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Method for improving storage stability of ketorolac tromethamine injection

A technology for ketorolac tromethamine and storage stability, which is applied in pharmaceutical formulations, organic active ingredients, non-central analgesics, etc., and can solve problems such as white dots or crystals, so as to ensure the safety of medication , stable quality, and the effect of improving storage stability

Active Publication Date: 2020-02-21
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The invention solves the problem that the ketorolac tromethamine injection is prone to produce white dots or crystals during the long-term storage process, and the visible foreign matter and insoluble particles are less, and the quality is stable

Method used

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  • Method for improving storage stability of ketorolac tromethamine injection
  • Method for improving storage stability of ketorolac tromethamine injection
  • Method for improving storage stability of ketorolac tromethamine injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] prescription:

[0023]

[0024]

[0025] Preparation Process:

[0026] Weigh the prescribed amount of ketorolac tromethamine, sodium chloride, and ethanol, add a certain amount of water for injection, stir to completely dissolve the main ingredient, then adjust the pH value to 7.0-7.7 with sodium hydroxide, and add water for injection To 500ml, use a blow-fill-seal integrated machine to fill in polypropylene ampoules with a volume of 1ml, sterilize at 121°C for 15 minutes, and finally put the polypropylene ampoule in an aluminum foil bag with a vacuum between the two.

Embodiment 2

[0028] prescription:

[0029]

[0030] Preparation Process:

[0031] Weigh the prescribed amount of ketorolac tromethamine, sodium chloride, and ethanol, add a certain amount of water for injection, stir to completely dissolve the main ingredient, then adjust the pH to 7.0-7.7 with sodium hydroxide, and add water for injection to 500ml, filled in polypropylene ampoules with a blow-fill-seal integrated machine, the filling volume is 1ml, sterilized at 121°C for 15 minutes, and finally the polypropylene ampoules are packed in PVA composite film bags, and the space between the two is filled with helium, namely Can.

Embodiment 3

[0033] prescription:

[0034]

[0035] Preparation Process:

[0036] Weigh the prescribed amount of ketorolac tromethamine and sodium chloride, add a certain amount of water for injection, stir to completely dissolve the main ingredient, then adjust the pH to 7.0-7.7 with sodium hydroxide, add water for injection to 500ml, Use a blow-fill-seal integrated machine to fill in polypropylene ampoules with a volume of 1ml, sterilize at 121°C for 15 minutes, and finally put the polypropylene ampoule in an aluminum foil bag with a vacuum between the two.

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PUM

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a method for improving storage stability of a ketorolac tromethamine injection. The prepared ketorolac tromethamine injection is filled into a polypropylene plastic ampoule or a cycloolefin polymer plastic bottle, so that the problem that visible foreign matters are unqualified due to the factthat the injection easily generates white dots in the long-term placement process of the ketorolac tromethamine injection is solved, insoluble particles are few, and the quality is stable.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a method for improving the storage stability of ketorolac tromethamine injection. Background technique [0002] Ketorolac tromethamine is a non-steroidal antipyretic and analgesic drug that achieves analgesic, anti-inflammatory and antipyretic effects by inhibiting the synthesis of prostaglandins (PG), rather than acting on opioid receptors or stimulating Release of opioid peptides in vivo. Ketorolac tromethamine relieves toxic pain in a variety of muscles, soft tissues, and joints. It is indicated for the short-term treatment of acute, more severe pain that requires opioid analgesics. It is usually used for postoperative pain and not for mild or The treatment of chronic pain, the drug is not addictive. In the standard animal model of labor pain activity, the analgesic activity of ketorolac tromethamine is 800 times that of aspirin, much stronger...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/407A61P29/00A61J1/05A61J1/06
CPCA61K9/0019A61K9/08A61K31/407A61P29/00A61J1/065A61J1/05
Inventor 秦士慧郝贵周
Owner LUNAN PHARMA GROUP CORPORATION
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