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Stable and non-irritant ketorolac tromethamine injection and preparation method thereof

A technology for ketorolac tromethamine and tromethamine, which is applied in the field of ketorolac tromethamine injection and its preparation, can solve problems such as instability of the injection, achieve a wide range of applications, improve Stability, effect of simple preparation method

Pending Publication Date: 2022-05-06
ZHENGZHOU CENT HOSPITAL +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Aiming at the problems existing in the prior art, the present invention improves the stability and solubility of ketorolac tromethamine in solution by constructing a ketorolac tromethamine-sorbitol complex system, and solves the problem of traditional ketorolac ammonia The problem of instability of butanetriol injection, and the construction of the complex system combined with the use of water for injection-glycerin solvent solves the problem of white spots in the injection after being placed for a long time, improves the safety of the injection, and reduces the risk of injection. Nerve stimulation, specifically, the present invention adopts the following technical solutions:

Method used

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  • Stable and non-irritant ketorolac tromethamine injection and preparation method thereof
  • Stable and non-irritant ketorolac tromethamine injection and preparation method thereof
  • Stable and non-irritant ketorolac tromethamine injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment 1 ketorolac tromethamine injection

[0025]

[0026] Injection preparation process

[0027] 1) Weigh the prescribed amount of ketorolac tromethamine, add an appropriate amount of ethanol, raise the temperature to 52 degrees Celsius, and stir until completely dissolved, slowly add the prescribed amount of sorbitol in batches to the dissolved mixed solution, and stir evenly. The mixed solution was placed in a rotary evaporator to distill off ethanol to obtain a complex of romethamine and sorbitol, and the complex was dried for use;

[0028] 2) adding the compound of romethamine and sorbitol obtained in step 1) into the mixed solution of glycerin and water for injection, stirring continuously, decarburizing and filtering with activated carbon, and filtering with a microporous membrane until the solution is clarified;

[0029] 3) Filling, sterilization at 121.5°C for 20 minutes, and inspection.

Embodiment 2

[0030] Embodiment 2 Ketorolac tromethamine injection

[0031] prescription

[0032]

[0033] Preparation method is the same as embodiment 1

Embodiment 3

[0034] Embodiment 3 ketorolac tromethamine injection

[0035] prescription

[0036]

[0037] The preparation method is the same as in Example 1, wherein the final product adopts polypropylene plastic ampoule packaging

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Abstract

The invention relates to a stable and non-irritant ketorolac tromethamine injection and a preparation method thereof. The invention discloses a ketorolac tromethamine injection. The ketorolac tromethamine injection is prepared from ketorolac tromethamine, sorbitol, glycerol and water for injection. The ketorolac tromethamine-sorbitol composite system is constructed, on one hand, the solubility of ketorolac tromethamine-sorbitol is improved, on the other hand, the stability of a core compound is improved through construction of the composite system, and white crystals are prevented from being separated out. Various auxiliary materials and proportions are optimized, the obtained injection system is stable, no macroscopic crystal is separated out after long-time storage, meanwhile, the preparation is wide in application range, the preparation method is simple, and the injection is suitable for large-scale industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a stable and non-irritating ketorolac tromethamine injection and a preparation method thereof. Background technique [0002] Ketorolac Tromethamine is a ketorolac derivative developed by Syntex Corporation of the United States. It was launched in 1990 and is commonly used for most pain relief. It can effectively synthesize prostaglandins and has labor pain and anti-inflammatory properties. As well as the effect of inhibiting platelet aggregation, its analgesic effect is strong, and the analgesic intensity after intramuscular injection is equivalent to a moderate dose of morphine. As an analgesic, it does not have the addictiveness of conventional analgesics, and the drug can be taken orally or It can be administered by injection, and the effect is remarkable. [0003] Ketorolac tromethamine is widely used in various types of operations, especially...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/26A61K47/10A61K31/407A61P29/00
CPCA61K9/08A61K9/0019A61K47/26A61K47/10A61K31/407A61P29/00
Inventor 徐记忠
Owner ZHENGZHOU CENT HOSPITAL