Drug composition for treating digestive system diseases

A digestive system disease and composition technology, applied in the field of medicine, can solve the problems that the dissolution rate of lansoprazole capsules cannot be better improved, the product yield and purity cannot reach the ideal effect, and it is not suitable for large-scale mechanized production. , to achieve good stability and impurity content, simple preparation method, and prevent damage

Inactive Publication Date: 2015-05-13
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 such as isolation layer and enteric coating, so the production process is complicated and the production volume is small. , high production cost, not suitable for large-scale mechanized production
Simultaneously although solve the dissolution rate problem by adding solubilizing agent in the prior art, still can not improve the dissolution rate of lansoprazole capsule better

Method used

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  • Drug composition for treating digestive system diseases
  • Drug composition for treating digestive system diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Example 1: Lansoprazole enteric-coated capsules of the present invention are prepared

[0041] (1) Ball core prescription (parts by weight): Lansoprazole 8, starch 15, sucrose 8, hydroxypropyl cellulose 1, potassium sodium tartrate 1.8, carboxymethyl cellulose sodium 2, sodium lauryl sulfate 0.4, Povidone K30 2, 95% ethanol 25.

[0042] (2) Prescription of enteric coating solution (parts by weight): 5.6% of hypromellose phthalate, 1% of n-butyl stearate, 1% of talcum powder, and 140% of 95% ethanol.

[0043] (3) Preparation method:

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

[0045] 1) Preparation of ball core

[0046] Lansoprazole, sucrose, potassium sodium tartrate, starch, hydroxypropyl cellulose, sodium carboxymethyl cellulose, and sodium lauryl sulfate are pulverized and mixed uniformly; use povidone K30 etha...

Embodiment 2

[0051] Example 2: Lansoprazole enteric-coated capsules of the present invention are prepared

[0052] (1) Ball core prescription (parts by weight): Lansoprazole 9, starch 16.4, sucrose 9.4, hydroxypropyl cellulose 1.5, potassium sodium tartrate 2.0, carboxymethylcellulose sodium 2.1, sodium lauryl sulfate 0.5, Povidone K30 2.4, 95% ethanol 26.1.

[0053] (2) Enteric coating solution prescription (parts by weight): Hypromellose phthalate 5.9, n-butyl stearate 1.25, talcum powder 1.1, 95% ethanol 145.

[0054] (3) Preparation method:

[0055] The preparation of the enteric-coated capsules of the present invention can be obtained by methods commonly used in the art, including but not limited to the following preparation methods:

[0056] 1) Preparation of ball core

[0057] Lansoprazole, sucrose, potassium sodium tartrate, starch, hydroxypropyl cellulose, sodium carboxymethyl cellulose, and sodium lauryl sulfate are pulverized and mixed uniformly; use povidone K30 ethanol so...

Embodiment 3

[0062] Example 3: Lansoprazole enteric-coated capsules of the present invention are prepared

[0063] (1) Ball core prescription (parts by weight): Lansoprazole 10, starch 21, sucrose 12, hydroxypropyl cellulose 2, potassium sodium tartrate 2.4, carboxymethyl cellulose sodium 3, sodium lauryl sulfate 0.6, Povidone K30 3, 95% ethanol 27.

[0064] (2) Enteric coating solution prescription (parts by weight): Hypromellose phthalate 7.3, n-butyl stearate 1.3, talcum powder 1.5, 95% ethanol 150.

[0065] (3) Preparation method:

[0066] The preparation of the enteric-coated capsules of the present invention can be obtained by methods commonly used in the art, including but not limited to the following preparation methods:

[0067] 1) Preparation of ball core

[0068] Lansoprazole, sucrose, potassium sodium tartrate, starch, hydroxypropyl cellulose, sodium carboxymethyl cellulose, and sodium lauryl sulfate are pulverized and mixed uniformly; use povidone K30 ethanol solution as ...

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Abstract

The invention relates to the technical field of medicines, in particular to drug composition for treating digestive system diseases. The drug composition comprises an active pill core and an enteric coating layer, wherein the active pill core is prepared from lansoprazole, starch, sucrose, hydroxypropylcellulose, sodium potassium tartrate, sodium carboxymethylcellulose, sodium dodecyl sulfate, povidone K30 and 95% ethanol; the enteric coating layer is prepared from hydroxypropyl methylcellulose phthalate, n-butyl stearate, talcum powder and 95% ethanol. A preparation process is simplified, the production cost is reduced, acceleration test and long-term test results show that a lansoprazole enteric capsule prepared from the composition has the advantages of good stability, high dissolution rate and low impurity content in comparison with the prior art, health and safety of a human body are relatively facilitated, and large-scale industrialized production is facilitated.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a pharmaceutical composition for treating digestive system diseases. Background technique [0002] Lansoprazole (Lansoprazole) is the second proton pump inhibitor anti-ulcer drug in the world after omeprazole. It is a strong inhibitor of the intramembrane proton pump secreted by the parietal cell tip. Its mechanism of action is similar to that of omeprazole. Like azoles, it also plays a role by inhibiting the last link of gastric acid secretion, H+-K+-ATPase (proton pump). Since this product is a weakly alkaline drug, the original drug has very little activity. After being absorbed into the blood, it is transported to the gastric mucosal cells, and finally reaches the secretory duct and the acidic cavity. It is continuously enriched and converted into biologically active sulfenic acid and sulfenic acid amine under the catalysis of acid. The active drug interacts with the H+-K+-...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/4439A61K47/38A61K47/14A61K47/04A61K47/10A61K47/12A61K47/32A61K47/20A61P1/04
Inventor 翟兆锋
Owner 崔银方
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