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Pantoprazole sodium enteric-coated tablet and preparation method thereof

A technology of pantoprazole sodium plain tablet and pantoprazole sodium, which is applied in the preparation of pharmaceutical preparations, pantoprazole sodium enteric-coated tablet and the field of preparation thereof, can solve the problems of limited application, easy discoloration of the tablet, and release rate. Instability and other problems, to achieve the effect of easy storage and transportation, stable product quality, and great application value

Inactive Publication Date: 2012-08-08
SHANGHAI TENRY PHARMCEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] There are some deficiencies in the existing formulations and preparation methods of pantoprazole sodium enteric-coated tablets, which limit its application
Because pantoprazole sodium has strong hygroscopicity and is sensitive to light and heat, the conventional preparation method of enteric-coated plain tablets is easy to change color and the release rate is unstable.

Method used

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  • 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

[0023] Embodiment 1 pantoprazole sodium enteric-coated tablet

[0024] formula

[0025] Pantoprazole Sodium Tablets:

[0026] Pantoprazole Sodium 44mg

[0027] Sodium carbonate 10mg

[0028] Mannitol 80mg

[0029] Microcrystalline Cellulose 18mg

[0030] Crospovidone 15mg

[0031] Povidone 11mg

[0032] Magnesium stearate 2mg

[0033] Isolation layer:

[0034] Hypromellose 1.8mg

[0035] Sodium carbonate 1.8mg

[0036] Enteric layer:

[0037] Acrylic resin 16mg

[0038] method:

[0039] (1) preparation of pantoprazole sodium tablet:

[0040] The pantoprazole sodium raw material is passed through a 100-mesh sieve, and other auxiliary materials are respectively passed through an 80-mesh sieve, and the raw and auxiliary materials (except magnesium stearate) are mixed evenly and granulated by a high-speed mixing granulator. After boiling and drying at 40-45°C, pass through a 24-mesh sieve, add magnesium stearate, and press into tablets for later use.

[0041] (2) mi...

Embodiment 2

[0046] Embodiment 2: pantoprazole sodium enteric-coated tablet

[0047] formula

[0048] Pantoprazole Sodium Tablets:

[0049] Pantoprazole Sodium 44mg

[0050] Sodium carbonate 10mg

[0051] Mannitol 80mg

[0052] Microcrystalline Cellulose 18mg

[0053] Crospovidone 15mg

[0054] Povidone 11mg

[0055] Magnesium stearate 2mg

[0056] Isolation layer:

[0057] Hypromellose 2.25mg

[0058] Magnesium Oxide 2.25mg

[0059] Enteric layer:

[0060] Acrylic resin 18mg

[0061] Method is with embodiment 1.

[0062] The acid resistance of the finished product reaches 94%, and the release rate is 88%, which meets and exceeds the requirements of "Chinese Pharmacopoeia" for enteric-coated tablets.

Embodiment 3

[0063] Embodiment 3: pantoprazole sodium enteric-coated tablet

[0064] formula

[0065] Pantoprazole Sodium Tablets:

[0066] Pantoprazole Sodium 44mg

[0067] Sodium carbonate 10mg

[0068] Mannitol 80mg

[0069] Microcrystalline Cellulose 18mg

[0070] Crospovidone 15mg

[0071] Povidone 11mg

[0072] Magnesium stearate 2mg

[0073] Isolation layer:

[0074] Hypromellose 1.8mg

[0075] Sodium bicarbonate 3.6mg

[0076] Enteric layer:

[0077] Acrylic resin 20mg

[0078] Method is with embodiment 1.

[0079] The acid resistance of the finished product reaches 93%, and the release rate exceeds 89%, which meets and exceeds the requirements of "Chinese Pharmacopoeia" for enteric-coated tablets.

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Abstract

The invention provides a pantoprazole sodium enteric-coated tablet, which consists of the following components in parts by weight: 1 part of a pantoprazole sodium plain film, 0.1-0.5 part of an isolating layer and 0.5-1 part of an enteric-coated layer, wherein the isolating layer consists of hydroxypropyl methylcellulose and an alkali in the weight part ratio of 1:5-5:1; and the enteric-coated layer is prepared from 0.5-1 part of acrylic resin. The invention provides a preparation method of the pantoprazole sodium enteric-coated tablet. Parameters such as spray speed, spray pressure, the rotating speed of a coating pan and the like are improved through process parameters of the isolating layer, an enteric liquid and a coating, so that the prepared pantoprazole sodium enteric-coated tablet has high acid tolerance and dissolution rate, the acid tolerance of a finished product is over 90 percent, the dissolution rate is over 75 percent, and the pantoprazole sodium enteric-coated tablet is accordant with and superior to the requirements of the Chinese Pharmacopoeia on the enteric tablet. The product has the advantages of stable quality, convenience for storing and transporting and contribution to clinical application. The method is simple, is suitable for industrial production, and has high application value.

Description

technical field [0001] The invention relates to medicines, in particular to a preparation method of pharmaceutical preparations, in particular to a pantoprazole sodium enteric-coated tablet and a preparation method thereof. Background technique [0002] Pantoprazole Sodium Enteric-Coated Tablets is a drug for treating digestive system diseases such as gastric ulcer, and has been widely used in clinical practice. Pantoprazole sodium is a proton pump inhibitor that can effectively reduce gastric acid secretion. Duodenal ulcer, gastric ulcer, reflux esophagitis, and Zoller-Ellison syndrome, especially for ulcers with bleeding, vomiting or inability to eat, as well as refractory ulcers and acute pancreatitis. It can also be used to prevent stress ulcers caused by major surgery or severe trauma. The drug has high selectivity and bioavailability, and is recognized by doctors and patients for its high safety in clinical treatment. [0003] There are some deficiencies in the exis...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/4439A61P1/04
Inventor 叶桃晁愚罗洪珍谢松
Owner SHANGHAI TENRY PHARMCEUTICAL CO LTD
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