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Ketorolac tromethamine injection

A technology of ketorolac tromethamine and injection, which is applied in the field of medicine, can solve problems such as increasing the probability of adverse reactions, limiting the scope of drug administration, and discounting the safety of injections, so as to improve clarity and stability , The preparation process is stable and reliable, and the effect of improving drug safety

Inactive Publication Date: 2013-01-02
TIANJIN CHASE SUN PHARM CO LTD
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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 CN 101199514B improves the clarity of ketorolac tromethamine injection by adding 10-60% propylene glycol to the traditional prescription, and improves the white spots after sterilization, but as high as 60% The addition of propylene glycol will undoubtedly greatly reduce the safety of the injection, and all use ethanol solvent in the preparation, which still cannot solve the adverse stimulation of the current use of ethanol injection injection, which is not conducive to the popularization and application of drugs

Method used

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  • Ketorolac tromethamine injection
  • Ketorolac tromethamine injection
  • Ketorolac tromethamine injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Example 1: Ketorolac Tromethamine Injection

[0036] prescription:

[0037]

[0038] Preparation Process:

[0039] 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 glycerin and add water for injection to 80% of the prescribed amount, stir well, and roughly adjust with 1m / L NaOH solution PH value to around 6.8,

[0040] 2) Add needles and stir with activated carbon for 20 minutes, decarbonize and filter. Add water for injection to the prescribed amount, adjust the final pH value of NaOH solution to 7.0-7.5, filter until the liquid medicine is clear, and test the content of semi-finished products.

[0041] 3) After the semi-finished product passes the test, fill each clean ampoule with nitrogen and fill with 1ml of qualified liquid medicine, seal it, and put it on a plate.

[0042] 4) Sterilize at 121°C for 15 minutes under circulating ste...

Embodiment 2

[0044] Example 2: Ketorolac Tromethamine Injection

[0045] prescription:

[0046]

[0047] Preparation process: with embodiment 1.

Embodiment 3

[0048] Embodiment 3: Ketorolac tromethamine injection

[0049] prescription:

[0050]

[0051] Preparation process: with embodiment 1.

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PUM

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Abstract

The invention discloses a prescription of a ketorolac tromethamine injection and a preparation method. The injection provided by the invention can not only effectively solve the problem that the existing ketorolac tromethamine injection containing ethanol causes irritation while being injected and improve the safety of the drugs and the compliance of the drugs, but also completely avoid the white points caused by the traditional technology after sterilization treatment, and thus the ketorolac tromethamine injection is good in stability, high in safety, reliable in quality and significant in efficacy.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an injection of ketorolac tromethamine 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 f...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/407A61K47/34A61K47/10A61P29/00
Inventor 李宝齐董凯王瑞卿
Owner TIANJIN CHASE SUN PHARM CO LTD
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