Enteric coated preparation of lansoprazole sodium and preparation method thereof

A technology for lansoprazole sodium and enteric-coated preparations is applied in the field of lansoprazole sodium enteric-coated preparations and the preparation thereof, and can solve the adverse effects of light, humidity and heat on drugs, inconvenient storage and transportation, and reduced drug stability. problems, to achieve the effect of easy control of product quality, easy storage and transportation, and improved drug stability

Inactive Publication Date: 2006-12-27
JINZHOU JIUTAI PHARML CHINA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the lansoprazole sodium preparation is an injection, and its existing problems are: it can only be injected, it cannot be taken orally, it is inconvenient to take, it is inconvenient to store and transport, and light, humidity and heat have adverse effects on the medicine, reducing the stability of the medicine

Method used

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  • Enteric coated preparation of lansoprazole sodium and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Take 15~30g of lansoprazole sodium, 5~25g of disintegrant and 150~300g of diluent, pulverize and sieve, mix well, add 20~110g of wetting agent or binder as soft material, sieve for granulation, Vacuum dry at 30~50℃, sizing, add 5~15g of lubricant and mix, φ=0.5~1.0mm concave punching tablet, take 30~100g of coating agent, spray the isolation layer and enteric coating respectively to obtain Lanso Prazole sodium enteric-coated tablets. The diluent refers to any one or any two or any three of mannitol, crospovidone, lactose, starch, microcrystalline cellulose, and sucrose. The binder or wetting agent refers to any one or any of acrylic resin No. I to IV, poloxamer, hydroxypropyl methyl cellulose, microcrystalline cellulose, polyvinyl pyrrolidone Two or any three. The disintegrant refers to one to three types of sodium lauryl sulfate, methyl cellulose, povidone, modified starch, and hydroxyethyl methyl cellulose. The lubricant refers to any one or any two or any three of steary...

Embodiment 2

[0020] 1. the core

[0021] Lansoprazole sodium (main medicine) 18.4~36.8g

[0022] Starch (disintegrant) 25~50g

[0023] Mannitol (diluent) 15~30g

[0024] Lactose (diluent) 15~30g

[0025] Hypromellose 8% solution (adhesive, wetting agent) 15~30g

[0026] Magnesium stearate (lubricant) 3~10g

[0027] 1000 pieces

[0028] 2. Isolation layer

[0029] Hypromellose (coating agent) 082~1.63g

[0030] Titanium dioxide (coating agent) 0.15~0.30g

[0031] Tween-80 (coating agent) 5~15g

[0032] 1000 pieces

[0033] 3. Enteric coating layer

[0034] Polyacrylic resin II (enteric coating agent) 2.9~5.90g

[0035] Polyacrylic resin III (enteric coating agent) 0.72~1.44g

[0036] 95% ethanol 5~30g

[0037] Tween-80 (solubilizer) 3~10g

[0038] 1000 pieces

[0039] Weigh lansoprazole sodium and starch, mannitol, lactose according to the prescription, crush and sieve, mix well, add 8% hypromellose solution as soft material; 16# sieve for granulation; 30~50℃ vacuum Dry, granulate; mix with mag...

Embodiment 3

[0041] 1. the core

[0042] Lansoprazole sodium (main medicine) 18.4~36.8g

[0043] Starch (disintegrant) 20~40g

[0044] Mannitol (diluent) 25~50g

[0045] Lactose (diluent) 15~30g

[0046] Hypromellose 3% solution (adhesive, wetting agent) 10~40g

[0047] Magnesium stearate (lubricant) 5~15g

[0048] 1000 pieces

[0049] 2. Isolation layer

[0050] Hypromellose (coating agent) 0.81~1.63g

[0051] Titanium dioxide (coating agent) 1.5~3.0g

[0052] Tween-80 (coating agent) 3~10g

[0053] 1000 pieces

[0054] 3. Enteric coating layer

[0055] Polyacrylic resin II (enteric coating agent) 5.45~10.90g

[0056] Polyacrylic resin III (enteric coating agent) 1.22~2.44g

[0057] 95% ethanol 10~50g

[0058] Tween-80 (solubilizer) 5~15g

[0059] 1000 pieces

[0060] Weigh lansoprazole sodium and starch, mannitol, lactose according to the prescription, crush and sieve, mix well, add 3% hypromellose solution as soft material; 16# sieve for granulation; 30~50℃ vacuum Dry, granulate; mix with mag...

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Abstract

Disclosed is a Lansoprazole sodium intestine-dissolving preparation, which is prepared from Lansoprazole sodium 15-30 parts, thinning agent 150-300 parts, moistening agent or binding agent 20-110 parts, crumbling agent 5-25 parts, lubricating agent 5-15 parts and coating agent 30-100 parts through the steps of disintegrating, sieving, mixing, tabletting, and dressing isolation layer.

Description

Technical field [0001] The invention relates to a lansoprazole sodium enteric-coated preparation for treating peptic ulcer and a preparation method thereof. Background technique [0002] Lansoprazole sodium is a kind of 16 H 13 F 3 N 3 NaO 2 The benzimidazole compounds of S have a molecular weight of 391.34 and the following chemical structure: [0003] [0004] Its chemical name is: 2-{[[3-methyl-4-(2, 2, 2-trifluoroethoxy)-2-pyridine]methyl]sulfinyl}-1H-benzimidazole sodium salt . [0005] Lansoprazole is the second proton pump inhibitor developed by Japan’s Takeda Company after omeprazole. It was first marketed in France in 1992 and is mainly used clinically to treat gastric ulcer, duodenal ulcer, and Fluid esophagitis, Zor-Eye's syndrome and other symptoms. [0006] Lansoprazole is difficult to dissolve in water and its stability is also poor, which brings a lot of inconvenience to the formulation; while the sodium salt of lansoprazole can be dissolved in water and its chem...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/48A61K31/4412A61K47/38A61P1/04
Inventor 李志清杜桂杰陈海民
Owner JINZHOU JIUTAI PHARML CHINA
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