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Omeprazole composition and preparing process thereof

A technology of omeprazole and omeprazole capsules, which is applied in the field of preparation of the composition, can solve the problems of large dosage, inability to ensure stable absorption of omeprazole, complex process operation, etc., and achieve the effect of stable pH value

Active Publication Date: 2010-09-29
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] The above two dosage forms are not coated with enteric coating, which cannot guarantee the stable absorption of omeprazole. In addition, these two dosage forms have large doses and complicated process operations, so they are not suitable for large-scale industrial production.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0071] 1. Preparation of enteric-coated pellets:

[0072] Ball core prescription:

[0073] Component Weight (g) Weight percentage (%)

[0074] Omeprazole 10 4.8

[0075] Sodium bicarbonate 100 47.6

[0076] Microcrystalline Cellulose PH301 100 47.6

[0077] Total 210 100

[0078] After the above prescription is mixed evenly, it is added into a centrifugal granulator to form several ball cores, and an appropriate amount of 2-4% hydroxypropyl methylcellulose (HPMC) aqueous solution is selected as the binder.

[0079] Isolation Layer Prescription:

[0080] Component Weight (g) Weight percentage (%)

[0081] HPMC 2 1.9

[0082] Talc 3 2.8

[0083] Propylene glycol 1 0.9

[0084] 75% ethanol 100 94.4

[0085] Total 106 100

[0086] Mix the above-mentioned isolation layer materials evenly, and use a centrifugal granulator to coat the above-mentioned pellet cores.

[0087] Enteric coating layer prescription:

[0088] Component Weight (g) Weight percentage (%)

[0089] D...

Embodiment 2

[0102] 1. Preparation of enteric-coated pellets:

[0103] Ball core prescription:

[0104] Component Weight (g) Weight percentage (%)

[0105] Omeprazole 10 3.7

[0106] Sodium bicarbonate 150 55.6

[0107] Microcrystalline cellulose 100 37.0

[0108] Sodium carboxymethyl starch 10 3.7

[0109] Total 270 100

[0110] After the above prescription is mixed evenly, it is added into a centrifugal granulator to make some ball cores, and an appropriate amount of 2% hydroxypropyl methylcellulose (HPMC) aqueous solution is selected as the binder.

[0111] Isolation Layer Prescription:

[0112] Component Weight (g) Weight percentage (%)

[0113] HPMC 2 1.9

[0114] Talc 3 2.8

[0115] Propylene glycol 1 0.9

[0116] 75% ethanol 100 94.4

[0117] Total 106 100

[0118] Mix the above-mentioned isolation layer materials evenly, and use a centrifugal granulator to coat the above-mentioned ball cores.

[0119] Enteric coating layer prescription:

[0120] Component Weight (g) W...

Embodiment 3

[0136] 1. Preparation of enteric-coated pellets:

[0137] Ball core prescription:

[0138] Component Weight (g) Weight percentage (%)

[0139] Omeprazole 10 3.2

[0140] Sodium bicarbonate 200 64.5

[0141] Microcrystalline cellulose 100 32.3

[0142] Total 310 100

[0143] After the above prescription is mixed evenly, it is added into a centrifugal granulator to form pellets, and an appropriate amount of 2-4% hydroxypropyl methylcellulose aqueous solution is selected as the binder.

[0144] Isolation Layer Prescription:

[0145] Component Weight (g) Weight percentage (%)

[0146] HPMC 2 1.9

[0147] Talc 3 2.8

[0148] Propylene glycol 1 0.9

[0149] 75% ethanol 100 94.4

[0150] Total 106 100

[0151] Mix the above-mentioned isolation layer materials evenly, and use a centrifugal granulator to coat the above-mentioned pellet cores.

[0152] Enteric coating layer prescription:

[0153] Component Weight (g) Weight percentage (%)

[0154] Domestic No. Ⅱ resin 4 3....

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PUM

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Abstract

A compound of the omeprazole and the Sodium Bicarbonate comprise a plurality of enteric-coated pellets composed by the omeprazole and the Sodium Bicarbonate, the capsules composed by Sodium Bicarbonate of any mode. The enteric-coated pellets comprise a pellet core, an isolation layer and an enteric-coated layer. The present invention has the advantages that acid degradation of the omeprazole is resolved by the enteric-coated layer, which prolongs binding between the gastric wall and omeprazole. When Sodium Bicarbonate of any mode neutralizing the gastric acid reaches a certain PH value, the enteric-coated layer can disintegrate and omeprazole can be released. PH value in the stomach remains stable during the releasing process. Another advantage of the present invention is that the compound can be taken at any time when stomachache happens.

Description

technical field [0001] The invention relates to a composition of omeprazole and sodium bicarbonate, and also relates to a preparation method of the composition. technical background [0002] Digestive system disease is one of common frequently-occurring diseases, wherein is based on ulcer disease, and total sickness rate accounts for about 10~20% of population. About 10% of patients with peptic ulcer disease in the United States, 12.3% in Germany; According to a survey in a few areas in my country, the incidence of digestive tract diseases is 11.43%, of which the incidence of peptic ulcer is 4.54%. [0003] With the social development of our country, environmental changes, changes in population structure and people's lifestyles, mainly due to smoking, drinking, emotional stress, drug stimulation, etc., the incidence of peptic ulcer has gradually increased, becoming a common and frequently-occurring disease. It causes great suffering to the patients and leads to a decline in...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K31/4439A61K47/02A61K47/34A61K47/38A61P1/04A61K47/32
Inventor 王金戌王会英刘海丽孙建华周桂荣李云立容彦华
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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