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Dexibuprofen injection drug composition and preparation method thereof

A technology of dextro-ibuprofen and dex-profen, which is applied in the directions of drug combination, pharmaceutical formula, drug delivery, etc., can solve problems such as unreasonable dosage, undisclosed product quality research data, and difficulty in confirming product quality and stability. , to achieve the effect of reducing production costs and steps, significant antipyretic cooling effect, and good product stability

Active Publication Date: 2015-04-29
CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Chinese patents CN201010004842.6, CN200910148217.6, and CN200910311929.5 all disclose injections of arginine and dexibuprofen, and specifically disclose the prescription and preparation process, but none of the above-mentioned patents discloses the quality of the obtained products Research data, it is difficult to confirm the quality and stability of the final product
At the same time, although the three patents all use Dexibuprofen as the active ingredient, their content is still consistent with the dosage of the racemic product Caldolor (both 100 mg / ml), that is, the dosage of Dexibuprofen is not specified in the three patents. In-depth research, there is a problem of unreasonable dosage

Method used

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  • Dexibuprofen injection drug composition and preparation method thereof
  • Dexibuprofen injection drug composition and preparation method thereof
  • Dexibuprofen injection drug composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Each 1000 injections preparation contains the following ingredients (75mg / 2ml):

[0030] Dextroibuprofen

[0031] Weigh arginine according to the prescription amount, add 800-1000ml water for injection, stir to dissolve it, then add the prescription amount of dextroibuprofen, keep stirring to dissolve it, then add water for injection to 2000ml, stir and mix well; add Prepare a total amount of 0.1% (W / V) activated carbon for needles, keep at 40~60℃ for 20 minutes, stir and absorb, filter and decarburize for later use; filter the above solution with 0.22μm and 0.45μm microporous membranes until the filtrate is clear. After the semi-finished product passes the inspection, it is packed and filled into 1000 2ml ampoules, so that the content of the main drug in each ampoule is 75mg / 2ml. Sterilize at 115℃ for 30 minutes with hot and humid steam, leak detection, and light inspection to obtain the finished product. .

Embodiment 2

[0033] Each 1000 injections preparation contains the following ingredients (75mg / 2ml):

[0034] Dextroibuprofen

[0035] Weigh arginine according to the prescription amount, add 800-1000ml water for injection, stir to dissolve it, then add the prescription amount of dextroibuprofen, keep stirring to dissolve it, then add water for injection to 2000ml, stir and mix well; add Prepare a total amount of 0.1% (W / V) activated carbon for needles, keep at 40~60℃ for 20 minutes, stir and absorb, filter and decarburize for later use; filter the above solution with 0.22μm and 0.45μm microporous membranes until the filtrate is clear. After the semi-finished product passes the inspection, it is packed and filled into 1000 2ml ampoules, so that the content of the main drug in each ampoule is 75mg / 2ml. Sterilize at 115℃ for 30 minutes with hot and humid steam, leak detection, and light inspection to obtain the finished product. .

Embodiment 3

[0037] Each 1000 injections preparation contains the following ingredients (75mg / 2ml):

[0038] Dextroibuprofen

[0039] Weigh arginine according to the prescription amount, add 800-1000ml water for injection, stir to dissolve it, then add the prescription amount of dextroibuprofen, keep stirring to dissolve it, then add water for injection to 2000ml, stir and mix well; add Prepare a total amount of 0.1% (W / V) activated carbon for needles, keep at 40~60℃ for 20 minutes, stir and absorb, filter and decarburize for later use; filter the above solution with 0.22μm and 0.45μm microporous membranes until the filtrate is clear. After the semi-finished product passes the inspection, it is packed and filled into 1000 2ml ampoules, so that the content of the main drug in each ampoule is 75mg / 2ml. Sterilize at 115℃ for 30 minutes with hot and humid steam, leak detection, and light inspection to obtain the finished product. .

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Abstract

The invention belongs to the field of pharmaceutical preparations, and particularly relates to a dexibuprofen injection and a preparation method thereof. The dexibuprofen injection per ml comprises 10-90 mg of dexibuprofen. The high temperature resistance and hard light tolerance of a dexibuprofen injection prepared according to the invention are obviously superior to those in the prior art, the product stability is better, the quality is better, the requirements of clinical intravenous drip can be satisfied, and the clinical compliance is better.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical preparations, and particularly relates to a dextroibuprofen injection and a preparation method thereof. Background technique [0002] Ibuprofen is a classic antipyretic and analgesic drug, which can inhibit the synthesis of prostaglandins, has analgesic, antipyretic and anti-inflammatory effects, and has become one of the world's best-selling OTC drugs. As the first new preparation of ibuprofen intravenous injection for the treatment of pain and fever, the US FDA has approved the marketing of ibuprofen intravenous injection (Caldolor) with specifications of 400mg / 4ml and 800mg / 8ml. [0003] There are two enantiomers of ibuprofen, namely levorotatory ibuprofen and dextroibuprofen, and racemic ibuprofen is currently widely used. Pharmacological tests have shown that dextro-ibuprofen is the active ingredient of racemic ibuprofen, and its pharmacological activity is 160 times that of l-ibuprofen and 1.6 times ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/192A61K47/18A61P29/00
Inventor 王颖张勇刘秀芝
Owner CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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