, sterilized by ste...

Embodiment 2

[0047] Each 1000 injection preparations contains the following ingredients:

[0048] Ibuprofen 200g

[0049] Histidine 155g

[0050] Add water for injection to 2000ml

[0051] Weigh histidine according to the prescription amount, add 1200-1800ml water for injection, stir to dissolve it, then add the prescribed amount of ibuprofen, stir continuously to dissolve it, measure the pH value of the solution to be about 7.2, and use sodium hydroxide solution Adjust the pH value of the solution to 8.0-9.0, add water for injection to 2000ml, stir and mix evenly; add activated carbon for needles with a total volume of 0.2% (W / V), heat and stir at 40-60°C for 20 minutes, filter and remove Carbon for standby; the above solution is finely filtered with 0.22 μm and 0.45 μm microporous membranes until the filtrate is clear. After the semi-finished product is qualified, it will be subpackaged and filled in 1000 2ml ampoules, so that the content of the main drug in each ampule is 200mg, ster...

Embodiment 3

[0053] Each 1000 injection preparations contains the following ingredients:

[0054] Ibuprofen 400g

[0055] Arginine 354g

[0056] Add water for injection to 4000ml

[0057] Weigh arginine according to the prescription amount, add 2400 ~ 3600ml of water for injection, stir to dissolve it, then add the prescription amount of ibuprofen, stir continuously to dissolve it, measure the pH value of the solution to 7.8 ~ 8.8, add water for injection to 4000ml, stir and mix evenly; add activated carbon for needles with a total amount of 0.1% (W / V), heat and stir at 40-60°C for 20 minutes, filter and decarbonize for later use; fine the above solution with a 0.22 μm microporous membrane filter Filtrate until the filtrate is clear and the semi-finished product is qualified, sub-package, fill and seal in 1000 5ml ampoules, so that the content of the main drug in each ampule is 400mg, sterilize at 115°C for 30 minutes, leak detection, light inspection , get the finished product.

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Abstract

The invention discloses an ibuprofen injection composite which can obviously improve the quality stability of products and meet the clinical compatibility demand and a preparation method thereof to overcome the defect of the traditional ibuprofen injection. The injection is prepared by mixing ibuprofen and cosolvent according to a molar ratio of 1: 1.001-2, and the pH value of the injection is 7.5-9.0. The ibuprofen injection prepared through the method has obviously improved tolerance capability to high temperature and strong light and better stability and no irritant to vessels, and can effectively meet the requirement of the clinical intravenous drip. Moreover, the preparation method of the invention has the advantages of simple process and good stability of the prepared product.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an ibuprofen injection and a preparation method thereof. Background technique [0002] Ibuprofen is a classic antipyretic and analgesic drug, which can inhibit the synthesis of prostaglandins and has analgesic, antipyretic and anti-inflammatory effects. Due to its remarkable curative effect and few adverse reactions, it was widely used in the world after it went on the market, and the market continued to expand. In the late 1980s, many countries in Europe and the United States turned it into an over-the-counter drug, which accelerated its sales growth and has now become the world's best-selling OTC. One of the drugs. Domestic existing ibuprofen tablets, ibuprofen dispersible tablets, ibuprofen orally disintegrating tablets, ibuprofen capsules, ibuprofen syrup, ibuprofen chewable tablets ibuprofen soft capsules, ibuprofen sustained-release capsules , Ibupro...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/192A61K47/16A61P29/00
Inventor 王颖袁明旭伍熹
Owner CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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