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A composition comprising a nonsteroidal anti-inflammatory drug and a proton pump inhibitor

A technology for proton pump inhibitor and non-steroidal anti-inflammatory drug, which is applied in the field of the composition comprising non-steroidal anti-inflammatory drug and proton pump inhibitor and its preparation field, can solve the problem that the proton pump inhibitor is unstable to acid, difficult to Industrial production, high requirements for capsule filling machine equipment, etc.

Active Publication Date: 2020-10-27
NANJING YOKO PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But the weight of naproxen pellets in this tablet is about 14 times of esomeprazole magnesium film-coated tablet, there is the problem of inhomogeneous mixing in the tablet that it is mixed in the same capsule that makes, simultaneously this process The requirements for capsule filling machine equipment are relatively high, and it is difficult to industrialize production
[0010] Therefore, there is a need to develop a new composition containing NSAIDs and PPIs, which can not only exert the protective effect of PPIs on gastric mucosa, but also reduce the effect of NSAIDs on gastric mucosa. Intestinal side effects, and it can also solve the problem of acid instability and uneven content of proton pump inhibitors

Method used

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  • A composition comprising a nonsteroidal anti-inflammatory drug and a proton pump inhibitor
  • A composition comprising a nonsteroidal anti-inflammatory drug and a proton pump inhibitor
  • A composition comprising a nonsteroidal anti-inflammatory drug and a proton pump inhibitor

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0079] Embodiment 1 naproxen esomeprazole magnesium multilayer tablet (1000)

[0080]

[0081]

[0082] The preparation method is as follows:

[0083] Tablet core: Weigh the prescribed amount of naproxen and croscarmellose sodium ND-2HS, use povidone K30 as the soft material with a mass fraction of 10%, granulate and dry with 20 meshes, add the prescribed amount of stearic acid Magnesium is blended, compressed into tablets to obtain tablet cores;

[0084] Enteric-coated layer: Dissolve the talcum powder and triethyl citrate of the prescribed amount in water, add Eudragit L30D-55 aqueous dispersion with a mass fraction of 30%, stir well, and use it as an enteric-coated coating liquid; Add it to the coating pan, start the machine, and wrap the enteric layer;

[0085] Isolation layer: Dissolve the prescribed amount of triethyl citrate in ethanol, add hypromellose E5, water and talcum powder in sequence, and stir evenly to obtain the coating solution for the isolation laye...

Embodiment 2

[0087] Embodiment 2 naproxen esomeprazole magnesium multilayer tablet (1000)

[0088]

[0089]

[0090] The preparation method is as follows:

[0091] Tablet core: Weigh the prescribed amount of naproxen and croscarmellose sodium ND-2HS, use povidone K30 as the soft material with a mass fraction of 10%, granulate and dry with 20 meshes, add the prescribed amount of stearic acid Magnesium is blended, compressed into tablets to obtain tablet cores;

[0092] Enteric-coated layer: Dissolve the talcum powder and triethyl citrate of the prescribed amount in water, add Eudragit L30D-55 aqueous dispersion with a mass fraction of 30%, stir well, and use it as an enteric-coated coating liquid; Add it to the coating pan, start the machine, and wrap the enteric layer;

[0093] Isolation layer: Dissolve the prescribed amount of triethyl citrate in ethanol, add hypromellose E5, water and talcum powder in sequence, and stir evenly to obtain the coating solution for the isolation laye...

Embodiment 3

[0095] Embodiment 3 naproxen esomeprazole magnesium multilayer tablet (1000)

[0096]

[0097]

[0098] The preparation method is as follows:

[0099] Tablet core: Weigh the prescribed amount of naproxen and croscarmellose sodium ND-2HS, use povidone K30 as the soft material with a mass fraction of 10%, granulate and dry with 20 meshes, add the prescribed amount of stearic acid Magnesium is blended, compressed into tablets to obtain tablet cores;

[0100] Enteric-coated layer: Dissolve the talcum powder and triethyl citrate of the prescribed amount in water, add Eudragit L30D-55 aqueous dispersion with a mass fraction of 30%, stir well, and use it as an enteric-coated coating liquid; Add it to the coating pan, start the machine, and wrap the enteric layer;

[0101] Isolation layer: Dissolve the prescribed amount of triethyl citrate in ethanol, add hypromellose E5, water and talcum powder in sequence, and stir evenly to obtain the coating solution for the isolation laye...

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PUM

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Abstract

The invention discloses a composition containing non-steroidal anti-inflammatory drugs and proton pump inhibitor and a preparation method of the composition, wherein the composition is represented as a multi-layer tablet which sequentially comprises a tablet core, an enteric layer, an isolating layer and a drug-containing layer from inside to outside. On the basis of formulation and technology screening, the weight of the drug-containing layer is increased by 7-30% and the weight of the isolating layer is increased by 5-15%. The pharmaceutical composition is good in stability and uniform in content, and the pharmaceutical composition conforms to Pharmacopoeia Standard.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a composition comprising a non-steroidal anti-inflammatory drug and a proton pump inhibitor and a preparation method thereof. Background technique [0002] Osteoarthritis is the most common type of arthritis, affecting approximately 151 million people worldwide. The prevalence rate of people over the age of 75 in my country is as high as 80%, and the disability rate of the disease is as high as 53%. This situation is exacerbated as China gradually enters an aging society and the average life expectancy in China increases. [0003] Non-steroidal anti-inflammatory drugs (NSAIDs) refer to drugs with antipyretic, analgesic and anti-inflammatory effects instead of steroid structure. This type of drugs is widely used, has fast onset and good analgesic effect. First-line drug for rheumatic diseases such as rheumatoid arthritis. Commonly used clinically are ibuprofen, naprox...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K45/06A61K31/4439A61K9/24A61P19/02A61P29/00A61P19/08A61P1/04A61P1/00A61K31/192A61K31/12
CPCA61K9/2054A61K9/209A61K31/12A61K31/192A61K31/4439A61K45/06A61K2300/00
Inventor 杨勇杨婷薛峪泉朱素华张峰
Owner NANJING YOKO PHARMA