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A kind of naproxen enteric-coated pellets and preparation method thereof

A technology of naproxen intestines and naproxen, which is applied in the direction of bulk transportation, bone diseases, non-central analgesics, etc., can solve the problems of complex structure of casing layer, high preparation difficulty, low yield, etc., and achieve the production process Simple and feasible operation, good effect and low price

Active Publication Date: 2018-06-19
HANGZHOU CONBA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are few technologies related to naproxen enteric-coated pellets. Occasionally reported enteric-coated pellets have a complex casing layer structure, and most of them are made by extrusion and spheronization. The preparation is difficult and the yield is not high.

Method used

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  • A kind of naproxen enteric-coated pellets and preparation method thereof
  • A kind of naproxen enteric-coated pellets and preparation method thereof
  • A kind of naproxen enteric-coated pellets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] prescription:

[0052] The preparation of naproxen medicinal powder: take by weighing 43.41kg of naproxen raw material and cross 20 mesh sieves, starch 3.08kg, microcrystalline cellulose 6.17kg, carboxymethyl starch sodium 2.34kg, all cross 80 mesh sieves; The material is placed in a wet mixing granulator, the stirring speed is set at 120 rpm, the cutting speed is 1200 rpm, mixed for 10 min, and discharged to obtain naproxen medicinal powder.

[0053] Preparation of adhesive: Weigh 2.28 kg of povidone K30 powder, add 40.72 kg of 50% ethanol solution, stir evenly, and obtain.

[0054] Preparation of enteric coating liquid: Weigh 0.95kg of polyacrylic resin II, 800.48kg of polysorbate, and 0.48kg of diethyl phthalate, and add them all to 33.29kg of 95% ethanol. After all are dissolved, add 0.95kg of castor oil, and stir After dissolving, add 1.85kg of purified water to obtain the product.

[0055] Preparation of pills: Get naproxen medicinal powder and place it in the t...

Embodiment 2

[0058] prescription:

[0059] The preparation of naproxen drug powder: take by weighing 43.41kg of naproxen raw material and cross 20 mesh sieves, starch 2.32kg, dextrin 4.50kg, carboxymethyl starch sodium 4.77kg, all cross 80 mesh sieves; In the wet mixing granulator, set the stirring speed at 120 rpm, the cutting speed at 1200 rpm, mix for 10 min, and discharge to obtain naproxen medicinal powder.

[0060] Preparation of binder: weigh 1.80 kg of hydroxypropyl methylcellulose powder, add 38.20 kg of purified water, stir evenly, and obtain.

[0061] Preparation of enteric coating liquid: Weigh 0.55kg of polyacrylic resin II, 800.28kg of polysorbate, 0.28kg of glyceryl monostearate and add them all to 14.99kg of 95% ethanol; Add 60000.14kg of polyethylene glycol to 5.76kg of purified water and stir to dissolve , mix the two evenly, that is.

[0062] Preparation of pills: take naproxen powder and place it in the turntable of the granulation coating machine, set the host speed ...

Embodiment 3

[0065] prescription:

[0066] Preparation of naproxen drug powder: Weigh 43.41kg of naproxen raw material and pass through a 20-mesh sieve, starch 2.04kg, dextrin 1.04kg, microcrystalline cellulose 7.47kg, hydroxypropyl cellulose 1.04kg, all pass through a 80-mesh sieve Place the above-mentioned materials after sieving in a wet mixing granulator, set the stirring speed at 120rpm, the cutting speed at 1200rpm, mix for 10min, and discharge to obtain naproxen medicinal powder.

[0067] Preparation of binder: weigh 2.24 kg of hydroxypropyl cellulose powder, add 41.76 kg of purified water, stir evenly, and obtain.

[0068] Preparation of enteric coating liquid: Weigh 1.00kg of polyacrylic resin II, 800.10kg of polysorbate, and 0.25kg of glyceryl monostearate, add them all to 18.94kg of 95% ethanol, add 1.00kg of castor oil after all dissolve, and add purified water 7.28kg is stirred and dissolved, and the two are mixed evenly to obtain the product.

[0069] Preparation of pills: ...

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Abstract

The invention provides a naproxen enteric-coated pellet and a preparation method thereof. The enteric-coated pellet includes a drug-loaded pellet core and an enteric coating layer from the inside to the outside; the drug-loaded pellet core is uniformly mixed with naproxen raw materials and auxiliary materials Finally, it is prepared by centrifugal pelleting process; the enteric coating layer is formed by wrapping the enteric coating liquid on the surface of the drug-loaded pellet core. The naproxen enteric-coated micropills of the present invention have simple steps, and can be obtained by wrapping a layer of sausage casing after removing the mother; the auxiliary materials used are all simple and easy to obtain, low in price, simple in process operation and high in yield; the pills are prepared by the centrifugal pelletizing process, and the time is less , Simple operation; the selected casing material has less weight gain; the production process of the present invention is simple and feasible in operation, low in cost, high in efficiency, and has good product stability, and it is easier to realize industrialized large-scale production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a naproxen enteric-coated pellet and a preparation method thereof. Background technique [0002] Naproxen is a non-steroidal anti-inflammatory drug with anti-inflammatory, antipyretic and analgesic effects. It is a reversible inhibitor of cyclooxygenase, which acts by inhibiting the cyclooxygenase in the metabolism of arachidonic acid, reducing the synthesis of prostaglandins. It is effective for rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout, chronic degenerative diseases of the motor system (such as joints, muscles and tendons) and mild to moderate pain such as dysmenorrhea. [0003] Although it has a good therapeutic effect, like other non-steroidal anti-inflammatory drugs, severe stomach discomfort reactions may occur at any time during the treatment of naproxen, manifested as stomach pain, nausea and vomiting, etc., this damaging effect It mainl...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/192A61P29/00A61P19/02
Inventor 徐春玲徐秀卉陆振宇王云蔚宋远征陈玲芳蒋国潮唐林平钱红弟
Owner HANGZHOU CONBA PHARMA