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Preparation method of 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, good stability effect and simplified production process

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 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 problem by adding solubilizing agent in the prior art, still can not improve the dissolution rate of lansoprazole tablet better

Method used

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  • Preparation method of pharmaceutical composition for treating digestive system disease
  • Preparation method of pharmaceutical composition for treating digestive system disease
  • Preparation method of pharmaceutical composition for treating digestive system disease

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Embodiment 1: the preparation of lansoprazole enteric-coated tablet

[0050] (1) Premixing and crushing: 10 parts by weight of lansoprazole, 49 parts by weight of lactose, and 8.5 parts by weight of potassium sodium tartrate were mixed with a mixer for 10 minutes at a speed of 15 Hz, and pulverized with a pulverizer after mixing 80 mesh screen, mill speed 30Hz;

[0051] (2) Prepare adhesive: add 1.0 parts by weight of povidone K30 to 20 parts by weight of adhesive solvent 95% ethanol and stir to dissolve, add 0.6 parts by weight of polysorbate 80, and stir evenly;

[0052] (3) Mixing and granulation: Put the mixed and pulverized raw and auxiliary materials in step (1), 15 parts by weight of microcrystalline cellulose, and 6 parts by weight of internally added disintegrant crospovidone in a wet mixing granulator In the process, dry mix for 10 minutes, add the prepared binder, stir and cut at high speed for 150 seconds to obtain a soft material, and use a nylon mesh to c...

Embodiment 2

[0059] Embodiment 2: the preparation of lansoprazole enteric-coated tablet

[0060] (1) Premixing and pulverization: 14 parts by weight of lansoprazole, 52 parts by weight of lactose, and 9.8 parts by weight of potassium sodium tartrate were mixed with a mixer for 10 minutes at a speed of 15 Hz, and pulverized with a pulverizer after mixing 80 mesh screen, mill speed 30Hz;

[0061] (2) Prepare adhesive: add 1.5 parts by weight of povidone K30 to 22 parts by weight of adhesive solvent 95% ethanol and stir to dissolve, add 0.7 parts by weight of polysorbate 80, and stir evenly;

[0062] (3) Mixing and granulation: Put the mixed and pulverized raw and auxiliary materials in step (1), 17 parts by weight of microcrystalline cellulose, and 7.5 parts by weight of internally added disintegrant crospovidone in a wet mixing granulator In the middle, dry mix for 10 minutes, add the prepared binder, stir and cut at high speed for 150 seconds to obtain a soft material, and use a nylon mes...

Embodiment 3

[0069] Embodiment 3: the preparation of lansoprazole enteric-coated tablet

[0070] (1) Premixing and crushing: 15.7 parts by weight of lansoprazole, 54.5 parts by weight of lactose, and 10.5 parts by weight of potassium sodium tartrate were mixed with a mixer for 10 minutes at a speed of 15 Hz, and pulverized with a pulverizer after mixing 80 mesh screen, mill speed 30Hz;

[0071] (2) Prepare adhesive: add 1.9 parts by weight of povidone K30 to 24.1 parts by weight of adhesive solvent 95% ethanol and stir to dissolve, add 0.8 parts by weight of polysorbate 80, and stir evenly;

[0072] (3) Mixing and granulation: Put the mixed and crushed raw and auxiliary materials in step (1), 20.0 parts by weight of microcrystalline cellulose, and 8.3 parts by weight of internally added disintegrant crospovidone in a wet mixing granulator In the process, dry mix for 10 minutes, add the prepared binder, stir and cut at high speed for 150 seconds to obtain a soft material, and use a nylon m...

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Abstract

The invention discloses a preparation method of a pharmaceutical composition for treating a digestive system disease. The preparation method comprises the following steps: preparing a tablet core from the medical components, such as lansoprazole, lactose, microcrystalline cellulose, sodium potassium tartrate, polyvinylpolypyrrolidone, povidone K30, 95% ethyl alcohol, polysorbate 80 and superfine silica powder by wet granulation; and then coating the tablet core with hydroxypropyl methylcellulose phthalate, n-butyl stearate, talcum powder and 95% ethanol to prepare an enteric coated tablet. Through screening by a lot of experiments, coating materials hydroxypropyl methylcellulose phthalate and n-butyl stearate are combined; and the sodium potassium tartrate in the tablet core is added, so that an isolating layer does not need to coat between an enteric coat layer and the tablet core; the preparation technology is simplified; the production cost is reduced; and acceleration test and long-term test results show that compared with the prior art, the lansoprazole enteric coated tablet prepared by the preparation method has the advantages of good stability, high dissolution degree and low impurity content.

Description

technical field [0001] The invention relates to the technical field of medicine, and relates to a preparation method of a pharmaceutical composition for treating digestive system diseases, in particular to a preparation method of lansoprazole enteric-coated tablets. 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 acidic cavity, where the pH<1, the original drug is positively charged after being protonate...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/4439A61K47/38A61K47/14A61K47/02A61K47/10A61K47/12A61K47/32A61K47/26A61K47/34A61P1/04
Inventor 季涛
Owner 崔银方
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