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Lansoprazole enteric-coated tablet and method for preparing same

A technology of lansoprazole enteric and lansoprazole, which is applied in the field of preparation of lansoprazole enteric-coated tablets, can solve problems such as the decrease of lansoprazole content, the increase of related substances, and poor compatibility stability, so as to achieve improvement Effects of bioavailability, enhanced release, and guaranteed stability

Active Publication Date: 2013-04-03
KANGYA OF NINGXIA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to the investigation results of the stability of this patented drug, the relevant substances have been significantly increased in the accelerated test of lansoprazole enteric-coated tablets for 6 months and the long-term sample retention for 12 months, which has a great impact on the quality of the drug
[0011] In the authorized patent "a stable lansoprazole enteric-coated tablet and its preparation method" (publication number: CN101716159A), sodium lauryl sulfate and magnesium stearate are used in the prescription, and in this prescription The compatibility stability of magnesium stearate and sodium lauryl sulfate with lansoprazole is poor, and the content of lansoprazole drops significantly after being placed at 40°C for a week, and sodium lauryl sulfate is mainly used for solubilization. However, lansoprazole is a poorly soluble drug, and the use of SDS can not completely release the drug. According to the results of the investigation of the stability of this patented drug, it can be seen that when the accelerated test of lansoprazole enteric-coated tablets lasts for 6 months and the long-term sample retention for 12 months , related substances have been significantly increased, which has a great impact on the quality of medicines

Method used

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  • Lansoprazole enteric-coated tablet and method for preparing same
  • Lansoprazole enteric-coated tablet and method for preparing same
  • Lansoprazole enteric-coated tablet and method for preparing same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] prescription

[0035]

[0036] Adhesive:

[0037]

[0038] Gown Prescription:

[0039]

[0040] Casing Prescription:

[0041]

[0042] Preparation Process

[0043] 1. Weigh the prescribed amount of povidone and poloxamer, dissolve with absolute ethanol, and prepare 4% povidone and 8% poloxamer absolute ethanol solution, as adhesive, for subsequent use;

[0044] 2. Under the condition of avoiding light, weigh the prescribed amount of lansoprazole and meglumine, anhydrous sodium sulfite, and anhydrous sodium carbonate, and mix them evenly by the method of equal amount addition, then pulverize them with an ultrafine pulverizer, and set aside ;

[0045] 3. Weigh the prescription amount of mannitol, microcrystalline cellulose and sodium carboxymethyl starch and mix them evenly with the 2-step mixed powder, pass through a 40-mesh sieve, add an appropriate amount of binder to make a soft material, granulate with a 30-mesh sieve, and dry at 40°C After 60 minute...

Embodiment 2

[0049] prescription

[0050]

[0051]

[0052] Adhesive:

[0053]

[0054] Gown Prescription:

[0055]

[0056] Casing Prescription:

[0057]

[0058] Preparation Process

[0059] 1. Weigh the prescribed amount of povidone and poloxamer, and dissolve them with absolute ethanol to make 4% povidone and 8% poloxamer absolute ethanol solution, as adhesive, for subsequent use;

[0060] 2. Under the condition of avoiding light, weigh the prescribed amount of lansoprazole, meglumine, sodium sulfite, and anhydrous sodium carbonate, mix them uniformly by using the equal-volume incremental method, and then pulverize them with an ultrafine pulverizer, and set them aside;

[0061] 3. Weigh the prescription amount of mannitol, microcrystalline cellulose and sodium carboxymethyl starch and mix them evenly with the 2-step mixed powder, pass through a 40-mesh sieve, then add an appropriate amount of binder to make a soft material, granulate with a 30-mesh sieve, and granulate ...

Embodiment 3

[0065] prescription

[0066]

[0067] Adhesive:

[0068]

[0069] Gown Prescription:

[0070]

[0071] Casing Prescription:

[0072]

[0073] Preparation Process

[0074] 1. Weigh the prescribed amount of povidone and poloxamer, and dissolve them with absolute ethanol to make 4% povidone and 8% poloxamer absolute ethanol solution, as adhesive, for subsequent use;

[0075] 2. Under the dark condition, weigh the prescription amount of lansoprazole and meglumine, anhydrous sodium sulfite, and sodium carbonate, mix them evenly by using the equal-volume incremental method, then pulverize them with an ultrafine pulverizer, and set them aside;

[0076] 3. Weigh the prescription amount of mannitol, microcrystalline cellulose and sodium carboxymethyl starch and mix them evenly with the 2-step mixed powder, pass through a 40-mesh sieve, granulate with a 30-mesh sieve, dry at 40°C for 60 minutes, take the dry granules, and pass through a 30-mesh sieve Whole grains, add th...

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PUM

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Abstract

The invention discloses a lansoprazole enteric-coated tablet which comprises lansoprazole, a stabilizer, an antioxidant, a filler, a disintegrant, a lubricant and an appropriate amount of adhesive, wherein the lansoprazole servers as an active component. The lansoprazole is made into the tablets for treating peptic ulcer. The lansoprazole enteric-coated tablet is characterized in that the alkaline stabilizer is adopted in the prescription so that a weak-alkaline microenvironment can be formed in the lansoprazole enteric-coated tablet and the degradation of medicament in the presence of other accessories and under the acidic condition is inhibited, and the antioxidant is added to the prescription so that the oxidation and the degradation of the medicament in the air are inhibited and the quality of the medicament is guaranteed. During production, the active pharmaceutical components and a part of accessories are micronized so that the particle size of the active pharmaceutical components is reduced and the solubility of the medicament is improved. Due to the adoption of the enteric coating process, the degradation of the medicament in the gastric acid is avoided, the targeted release of the medicament is guaranteed, and the bioavailability of the medicament is improved. Due to the optimization of the prescription and the process, the stability of the medicament during production is guaranteed, and the quality of the production is improved.

Description

technical field [0001] The invention relates to a preparation method of lansoprazole enteric-coated tablets, in particular to a pharmaceutical preparation, formula composition and preparation method of lansoprazole. Background technique [0002] Peptic ulcer refers to the chronic ulcer in the contact part of gastrointestinal tract and gastric juice. It has a high incidence rate and is one of the common chronic diseases of the digestive system. Its formation and development are closely related to the digestion of gastric acid and pepsin. The prevalence rate in the population accounts for about 10%, and it can be seen at any age, but most of them are 20-50 years old, and there are more men than women, the ratio of the two is about 2-4:1, and the proportion of elderly patients increases with the average age. increased. [0003] Lansoprazole is a second-generation proton pump inhibitor that reduces gastric acid secretion in vivo by acting on the acid pump of gastric parietal (o...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/4439A61K47/26A61K47/04A61P1/04A61P35/00
Inventor 杨亚军李娟
Owner KANGYA OF NINGXIA PHARMA
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