Ibuprofen arginine sodium chloride injection as well as preparation method and use thereof

A technology of sodium arginine chloride and injection, which is applied in the fields of ibuprofen arginine sodium chloride injection and its preparation and application, can solve the problems of low activity of ibuprofen, achieve convenient clinical use, avoid The effect of secondary pollution

Inactive Publication Date: 2012-10-10
HC SYNTHETIC PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Relatively low activity of ibup...

Method used

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  • Ibuprofen arginine sodium chloride injection as well as preparation method and use thereof
  • Ibuprofen arginine sodium chloride injection as well as preparation method and use thereof
  • Ibuprofen arginine sodium chloride injection as well as preparation method and use thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Embodiment 1: the preparation of ibuprofen arginine sodium chloride injection (0.4g / 100ml)

[0033] prescription:

[0034] 1) Receive qualified ibuprofen raw materials, sodium chloride and arginine according to the ingredient list;

[0035] 2) Add water for injection with a batch volume of 95% in the batching tank, add sodium chloride, ibuprofen, and arginine in batches, slowly add sodium hydroxide to adjust the pH value to about 7.4 under stirring, and 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;

[0036] 3) After the intermediates pass the test, notify the filling section to start filling;

[0037] 6) Send the filled semi-finished product into the sterilization cabinet for sterilization, sterilization conditions: 121 ° C hot-pressed steam sterilization for 12 minutes, come out of the cabin...

Embodiment 2

[0040] Embodiment 2: the preparation of ibuprofen sodium chloride injection (0.4g / 250ml)

[0041] prescription:

[0042] 1) Receive qualified ibuprofen raw materials, sodium chloride and arginine according to the ingredient list;

[0043] 2) Add water for injection with a batch volume of 95% in the batching tank, add sodium chloride, ibuprofen, and arginine in batches, slowly add sodium hydroxide to adjust the pH value to about 7.4 under stirring, and 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;

[0044] 3) After the intermediates pass the test, notify the filling section to start filling;

[0045] 6) Send the filled semi-finished product into the sterilization cabinet for sterilization, sterilization conditions: 121 ° C hot-pressed steam sterilization for 12 minutes, come out of the cabinet accord...

Embodiment 3

[0048] Embodiment 3: the preparation of ibuprofen arginine sodium chloride injection (0.8g / 100ml)

[0049] prescription:

[0050]

[0051] 1) Receive qualified ibuprofen raw materials, sodium chloride and arginine according to the ingredient list;

[0052] 2) Add water for injection with a batch volume of 95% in the batching tank, add sodium chloride, ibuprofen, and arginine in batches, slowly add sodium hydroxide to adjust the pH value to about 7.4 under stirring, and 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;

[0053] 3) After the intermediates pass the test, notify the filling section to start filling;

[0054] 6) Send the filled semi-finished product into the sterilization cabinet for sterilization, sterilization conditions: 121 ° C hot-pressed steam sterilization for 12 minutes, come out ...

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PUM

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Abstract

The invention provides an intravenous administration preparation which can be directly used without being diluted and contains arginine and ibuprofen at a molar rate of 0.92, wherein the adding amount of sodium chloride is 0.75-0.9 percent by weight per volume. The intravenous administration preparation is prepared by the following steps of: a, adding injection water into a dosing tank, and adding ibuprofen, sodium chloride and arginine according to ingredient amount; b, stirring the mixture, and regulating pH value to about 7.4 by using 10 percent of sodium hydroxide solution, adding the injection water to the required amount, adding activated carbon for injection, stirring, removing carbon by using a titanium rod, and performing fine filtering on the mixture by microporous filter membrane (preferably, a cylindrical filter with the pore diameters of 0.45 microns or 0.22 microns); c, filling the injection after the detection of an intermediate is qualified; and d, feeding the filled semi-finished product into a sterilization cabinet for sterilizing in a hot-pressing mode.

Description

Technical field: [0001] The invention relates to a preparation of an injection containing ibuprofen as a main medicinal component, a preparation method and an application thereof. technical background: [0002] 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 . [0003] The analgesia of ibuprofen is peripheral rather than central. This compound does not have glucocorticoid or adrenocorticoid stimulating properties. [0004] Ibuprofen injection (ibuprofen, Caldolor) was developed by Cumberland Company and was approved by FDA in the U...

Claims

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Application Information

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IPC IPC(8): A61K31/192A61K9/08A61P29/00A61K31/198
Inventor 杨成强建华
Owner HC SYNTHETIC PHARMA CO LTD
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