A kind of ketorolac tromethamine injection that reduces irritation and does not contain organic solvents

A technology of ketorolac tromethamine and ketorolac tromethamine, which is applied in the field of ketorolac tromethamine injection, can solve the problems of patients with strong pain, vasospasm, and obvious pain, and achieve insoluble particles and Reduced white spots, reduced risk of vascular embolism, and improved overall quality

A technology of ketorolac tromethamine and ketorolac tromethamine, which is applied in the field of ketorolac tromethamine injection, can solve the problems of patients with strong pain, vasospasm, and obvious pain, and achieve insoluble particles and Reduced white spots, reduced risk of vascular embolism, and improved overall quality

CN111481501BActive Publication Date: 2022-04-29南京锐志生物医药有限公司
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  • A kind of ketorolac tromethamine injection that reduces irritation and does not contain organic solvents
  • A kind of ketorolac tromethamine injection that reduces irritation and does not contain organic solvents
  • A kind of ketorolac tromethamine injection that reduces irritation and does not contain organic solvents

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0095] A: Prescription composition

[0096] Ketorolac tromethamine 10g trometamol 11.78g Sodium chloride 2.70g hydrochloric acid Appropriate amount, adjusted to pH about 7.3 Water for Injection to 1L batch 1000 pieces

[0097] B: Preparation method:

[0098] 1. Add tromethamine and sodium chloride into 95% prescription water for injection cooled to room temperature, and stir until completely dissolved;

[0099] 2. Add ketorolac tromethamine and stir until completely dissolved;

[0100] 3. Add 1M hydrochloric acid aqueous solution to adjust the pH of the liquid to about 7.26;

[0101] 4. Use the remaining amount of water for injection to adjust the concentration of ketorolac tromethamine to 10 mg / mL;

[0102] 5. The liquid medicine is filtered through a 0.2μm filter element to the buffer tank of the filling machine;

[0103] 6. Under the protection of nitrogen, fill the liquid medicine into the cleaned and dry heat sterilized gla...

Embodiment 2

[0108] A: Prescription composition

[0109]

[0110]

[0111] B: Preparation method:

[0112] 1. Add tromethamine and sodium chloride into 95% prescription water for injection cooled to room temperature, and stir until completely dissolved;

[0113] 2. Add ketorolac tromethamine and stir until completely dissolved;

[0114] 3. Add 1M hydrochloric acid aqueous solution to adjust the pH of the liquid to about 7.29;

[0115] 4. Use the remaining amount of water for injection to adjust the concentration of ketorolac tromethamine to 15 mg / mL;

[0116] 5. The liquid medicine is filtered through a 0.2μm filter element to the buffer tank of the filling machine;

[0117] 6. Under the protection of nitrogen, fill the liquid medicine into the cleaned and dry heat sterilized glass ampoule, and seal it;

[0118] 7. Moist heat sterilization, F 0 ≥12;

[0119] 8. Inspection and elimination of unqualified products;

[0120] 9. Outsource the labeling of qualified products.

Embodiment 3

[0122] A: Prescription composition

[0123] Ketorolac tromethamine 30g trometamol 2.46g Sodium chloride 4.03g hydrochloric acid Appropriate amount, adjusted to pH about 7.3 Water for Injection to 1L batch 1000 pieces

[0124] B: Preparation method:

[0125] 1. Add tromethamine and sodium chloride into 95% prescription water for injection cooled to room temperature, and stir until completely dissolved;

[0126] 2. Add ketorolac tromethamine and stir until completely dissolved;

[0127] 3. Add 1M hydrochloric acid aqueous solution to adjust the pH of the liquid to about 7.32;

[0128] 4. Use the remaining amount of water for injection to adjust the concentration of ketorolac tromethamine to 30mg / mL;

[0129] 5. The liquid medicine is filtered through a 0.2μm filter element to the buffer tank of the filling machine;

[0130] 6. Under the protection of nitrogen, fill the liquid medicine into the cleaned and dry heat sterilized gla...

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Abstract

The invention provides a ketorolac tromethamine injection that reduces irritation and does not contain organic solvents. By using the tromethamine-acidulant buffer system as a protective agent, the adverse effects of ethanol and potassium dihydrogen phosphate on the packaging material and the serious irritation at the injection site in the prior art are avoided. The production process of the invention is simple and controllable, the physical and chemical properties of the medicinal liquid are relatively stable, and the drug safety and compliance of patients can be improved.

Description

technical field [0001] The invention relates to a ketorolac tromethamine injection, in particular to a ketorolac tromethamine injection which reduces irritation and does not contain an organic solvent, and belongs to the field of pharmaceutical preparations. Background technique [0002] Ketorolac tromethamine is a non-steroidal anti-inflammatory drug, mainly by reducing the activity of peripheral cyclooxygenase and prostaglandin synthase, thereby reducing the effect of endogenous inflammatory factors on nociceptive fine fibers (such as A-δ and C) stimulation and excitatory effects, so as to achieve the therapeutic effect of pain relief and anti-inflammation. This product rarely occurs central nervous system adverse reactions such as respiratory depression, and does not act on opioid receptors or stimulate the release of opioid peptides in the body. Therefore, it is a relatively safe drug that can replace opioids to a certain extent. Short-term treatment of acute moderate t...

Claims

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Application Information

Patent Timeline
29 Apr 2022
Publication
CN111481501B
IPC
A61K9/08; A61K31/407; A61K47/18; A61P29/00
CPC
A61K31/407; A61K47/18; A61K9/08; A61K9/0019; A61P29/00
Inventors
孙蕴哲; 沙向阳