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Ketoprofen intravenous administration preparation and preparation method thereof

A ketoprofen and administration technology, applied in pharmaceutical formulations, antipyretics, anti-inflammatory agents, etc., can solve problems such as reducing the safety of intravenous administration preparations, and achieve no hemolysis and less vascular irritation. , good stability effect

Inactive Publication Date: 2013-01-30
HC SYNTHETIC PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Chinese patent CN200610170923.7 discloses a kind of ibuprofen intravenous preparation, but must add organic solvent (propylene glycol, ethanol etc.) to solubilize and a large amount of stabilizing agents (EDTA-2Na, sodium sulfite etc.) in the preparation process of this preparation, organic The addition of solvents in intravenous administration preparations reduces the safety of intravenous administration preparations, and its clinical use value is questionable

Method used

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  • Ketoprofen intravenous administration preparation and preparation method thereof
  • Ketoprofen intravenous administration preparation and preparation method thereof
  • Ketoprofen intravenous administration preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Embodiment 1: the preparation of ibuprofen sodium chloride injection (0.1g / 100ml)

[0064]

[0065] 1) Obtain qualified ibuprofen raw materials, sodium chloride and L-arginine according to the ingredient list;

[0066] 2) Add water for injection with a batch volume of 95% in the batching tank, add sodium chloride and ibuprofen in the batching amount, under stirring, slowly add arginine to adjust the pH value to about 6.5, stir for 1 hour, add water for injection to For the full amount, add medicinal charcoal according to 0.05% (W / V) of the total volume, stir evenly, keep warm at 50°C to 80°C for 20 minutes, and circulate and filter for more than 20 minutes;

[0067] 3) After the intermediates pass the test, notify the filling section to start filling;

[0068] 4) Send the filled semi-finished product into the sterilization cabinet for sterilization. Sterilization conditions: 121°C hot-pressed steam sterilization for 12 minutes, take out the cabinet according to the ...

Embodiment 2

[0070] Embodiment 2: the preparation of ibuprofen sodium chloride injection (0.4g / 100ml)

[0071]

[0072] 1) Receive qualified ibuprofen raw materials, sodium chloride and arginine according to the ingredient list;

[0073] 2) Add water for injection with a batch volume of 95% in the batching tank, add sodium chloride and ibuprofen in the batching amount, under stirring, slowly add L-arginine to adjust the pH value to about 7.4, stir for 1 hour, add injection Add water to the full amount, add medicinal charcoal according to 0.05% (W / V) of the total volume, stir evenly, keep warm at 50°C to 80°C for 20 minutes, and circulate and filter for more than 20 minutes;

[0074] 3) After the intermediates pass the test, notify the filling section to start filling;

[0075] 4) Send the filled semi-finished product into the sterilization cabinet for sterilization, sterilization conditions: 121 ° C hot-pressed steam sterilization for 12 minutes, take out the cabinet according to the s...

Embodiment 3

[0078] Embodiment 3: the preparation of ibuprofen sodium chloride injection (0.4g / 100ml)

[0079]

[0080] 1) Receive qualified ibuprofen raw materials, sodium chloride and arginine according to the ingredient list;

[0081] 2) Add water for injection with a batch volume of 95% in the batching tank, add sodium chloride and ibuprofen in the batching amount, under stirring, slowly add D-arginine to adjust the pH value to about 8.5, stir for 40 minutes, add injection Add water to the full amount, add medicinal charcoal according to 0.05% (W / V) of the total volume, stir evenly, keep warm at 50°C to 80°C for 20 minutes, and circulate and filter for more than 20 minutes;

[0082] 3) After the intermediates pass the test, notify the filling section to start filling;

[0083] 4) Send the filled semi-finished product into the sterilization cabinet for sterilization, sterilization conditions: 121 ° C hot-pressed steam sterilization for 12 minutes, take out the cabinet according to t...

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Abstract

The invention provides a ketoprofen intravenous administration preparation and a preparation method thereof. The injection contains 0.4mg / ml-4mg / ml ibuprofen, an alkali modifier in the amount required for adjusting pH to 6.5-9.0, 0.70%-0.90% w / v sodium chloride and water for injection.

Description

[0001] The present invention is a divisional application of CN102166360A for an invention patent. The original application is a preparation for intravenous administration of ibuprofen and its preparation method proposed on February 21, 2011, and the application number is 201110041127.4. Technical field: [0002] The invention relates to a preparation of an injection containing ketoprofen as a main medicinal component and a preparation method thereof. technical background: [0003] Ibuprofen has anti-inflammatory, analgesic and antipyretic effects. In many experiments using commonly used animals, the effect of ibuprofen is 16 to 32 times that of aspirin. In rats with adjuvant arthritis, ibuprofen has relatively low activity. Topical administration of human ibuprofen 300 mg reduces erythema associated with nicotinate furfurate emulsion application and is similar in this respect to aspirin and ibufenac but not sodium salicylate, phenylbutazone, and hydroxyphenylbutazone . [...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/192A61K9/08A61P29/00
Inventor 杨成施维强建华
Owner HC SYNTHETIC PHARMA CO LTD
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