Levo-pantoprazole salt aquo-complex enteric-coated tablet and preparation method thereof

A technology for pantoprazole salts and hydrates, applied in the field of enteric-coated tablets and their preparation, can solve the problems of being easily affected by various environmental factors, being difficult to develop, and being unstable, so as to avoid adverse reactions and achieve stable quality. Reliable and uniform results

Inactive Publication Date: 2013-07-24
沈阳双鼎制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the instability of its own nature, it is easily affected by various environmental factors, making the development of its prescription and process more difficult.

Method used

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  • Levo-pantoprazole salt aquo-complex enteric-coated tablet and preparation method thereof
  • Levo-pantoprazole salt aquo-complex enteric-coated tablet and preparation method thereof
  • Levo-pantoprazole salt aquo-complex enteric-coated tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] A levo-pantoprazole salt hydrate enteric-coated tablet is characterized in that: 40 g of le-pantoprazole sodium sesquihydrate (calculated as le-pantoprazole), 10 g of anhydrous sodium carbonate, cross-linked polyethylene 20g of pyrrolidone, 188g of microcrystalline cellulose, 2g of colloidal silicon dioxide, 25g of Opadry (03K19229) (separation layer) and 28.6g of Acryl (93F19255) (enteric-coated layer) were prepared into 2000 tablets.

[0041] A kind of preparation method of L-pantoprazole salt hydrate enteric-coated tablet is characterized in that comprising the steps:

[0042] 1) Preparation of tablet core

[0043] Pass the raw and auxiliary materials through a 80-mesh sieve, weigh 40 g of levo-pantoprazole sodium sesquihydrate, 10 g of anhydrous sodium carbonate, and 10 g of cross-linked polyvinylpyrrolidone, mix well, and then add microcrystalline fiber Plain 188g, mixing, dry granulation, add cross-linked polyvinylpyrrolidone 10g and colloidal silicon dioxide 2g,...

Embodiment 2

[0051] A levo-pantoprazole salt hydrate enteric-coated tablet is characterized in that it is composed of 40 g of le-pantoprazole sodium sesquihydrate (calculated as le-pantoprazole), 12 g of anhydrous sodium carbonate, and cross-linked polyvinylpyrrolidone 10g, microcrystalline cellulose 135g, colloidal silicon dioxide 3g, Opadry (03K19229) 8g and Acryl (93F19255) 24g to make 2000 tablets.

[0052] A preparation method for L-pantoprazole salt hydrate enteric-coated tablets, comprising the steps of:

[0053] 1) Preparation of tablet core

[0054] Pass the raw and auxiliary materials through a 80-mesh sieve, weigh 40g of levopantoprazole sodium sesquihydrate hydrate, 12g of anhydrous sodium carbonate and 5g of cross-linked polyvinylpyrrolidone, mix well, and then add microcrystalline Cellulose 135g, mix evenly, dry granulate, add remaining cross-linked polyvinylpyrrolidone 5g and colloidal silicon dioxide 3g, mix uniformly, tabletting, obtain the tablet core of L-pantoprazole s...

Embodiment 3

[0062] A levo-pantoprazole salt hydrate enteric-coated tablet is characterized in that it is composed of 65 g of le-pantoprazole sodium sesquihydrate (calculated as le-pantoprazole), 17 g of anhydrous sodium carbonate, and cross-linked polyvinylpyrrolidone 20g, microcrystalline cellulose 156g, colloidal silicon dioxide 2g, Opadry (03K19229) 16g and Acryl (93F19255) 26g to make 2000 tablets.

[0063] A preparation method for L-pantoprazole salt hydrate enteric-coated tablets, comprising the steps of:

[0064] 1) Preparation of tablet core

[0065] The raw and auxiliary materials are passed through an 80 mesh sieve, 65g of levopantoprazole sodium sesquihydrate hydrate, 17g of anhydrous sodium carbonate and 10g of cross-linked polyvinylpyrrolidone, which are weighed, are mixed, and then added in micro Crystalline cellulose 156g, mixing, dry granulation, add remaining cross-linked polyvinylpyrrolidone 10g and colloidal silicon dioxide 2g, mix homogeneously, compress tablet, obtai...

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Abstract

The invention discloses a levo-pantoprazole salt aquo-complex enteric-coated tablet which comprises a tablet core, an isolation layer and an enteric-coated layer. The tablet is characterized in that the tablet core comprises a levo-pantoprazole salt aquo-complex, a shaping agent, a pH conditioning agent, a disintegrating agent and a lubricant; the levo-pantoprazole salt aquo-complex is 15-25% of the total weight of the tablet core by the weight of levo-pantoprazole; the shaping agent is 60-75% of the total weight of the tablet core; the disintegrating agent is 5-10% of the total weight of the tablet core; the pH conditioning agent is 3-7% of the total weight of the tablet core; the lubricant is 0.5-1.5% of the total weight of the tablet core; and the percentage is of percentage by weight. The enteric-coated tablet of the levo-pantoprazole or the salt of the levo-pantoprazole is convenient to carry over, transport and take; the enteric-coated tablet is high in process operability and is applicable to industrial production; and compared with a racemate preparation, the enteric-coated tablet reduces the dosage and avoids adverse effects of dextroisomer, thereby being better in clinical security.

Description

technical field [0001] The invention belongs to the technical field of medicines, and relates to an enteric-coated tablet with L-pantoprazole salt hydrate as an active ingredient for treating digestive tract diseases and a preparation method thereof. Background technique [0002] Substituted 2-(2-pyridylmethyl)sulfinyl-1H-benzimidazole derivatives are well known gastric proton pump inhibitors, these benzimidazole derivatives include omeprazole, pantoprazole, lanzo Larazole and Rabeprazole etc. They have the same function of inhibiting gastric acid secretion, so they are often used as anti-ulcer agents. [0003] The chemical name of pantoprazole sodium is 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridyl)methyl]sulfinyl-1H-benzoimidazole Sodium, the structural formula is: [0004] [0005] Pantoprazole is a sulfoxide and a chiral compound in which the sulfur atom is the stereogenic center. Thus, pantoprazole is a racemic mixture of two single enantiomers, R and S, and its ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4439A61P1/04
Inventor 马占芝李皓刘宇李铁
Owner 沈阳双鼎制药有限公司
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