Low-irritation ketorolac tromethamine injection with stable chemical property

A technology of irritating ketorolac tromethamine and ketorolac tromethamine, applied in the direction of organic active ingredients, non-central analgesics, medical preparations of non-active ingredients, etc., can solve the irritating effect of potassium salts , did not solve the problems of irritation and complex ingredients, and achieved the effects of stable quality, reduced risk of phlebitis, and increased drug safety

Active Publication Date: 2022-03-11
南京锐志生物医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In order to avoid the injection of organic solvents to patients and the additional production process control and quality control caused by the use of organic solvents, Yongxin Pharmaceutical Industry (Kunshan) Co., Ltd. replaced ethanol with potassium dihydrogen phosphate, but potassium salts are also irritating
In addition, there is also the use of surfactants to improve product quality in the prior art, such as cholesterol, oleic acid, sodium oleate, glycerin or poloxamer in CN201210365740.6, phospholipids in WO2008013822A2, etc., but these functional auxiliary ingredients It is complicated, and there is a certain degree of difficulty in quality control, and it has not solved the irritation problem. So far, no mature products have been put on the market.

Method used

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  • Low-irritation ketorolac tromethamine injection with stable chemical property
  • Low-irritation ketorolac tromethamine injection with stable chemical property
  • Low-irritation ketorolac tromethamine injection with stable chemical property

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] (1) Prescription composition

[0074] Ketorolac tromethamine 30g Sodium chloride 4.35g sodium hydroxide Appropriate amount, adjusted to pH about 7.4 Water for Injection to 1L batch 1000 pieces inner packaging container 1mL amber glass ampoule

[0075] (2) Preparation method:

[0076] 1. Add sodium chloride to 90% prescription water for injection cooled to room temperature, and stir until completely dissolved;

[0077] 2. Add ketorolac tromethamine and stir until completely dissolved;

[0078] 3. Add 2M sodium hydroxide aqueous solution to adjust the pH of the liquid to about 7.39;

[0079] 4. Use the remaining amount of water for injection to adjust the concentration of ketorolac tromethamine to 30mg / mL;

[0080] 5. The liquid medicine is filtered through a 0.2μm filter element;

[0081] 6. Filling and sealing under nitrogen protection;

[0082] 7. Moist heat sterilization, 121°C for 15 minutes;

[0083] 8. Visual in...

Embodiment 2

[0086] (1) Prescription composition

[0087] Ketorolac tromethamine 30g Sodium chloride 4.35g sodium hydroxide Appropriate amount, adjusted to pH about 7.4 citric acid 5g Water for Injection to 1L batch 1000 pieces inner packaging container 1mL amber glass ampoule

[0088] (2) Preparation method:

[0089] 1. Add sodium chloride and citric acid to 90% prescription water for injection cooled to room temperature, and stir until completely dissolved;

[0090] 2. Add ketorolac tromethamine and stir until completely dissolved;

[0091] 3. Add 2M sodium hydroxide aqueous solution to adjust the pH of the liquid to about 7.40;

[0092] 4. Use the remaining amount of water for injection to adjust the concentration of ketorolac tromethamine to 30mg / mL;

[0093] 5. The liquid medicine is filtered through a 0.2μm filter element;

[0094] 6. Filling and sealing under nitrogen protection;

[0095] 7. Moist heat sterilization, 121°C f...

Embodiment 3

[0099] (1) Prescription composition

[0100] Ketorolac tromethamine 15g Sodium chloride 6.68g sodium hydroxide Appropriate amount, adjusted to pH about 7.4 citric acid 5g Water for Injection to 1L batch 1000 pieces inner packaging container 2mL amber glass tube injection bottle, bromobutyl rubber stopper

[0101] (2) Preparation method:

[0102] 1. Add sodium chloride and citric acid to 90% prescription water for injection cooled to room temperature, and stir until completely dissolved;

[0103] 2. Add ketorolac tromethamine and stir until completely dissolved;

[0104] 3. Add 2M sodium hydroxide aqueous solution to adjust the pH of the liquid to about 7.40;

[0105] 4. Use the remaining amount of water for injection to adjust the concentration of ketorolac tromethamine to 15 mg / mL;

[0106] 5. The liquid medicine is filtered through a 0.2μm filter element;

[0107] 6. Filling, stoppering and capping under nitrogen prot...

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PUM

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Abstract

The invention provides a ketorolac tromethamine injection with stable chemical properties and low irritation. By using the brown inner packaging material and further adding the antioxidant, the chemical stability, especially the light stability, of the product is improved; and the use of organic solvents, surfactants and other substances with serious irritation in the prior art is avoided, and the pain of the injection site is relieved. The production process is simple and controllable, the physicochemical property of the liquid medicine is stable, and the medication safety and compliance of patients are improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a low-irritation ketorolac tromethamine injection with stable chemical properties. Background technique [0002] Ketorolac tromethamine is a potent nonsteroidal anti-inflammatory drug that inhibits prostaglandin biosynthesis, thereby producing analgesic effects, and is indicated for the short-term treatment of acute moderate to severe pain requiring opioid-level analgesics (adult The treatment period generally does not exceed 5 days). The product seldom has 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 relatively safe and can replace opioids to a certain extent. [0003] The marketed products of ketorolac tromethamine include oral tablets / capsules, injections, eye drops, nasal sprays, etc. Among them, injections have the fastest onse...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/407A61K47/12A61P29/00
CPCA61K9/08A61K9/0019A61K31/407A61K47/12A61P29/00Y02A50/30
Inventor 孙蕴哲尹德燕张倩颖叶仕春沙向阳
Owner 南京锐志生物医药有限公司
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