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Ketoralac ammonia butanetriol injection and preparing method thereof

A technology of ketorolac tromethamine and tromethamine, which is applied to the injection of non-steroidal anti-inflammatory drug ketorolac tromethamine and the field of preparation thereof, 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: 2008-06-18
鲁南新时代生物技术有限公司
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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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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 20000 sticks

[0020] Preparation Process:

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

[0022] 2. Add needle activated carbon and stir for 20 minutes, decarburize 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 with a microporous membrane until the liquid is clarified, and detect the content of semi-finished products.

[0023] 3. Fill each clean ampoule ...

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 20000 sticks

[0033] Preparation Process:

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

[0035] 2. Add needle activated carbon and stir for 20 minutes, decarburize 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 with a microporous membrane until the liquid is clarified, and detect the content of semi-finished products.

[0036] 3. Fill each clean ampoule ...

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 into 20,000 sticks

[0046] Preparation Process:

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

[0048] 2. Add needle activated carbon and stir for 20 minutes, decarburize 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 with a microporous membrane until the liquid is clarified, and detect the content of semi-finished products.

[0049] 3. Fill each clean a...

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PUM

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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 improves the stability and the clarity of the preparation with stable process.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a new non-steroidal anti-inflammatory drug ketorolac tromethamine injection and a preparation method thereof. Background technique [0002] Ketorolac Tromethamine (Ketorolac Tromethamine) is a new non-steroidal anti-inflammatory drug developed by Syntex in the United States and first marketed in Italy in 1990. It can effectively inhibit the synthesis of prostaglandin (PG) , Has analgesic, anti-inflammatory, antipyretic and inhibiting platelet aggregation effects. Its analgesic strength is similar to aspirin, and the analgesic effect after intramuscular injection is similar to a moderate amount of morphine, but it does not inhibit breathing or addictive. It is effective both by oral and injection without local irritation. It is clinically suitable for the short-term treatment of acute and severe pain that requires opioid-level analgesics. It is usually used for postoperativ...

Claims

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Application Information

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IPC IPC(8): A61K31/407A61K47/10A61P29/00
Inventor 赵志全
Owner 鲁南新时代生物技术有限公司
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