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Pantoprazole sodium enteric-coated pellet

A technology of pantoprazole sodium pellets and pantoprazole sodium, applied in the field of pharmacy, can solve problems such as difficulties

Active Publication Date: 2009-12-09
Yung Shin Pharm Ind (Kunshan) Co Ltd
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] There are some difficulties in the preparation of enteric-coated pellets of pantoprazole sodium

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] 40mg Pantoprazole Sodium Enteric-Coated Pellet Capsules

[0063] Raw material list

[0064] Blank pellet core, 20-24 mesh 60mg

[0065] Pantoprazole Sodium 40mg

[0066] Sodium Carbonate 19mg

[0067] Corn starch 12.5mg

[0068] Hydroxypropyl Cellulose 3.5mg

[0069] Hydroxypropyl methylcellulose 26.25mg

[0070] Glycerin acetate 2.75mg

[0071] Eudragit L-100 29.7mg

[0072] Tributyl citrate 6.3mg

[0073] Pantoprazole sodium, cornstarch, sodium carbonate are pulverized and passed through a 150-mesh sieve, and mixed uniformly with a binder solution composed of hydroxypropyl cellulose to construct the pantoprazole sodium layer. Then will be crushed through 150 orders, the powder that mixes homogeneously, adopts the powder coating method to be coated on the blank ball core of 290g in the sugar coating pan. After coating the required amount of pantoprazole sodium mixed powder, the ball core containing pantoprazole sodium is put into a ventilating dryer to dry.

...

Embodiment 2

[0078] 40mg Pantoprazole Sodium Enteric-Coated Pellet Capsules

[0079] Raw material list

[0080] Blank pellet core, 20-24 mesh 60mg

[0081] Pantoprazole Sodium 40mg

[0082] Sodium Carbonate 19mg

[0083] Corn starch 12.5mg

[0084] Polyvinylpyrrolidone 3.5mg

[0085] Hydroxypropyl Methyl Cellulose 26.25mg

[0086] Glycerin acetate 2.75mg

[0087] Eudragit L100 46.58mg

[0088] Tributyl citrate 9.23mg

[0089] The pantoprazole sodium layer is constructed by pulverizing pantoprazole sodium, cornstarch and sodium carbonate and passing through a 150-mesh sieve, and mixing uniformly with a binder solution composed of polyvinylpyrrolidone. Then will be crushed through 150 orders, the powder that mixes homogeneously, adopts the powder coating method to be coated on the blank ball core of 290g in the sugar coating pan. After coating the required amount of pantoprazole sodium mixed powder, the pantoprazole sodium pellets are put into a ventilating dryer and dried.

[0090...

Embodiment 3

[0094]40mg Pantoprazole Sodium Enteric-Coated Pellet Capsules

[0095] Raw material list

[0096] Blank pellet core, 20-24 mesh 100mg

[0097] Pantoprazole Sodium 40mg

[0098] Calcium Carbonate 19mg

[0099] Corn starch 12.5mg

[0100] Hydroxypropyl Cellulose 3.5mg

[0101] Hydroxypropyl Methyl Cellulose 8.75mg

[0102] Glycerin acetate 1.25mg

[0103] Eudragit L-30D-55 272.8mg

[0104] Triethyl citrate 27.2mg

[0105] The pantoprazole sodium layer is constructed by pulverizing pantoprazole sodium, cornstarch and calcium carbonate and passing through a 150 mesh sieve, and mixing uniformly with a binder solution composed of hydroxypropyl cellulose. Then will be crushed through 150 orders, the powder that mixes homogeneously, adopts the powder coating method to be coated on the blank ball core of 2900g in the sugar coating pan. After coating the required amount of pantoprazole sodium mixed powder, the pantoprazole sodium pellets are put into a ventilating dryer and dri...

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Abstract

The invention discloses a pantoprazole sodium enteric-coated pellet which contains the following components in percentage by weight from inside to outside: 20-60 percent of blank core pellet, 4-38 percent of medicinal layer containing pantoprazole sodium and one or more medicinal excipients, 2-15 percent of isolated layer and 15-26 percent of enteric-coated layer. The invention also discloses a preparation method and an application of the enteric-coated pantoprazole sodium pellet. The pantoprazole sodium enteric-coated capsule has the advantages of better stability, uniform absorption, smaller difference of bioavailability among individuals, and the like.

Description

technical field [0001] The invention belongs to the field of pharmacy. Specifically, the invention relates to an enteric-coated pellet of pantoprazole sodium, a medicine for treating peptic ulcer. Background technique [0002] At present, there have been four generations of proton pump inhibitors, Omeprazole (Omeprazole) has been widely used in the treatment of peptic ulcer as the first generation; Lansoprazole (Lansoprazole) has also been used as the second generation drug Obtained widely application; Pantoprazole (Pantoprazole) is as the third generation drug, compared with the previous two generations, its stability is higher, selectivity is higher, and there is no drug-drug interaction, and it has gradually obtained the recognition of the majority of patients. It has also become the drug of choice for the treatment of peptic ulcer. [0003] Pantoprazole sodium (5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridyl)methyl]sulfinyl-1H-benzimidazole sodium salt monohydrate) It is...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/4439A61K47/34A61K47/36A61K47/38A61P1/04A61K47/32
Inventor 李芳全苏龙吴保祥陶剑
Owner Yung Shin Pharm Ind (Kunshan) Co Ltd
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