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Ketorolac tromethamine injection

A technology of ketorolac tromethamine injection and ketorolac tromethamine, applied in anti-inflammatory agents, non-central analgesics, medical preparations of non-active ingredients, etc., can solve toxicity and increase adverse effects Response probability, lower patient compliance, etc.

Inactive Publication Date: 2011-08-03
Yung Shin Pharm Ind (Kunshan) Co Ltd
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Traditional ketorolac tromethamine injections contain ethanol or other solvent injections. However, injections containing ethanol and other organic solvents have certain toxicity, and are prone to irritation during injection, which reduces patient compliance.
In addition, clinically, ketorolac tromethamine injection is often used in combination with morphine and other injections, and ethanol has a certain impact on the absorption and metabolism of morphine, which increases the probability of adverse reactions. Therefore, traditional ketones containing ethanol are used clinically. Roloac tromethamine injection may increase the risk of adverse reactions

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] A: Injection composition

[0050] Ketorolac Tromethamine (Ketorolac Tromethamine) 1800g

[0051] Sodium chloride (NaCl) 261g

[0052] Potassium phosphate (K 3 PO 4 ) 445g

[0053] Potassium Dihydrogen Phosphate (KH 2 PO 4 ) 41g

[0054] Sodium hydroxide (NaOH) or hydrochloric acid (HCl) q.s.

[0055] Add Water For Injection to 60L

[0056] B: Preparation method

[0057] 1) Add phosphate and sodium chloride to appropriate amount of water for injection, stir to dissolve to prepare a phosphate solution; add ketorolac tromethamine or its salt to appropriate amount of water for injection and stir to dissolve to obtain ketorolac ammonia Butanetriol solution: Take sodium hydroxide or hydrochloric acid and use appropriate amount of water for injection to make lye or acid solution for use.

[0058] 2) Take the lye or acid prepared above to adjust the pH of the prepared phosphate buffer to 7.2±0.1;

[0059] 3) Add the buffer prepared in 2) to the ketorolac tromethamine solution in 1) and mix w...

Embodiment 2

[0063] A: Injection composition

[0064] Ketorolac Tromethamine 600g

[0065] Sodium Chloride 261g

[0066] Disodium hydrogen phosphate (Na 2 HPO 4 .12H 2 O) 215g

[0067] Tris (Tromethamine) or hydrochloric acid (HCl) appropriate amount

[0068] Add Water For Injection to 60L

[0069] B: Preparation method

[0070] 1) Add phosphate and sodium chloride to appropriate amount of water for injection, stir to dissolve to prepare a phosphate solution; add ketorolac tromethamine or its salt to appropriate amount of water for injection and stir to dissolve to obtain ketorolac ammonia Butanetriol solution: Take tris or hydrochloric acid to prepare lye or acid solution with appropriate amount of water for injection, and set aside.

[0071] 2) Take the lye or acid prepared above to adjust the pH of the prepared phosphate buffer to 7.4±0.1;

[0072] 3) Add the buffer prepared in 2) to the ketorolac tromethamine solution in 1) and mix well;

[0073] 4) Take the aforementioned lye or acid solution to ad...

Embodiment 3

[0076] A: Injection composition

[0077] Ketorolac Tromethamine 3000g

[0078] Sodium chloride (NaCl) 261g

[0079] Potassium Dihydrogen Phosphate (KH 2 PO 4 ) 300g

[0080] Sodium hydroxide (NaOH) or hydrochloric acid (HCl) appropriate amount

[0081] Add Water For Injection to 60L

[0082] B: Preparation method

[0083] 1) Add phosphate and sodium chloride to appropriate amount of water for injection, stir to dissolve to prepare a phosphate solution; add ketorolac tromethamine or its salt to appropriate amount of water for injection and stir to dissolve to obtain ketorolac ammonia Butanetriol solution: Take sodium hydroxide or hydrochloric acid and use appropriate amount of water for injection to make lye or acid solution for use.

[0084] 2) Take the lye or acid prepared above to adjust the pH value of the prepared phosphate buffer to 7.5±0.1;

[0085] 3) Add the buffer prepared in 2) to the ketorolac tromethamine solution in 1) and mix well;

[0086] 4) Take the aforementioned lye or ac...

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PUM

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Abstract

The invention discloses a ketorolac tromethamine injection characterized by being prepared from the following components in percentage by weight: 0.1-15 percent of ketorolac tromethamine, 0.01-10 percent of buffering agent and 0.001-5 percent of pH value regulator. In the invention, because a traditional menstruum, such as ethanol is replaced by a phosphate buffer solution, the ketorolac tromethamine injection with good stability, less irritation, safety and more convenience is obtained so as to improve the medicament compliance of patients and the clinical medication convenience.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical preparations. Specifically, the invention relates to a non-steroidal anti-inflammatory drug ketorolac tromethamine injection system. Background technique [0002] Ketorolac Tromethamine is a non-steroidal anti-inflammatory drug. Clinically, it is mainly used for the analgesic of moderate and severe pain such as postoperative, fracture, sprain, toothache and cancer pain. It is a cyclooxygenase inhibitor that can selectively block the production of arachidonic acid cyclooxygenase and prostaglandin, thereby exerting excellent analgesic, anti-inflammatory and antipyretic effects. It does not directly act on opioid receptors, so there is no tendency to become addicted, let alone adverse reactions of central nervous system or narcotic analgesics. [0003] Ketorolac tromethamine has no addictive and contraindicated symptoms of morphine. After intravenous injection of 30 mg, the average maximum blood concentratio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/12A61K47/18A61K31/407A61K47/02A61P29/00A61K9/08
Inventor 李芳全苏龙吴保祥陶剑
Owner Yung Shin Pharm Ind (Kunshan) Co Ltd
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