Ketoralac ammonia butanetriol injection and preparing method thereof

The technology of ketorolac tromethamine and tromethamine is applied to the injection of non-steroidal anti-inflammatory drug ketorolac tromethamine and the field of preparation thereof, and can solve the problem of white spot crystal clarity, substance Increase the content, check unqualified problems, etc., to achieve the effect of improving the white dots, improving the stability, and optimizing the dosage

Active Publication Date: 2010-05-12
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Ketorolac tromethamine salt is clinically used, and sodium chloride is used as an osmotic pressure regulator in the traditional production process of ketorolac tromethamine injection, but it is limited in clinical use, and it is necessary to limit sodium in clinical practice. Patients with salt cannot use it. At the same time, when preparing according to the prescription of ketorolac tromethamine as the main drug, sodium chloride as the osmotic pressure regulator, ethanol as the solution stabilizer and sodium hydroxide as the pH regulator, the ketone produced Rolac acid tromethamine injection is prone to discoloration, and white dot crystals are prone to appear on the inner wall of the ampoule, making the clarity inspection unqualified, and the content of related substances will also increase during the production process

Method used

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  • Ketoralac ammonia butanetriol injection and preparing method thereof
  • Ketoralac ammonia butanetriol injection and preparing method thereof
  • Ketoralac ammonia butanetriol injection and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Prescription: Ketorolac Tromethamine 600g

[0015] Medicinal absolute ethanol 2000g

[0016] 1,2-Propanediol 5L

[0017] 1mol / LNaOH solution appropriate amount

[0018] Add water for injection to 20L

[0019] Made 20,000 pieces

[0020] Preparation Process:

[0021] 1. Weigh the main drug and medicinal ethanol in the prescribed amount, stir with a small amount of water for injection until completely dissolved, then add the prescribed amount of propylene glycol and water for injection to 80% of the prescribed amount, stir evenly, and roughly adjust the pH of the 1mol / L NaOH solution The value is around 6.8.

[0022] 2. Add the needle and stir with activated carbon for 20 minutes, decarbonize and filter. Add water for injection to the prescribed amount, adjust the final pH value to 7.20-7.30 with 1mol / L NaOH solution, filter through a microporous membrane until the liquid is clear, and test the content of the semi-finished product. ...

Embodiment 2

[0027] Prescription: Ketorolac Tromethamine 600g

[0028] Medicinal absolute ethanol 2000g

[0029] 1,2-Propanediol 2L

[0030] 1mol / LNaOH solution appropriate amount

[0031] Add water for injection to 20L

[0032] Made 20,000 pieces

[0033] Preparation Process:

[0034] 1. Weigh the main drug and medicinal ethanol in the prescribed amount, stir with a small amount of water for injection until completely dissolved, then add the prescribed amount of propylene glycol and water for injection to 80% of the prescribed amount, stir evenly, and roughly adjust the pH of the 1mol / L NaOH solution The value is around 6.8.

[0035] 2. Add the needle and stir with activated carbon for 20 minutes, decarbonize and filter. Add water for injection to the prescribed amount, adjust the final pH value to 7.20-7.30 with 1mol / L NaOH solution, filter through a microporous membrane until the liquid is clear, and test the content of the semi-finished product.

[...

Embodiment 3

[0040] Prescription: Ketorolac Tromethamine 600g

[0041] Medicinal absolute ethanol 2000g

[0042] 1,2-Propanediol 12L

[0043] 1mol / LNaOH solution appropriate amount

[0044] Add water for injection to 20L

[0045] Made 20,000 pieces

[0046] Preparation Process:

[0047] 1. Weigh the main drug and medicinal ethanol in the prescribed amount, stir with a small amount of water for injection until completely dissolved, then add the prescribed amount of propylene glycol and water for injection to 80% of the prescribed amount, stir evenly, and roughly adjust the pH of the 1mol / L NaOH solution The value is around 6.8.

[0048] 2. Add the needle and stir with activated carbon for 20 minutes, decarbonize and filter. Add water for injection to the prescribed amount, adjust the final pH value to 7.20-7.30 with 1mol / L NaOH solution, filter through a microporous membrane until the liquid is clear, and test the content of the semi-finished product.

...

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Abstract

Disclosed is ketorolac tromethamine, which is a pyrrole acid derivative developed by the Syntex company in the U.S. The invention can effectively inhibit prostaglandin (PG) from synthesizing with functions of analgesia, anti-inflammation, antipyresis and inhibiting the platelets from aggregating. The invention provides a preparation method of ketorolac tromethamine injection, which well improvesthe stability and the clarity of the preparation with stable process.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a new injection of a non-steroidal anti-inflammatory drug ketorolac trometamol and a preparation method thereof. Background technique [0002] Ketorolac Tromethamine (Ketorolac Tromethamine) is a derivative of pyrrole acid developed by Syntex Corporation of the United States. It is a new non-steroidal anti-inflammatory drug that was first listed in Italy in 1990. It 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 the analgesic effect after intramuscular injection is similar to that of moderate doses of morphine, but it has the characteristics of not inhibiting breathing and not being addictive. It is effective for oral administration and injection, and has no local irritation. It is clinically...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/407A61K47/10A61K9/08A61P29/00
Inventor 赵志全
Owner SHANDONG NEWTIME PHARMA
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