Preparing method of proton pump inhibitor biological adhesive preparation

A technology of proton pump inhibitor and bioadhesion, which is applied in the field of medicine to achieve the effect of improving curative effect, prolonging action time and prolonging residence time

Inactive Publication Date: 2009-11-25
SHANGHAI CHENPON PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It has been reported that pantoprazole is made into slow-release preparations and antibacterial drugs in combination to treat Helicobacter pylori infection and peptic ulcer [United States Patent: 6274173], or lansoprazole is made into enteric-coated preparations (tablet, micro pills or granules), the preparation contains alkaline substances (sodium hydroxide, potassium hydroxide or sodium carbonate) to maintain the alkaline environment of the preparation to maintain the stability of the drug, and the prepared preparation is used for gastrointestinal ulcers Treatment [United States Patent: 7276253], there are no relevant literature reports and patents on making proton pump inhibitors into adhesive preparations (tablets, microspheres, granules, etc.)

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Embodiment 1 prepares lansoprazole bioadhesive sheet

[0017] Tablet core preparation Lansoprazole 30g, lactose 114g, mannitol 30g, sodium carbonate 15g, carbomer 934P 20g, hydroxypropyl methylcellulose K 15M 40g mixed well, polyvinylpyrrolidone K 30 The ethanol solution is used as the binder for wet granulation, and after drying, 1000 tablets are compressed.

[0018] Tablet core coating Take 76g of water, add EudragitL100-5513g to make it wet, fully disperse, add 1N NaOH 5g, and mix well. Dissolve 2 g of polyethylene glycol in 4 g of water, mix the aqueous solution of polyethylene glycol, 3 g of talc, 1.6 g of titanium dioxide and Eudragit L100-55 solution, and set aside. The coating inlet air temperature is 40°C, the tablet bed temperature is 30°C, the spray pressure is 0.15MPa, and the spray speed is 11g / min. After coating, the tablet has a good appearance, soaked in pH 1 hydrochloric acid for 2 hours, and the coating film is complete, and slowly releases the drug...

Embodiment 2

[0022] Example 2 Preparation of omeprazole enteric-coated adhesive granules

[0023] Get omeprazole 10g, chitosan 30g, microcrystalline cellulose 100g, micropowder silica gel 3g, PVPK 30 After 10g and 80g of lactose are mixed, adopt polyvinyl phthalate (10%) ethanol liquid to spray fluidized bed coating, coating weight gain is 30%, and the obtained enteric-coated adhesion granules are divided into 1000 bag.

Embodiment 3

[0024] Embodiment 3 prepares pantoprazole bioadhesive microsphere

[0025] Preparation of Drug-Material Suspension Colloidal Solution Using anhydrous acetone as the dissolution medium, ethyl cellulose (20cps) was prepared into a transparent colloidal solution with a concentration of 100mg / ml for later use. Take the above ethyl cellulose solution and dilute it to different concentrations with acetone, add Carbomer 934P and stir on a magnetic stirrer to obtain a well-dispersed ethyl cellulose-carbomer suspension. Add pantoprazole, continue stirring, pantoprazole is dissolved and dispersed in the above-mentioned suspension colloidal liquid, for subsequent use.

[0026] Preparation of microspheres Pantoprazole bioadhesive microspheres were prepared by the solvent evaporation method, liquid paraffin was used as the continuous phase, Span 80 was used as the emulsifier, the temperature of the system was controlled at 30°C, and acetone was removed by stirring to obtain pantoprazole ad...

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PUM

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Abstract

The invention discloses a preparing method of a proton pump inhibitor biological adhesive preparation, which comprises the following steps: selecting peroral proton pump inhibitor medicaments, alkaline substances, carrier materials and biological adhesive materials to prepare the adhesive preparation by a preparation preparing method; making enteric coating on the outer layer of the preparation; and finally, preparing the medical preparation containing the adhesive materials. The proton pump inhibitor biological adhesive preparation prepared by the preparing method has the advantages of indissolvableness in gastric acid, coating film degradation in intestinal juice, and the like, is adhered to the intestinal mucosa for slowly releasing, and is suitable for treating gastric ulcer and duodenal ulcer.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a method for preparing a bioadhesive pharmaceutical preparation of a proton pump inhibitor. Background technique [0002] Since the early 1980s, studies have shown that highly negatively charged carboxylated polymers (such as acrylic polymers) have significantly high bioadhesion and low biotoxicity to human conjunctival epithelial cells cultured in vitro[ Park K. et al, Int J Pharm 1984, 19: 107-127]; gastrointestinal tract adhesion experiments in vivo and in vitro in animals have proved that the interaction between acrylic polymers (such as Polycarbophil) and mucin on the surface of the gastrointestinal tract makes the stomach The intestinal emptying time is significantly prolonged, so it can be concluded that this type of polymer can be used as a bioadhesive material for oral drug release preparations [Ch'ng H.S. et al, J Pharm Sci 1985, 74: 399-405]. It is believ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K9/32A61K9/36A61K47/32A61K47/34A61K47/36A61K47/38A61P1/04A61K31/4439A61K31/444A61K47/10
Inventor 刘哲鹏杨世霆杜狄峥
Owner SHANGHAI CHENPON PHARMA TECH
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