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A kind of esomeprazole enteric-coated pellets and preparation method thereof

A technology for esomeprazole and pellets, which is applied in pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve the problems of sudden release risks and side effects, and achieve no sudden release. risk, solving the risk of sudden release, the effect of clinical application safety

Inactive Publication Date: 2016-10-19
JINAN KANGHE MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The invention provides a preparation of esomeprazole enteric-coated pellets and a preparation method thereof. The preparation is safe and effective in clinical application, and solves the defects of sudden release risk and relatively large side effects after taking the drug in the current similar products. The product has higher quality stability

Method used

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  • A kind of esomeprazole enteric-coated pellets and preparation method thereof
  • A kind of esomeprazole enteric-coated pellets and preparation method thereof
  • A kind of esomeprazole enteric-coated pellets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034]Example 1: Preparation of Esomeprazole Magnesium Enteric-Coated Capsules

[0035]

[0036] Preparation Process:

[0037] 1. Prepare blank cores:

[0038] After the microcrystalline cellulose is crushed and passed through a 200 mesh sieve, part of it is added to the centrifugal pellet machine for mother use, and part of it is reserved for dusting; the starch is dissolved in an appropriate amount of hot purified water to prepare a starch with a concentration of 5% (g / ml) The slurry is used as a binder for standby; the centrifugal pellet machine is turned on to prepare pellets; after the pellets are raised, powder is added, and the pellets are enlarged according to the ratio of powder supply and liquid supply 2:1-3:1. , dried, and sieved to leave 35 mesh-45 mesh microcrystalline cellulose pellets for subsequent use.

[0039] 2. Calcium carbonate is pulverized to control the particle size of 0.5 μm-15 μm for later use; the crystal form stabilizer polyoxyethylene PEO a...

Embodiment 2

[0043] Embodiment two: the preparation of esomeprazole strontium dry suspension

[0044]

[0045] Preparation Process:

[0046] 1. Magnesium hydroxide is pulverized, and the particle size is controlled to be 0.5 μm-15 μm as a powder for later use. Polyoxyethylene PEO, polyvinyl pyrrolidone, and esomeprazole strontium are dissolved in 30% acetone solution to prepare a 10% (g / g) concentration, as a binder;

[0047] 2. Put the commercially available sugar pills into the centrifugal pill making machine, adopt the solid phase lamination process, spray the adhesive while dusting, control the centrifugal speed at 350-600 rpm, and the ratio of powder dusting and liquid spraying is 2:1: -3:1 for drug application, 30-40 ℃ blowing hot air to dry, to obtain drug-containing pellets.

[0048] 3. The product name "Opadry" gastric soluble coating powder is dissolved in the aqueous solution to prepare a solution of 8%-12% (g / g), and the core of the pill containing the drug is coated w...

Embodiment 3

[0068] Embodiment three: result analysis

[0069] 1. Stability comparison results:

[0070] The samples prepared in Examples 1, 2 and Comparative Examples were respectively placed under the conditions of accelerated (temperature 40°C, humidity 75%) and long-term test (temperature 25°C, humidity 65%) according to the Chinese Pharmacopoeia method to detect product content, related Dissolution curves in substances and standard media, as follows:

[0071]

[0072] From the above experimental results, it can be clearly seen that the sample content and related substances prepared according to the technology provided by this patent are relatively stable during the stable storage period, and the release curve basically does not drift in 0 months, accelerated 6 months, and long-term 24 months.

[0073] , DSC test comparison results:

[0074] Differential scanning calorimeter (DSC) is a technology that measures the energy difference between substances with temperature under program...

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Abstract

The invention discloses an enteric-coated micropill preparation of esomeprazole and a preparation method thereof, which is prepared by coating the drug-containing micropill with an isolation coat and an enteric-coated coating; Meprazole active ingredient, crystal form stabilizer, basifying agent; the active ingredient of esomeprazole is the crystalline hydrate of esomeprazole strontium salt or magnesium salt; the crystal form stabilizer is polyoxyethylene A mixture of PEO and hypromellose or a mixture of polyoxyethylene PEO and polyvinylpyrrolidone; the weight ratio of the esomeprazole active ingredient, crystal form stabilizer and alkalizing agent is 20:4-10: 10‑20. Adding a certain proportion of crystal form stabilizer and basifying agent to the specific solvent of the present invention enables esomeprazole strontium or magnesium salt to obtain a pharmaceutical preparation with extremely high optical and crystal form purity. The preparation is safe and effective in clinical application, and solves the defects of sudden release risk and relatively large side effects after taking the drug that exist in similar products at present, and the product has higher quality stability.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an esomeprazole enteric-coated pellet and a preparation method thereof. Background technique [0002] Gastric ulcer and drug treatment With the development of our society, environmental changes, population structure and changes in people's lifestyles, peptic ulcers mainly caused by smoking, drinking, emotional stress, and drug stimulation have become a common and frequently-occurring disease. According to statistics, the incidence of gastrointestinal diseases in our country is 11.43%, among which the incidence of peptic ulcer is 4.54%, which brings great pain to patients and leads to a decrease in the quality of life of patients. For these reasons, the treatment of peptic ulcer has received more and more attention and attention in clinical practice. [0003] Commonly used drugs include proton pump inhibitors (PPIs), H 2 Receptor antagonists, antacids, gastric mucosal ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/4439A61K47/34A61K47/38A61K47/32A61P1/04
Inventor 张颖刘元鑫时耿青杨江勇赫红曲延伟
Owner JINAN KANGHE MEDICAL TECH
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