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Ibuprofen injection for intravenous administration

An injection and intravenous technology, which is applied in the field of ibuprofen injection and its preparation, can solve problems such as high pH of the final product, pitting in ampoules, and pain at the injection site, so as to improve compatibility stability, reduce clinical risks, and reduce The effect of production costs

Active Publication Date: 2017-09-26
燃点(南京)生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

First of all, the test has proved that under the condition of higher pH, the stability of ibuprofen injection decreases, which is manifested by the rapid increase of the amount of impurities, and the index of insoluble particles is unqualified
Secondly, the high-pH drug solution puts forward higher requirements on the ampoule. If the ampoule with low specifications is used, the compatibility of the packaging material will easily fail, pitting will appear on the inner surface of the ampoule, and the glass will fall off. Pb, Al, Se, Gr, Si and other metal elements in the glass material are leached out and enter the injection solution, causing great clinical risks
Finally, the high-pH medicinal solution will cause pain at the injection site and cannot be directly used by patients, which is not conducive to clinical emergency use
[0015] Therefore, we need to overcome the existing problems of poor solubility of ibuprofen, high risk of clinical compatibility, and high pH of the final product

Method used

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  • Ibuprofen injection for intravenous administration
  • Ibuprofen injection for intravenous administration
  • Ibuprofen injection for intravenous administration

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Prescription (1000 formulation units):

[0055] ibuprofen

[0056] Preparation process: Add water for injection with a total volume of about 7200ml into the container, add 684.8g of arginine and 40g of poloxamer 188, stir until completely dissolved, add 800g of ibuprofen, stir until completely dissolved, add 4g of needle Use activated carbon, keep warm and stir for 30 minutes, decarburize by filtering with a 0.45μm filter element, add water for injection to 8000ml, and decarburize through a 0.20μm filter element, fill it into an ampoule, and sterilize it at 121°C for 12 minutes to obtain the product.

Embodiment 2

[0058] Prescription (1000 formulation units):

[0059] ibuprofen

[0060] Preparation process: Add water for injection with a total volume of about 7200ml into the container, add 684.8g arginine and 80g poloxamer 188, stir until completely dissolved, add 800g of ibuprofen, stir until completely dissolved, add 4g of needle Use activated carbon, keep warm and stir for 20 minutes, decarburize by filtering with a 0.45 μm filter element, add water for injection to 8000 ml, decarbonize through a 0.20 μm filter element, fill and seal it into an ampoule, and sterilize it at 121°C for 12 minutes to obtain the product.

Embodiment 3

[0062] Prescription (1000 formulation units):

[0063] ibuprofen

[0064] Preparation process: Add water for injection with a total volume of about 7200ml into the container, add 684.8g arginine and 100g poloxamer 188, stir until completely dissolved, add 800g of ibuprofen, stir until completely dissolved, add 4g of needle Use activated carbon, keep warm and stir for 20 minutes, decarburize by filtering with a 0.45 μm filter element, add water for injection to 8000 ml, decarbonize through a 0.20 μm filter element, fill and seal it into an ampoule, and sterilize it at 121°C for 12 minutes to obtain the product.

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Abstract

The invention discloses an ibuprofen injection for intravenous administration and a preparation method thereof. The ibuprofen injection for intravenous administration is prepared from ibuprofen, arginine, a cosolvent and water for injection, wherein the cosolvent is poloxamer 188. The ibuprofen injection disclosed by the invention has the advantages of stable quality, high sterile level, moderate pH and good compatibility of clinical application. The preparation method of the ibuprofen injection disclosed by the invention has the advantages that the technology is simple and efficient, the quality is controllable, and industrial mass production is facilitated.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to an ibuprofen injection for intravenous administration and a preparation method thereof. Background technique [0002] The chemical name of ibuprofen is 2-(-4-isobutylphenyl)propionic acid [0003] Chemical Structure: [0004] [0005] Molecular formula: C 8 h 14 o 2 S 2 [0006] Molecular weight: 206.33 [0007] Properties: Melting point 75-78°C, boiling point 157°C (4mmHg), water insoluble. [0008] Antipyretic and analgesic drugs have been used by humans for more than 150 years. Now, antipyretic and analgesic drugs have become an indispensable and important drug in human daily life, and they are one of the most widely used and most widely used medicines in the world. In recent years, the domestic and foreign antipyretic and analgesic drug markets have shown a steady growth trend, and the market is expected to continue to expand in the future. [0009] Among many no...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/192A61K47/18A61K47/10A61P29/00
CPCA61K47/10A61K47/183A61K9/0019A61K9/08A61K31/192
Inventor 秦勇徐成唐亚军林峰金春谷丽高瑞雪
Owner 燃点(南京)生物医药科技有限公司
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