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Ketorolac tromethamine tablet

A technology of ketorolac tromethamine tablet and ketorolac tromethamine, which is applied in the directions of anti-inflammatory agent, pill delivery, non-central pain reliever, etc., can solve the problem of slow dissolution of ketorolac tromethamine. , Affect clinical drug safety, slow drug absorption and other problems, to achieve the effect of shortening the onset time, drug stability, and reducing the generation of impurities

Active Publication Date: 2018-08-28
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the solid oral administration method is slow in drug absorption, and patients with acute and severe pain most need a rapid analgesic method
The main reason for the slow onset of solid oral administration drugs is that ketorolac tromethamine dissolves slowly; and ketorolac tromethamine is unstable to light, heat, acid, and alkali, and is prone to decarboxylation and oxidation reactions to produce impurities , to a certain extent, affects the safety of clinical medication

Method used

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  • Ketorolac tromethamine tablet
  • Ketorolac tromethamine tablet
  • Ketorolac tromethamine tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Solid Dispersion Formulation:

[0028] Ketorolac Tromethamine 10g

[0029] Poloxamer 188 10g

[0030] PEG4000 40g

[0031] Preparation method: dissolve ketorolac tromethamine in ethanol; dissolve or disperse PEG4000 and poloxamer 188 in ethanol with stirring; mix the above solutions by adding while stirring; in a rotary evaporator Ethanol was removed to obtain a solid dispersion.

[0032] Preparation of Ketorolac Tromethamine Tablets:

[0033] prescription:

[0034]

[0035] Preparation method: mechanically pulverize the ketorolac tromethamine solid dispersion; weigh the prescription amount of the pulverized ketorolac tromethamine solid dispersion and mix them evenly with additional excipients, press into tablets, and film-coat to obtain Ketorolac Tromethamine Tablets.

Embodiment 2

[0037] Solid Dispersion Formulation:

[0038] Ketorolac Tromethamine 10g

[0039] Poloxamer 188 20g

[0040] PEG6000 40g

[0041] Preparation method: dissolve ketorolac tromethamine in dichloromethane; dissolve or disperse PEG6000 and poloxamer 188 in dichloromethane with stirring; mix the above solutions by adding while stirring; The dichloromethane was removed by fluidized bed drying to obtain a solid dispersion.

[0042] Preparation of Ketorolac Tromethamine Tablets:

[0043] prescription:

[0044]

[0045] Preparation method: mechanically pulverize the ketorolac tromethamine solid dispersion; weigh the prescription amount of the pulverized ketorolac tromethamine solid dispersion and mix them evenly with additional excipients, press into tablets, and film-coat to obtain Ketorolac Tromethamine Tablets.

Embodiment 3

[0047] Solid Dispersion Formulation:

[0048] Ketorolac Tromethamine 10g

[0049] Poloxamer 188 20g

[0050] Povidone K15 60g

[0051] Preparation method: dissolve ketorolac tromethamine in chloroform; dissolve or disperse povidone K15 and poloxamer 188 in chloroform with stirring; add the above The solutions were mixed; the chloroform was removed by spray drying to obtain a solid dispersion.

[0052] Preparation of Ketorolac Tromethamine Tablets:

[0053] prescription:

[0054]

[0055] Preparation method: mechanically pulverize the ketorolac tromethamine solid dispersion; weigh the prescription amount of the pulverized ketorolac tromethamine solid dispersion and mix them evenly with additional excipients, press into tablets, and film-coat to obtain Ketorolac Tromethamine Tablets.

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Abstract

The invention belongs to the field of medicine preparation, and particularly relates to a ketorolac tromethamine tablet. According to the ketorolac tromethamine tablet, the ketorolac tromethamine is prepared into a solid dispersion body and is then prepared into the tablet, so that a dissolution ratio of the ketorolac tromethamine is greatly improved, the stability of the ketorolac tromethamine isalso effectively improved, impurities of the ketorolac tromethamine produced by factors such as light heat are effectively avoided, and the security of clinical medicine application is improved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a ketorolac tromethamine tablet. 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 can be converted into ketorolac in the human body to exert curative effect. Ketorolac can inhibit platelet aggregation induced by arachidonic acid or collagen, but is ineffective against platelet aggregation induced by ADP. It is different from other non- The mechanism of action of steroidal drugs is similar, and the sites of action are PG and arachidonic acid. Ketorolac tromethamine relieves toxic pain in a variety of muscles, soft tissues, and joints. It is indicated for the short-term treatment...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K9/20A61K9/28A61K31/407A61K47/10A61K47/32A61P29/00
CPCA61K9/146A61K9/2027A61K9/2031A61K9/28A61K31/407A61P29/00
Inventor 孙建合丁兵
Owner LUNAN PHARMA GROUP CORPORATION
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