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Enteric-coated tablet of S-pantoprazole or salt of S-pantoprazole, and preparation method thereof

A technology of pantoprazole salt and pantoprazole, which is applied in the field of pharmaceutical dosage forms, can solve the problems of infusion drug efficacy decline, capillary embolism, and poor firmness, and achieve the effects of accurate dosage, high bioavailability, and low cost

Active Publication Date: 2013-01-16
YANGTZE RIVER PHARM GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because S-pantoprazole or its salt are unstable in acidic environment, impurity can be caused to increase, so it is not suitable to be developed into oral constant-release preparation; The firmness of salt formation is poor, and it is easy to precipitate in the form of S-pantoprazole under acidic and weakly alkaline conditions, resulting in a decrease in the efficacy of the infusion. What is more harmful is that the precipitated particles of S-pantoprazole enter the human body, causing Capillary embolism and granulomas

Method used

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  • Enteric-coated tablet of S-pantoprazole or salt of S-pantoprazole, and preparation method thereof
  • Enteric-coated tablet of S-pantoprazole or salt of S-pantoprazole, and preparation method thereof
  • Enteric-coated tablet of S-pantoprazole or salt of S-pantoprazole, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0095] Prescription (make 5000 tablets):

[0096] (1) Chip core:

[0097]

[0098] (2) Isolation layer (1000g):

[0099] Opadry (03K19229) 50g

[0100] 80% ethanol 350g

[0101] (3) Enteric-coated layer (1000g):

[0102] Opadry (94O62488) 100g

[0103] 85% ethanol 900g

[0104] Preparation:

[0105] 1) Preparation of tablet core

[0106] Get the S-pantoprazole sodium two times hemihydrate of recipe quantity, microcrystalline cellulose, lactose, croscarmellose sodium, anhydrous sodium carbonate, cross 65 mesh sieves and mix homogeneously; According to the actual prescription powder obtained amount, add an appropriate amount of magnesium stearate and talcum powder, mix uniformly, and the powder is directly compressed into tablets to obtain the tablet core of S-pantoprazole sodium.

[0107] 2) Preparation of isolation layer coating solution

[0108] Prepare ethanol with a concentration of 80%, dissolve Opadry (03K19229) in the ethanol solution, and mix well to obtain ...

Embodiment 2

[0114]Prescription (make 5000 tablets):

[0115] (1) Chip core:

[0116]

[0117] (2) Isolation layer (1000g):

[0118] Opadry (17K690000) 50g

[0119] 85% ethanol 350g

[0120] (3) Enteric-coated layer (1000g):

[0121] Opadry (94O62488) 100g

[0122] 85% ethanol 900g

[0123] Preparation:

[0124] 1) Preparation of tablet core

[0125] Get the prescription amount of S-pantoprazole magnesium, microcrystalline cellulose, lactose, croscarmellose sodium, anhydrous sodium carbonate, pass through a 65 mesh sieve and mix evenly; Magnesium fatty acid and talcum powder are uniformly mixed, and the powder is directly compressed into tablets to obtain the tablet core of S-pantoprazole magnesium.

[0126] 2) Preparation of isolation layer coating solution

[0127] Prepare ethanol with a concentration of 85%, dissolve Opadry (17K690000) in the ethanol solution, and mix well to obtain a coating solution for the isolation layer.

[0128] 3) Preparation of coating liquid

[01...

Embodiment 3

[0133] Prescription (make 5000 tablets):

[0134] (1) Chip core:

[0135]

[0136] (2) Isolation layer (1000g):

[0137] Opadry (17K690000) 50g

[0138] 75% ethanol 350g

[0139] (3) Enteric-coated layer (1000g):

[0140] Opadry (94O62488) 100g

[0141] 80% Alcohol 900g

[0142] Preparation:

[0143] 1) Preparation of tablet core

[0144] Get the S-pantoprazole magnesium dihydrate, microcrystalline cellulose, lactose, croscarmellose sodium, anhydrous sodium carbonate of prescription quantity, cross 65 mesh sieves and mix; According to the actual prescription powder quantity of gained, Add appropriate amount of magnesium stearate and talcum powder, mix evenly, and directly compress the powder into tablets to obtain the tablet core of S-pantoprazole magnesium.

[0145] 2) Preparation of isolation layer coating solution

[0146] Prepare ethanol with a concentration of 75%, dissolve Opadry (17K690000) in the ethanol solution, and mix well to obtain a coating solution f...

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Abstract

The invention relates to an enteric-coated tablet of S-pantoprazole or salt of the S-pantoprazole, and a preparation method thereof, wherein the enteric-coated tablet comprises the components: a) a tablet core formed by the S-pantoprazole or the salt of the S-pantoprazole and pharmaceutic adjuvant; b) an isolating layer; and c) an enteric layer. The tablet core of the S-pantoprazole or the salt of the S-pantoprazole is formed by directly tabletting full powder, so that the damage of high temperature to the S-pantoprazole or the salt of the S-pantoprazole in the process of drying water and granules during wet granulation can be effectively avoided, and the stability of the preparation is improved. Furthermore, the isolating layer and the enteric layer have less composition, so that the preparation is simple and convenient. According to the invention, the preparation technology is simplified and the production cost is reduced; and the prepared S-pantoprazole enteric-coated tablet is better in dissolution rate and good in stability.

Description

technical field [0001] The present invention relates to a pharmaceutical dosage form, in particular to an enteric-coated tablet in which S-pantoprazole and its pharmaceutically acceptable salt or hydrate are used for treating digestive tract diseases, preferably for digestive tract ulcers, as active ingredients and its preparation method. 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 usually used as anti-ulcer agents, such as for peptic ulcer (gastric ulcer, duodenal ulcer, anastomotic ulcer, etc.) Treatment of diseases such as Ehrlich syndrome. Wherein, pantoprazole is all stable than omeprazole and lansoprazole under weakly acidic environment, and its bioavailability improves 7 times than omepra...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K9/36A61K31/4439A61P1/04
Inventor 何达路显锋张贤斌赵文镜尹必喜
Owner YANGTZE RIVER PHARM GRP CO LTD
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