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Omeprazole enteric micro-pellet, capsule and preparation method of omeprazole enteric micro-pellet

A technology for omeprazole intestines and omeprazole, which is applied in the field of pharmaceutical preparations and their preparation, can solve the problems of omeprazole being unstable in damp heat, insoluble in liquid, and low in industrialized production yield, etc., and achieves improved stability. properties and utilization, improved in vitro release, and quality controllable effects

Active Publication Date: 2018-03-16
南京润瞳畅达医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patents CN103127003A and CN101036633A disclose a kind of omeprazole enteric-coated pellets and capsules prepared therefrom. The preparation process adopts blank pellets with drug-loading coating; Omeprazole is unstable due to humidity and heat, and its hydrophobicity is extremely strong. , poorly soluble in liquid and poor compatibility with liquid, low yield in industrial production, long time-consuming drug coating increases the risk of omeprazole degradation
[0011] CN101366703A discloses a kind of omeprazole enteric-coated pellet preparation and preparation method thereof, and this patent utilizes zein as the isolation coating material, and zein is a water-insoluble material that seriously affects the release and absorption of omeprazole ball cores and is unfavorable treatment effect

Method used

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  • Omeprazole enteric micro-pellet, capsule and preparation method of omeprazole enteric micro-pellet
  • Omeprazole enteric micro-pellet, capsule and preparation method of omeprazole enteric micro-pellet
  • Omeprazole enteric micro-pellet, capsule and preparation method of omeprazole enteric micro-pellet

Examples

Experimental program
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Effect test

Embodiment 1

[0039]

[0040]

[0041] Preparation:

[0042] 1. Soft material

[0043] Use a high-efficiency wet mixing granulator to prepare soft materials: ①Preparation of wetting agent: completely dissolve sodium lauryl sulfate and disodium hydrogen phosphate in purified water; ②Pre-treated and weighed omeprazole , mannitol, microcrystalline cellulose, anhydrous lactose, and hydroxypropyl cellulose were put into a high-efficiency wet granulator pot and dry-mixed for 15 minutes, then added a wetting agent, and increased the shear speed to make soft materials for 2 minutes.

[0044] 2. Granulation

[0045] Put the wet and soft material into the extrusion spheronizer, squeeze twice and then spheronize for 2min / time;

[0046] 3. Dry

[0047] Dry the granules in a fluidized bed at about 50°C until the water content is below 1.5%, and sieve through a 14-mesh sieve.

[0048] 4. Isolation layer coating

[0049] Dissolve hypromellose in water, add talcum powder under stirring, and disp...

Embodiment 2

[0053]

[0054]

[0055] The preparation method is the same as in Example 1.

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Abstract

The invention relates to an omeprazole enteric micro-pellet, a capsule and a preparation method of the omeprazole enteric micro-pellet. The omeprazole enteric micro-pellet specifically comprises a pill core, an isolating layer coating and an enteric coating, wherein the pill core is prepared from the following components in percentage by weight: 10 to 13 percent of omeprazole, 82 to 87 percent offiller, 2 to 5 percent of an adhesive, 0.4 to 0.8 percent of a surfactant and 0.4 to 0.8 percent of an alkaline stabilizer; the isolating layer coating is prepared from hydroxypropyl methylcellulose and talcum powder of which the weight ratio is 4 to 1, and the coating weight gain rate is 5 to 10 percent; the enteric layer coating is prepared from eudragit L30D-55, triethyl citrate and talcum powder of which the weight ratio is 1 to 0.1 to 0.1, and the coating weight gain rate is 25 to 30 percent.

Description

Technical field: [0001] The invention relates to a pharmaceutical preparation and a preparation method thereof, in particular to an omeprazole enteric-coated pellet, a capsule and a preparation method thereof. Background technique [0002] Omeprazole, English name: Omeprazole [0003] [0004] Its physical and chemical properties are as follows: [0005] Melting point: 156°C [0006] Storage conditions: 2-8°C [0007] Solubility: H2O:0.5mg / mL [0008] Chemical Properties: Crystallized from acetonitrile, [0009] As a proton pump inhibitor, it has a strong and long-lasting effect of inhibiting gastric acid secretion caused by basal gastric acid and food and pentaglandin. It is suitable for peptic ulcer, reflux esophagitis, etc. [0010] Existing products include omeprazole enteric-coated capsules and enteric-coated tablets. Chinese patents CN103127003A and CN101036633A disclose a kind of omeprazole enteric-coated pellets and capsules prepared therefrom. The preparat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/50A61K47/38A61K47/32A61K31/4439A61P1/04
CPCA61K9/5026A61K9/5047A61K9/5073A61K9/5089A61K31/4439
Inventor 陈刚张露方
Owner 南京润瞳畅达医药科技有限公司
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