Omeprazole enteric capsule and preparation method thereof

A technology of omeprazole enteric and omeprazole is applied in the field of omeprazole enteric-coated capsules, the preparation of omeprazole enteric-coated capsules, and the field of omeprazole enteric-coated pellets, which can solve difficult realization, etc. problems, to achieve consistent peak time, improve in vitro dissolution, and achieve the effect of good application value

Active Publication Date: 2019-01-04
珠海润都制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In general, the speed and ability of this enzyme metabolism causes inter-individual di

Method used

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  • Omeprazole enteric capsule and preparation method thereof
  • Omeprazole enteric capsule and preparation method thereof
  • Omeprazole enteric capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] Embodiment 1 The processing of omeprazole micronization

[0062] Weigh 50Kg of omeprazole raw material passing through a 80 mesh sieve, put it into an MQL03 jet mill (manufactured by Weifang Erpai Powder Technology Equipment Co., Ltd.) for micronization, and pass through a 325 mesh sieve to obtain micronized Ogilvy Prazole 46.8Kg, yield is 93.6%. Take the micronized omeprazole sample and detect it with a Mastersizer 2000 Malvern laser particle size analyzer (manufactured by Malvern Instruments, UK). The D50 is 2.93um and the D90 is 7.32um.

Embodiment 2

[0063] The preparation of embodiment 2 omeprazole enteric-coated capsules

[0064] (1) Preparation of omeprazole drug-loaded layer

[0065] Weigh 1180 g of pulverized mannitol and set aside. Under the state of stirring, 20 g of disodium hydrogen phosphate weighed was added to 391 g of purified water. After fully stirring until clear and transparent, 2 g of sodium lauryl sulfate (and 1 g of Tween 80) were added. After stirring until uniform and no lumps, add 200g of omeprazole, stir for not less than 15 minutes, and set aside. Weigh mannitol, lactose, microcrystalline cellulose, high-substituted hydroxypropyl cellulose (and low-substituted hydroxypropyl cellulose) according to the prescription amount, put them into the wet mixing granulator in turn, set reasonable process parameters, and wait for the preparation grain. Weigh the granulation solution, set reasonable process parameters, and granulate. Put the wet granules into the extrusion spheronizer, according to the reas...

Embodiment 3

[0074] Example 3 Comparison of the in vitro dissolution characteristics of omeprazole enteric-coated capsules (T1, T2) prepared by the preparation method of the present invention and the original research product of omeprazole enteric-coated capsules (R)

[0075] Refer to the "Chinese Pharmacopoeia" 2015 edition two monographs on the acid resistance and dissolution determination method of omeprazole enteric-coated capsules, acid resistance, water, pH6.8 phosphate buffer using high performance liquid chromatography, chromatographic conditions according to Austrian Under the item of content determination of meprazole enteric-coated capsules; since omeprazole enteric-coated capsules have been degraded in the process of dissolution in pH6.0 phosphate buffer solution, the determination by high performance liquid chromatography is not applicable, so Determination by UV spectrophotometry.

[0076] High performance liquid chromatography chromatographic conditions: use octylsilane bonded...

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Abstract

The invention discloses an omeprazole enteric capsule and a preparation method thereof. The omeprazole enteric capsule comprises omeprazole enteric pellets filled into a gelatin capsule shell. Each omeprazole enteric pellet sequentially comprises an omeprazole carrying pellet core, an isolation layer and an enteric layer from inside to outside, wherein the omeprazole carrying pellet core is prepared through an extrusion spheronization method, and the isolation layer and the enteric layer are prepared through a fluidized bed coating method. The omeprazole enteric capsule is different from original products in a way that Tween 80 and low-substituted hydroxypropyl cellulose are added to the omeprazole carrying pellet cores on the basis of omeprazole, lactose anhydrous, microcrystalline cellulose, mannitol, disodium hydrogen phosphate, hydroxypropyl cellulose and lauryl sodium sulfate. The prepared omeprazole enteric capsule does not change the stability and reproducibility of the capsule,increases the in-vitro dissolution rate of the capsule, especially increases capsule homogeneity to allow the blood drug concentration peak reaching time of different health volunteers to be consistent and has a good application value in clinical application.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an omeprazole enteric-coated pellet, an omeprazole enteric-coated capsule prepared from the enteric-coated pellet, and a preparation method of the omeprazole enteric-coated capsule. Background technique [0002] Proton pump inhibitors are benzimidazole compounds used for the treatment of peptic ulcer, esophageal reflux disease, gastrinoma syndrome and Helicobacter pylori. So far, proton pump inhibitors that have been marketed abroad include omeprazole, esomeprazole, pantoprazole, lansoprazole, rabeprazole, dex-rabeprazole, dex-lansoprazole azoles, etc. The proton pump inhibitors listed in China include omeprazole, esomeprazole, pantoprazole, lansoprazole, rabeprazole, etc., and dex-rabeprazole, Dexlansoprazole, etc. Omeprazole was launched in the United States in 1988 and is the earliest benzimidazole proton pump inhibitor on the market. [0003] According to the Tho...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K9/50A61K31/4439A61P1/04A61P35/00A61P31/04
CPCA61K9/5042A61K9/5073A61K31/4439A61P1/04A61P31/04A61P35/00
Inventor 徐维莫泽艺谢斌祁红林黄俊鹏张剑明杨刘增杨冬冯伟霞陈新民
Owner 珠海润都制药股份有限公司
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