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Naproxen esomeprazole enteric preparation and preparation method thereof

A technology for esomeprazole magnesium and enteric-coated preparations, which is applied in the field of pharmaceutical preparations, can solve the problems of difficulty in evenly coating tablet cores with enteric-coated coatings, affecting enteric-coated effects, and complicated processes, and achieves simple, easy, and good formulation. Bioavailability, uniform coating effect

Active Publication Date: 2014-12-17
杭州新诺华医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] (1) The process is particularly complicated, with many steps and relatively many parameters to be controlled;
[0008] (2) It is difficult to wrap the enteric coating on the tablet core evenly, and the tablet has edges, which tend to be thinner than the coating film on the tablet, which affects the enteric coating effect;

Method used

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  • Naproxen esomeprazole enteric preparation and preparation method thereof
  • Naproxen esomeprazole enteric preparation and preparation method thereof
  • Naproxen esomeprazole enteric preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] Example 1 Preparation of naproxen enteric-coated pellets

[0059] Contains pills:

[0060] Naproxen 375g

[0061] Microcrystalline Cellulose 50g

[0062] Povidone K30 10g

[0063] Croscarmellose Sodium 5g

[0064] Purified water 190g.

[0065] Enteric-coated pellets:

[0066] Contains pills 440g

[0067] EUDRAGIT® L30D-55 440g

[0068] Glyceryl monostearate 6.6g

[0069] Tween-80 0.26g

[0070] Triethyl citrate 13.2g

[0071] Purified water 440g

[0072] Makes 1000 capsules.

[0073] The preparation method is as follows:

[0074] ① Take the prescribed amount of povidone and add it to an appropriate amount of water, stir until dissolved, and prepare a 5% aqueous solution of povidone, as a wetting agent, for later use;

[0075] ②Naproxen micronization treatment, the prescription amount weighs naproxen, microcrystalline cellulose, and croscarmellose sodium to pass through an 80-mesh sieve in turn, and mix evenly;

[0076] ③ Add the above-mentioned wettin...

Embodiment 2

[0083] Example 2 Preparation of naproxen enteric-coated pellets

[0084] Contains pills:

[0085] Naproxen 500g

[0086] Microcrystalline Cellulose 60g

[0087] Povidone K30 12g

[0088] Croscarmellose Sodium 8g

[0089] Purified water 228g.

[0090] Enteric-coated pellets:

[0091] Contains pills 580g

[0092] EUDRAGIT® L30D-55 541g

[0093] Glyceryl monostearate 8.1g

[0094] Tween-80 0.32g

[0095] Triethyl citrate 16.2g

[0096] Purified water 541g

[0097] Makes 1000 capsules.

[0098] The preparation method is as follows:

[0099] ① Take the prescribed amount of povidone and add it to an appropriate amount of water, stir until dissolved, and prepare a 5% aqueous solution of povidone, as a wetting agent, for later use;

[0100] ②Naproxen micronization treatment, the prescription amount weighs naproxen, microcrystalline cellulose, and croscarmellose sodium to pass through an 80-mesh sieve in turn, and mix evenly;

[0101] ③ Add the above-mentioned wett...

Embodiment 3

[0109] Example 3 Preparation of esomeprazole magnesium film-coated tablets

[0110] Tablets:

[0111] Esomeprazole magnesium (calculated as esomeprazole) 20g

[0112] Microcrystalline Cellulose 20g

[0113] Hypromellose 0.6g

[0114] Magnesium stearate 0.4g

[0115] Purified water 19.4g.

[0116] Coated tablets:

[0117] Vegetarian Tablets 41g

[0118] Hypromellose 1.2g

[0119] Talc powder 0.6g

[0120] Purified water 38.8g

[0121] Made in 1000 pieces.

[0122] The preparation method is as follows:

[0123] ① Weigh an appropriate amount of hydroxypropyl methylcellulose and add it to an appropriate amount of water, stir until dissolved, and prepare a 3% aqueous solution of hydroxypropyl methylcellulose, which will be used as a binder for later use;

[0124] ② Take esomeprazole magnesium and microcrystalline cellulose respectively, and pass through 80 mesh sieves successively, and mix well;

[0125] ③Add the above-mentioned binder to the mixed powder to ...

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Abstract

The invention discloses a naproxen esomeprazole enteric preparation and a preparation method thereof, wherein the preparation is obtained by filling a naproxen enteric pill and an esomeprazole thin membrane coated tablet into the same capsule, wherein each esomeprazole thin membrane coated tablet contains 20 mg esomeprazole, and the naproxen enteric pill in each capsule contains 375mg or 500mg naproxen. The preparation method for the naproxen esomeprazole enteric preparation is that the naproxen and the esomeprazole are prepared into the enteric pill and tablets respectively, and thus, influences of the acid enteric material on the stability of the esomeprazole are avoided; moreover, the method is reasonable in design, simplified in a coating step and simple in process; and the prepared naproxen esomeprazole enteric preparation has stable quality, high bioavailability, a high economic value and important social meaning.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an enteric-coated preparation of naproxen and esomeprazole magnesium and a preparation method thereof. Background technique [0002] Naproxen is a non-steroidal anti-inflammatory drug, which is an older variety. It has been used in the market for many years and has a wide range of clinical applications. It can reduce inflammation and swelling, relieve fever, relieve pain and improve function. But it also has obvious gastrointestinal side effects, which can lead to peptic ulcer, bleeding, perforation, etc. in severe cases. Esomeprazole is an excellent drug for the prevention and treatment of peptic ulcer, and the combination of the two can solve the above problems very cleverly. Provides a potent pain reliever and an embedded proton pump inhibitor in a single capsule or tablet for the treatment of arthritis patients at risk for NSAID-associated gastric ulcer...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/4439A61K47/38A61P29/00A61P19/02A61K31/192
Inventor 姚成志姜新东石晓宝潘冰
Owner 杭州新诺华医药有限公司
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