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Omeprazole micro-tablet capsule preparation and preparation method thereof

A technology of omeprazole microtablets and capsules, which is applied in the field of pharmaceutical preparations, can solve the problems of affecting the acid environment in the body, affecting the controlled release effect of hypertension drugs, and blood pressure fluctuations, and achieves simple and convenient preparation methods, reduced impact, and acid environment smooth effect

Inactive Publication Date: 2015-11-04
SHANGHAI SINE WANXIANG PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The invention provides an omeprazole microtablet capsule preparation and a preparation method thereof, which are used to solve the problem in the prior art that when hypertension and gastric ulcer are used in combination, changes in the blood concentration of omeprazole affect the acid environment in the body, Thus affecting the controlled release effect of hypertension drugs, causing the problem of blood pressure fluctuations

Method used

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  • Omeprazole micro-tablet capsule preparation and preparation method thereof
  • Omeprazole micro-tablet capsule preparation and preparation method thereof
  • Omeprazole micro-tablet capsule preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060]Embodiment 1: This preparation consists of the following components (unit: g / 1000 grains)

[0061] a. Tablet core prescription

[0062]

[0063] b. Coating prescription for controlled release layer

[0064] Hypromellose 13.5

[0065] Propylene Glycol 1

[0066] c. Immediate release layer coating prescription

[0067] Omeprazole 11

[0068] PVP K30 7

[0069] Dibutyl ester 1

[0070] d. Isolation layer coating prescription

[0071] Hypromellose 3.5

[0072] e. Enteric layer coating prescription

[0073] Methacrylic acid copolymer L30D-55 34

[0074] Diethyl phthalate 1.5

[0075] Concrete preparation steps are as follows:

[0076] 1) Preparation of tablet core: Omeprazole, sodium hydroxymethylcellulose, magnesium stearate, hydrogenated castor oil, microcrystalline fiber Preparing tablet cores with a diameter of 1-3 mm from plain element and methyl cellulose;

[0077] 2) Controlled-release layer coating: add hypromellose, propylene glycol, stearic acid, and...

example 2

[0082] Example 2: This preparation consists of the following components (unit: g / 1000 grains)

[0083] a. Tablet core prescription

[0084]

[0085] b. Coating prescription for controlled release layer

[0086] Eudragit RS 12

[0087] Eudragit E 1.5

[0088] Diethyl phthalate 1

[0089] c. Immediate release layer coating prescription

[0090] Omeprazole 5

[0091] PVP K30 9

[0092] Propylene glycol 0.5

[0093] d. Isolation layer coating prescription

[0094] PVP S630 6

[0095] e. Enteric layer coating prescription

[0096] Methacrylic acid copolymer L30D-55 31

[0097] Triethyl citrate 1.5

[0098] Concrete preparation steps are as follows:

[0099] 1) Preparation of tablet core: Omeprazole, sodium carboxymethylcellulose, stearic acid, magnesium stearate, pregelatinized The mixture of starch and methyl cellulose is prepared into a tablet core with a diameter of 1-3 mm;

[0100] 2) Controlled-release layer coating: Add Eudragit RS, Eudragit E, and diethyl ph...

Embodiment 3

[0105] Embodiment 3: This preparation consists of the following components (unit: g / 1000 grains)

[0106] a. Tablet core prescription

[0107]

[0108] b. Coating prescription for controlled release layer

[0109] PVP K30 18

[0110] Polyethylene glycol 1.5

[0111] c. Immediate release layer coating prescription

[0112] Omeprazole 14

[0113] HPMC 8

[0114] Polyethylene glycol 0.5

[0115] d. Isolation layer coating prescription

[0116] PVP K30 3

[0117] e. Enteric layer coating prescription

[0118] Methacrylic acid copolymer L30D-55 30

[0119] Propylene Glycol 2

[0120] Concrete preparation steps are as follows:

[0121] 1) Preparation of tablet core: Omeprazole, hypromellose, hydrogenated castor oil, stearic acid, microcrystalline cellulose and The mixture of PVP S630, magnesium stearate and micro silica gel is prepared into tablet cores with a diameter of 1-3mm;

[0122] 2) Coating of controlled release layer: add PVP K30, polyethylene glycol, steari...

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Abstract

Belonging to field of drug preparations, the invention discloses an omeprazole micro-tablet capsule preparation and a preparation method thereof. The omeprazole micro-tablet capsule preparation comprises a tablet core, a controlled release layer, a quick release layer, an isolation layer and an enteric layer. The omeprazole micro-tablet capsule preparation provided by the invention is an enteric controlled release micro-tablet capsule preparation of omeprazole, employs the structure of the tablet core and four layers of coatings to realize linear release of omeprazole, maintains in-vivo acid environment balance, can be used during combined medication of high blood pressure and gastric ulcer, reduces the influence to the controlled release effect of high blood pressure drugs and the blood pressure fluctuation caused thereby.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an omeprazole microtablet capsule preparation and a preparation method thereof. Background technique [0002] With the development of society, people's lifestyles are constantly changing, mainly due to smoking, drinking, emotional stress, drug stimulation, etc., the incidence of peptic ulcer is getting higher and higher, and it has become a common and frequently-occurring disease. It causes great pain and reduces the quality of life of patients. Based on the above reasons, the treatment of peptic ulcer has been paid more and more attention in clinical practice. Therefore, safe and effective anti-peptic ulcer drugs have attracted attention and become one of the focuses and directions of drug research and development. [0003] Omeprazole is an alternative to benzimidazole and the first proton pump inhibitor to be used clinically. It can inhibit gastric acid secretion by...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/4439A61P1/04
Inventor 顾煜董佳丽顾珽卢小玲郭晶晶王平
Owner SHANGHAI SINE WANXIANG PHARMA