Preparation method of proton pump inhibitor enteric-coated tablet

A proton pump inhibitor and proton pump technology, which is applied in the field of pharmacy, can solve problems such as low solubility, and achieve the effect of stable product quality and good market prospects

Active Publication Date: 2015-09-23
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

[0059] The difference between the above patent and the present invention is that the above patent regards the isolation layer as an isolation between the alkaline environment of the drug-containing tablet core and the acidic environment of the enteric material, and the film-forming material of the isolation layer selected is basically Opadry. Water-soluble materials are mainly used, and there is no systematic

Method used

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  • Preparation method of proton pump inhibitor enteric-coated tablet
  • Preparation method of proton pump inhibitor enteric-coated tablet
  • Preparation method of proton pump inhibitor enteric-coated tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0098] The pretreatment of embodiment 1 proton pump inhibitor bulk drug

[0099] (1) Micronization treatment of omeprazole bulk drug

[0100] Weighed 2.5Kg of omeprazole crude drug through 80 mesh sieve, put it into QYF-100 jet mill and micronized to obtain 2.1Kg of micronized omeprazole, with a yield of 84.0%. Take the micronized omeprazole bulk drug sample and detect it with a Mastersizer 2000 Malvern laser particle size analyzer. The D50 is 1.9um and the D90 is 3.9um.

[0101] (2) Micronization treatment of esomeprazole magnesium bulk drug

[0102] Take by weighing 3Kg of the esomeprazole magnesium raw material medicine of 80 mesh sieves, put in QYF-100 jet mill and pulverize, obtain the esomeprazole magnesium of micronization 2.6Kg, the yield is 86.7%. Get the micronized esomeprazole magnesium crude drug sample, and detect it with a Mastersizer 2000 Malvern laser particle size analyzer, D50 is 2.2um, and D90 is 4.6um.

[0103] (3) micronization treatment of lansoprazole...

Embodiment 2

[0107] Preparation of Example 2 Proton Pump Inhibitor Enteric-coated Tablets

[0108] A. Preparation of Drug-Containing Tablet Cores

[0109] According to the prescription design in Table 1, take high-substituted hydroxypropyl cellulose and dissolve it in an appropriate amount of 75% ethanol aqueous solution, stir to dissolve completely, then add sodium hydroxide and Tween 80, stir to dissolve completely, and set aside; weigh according to the prescription design amount Proton pump inhibitor raw materials, mannitol, crospovidone XL-10, and magnesium oxide were passed through an 80-mesh sieve, and mixed in a one-step granulation mixer at a speed of 3 r / min for 10 minutes. Then, the above-mentioned binder was evenly added to the above-mentioned material, and the material was sheared at a high speed for 3 minutes, and the material was discharged. In the oscillating granulator, pass through a 24-mesh sieve. The wet granules of the proton pump inhibitor composition are placed in a...

Embodiment 3

[0114] Example 3 In vitro release of omeprazole enteric-coated tablets prepared by the present invention in different dissolution media

[0115] Get the omeprazole enteric-coated tablet (10mg) that embodiment 2 prepares as test group object, according to release assay (appendix XD second method), adopt dissolution assay (appendix XC first method) device, with chlorine The hydrochloric acid solution of sodium chloride (take 1g of sodium chloride, add 3.5ml of hydrochloric acid, add water to 500ml) 500ml is the release medium, the rotating speed is 100 revolutions per minute, operate according to the law, after 120 minutes, immediately lift the rotating basket out of the liquid surface, None of the test pieces should have discoloration, cracks or disintegration. Immediately add 400ml of pH6.0 phosphate buffer solution or pH6.8 phosphate buffer solution preheated to 37°C to the operating container, keep the rotation speed unchanged, and continue to operate according to the law. A...

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Abstract

The invention discloses a preparation method of a proton pump inhibitor enteric-coated tablet. The proton pump inhibitor enteric-coated tablet consists of a medicated tablet core, an isolating layer and an enteric-coated layer, wherein the medicated tablet core consists of active ingredients, filling agents, disintegrating agents, stabilizing agents, adhesion agents, surface active agents and lubricating agents; the isolating layer consists of film-forming agents, pore-foaming agents and hydrophobic materials; and the enteric-coated layer consists of an enteric-coated material, plasticizers, antisticking agents and light-screening agents. The formula and the preparation technology of the isolating layer are key and core technologies of controlling in-vitro release of drugs. By control on the formula and the preparation technology of the isolating layer and weight increment of the isolating layer, the releasing rate of the proton pump inhibitor enteric-coated tablet in different dissolution media with pH (potential of hydrogen) 1.2, pH 6.0, pH 6.8 and pH 8.0 and water. A prepared proton pump inhibitor enteric-coated tablet product is stable in quality and has a good market prospect.

Description

technical field [0001] The invention belongs to the field of pharmacy, and relates to a proton pump inhibitor enteric-coated tablet and a preparation method thereof. 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, the proton pump inhibitors that have been listed abroad include Omeprazole (Omeprazole), Esomeprazole (Esomeprazole), Pantoprazole (Pantoprazole), Levopantoprazole (S-pantoprazole), Rabe Rabeprazole, Dexrabeprazole, Lansoprazole, Dexlansoprazole, Ilaprazole, etc., domestic marketed proton pump inhibitors There are omeprazole, esomeprazole, pantoprazole, lansoprazole, rabeprazole, etc., and dex-rabeprazole, dex-lansoprazole, etc. are being applied for registration. Omeprazole was launched in the United States in 1988 and is the earliest benzimidazole proton pump inhibitor on the market. [0003] The invention pat...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K47/36A61K47/32A61K47/12A61P1/04
Inventor 谢斌黄俊鹏陈新民朱俊杰杨刘增林海涛李秀梅黄云霞
Owner 珠海润都制药股份有限公司
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