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Pantoprazole sodium enteric-coated tablet and preparation method thereof

A technology for pantoprazole sodium tablet and pantoprazole sodium is applied in the directions of pharmaceutical formulations, medical preparations with inactive ingredients, medical preparations containing active ingredients, etc., and can solve problems such as non-compliance with quality control requirements and the like , to ensure the coating effect, improve product quality, and facilitate the effect of coating

Active Publication Date: 2015-03-04
HANGZHOU CONBA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It can be deduced from the patent that the specification of its enteric-coated tablet is 20mg, and its release behavior is compared with that of the original preparation developed by India Ruidi (India Ruidi’s product specification is 20mg, compared with Japan’s Takeda’s 40mg product, the dissolution curve is different), which belongs to The Chinese generic drug of Reddy, India; in addition, it can be seen from its examples that the product did not strictly follow the requirements of China's "Generic Drug Consistency Evaluation" for comparison of dissolution curves in four dissolution media, and did not meet the quality control stipulated by the state Require

Method used

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  • Pantoprazole sodium enteric-coated tablet and preparation method thereof
  • Pantoprazole sodium enteric-coated tablet and preparation method thereof
  • Pantoprazole sodium enteric-coated tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] The preparation of embodiment 1 pantoprazole sodium enteric-coated tablet

[0044] 1. Components and contents of pantoprazole sodium tablets

[0045] Name of raw material 1000 tablets (g) Proportion (%) effect Pantoprazole Sodium 44.3 35.00 Main drug Mannitol 44.00 34.76 filler microcrystalline cellulose 11.00 8.70 filler Sodium carboxymethyl starch (additional) 4.85 3.83 disintegrant Anhydrous Sodium Carbonate 9.56 7.55 stabilizer Crospovidone (additional) 9.71 7.67 disintegrant 16% povidone K30 50% ethanol solution 15.75 1.99 Adhesive Magnesium Stearate (additional) 0.63 0.50 lubricant

[0046] 2. The composition and content of the isolation layer

[0047] Excipient name Proportion (%) effect Hydroxypropylmethylcellulose 31.25 Gown material Titanium dioxide 18.75 Sunscreen talcum powder 50 Antisticking agent 50% ethanol Prepare 8% HP...

Embodiment 2

[0056] The preparation of embodiment 2 pantoprazole sodium enteric-coated tablets

[0057] (1) Components and content of pantoprazole sodium tablet

[0058] Name of raw material 1000 tablets (g) Proportion (%) effect Pantoprazole Sodium 44.3 45 Main drug Mannitol 14.77 15 filler microcrystalline cellulose 14.77 15 filler Sodium carboxymethyl starch (additional) 8.86 9 disintegrant Anhydrous Sodium Carbonate 4.92 5 stabilizer Crospovidone (additional) 8.86 9 disintegrant 16% povidone K30 50% ethanol solution 9.23 1.5 Adhesive Magnesium Stearate (additional) 0.49 0.5 lubricant

[0059] (2) The composition and content of the isolation layer

[0060]

[0061] The coating weight gain of the isolation layer is 6% of the plain tablet.

[0062] (3) Components and content of enteric-coated layer

[0063] Excipient name effect Udage L30D-55 Polymer solids are 18% of the...

Embodiment 3

[0067] The preparation of embodiment 3 pantoprazole sodium enteric-coated tablets

[0068] (1) Components and content of pantoprazole sodium tablet

[0069] Name of raw material 1000 pieces Proportion (%) effect Pantoprazole Sodium 44.3 35 Main drug Mannitol 52.14 41.2 filler microcrystalline cellulose 13.04 10.3 filler Sodium carboxymethyl starch (additional) 3.42 2.7 disintegrant magnesium oxide 6.33 5 stabilizer Crospovidone (internal addition) 6.83 5.4 disintegrant 2% povidone K30 50% ethanol solution 12.66 0.2 Adhesive Magnesium Stearate (additional) 0.25 0.2 lubricant

[0070] (2) The composition and content of the isolation layer

[0071] Excipient name Proportion (%) effect Hydroxypropylmethylcellulose 31.25 Gown material Titanium dioxide 18.75 Sunscreen Magnesium stearate 50 Antisticking agent 50% ethanol Prepare 6% HPMC50% ethanol s...

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Abstract

The invention provides a pantoprazole sodium enteric-coated tablet. The pantoprazole sodium enteric-coated tablet is prepared by coating a pantoprazole sodium tablet with an isolation layer and an enteric-coated layer, wherein the pantoprazole sodium tablet comprises the following components in percentage by weight: 35-45% of pantoprazole sodium, 30-59% of a filling agent, 0.2-3% of a binder, 8.1-18% of a disintegrant, 5-15% of a stabilizer and 0.2-1.5% of a lubricant. According to the pantoprazole sodium enteric-coated tablet and the preparation method thereof provided by the invention, a dissolution curve of the pantoprazole sodium enteric-coated tablet in each of four dissolution media is consistent with that of an originally developed preparation, thereby being in line with the requirements of consistency evaluation; and furthermore, the stability of the pantoprazole sodium enteric-coated tablet is better than that of the originally developed preparation.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a pantoprazole sodium enteric-coated tablet and a preparation method thereof. Background technique [0002] Pantoprazole sodium (trade name Pantoloc) is the third proton pump inhibitor listed after omeprazole and lansoprazole, due to the presence of pantoprazole sodium on the pyridine ring and benzimidazole ring The substituent group is different from omeprazole and lansoprazole, which determines its differences in biochemical, pharmacokinetic, pharmacological and other properties, making it more selective and different. That is, pantoprazole sodium can specifically inhibit the secretion of microtubules formed by the apical membrane of the parietal cells and the H on the tubular vesicles in the cytoplasm. + 、K + -ATPase, causing irreversible inhibition of the enzyme, thereby effectively inhibiting the secretion of gastric acid, not only non-competitively inh...

Claims

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Application Information

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IPC IPC(8): A61K9/32A61K9/36A61K31/4439A61K47/38A61K47/32A61K47/10A61P1/04
Inventor 徐春玲徐秀卉蒋国潮陈冠华宋远征王云蔚姚丽萍宋丹丹陈玲芳陆振宇
Owner HANGZHOU CONBA PHARMA
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