Medical lansoprazole composition for treating gastric ulcer

A technology of lansoprazole and composition, which is applied in the field of lansoprazole enteric-coated tablet composition, can solve problems such as unsatisfactory results and influence on drug quality, achieve small content changes, improve dissolution rate, and good fluidity Effect

Inactive Publication Date: 2015-09-02
苗怡文
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] However, according to the chemical structure characteristics of lansoprazole, lansoprazole easily produces the following impurity A, impurity B and impurity E during production and storage, and these trace impurities will affect the quality of the drug
Although some crystal forms of the above-mentioned lansoprazole have improved its hygroscopicity, solubility or stability to a certain extent, the inventors' results are not ideal after investigating the impurities of the above-mentioned certain crystal forms

Method used

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  • Medical lansoprazole composition for treating gastric ulcer
  • Medical lansoprazole composition for treating gastric ulcer
  • Medical lansoprazole composition for treating gastric ulcer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Example 1: Preparation of Lansoprazole Crystals

[0044] Get lansoprazole crude drug, add 15-25 ℃ volume in the mixed solvent of methanol, dimethylformamide, carbon tetrachloride that is 8 times of the weight of lansoprazole, methanol, dimethylformamide, tetrachloride Carbon chloride volume ratio is 3:2.5:1, obtains solution; Apply the constant magnetic field that magnetic field intensity is 0.5T-0.8T then on the horizontal direction of the liquid surface of gained solution, and under the condition of this constant magnetic field, to solution Dropping volume is lansoprazole weight 10 times the mixed solvent of acetone, ethyl acetate, ether, the volume ratio of acetone, ethyl acetate and ether is 5:3:2.5; , washed, and vacuum-dried for 3 hours to obtain the lansoprazole compound.

[0045] The X-ray powder diffraction pattern that the prepared lansoprazole crystal uses Cu-Kα ray measurement to obtain is as follows figure 1 Shown, its purity as determined by high perfo...

Embodiment 2

[0046] Example 2: The preparation of Lansol enteric-coated tablets, the steps are as follows:

[0047] Prescription: in parts by weight

[0048]

[0049] Preparation:

[0050] 1) Processing of raw and auxiliary materials: use a vibrating sieve powder machine to sieve the raw material lansoprazole to 80 mesh, and use a pulverizer to crush calcium hydrogen phosphate to pass through a 120 mesh sieve;

[0051] 2) Weigh the raw and auxiliary materials according to the prescription quantity;

[0052] 3) Preparation of adhesive: Take purified water at 70-80°C and place it in a stainless steel bucket, add hypromellose while stirring, stir until completely dissolved, wait until the temperature drops to room temperature, add sodium lauryl sulfate, and stir 4) Mix and granulate: add lansoprazole crystals, lactose, microcrystalline cellulose, carboxymethyl starch sodium, and calcium hydrogen phosphate into the wet mixing granulator, turn on the stirring motor and dry mix for 10 min...

Embodiment 3

[0058] Example 3: The preparation of Lansol enteric-coated tablets, the steps are as follows:

[0059] Prescription: in parts by weight

[0060]

[0061] Preparation:

[0062] 1) Processing of raw and auxiliary materials: use a vibrating sieve powder machine to sieve the raw material lansoprazole to 80 mesh, and use a pulverizer to crush calcium hydrogen phosphate to pass through a 120 mesh sieve;

[0063] 2) Weigh the raw and auxiliary materials according to the prescription quantity;

[0064] 3) Preparation of adhesive: Take purified water at 70-80°C and place it in a stainless steel bucket, add hypromellose while stirring, stir until completely dissolved, wait until the temperature drops to room temperature, add sodium lauryl sulfate, and stir 4) Mix and granulate: add lansoprazole crystals, lactose, microcrystalline cellulose, carboxymethyl starch sodium, and calcium hydrogen phosphate into the wet mixing granulator, turn on the stirring motor and dry mix for 10 min...

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Abstract

The invention discloses a medical lansoprazole composition for treating gastric ulcer, and belongs to the technical field of medicines. The composition comprises a tablet core, an isolating layer and an enteric coated layer, wherein the tablet core is prepared from a lansoprazole crystal, lactose, microcrystalline cellulose, carboxymethyl starch sodium, calcium hydrophosphate, hydroxypropyl methylcellulose, purified water, lauryl sodium sulfate and silicon dioxide; the isolating layer is prepared by dissolving a film coating premixing agent into 95% ethanol; the enteric coated layer is prepared by dissolving opadry into 95% ethanol. The lansoprazole crystal compound is free of impurity E; the contents of impurity A and impurity B are obviously reduced and changed a little as the storage time goes on; the composition is outstanding in mobility, and the dissolution rate is obviously improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a drug lansoprazole composition for treating gastric ulcer, in particular to a lansoprazole enteric-coated tablet composition. Background technique [0002] Lansoprazole is a benzimidazole derivative with anti-acid effect developed by Takeda Corporation of Japan in December 1991. It acts on the H+-K+-ATPase of gastric parietal cells, so that the H+ of parietal cells cannot be transported into the stomach It is used to treat gastric ulcer, duodenal ulcer and reflux esophagitis, and to eradicate Helicobacter pylori. [0003] Lansoprazole is a new type of proton pump inhibitor, which is an upgraded product of omeprazole. Lansoprazole has introduced fluorine into the side chain at the 4-position of the pyridine ring and has a trifluoroethoxy substituent, so that its bioavailability is relatively low. Omeprazole is increased by more than 30%, and its lipophilicity is stronger than tha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4439A61P1/04A61P31/04C07D401/12
Inventor 曹荣美鲁华荣
Owner 苗怡文
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