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Ketorolac tromethamine injection and preparation method thereof

A technology of ketorolac tromethamine and injection, which is applied in the field of medicine, can solve problems such as easy precipitation of white spots, easy generation of irritation, and increased probability of adverse reactions, so as to achieve simple and easy process and improve stability Effect

Active Publication Date: 2014-06-04
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Traditional ketorolac tromethamine injections contain organic solvents such as ethanol, which are prone to irritation during injection and reduce patient compliance. Absorption and metabolism are affected to a certain extent, which increases the probability of adverse reactions, so ketorolac tromethamine injection containing ethanol may increase the risk of adverse reactions, and ketorolac tromethamine injection is contraindicated because it contains ethanol Administered intrathecally or epidurally, limiting the range of drug delivery
[0004] Chinese patent CN101199514B improves the clarity of ketorolac tromethamine injection by adding 10-60% propylene glycol in the traditional prescription, and improves the white spots after sterilization. The use of ethanol solvent still cannot solve the adverse stimulation of the current injection of ethanol injection, which is not conducive to the popularization and application of drugs
But it has not fundamentally solved the problem that ketorolac tromethamine injection is easy to precipitate white spots

Method used

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  • Ketorolac tromethamine injection and preparation method thereof
  • Ketorolac tromethamine injection and preparation method thereof
  • Ketorolac tromethamine injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025]

[0026] Preparation Process:

[0027] 1) Weigh the prescribed amount of ketorolac trometamol, stir it with an appropriate amount of water for injection until it is completely dissolved, add the prescribed amount of ethanol and add water for injection to the prescribed amount, stir evenly, and roughly adjust the 0.1mol / L NaOH solution p H value to about 6.8;

[0028] 2) Add needles and stir with activated carbon for 15 minutes, decarbonize and filter. Add water for injection to the prescribed amount, adjust the final pH value of NaOH solution to 7.2, and filter until the liquid medicine is clear;

[0029] 3) Fill each clean ampoule or vial with nitrogen and fill with 0.5ml of qualified liquid medicine, and seal it;

[0030] 4) Sterilize at 121°C for 15 minutes under circulating steam;

[0031] 5) Carry out light inspection on the sterilized medicine, and the product is obtained.

Embodiment 2

[0033]

[0034] Preparation Process:

[0035] 1) Weigh the prescribed amount of ketorolac trometamol, stir with an appropriate amount of water for injection until it is completely dissolved, add the prescribed amount of ethanol and add water for injection to the prescribed amount, stir evenly, and roughly adjust the pH value of the 0.3mol / L NaOH solution to around 6.8;

[0036] 2) Add needles and stir with activated carbon for 15 minutes, decarbonize and filter. Add water for injection to the prescribed amount, adjust the final pH value of NaOH solution to 7.3, and filter until the liquid medicine is clear;

[0037] 3) Fill each clean ampoule or vial with nitrogen and fill with 0.5ml of qualified liquid medicine, and seal it;

[0038] 4) Sterilize at 121°C for 15 minutes under circulating steam;

[0039] 5) Carry out light inspection on the sterilized medicine, and the product is obtained.

Embodiment 3

[0041]

[0042] Preparation Process:

[0043] 1) Weigh the prescribed amount of ketorolac trometamol, stir it with an appropriate amount of water for injection until it is completely dissolved, add the prescribed amount of ethanol and add water for injection to the prescribed amount, stir evenly, and roughly adjust the pH value of the 0.5mol / L NaOH solution to around 6.8;

[0044] 2) Add needles and stir with activated carbon for 15 minutes, decarbonize and filter. Add water for injection to the prescribed amount, adjust the final pH value of NaOH solution to 7.3, and filter until the liquid medicine is clear;

[0045] 3) Fill each clean ampoule or vial with nitrogen and fill with 0.5ml of qualified liquid medicine, and seal it;

[0046] 4) Sterilize at 121°C for 15 minutes under circulating steam;

[0047] 5) Carry out light inspection on the sterilized medicine, and the product is obtained.

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Abstract

The invention provides a ketorolac tromethamine injection. The packing volume of the injection is 0.5ml, and the content of ethanol is 10-18 percent (W / V). Furthermore, the preparation method is improved. Compared with the prior art, the injection provided by the invention has the advantages that the usage of the ethanol is reduced, the stability of the injection is improved, and the white spots cannot be separated out from the medicine; the administration safety can be improved because propylene glycol, phosphate and other additional components are not added; the process is simple and feasible, and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a ketorolac tromethamine injection and a preparation method thereof. Background technique [0002] Ketorolac Tromethamine is a derivative of ketorolac developed by Syntex Corporation of the United States. It was first launched in Italy in 1990. It is a non-steroidal anti-inflammatory drug that can effectively inhibit the synthesis of prostaglandins (PG). , with analgesic, anti-inflammatory, antipyretic and inhibition of platelet aggregation. The intensity of its analgesic effect is similar to that of aspirin, and its analgesic effect after intramuscular injection is similar to that of moderate doses of morphine, but it does not have the disadvantages of morphine's inhibition of breathing and addiction, and is effective both oral and injection. It is clinically indicated for the short-term treatment of acute severe pain requiring opioid level analgesia, usually for p...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/407A61K47/10A61P29/00A61P7/02
Inventor 赵志全郝贵周程战立韩忠丽
Owner LUNAN PHARMA GROUP CORPORATION
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