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Ketorolac tromethamine freezing-dried power injection and preparation method thereof

A technology of ketorolac tromethamine and freeze-dried powder injection, which is applied to the freeze-dried powder injection of ketorolac tromethamine for injection and its preparation, recipe and method field, and can solve the problem that the quality of injection is not stable. , hidden safety hazards of clinical medication, difficult process control and other problems, to overcome the low bioavailability, prolong the storage time, and achieve the effect of stable quality

Active Publication Date: 2008-04-30
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to the latest research results, the solid oral administration method is slow in drug absorption, and for patients with acute and severe pain who need the most rapid analgesic method, the choice of the administration method is particularly important. Many inconveniences, mainly manifested as slow onset
[0005] At present, the injections used mainly include foreign varieties, which are of better quality but higher in price, while domestic injections are not stable in quality, difficult to control in process, poor in clarity, etc., and bring great safety hazards to clinical medication.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Preparation of Ketorolac Tromethamine Frozen Powder for Injection

[0025] Ketorolac Tromethamine 10g

[0026] Mannitol 40g

[0027] Sodium chloride 4g

[0028] Sodium thiosulfate 1g

[0029] Appropriate amount of sodium hydroxide

[0030] Add water for injection to 2000ml

[0031] Preparation Process:

[0032] (1) Weigh the prescribed amount of ketorolac tromethamine, mannitol, sodium chloride, sodium thiosulfate, add an appropriate amount (about 40% of the prescribed amount of water for injection) of water for injection and stir evenly, then add activated carbon for injection , the add-on of activated carbon is about 0.02% (g / v), heat preservation 15 minutes, filter decarbonization.

[0033] (2) Add water for injection to the full amount, stir evenly, and adjust the pH value to 7.5 with pre-prepared 1ml / L sodium hydroxide. The prepared solution was filtered sequentially through 0.45 μm and 0.22 μm microporous membranes. After the filtrate was tested, it was pac...

Embodiment 2

[0037] Preparation of Ketorolac Tromethamine Frozen Powder for Injection

[0038] Ketorolac Tromethamine 20g

[0039] Mannitol 60g

[0040] Sodium chloride 5g

[0041] Sodium thiosulfate 3g

[0042] Appropriate amount of sodium hydroxide

[0043] Add water for injection to 2000ml

[0044] Preparation Process:

[0045] (1) Weigh the prescribed amount of ketorolac tromethamine, mannitol, sodium chloride, sodium thiosulfate, add an appropriate amount (about 40% of the prescribed amount of water for injection) of water for injection and stir evenly, then add activated carbon for injection , the add-on of activated carbon is about 0.02% (g / v), heat preservation 15 minutes, filter decarbonization.

[0046] (2) Add water for injection to the full amount, stir evenly, and adjust the pH value to 7.6 with pre-prepared 1ml / L sodium hydroxide. The prepared solution was filtered sequentially through 0.45 μm and 0.22 μm microporous membranes. After the filtrate was tested, it was pac...

Embodiment 3

[0050] Preparation of ketorolac tromethamine freeze-dried powder for injection

[0051] Ketorolac Tromethamine 30g

[0052] Mannitol 70g

[0053] Sodium sulfite 6g

[0054] Appropriate amount of sodium hydroxide

[0055] Add water for injection to 2000ml

[0056] Preparation Process:

[0057] (1) Weigh the prescribed amount of ketorolac tromethamine, mannitol, and sodium sulfite, add an appropriate amount (about 40% of the prescribed amount of water for injection) of water for injection and stir evenly, and then add activated carbon for injection. The amount of activated carbon added is about 0.02% (g / v), keep warm for 15 minutes, filter and decarbonize.

[0058] (2) Add water for injection to the full amount, stir evenly, and adjust the pH value to 7.5 with pre-prepared 1ml / L sodium hydroxide. The prepared solution was filtered sequentially through 0.45 μm and 0.22 μm microporous membranes. After the filtrate was tested, it was packed in vials, each bottle was filled with...

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PUM

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Abstract

Ketorolac tromethamine is a new type of non-steroidal analgesic and anti-inflammatory drug with strong analgesic effect, which can be administered orally or by injection. It is mainly used to relieve moderate to severe postoperative pain, and Acute renal colic related to trauma, visceral pain related to cancer, anti-inflammatory of local inflammation, etc., the present invention provides a preparation method of ketorolac tromethamine freeze-dried powder preparation, which greatly improves the stability of the main drug, It not only overcomes the shortcoming of slow onset of oral administration, but more importantly, overcomes the problems of unstable main drug of liquid injection and unstable process in actual production.

Description

[0001] Field [0002] The invention relates to a new pharmaceutical preparation, in particular to a ketorolac trometamol freeze-dried powder preparation for injection and a preparation method thereof. Background technique [0003] Ketorolac Tromethamine (Ketorolac Tromethamine) is a derivative of pyrrolac developed by Syntex Corporation. Ketorolac Tromethamine is a new type of non-steroidal drug with strong analgesic effect that can be administered orally and injected. Analgesic and anti-inflammatory drugs, mainly used to relieve moderate to severe postoperative pain, acute renal colic related to trauma, and visceral pain related to cancer, etc. Foreign data studies have shown that the drug has an analgesic effect that is effective quickly, It has a long duration and similar strength to morphine and pethidine, but the biggest advantage is that it is not addictive; it can also be used for local inflammation, and has analgesic and anti-inflammatory effects. [0004] Currently c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/407A61K9/19A61K47/02A61K47/10A61K47/26A61P29/00
Inventor 赵志全
Owner LUNAN PHARMA GROUP CORPORATION
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