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Ketorolac tromethamine capsule and preparation method thereof

A technology of ketorolac tromethamine and capsules is applied in the directions of capsule delivery, medical preparations containing active ingredients, anti-inflammatory agents, etc. The effect of compliance, maintenance of blood drug concentration, and reduction of adverse reactions

Active Publication Date: 2010-06-30
鲁南新时代生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Ketorolac tromethamine is strongly irritating to the gastrointestinal tract in terms of physical and chemical properties, and is likely to cause various adverse reactions (such as causing gastrointestinal ulcers, bleeding and perforation, postoperative bleeding, renal failure, Allergies and anaphylaxis and liver failure, etc.), and the short half-life that common tablets have in the prior art, the clinical oral dose 10mg / time, 4 times / day, frequent administration, takes the defective that brings inconvenience to the patient

Method used

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  • Ketorolac tromethamine capsule and preparation method thereof
  • Ketorolac tromethamine capsule and preparation method thereof
  • Ketorolac tromethamine capsule and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0019]

[0020] Preparation:

[0021] (1) Take ketorolac tromethamine, microcrystalline cellulose and lactose in the prescribed amount by weighing and mix them uniformly in a fluidized bed system, and use 15% hypromellose aqueous solution as a binder spray to prepare pills containing pellets, dried, and sieved into 0.3mm-0.8mm pellets for later use.

[0022] (2) According to the coating prescription, dissolve Eudragit RS-100 and Eudragit RL-100 in ethanol, add triacetin and talcum powder, and stir evenly to obtain a coating suspension. Place the pellets prepared in step (1) in a fluidized bed system, and use the bottom spray coating method to coat, set the inlet air temperature to 40°C to 60°C, and the spray pressure to be 1.5 to 3 bar, stop spraying when the weight of the solid content of the pellets increases by 10%, and dry to obtain coated pellets.

[0023] (3) Mix the prepared ordinary pellets and coated pellets uniformly at a weight ratio of 1:3, and then fill the c...

Embodiment 2

[0025]

[0026] Preparation:

[0027] (1) Take ketorolac tromethamine, dextrin and mannitol of the prescribed amount and place them in a fluidized bed system to mix evenly, and use 10% hydroxypropyl cellulose aqueous solution as a binder spray to prepare drug-containing pellets , and dried to obtain ketorolac tromethamine drug-loaded pellets, which were sieved into 0.3mm-0.8mm pellets for subsequent use.

[0028] (2) According to the coating prescription, dissolve Eudragit RS-100 and Eudragit RL-100 in ethanol, add propylene glycol and magnesium stearate, and stir evenly to obtain a coating suspension. Place the micropellets prepared in step (1) in a fluidized bed system, and use the coating method of tangential spraying to coat the pellets. Stop spraying when the weight of the solid content increases by 12%, and dry to obtain coated pellets.

[0029] (3) Mix the prepared ordinary pellets and coated pellets uniformly in a weight ratio of 1:4, and then fill the capsule she...

Embodiment 3

[0031]

[0032] Preparation:

[0033] (1) Ketorolac tromethamine, lactose and pregelatinized starch taking by weighing prescription quantity are placed in the fluidized bed system and fluidized evenly, with 15% povidone aqueous solution as binding agent spraying and making drug-containing pellets, drying to obtain ketorolac tromethamine drug-loaded pellets, which are sieved into 0.3mm-0.8mm pellets for later use.

[0034] (2) According to the coating prescription, dissolve ethyl acrylate and hypromellose with 75% ethanol, add polyethylene glycol 6000 and talcum powder, and stir evenly to obtain a coating suspension. Place the pellets prepared in step (1) in a fluidized bed system, and use the bottom spray coating method for coating, set the inlet air temperature at 40°C-60°C, and the spray pressure at 1.5-3bar Stop spraying when the weight of the solid content increases by 8%, and dry to obtain coated pellets.

[0035] (3) Mix the prepared common pellets and coated pellet...

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Abstract

The invention provides a ketorolac tromethamine capsule and a preparation method thereof, which belong to the technical field of medicine preparations. The ketorolac tromethamine capsule is prepared by the following steps: making ketorolac tromethamine into slow-release coated micropills and ordinary micropills; and then, uniformly and proportionally mixing the two kinds of micropills to be put into capsule cases. After the capsule enters the gastrointestinal tract, the ordinary micropills fast release medicine for taking effect, and the slow-release micropills persistently release the medicine through regulating the thickness and the materials of coated films, so the peak valley phenomenon of ordinary capsules is avoided, good release curves and repeatability can be obtained, the occurrence of untoward effects of the medicine is reduced, in addition, the medicine using times are reduced, and the adaptability of patients is improved. The preparation method of the capsule has the advantages of simple process and good controllability, and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a capsule of ketorolac tromethamine and a preparation method thereof. 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 moderate pain in a variety of muscles, soft tissues, and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/407A61P29/00
Inventor 赵志全陈小伟曹淑忠
Owner 鲁南新时代生物技术有限公司
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