Etodolac sustained-release pellets and preparation method thereof

A technology of etodolac and sustained-release pellets, which is used in bone diseases, non-central analgesics, antipyretics, etc., can solve the problems of inconvenience in packaging, transportation, storage, low drug release stability, and gastrointestinal irritation. Large and other problems, to achieve the effect of improving bioavailability, small individual differences, and easy absorption

Inactive Publication Date: 2016-01-27
HEILONGJIANG ZHICHENG MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, in the etodolac drugs for the treatment of symptoms and signs of rheumatoid arthritis and osteoarthritis on the market, there are low drug release stability effects, high irritation to the gastrointestinal tract, low bioavailability, and problems in packaging, transportation, and storage. Inconvenience, and preparation methods are complicated and other deficiencies

Method used

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  • Etodolac sustained-release pellets and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] An etodolac sustained-release pellet, comprising drug-containing pellets and a coating layer, characterized in that: the coating layer wraps the drug-containing pellets, and the drug-containing pellets include: 200 mg etodolac, 70 mg Blank pellet core, 110-150mg filler, 18-68mg lubricant, 2-10mg binder, and the coating layer includes: 45-225mg Eudragit NE30D, 7-68mg talcum powder.

[0030] The optimal mass ratio of raw materials in the drug-containing pellets is: 200mg etodolac, 70mg blank pellet core, 140mg filler, 35mg lubricant, 5mg binder.

[0031] The optimal mass ratio of raw materials in the coating layer is: 135mg Eudragit NE30D, 30mg talcum powder.

[0032] The filler is microcrystalline cellulose.

[0033] Described lubricant is talcum powder.

[0034] The binder is hypromellose.

[0035] The coating layer also includes traces of sodium lauryl sulfate or polyethylene glycol.

Embodiment 2

[0037] A preparation method of etodolac sustained-release pellets, comprising the following steps:

[0038] Step 1: material preparation: according to the above mass ratio, etodolac is pulverized with a pulverizer, and passed through a 100-mesh sieve;

[0039] Step 2: Mixing: Weigh etodolac and microcrystalline cellulose according to the above mass ratio, put them into a three-dimensional mixer and mix for 30 minutes to make drug fine powder, take them out for later use;

[0040] Step 3: Preparation of adhesive: Weigh an appropriate amount of hypromellose according to the above mass ratio, add an appropriate amount of hot water to prepare an adhesive with a concentration of 2%, and set aside;

[0041] Step 4: Pill making: put the mixed drug fine powder into the feeding tank of the centrifugal pellet machine, put the adhesive into the liquid supply tank, put the blank pellet core into the pot, turn on the machine, adjust the parameters, and start spraying When the ball core fe...

Embodiment 3

[0047] Indications: For the treatment of symptoms and signs of rheumatoid arthritis and osteoarthritis.

[0048] medicine interactions:

[0049] 1. It is not recommended to take this product with aspirin at the same time, so as not to increase the possibility of adverse events;

[0050] 2. Combined use of warfarin and non-steroidal anti-inflammatory drugs will increase the risk of gastrointestinal bleeding;

[0051] 3. Non-steroidal anti-inflammatory drugs will competitively inhibit the accumulation of methotrexate in the kidney, which may increase the toxicity of methotrexate;

[0052] 4. Non-steroidal anti-inflammatory drugs will weaken the antihypertensive effect of ACE inhibitors;

[0053]5. When diuretics are used in combination with non-steroidal anti-inflammatory drugs, patients should be carefully observed for signs of renal failure;

[0054] 6. Lithium: Non-steroidal anti-inflammatory drugs inhibit the synthesis of renal prostaglandins. The use of such drugs will l...

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Abstract

Etodolac sustained-release pellets comprise medicated pellet bodies and coating layers, wherein the coating layers wrap the medicated pellet bodies, the medicated pellet bodies are prepared from etodolic acid, empty pellet cores, a filling agent, a lubricating agent and an adhesive, and the coating layers are prepared from eudragit NE30D and talcum powder. A preparation method of the etodolac sustained-release pellets comprises the steps that 1 material preparation, 2 mixing, 3 preparation of the adhesive, 4 pellet preparation, 5 preparation of coating materials, 6 coating, 7 filling and 8 obtaining of an aluminum plastic finished product. The etodolac sustained-release pellets are suitable for treatment of symptoms and signs of rheumatoid arthritis and osteoarthritis, have good medicine release stabilizing effect, small irritation to the gastrointestinal tract and good bioavailability, are convenient to package, transport and store and are suitable for industrial production. The etodolac sustained-release pellets are good in absorption after being taken orally and release medicines, and foods can promote increase of the total absorption amount of the medicines although the etodolac sustained-release pellets can be taken on an empty stomach or after meal.

Description

technical field [0001] The invention belongs to the field of chemical drug sustained-release preparations, and in particular relates to etodolac sustained-release pellets and a preparation method thereof. Background technique [0002] Rheumatoid arthritis is a chronic systemic autoimmune disease mainly characterized by joint disease. The main clinical manifestations are joint swelling and pain caused by the synovial membrane of the facet joints, followed by cartilage destruction and joint space narrowing. In the late stage, severe bone destruction and absorption lead to joint stiffness, deformity, and dysfunction. [0003] Osteoarthritis is a degenerative disease, which is caused by many factors such as aging, obesity, strain, trauma, congenital abnormalities of joints, joint deformities and other factors. Osteoarthritis, degenerative arthritis, senile arthritis, hypertrophic arthritis, etc., the clinical manifestations are slowly developing joint pain, tenderness, stiffnes...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/407A61K47/38A61P19/02A61P29/00
Inventor 张昕
Owner HEILONGJIANG ZHICHENG MEDICAL TECH
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