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Stable ibuprofen arginine injection and preparation method thereof

An injection, arginine technology, applied in the field of pharmaceutical preparations, can solve the problems of white opalescence or turbidity, side effects, unfavorable intravenous injection or intramuscular injection, etc., to reduce irritation, reduce production costs, and solve the problems of chemical stability. Effect

Inactive Publication Date: 2012-02-01
CHONGQING PHARMA RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In clinical use, ibuprofen injection often needs to be diluted with normal saline or glucose injection and then intravenously injected or infused. The inventor found in the process of studying ibuprofen arginine injection that according to the methods disclosed in the above two patents, Prepared arginine and ibuprofen mixed solution injection or listed product Caldolor TM It is unstable when diluted with normal saline or 5% glucose injection before clinical use, and it is easy to produce white opalescence or turbidity, which is not conducive to intravenous or intramuscular injection, and serious side effects may occur after injection or infusion

Method used

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  • Stable ibuprofen arginine injection and preparation method thereof
  • Stable ibuprofen arginine injection and preparation method thereof
  • Stable ibuprofen arginine injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] See Table 1 for the formula (prescription) of ibuprofen arginine injection.

[0046] Table 1 Prescription List of Ibuprofen Amino Acid Injection

[0047]

[0048] Preparation Process:

[0049] 1. Weigh the prescribed amount of arginine in a beaker, add 80% water for injection (wherein, prescription 6 adds 1% water for injection), stir to make it dissolve, and form a solution;

[0050] 2. Add ibuprofen into the solution while stirring until completely dissolved;

[0051] 3. Add antioxidant, meglumine, sodium dihydrogen phosphate, and sodium chloride (prescription 6) into the solution, stir to dissolve completely;

[0052] 4. Measure the pH value of the solution, adjust the pH to 7.0-8.0 with hydrochloric acid or sodium hydroxide if necessary, and add water for injection to the configured volume;

[0053] 5. Add 0.5% activated carbon and stir for 30 minutes;

[0054] 6. First use 0.45μm filter to decarbonize, and then use 0.22μm fine filter to obtain the filtrate; ...

Embodiment 2

[0059] Stability test:

[0060] The sample is subjected to the influence factor test, and the changes of related substances and colors of the sample before and after the influence factor are measured.

[0061] The samples of the ibuprofen arginine injection prepared by the above 6 prescriptions were placed in the light, 40°C and 60°C influencing factor test chambers for investigation, and the related substances and color changes were measured on the 5th and 10th days respectively. And compared with 0 days, the specific data are shown in Table 2 and Table 3.

[0062] Table 2 Influencing factors Experimental related substances (%)

[0063]

[0064] Table 3 Influencing factors Experimental color

[0065]

[0066] Conclusion: The color of the prescription without antioxidant (prescription 7) turns yellow obviously at 40°C and 60°C, and the related substances also increase significantly. The samples prepared by other prescriptions and processes of the present invention have...

Embodiment 3

[0068] Clarity test after sample dilution

[0069] Take the above-mentioned samples of prescription 1 to prescription 5 and prescription 7 (among them, prescription 5 is the sample reconstituted by adding an equal volume of water for injection before freeze-drying) and take 4ml, dilute with 100ml water for injection and 100ml 5% glucose injection respectively Afterwards, observe the clarity of the solution and check with Caldolor TM For comparison, the specific results are shown in Table 4.

[0070] Table 4 Clarity after sample dilution

[0071]

[0072] Conclusion: after the sample that adopts prescription and technology preparation of the present invention only needs to be diluted with 100ml normal saline and 100ml 5% glucose injection, the solution can be clarified, and Caldolor TM It needs to be diluted with at least 250ml of normal saline to clarify, and 250ml of 5% glucose injection still cannot make the solution clear. Since the commonly used clinical saline and 5...

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Abstract

The invention relates to a stable ibuprofen arginine injection and a preparation method thereof. The injection comprises ibuprofen, arginine, and meglumine. Also, sodium dihydrogen phosphate and sodium thiosulfate can be contained in the injection. The injection can be an injection liquid, a transfusion liquid or a lyophilized powder injection. The ibuprofen arginine injection provided by the invention brings no problem in respects of haemolyticus, vascular stimulation or allergy. When a prior product is diluted by using physiological saline or a 5% glucose injection, a white opalescence or turbid phenomenon is occurred. With the injection and the preparation provided by the invention, the problem is solved, the physical stability problem of the product is solved, and the quality stability and safety of the product are ensured.

Description

Technical field: [0001] The invention belongs to the field of pharmaceutical preparations, and specifically relates to a stable ibuprofen arginine injection and a preparation method thereof. The injection contains ibuprofen, arginine and meglumine, and may further contain sodium dihydrogen phosphate and sulfur sodium sulfate. The injection can be injection, infusion and freeze-dried powder. Background technique: [0002] The chemical structural formula of ibuprofen is: [0003] [0004] The chemical name is: α-methyl-4-(2-methylpropyl)phenylacetic acid. [0005] Ibuprofen is a white crystalline powder; it has a slightly peculiar smell and is almost tasteless. Ibuprofen is soluble in ethanol, acetone, chloroform or ether, almost insoluble in water; soluble in sodium hydroxide or alkaline amino acid solution. [0006] Ibuprofen is a phenylpropionic acid non-steroidal anti-inflammatory analgesic. Its anti-inflammatory, analgesic and antipyretic effects are similar to tho...

Claims

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Application Information

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IPC IPC(8): A61K47/26A61K9/08A61K9/00A61K9/19A61P29/00A61K31/192
Inventor 宗太丽姚玲红钟晓东沈沅郑涛瑞
Owner CHONGQING PHARMA RES INST
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