Pharmaceutical composition for treating digestive system disease

A technology for diseases of the digestive system and composition, applied in the field of medicine, can solve the problems of complex production process, high production cost, small production volume and the like, and achieve the effects of simple preparation method, reduced impurity content and high dissolution rate

Inactive Publication Date: 2015-07-01
崔银方
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method solves the unstable problem of lansoprazole to a certain extent, but the yield and the purity of the product are far from reaching the ideal effect
[0013] It can be seen that in the prior art, whether it is to prepare enteric-coated capsules or enteric-coated tablets, in order to improve the stability of the drug, it is necessary to perform multiple coatings

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0040] Example 1: Preparation of the lansoprazole enteric-coated tablet composition of the present invention

[0041] Tablet core prescription (parts by weight): 10 parts lansoprazole, 49 parts lactose, 15 parts microcrystalline cellulose, 8.5 parts potassium sodium tartrate, 7 parts crospovidone, 1 part povidone K30, 95% ethanol 20 parts, 0.6 parts of polysorbate 80, 1 part of finely powdered silica gel.

[0042] Enteric coating formulation (parts by weight): 5.2 parts of hypromellose phthalate, 0.5 parts of n-butyl stearate, 1.5 parts of talc, 140 parts of 95% ethanol.

[0043] Preparation:

[0044] The enteric-coated tablet composition of the present invention can be prepared by methods commonly used in the art, including but not limited to the following preparation methods:

[0045] 1) Preparation of tablet core

[0046] The prescription amount of lansoprazole raw material and lactose, microcrystalline cellulose, potassium sodium tartrate, and crospovidone are sieved and mixed, and the

Example Embodiment

[0051] Example 2: Preparation of the lansoprazole enteric-coated tablet composition of the present invention

[0052] Tablet core prescription (parts by weight): 14 parts lansoprazole, 52 parts lactose, 17 parts microcrystalline cellulose, 9.8 parts potassium sodium tartrate, 10 parts crospovidone, 1.5 parts povidone K30, 95% ethanol 22 parts, 0.7 parts of polysorbate 80,

[0053] Micro-powder silica gel 1.2 parts.

[0054] Enteric coating formulation (parts by weight): 6.4 parts of hypromellose phthalate, 0.6 parts of n-butyl stearate, 2.0 parts of talc, and 145 parts of 95% ethanol.

[0055] Preparation:

[0056] The enteric-coated tablet composition of the present invention can be prepared by methods commonly used in the art, including but not limited to the following preparation methods:

[0057] 1) Preparation of tablet core

[0058] The prescription amount of lansoprazole raw material and lactose, microcrystalline cellulose, potassium sodium tartrate, and crospovidone are sieved and m

Example Embodiment

[0063] Example 3: Preparation of the lansoprazole enteric-coated tablet composition of the present invention

[0064] Tablet core prescription (parts by weight): 15.7 parts of lansoprazole, 54.5 parts of lactose, 20.0 parts of microcrystalline cellulose, 10.5 parts of potassium sodium tartrate, 12.0 parts of crospovidone, 1.9 parts of povidone K30, 95% ethanol 24.1 parts, 0.8 parts of polysorbate 80, 1.5 parts of micro-powder silica gel.

[0065] Enteric coating formulation (parts by weight): 7.4 parts of hypromellose phthalate, 0.9 parts of n-butyl stearate, 2.4 parts of talc, and 150 parts by 95% ethanol.

[0066] Preparation:

[0067] The enteric-coated tablet composition of the present invention can be prepared by methods commonly used in the art, including but not limited to the following preparation methods:

[0068] 1) Preparation of tablet core

[0069] The prescription amount of lansoprazole raw material and lactose, microcrystalline cellulose, potassium sodium tartrate, and crosp

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PUM

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Abstract

The invention discloses a pharmaceutical composition for treating a digestive system disease. The pharmaceutical composition comprises a tablet core and an enteric coating layer, wherein the tablet core is prepared from lansoprazole, lactose, microcrystalline cellulose, sodium potassium tartrate tetrahydrate, polyvinylpolypyrrolidone, povidone K30, 95% ethyl alcohol, polysorbate 80 and aerosi; and the enteric coating layer is prepared from hydroxypropyl methylcellulose phthalate, n-butyl stearate, talcum powder and 95% ethyl alcohol. Through screening by a lot of experiments, coating materials hydroxypropyl methylcellulose phthalate and n-butyl stearate are combined; and sodium potassium tartrate tetrahydrate in the tablet core is added, so that an isolation layer does not need coats between the enteric coating layer and the tablet core; the preparation technology is simplified; the production cost is reduced; acceleration test and long-term experiment results show that the lansoprazole enteric-coated tablet prepared by the composition has the advantages of good stability, high dissolution degree and low impurity content in comparison with the prior art, and is beneficial to human health and suitable for industrialized mass production.

Description

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Claims

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Application Information

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Owner 崔银方
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