A kind of preparation method of omeprazole enteric-coated tablet

Abstract

The invention relates to a preparation method for an omeprazole enteric coated tablet. The components comprise in percents by weight: 10-50% of omeprazole, 1.25-6.25% of superfine silica powder, 30-78% of lactose, 2-3% of copolyvinylpyrrolidone, 5-12% of crospovidone, 1.5-2.0% of sodium octadecyl fumarate and 0.5-1.0% of magnesium stearate. The preparation method comprises: uniformly mixing micronized omeprazole and superfine silica powder, sieving; sieving copolyvinylpyrrolidone, crospovidone, lactose and sodium octadecyl fumarate, uniformly mixing with omeprazole and superfine silica powder, adding into a drying-method granulator, granulating for 3-4 times, screening out integrated particles with a 60 mesh sieve and obtaining dry particles; blending uniformly the dry particles and magnesium stearate by a three-dimensional mixer, adding into a tablet press for pressing tablets; and then coating to obtain the omeprazole enteric coated tablet. The formula is simple; the preparation method helps to solve the industrialized production problem of omeprazole enteric coated tablet high-specification products such as a product with a specification of 40 mg / tablet; and the preparation is controllable in quality, the product is good in uniformity, and impurity content is low.

Description

Technical field:

[0001] The invention relates to a preparation method of omeprazole enteric-coated tablets, belonging to the technical field of medicine preparation. Background technique:

[0002] The localized defect of the endometrial tissue in the part of the digestive tract that contacts the gastric juice, including the lower part of the esophagus and the first segment of the gastroduodenum, is usually called gastric ulcer and duodenal ulcer, collectively called peptic ulcer, and erosive gastritis can be Evolve into ulcer disease, motherland's medicine claims epigastric pain. In terms of epidemiology, peptic ulcer is a common disease, and its incidence rate varies greatly in different periods and regions, and the total incidence rate accounts for about 10-20% of the 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...

Examples

Embodiment 1

[0026] Drug specification: 10mg

[0027] The formula is as follows:

[0028]

[0029] Preparation method: The drug formula is the same as above.

[0030] 1. Omeprazole raw material is micronized, mixed with micropowder silica gel and passed through a 200-mesh sieve; Magnesium fatty acid passed through a 100-mesh sieve, set aside;

[0031] 2. Mix the raw and auxiliary materials except magnesium stearate for 60 minutes, and mix well;

[0032]3. Put the uniformly mixed material into the dry granulator for granulation, the filling speed frequency is 10 Hz, the granulation speed frequency is 30 Hz, the granulation pressure is 2-3 MPa, the size of the granulation screen is about 30 mesh, and pass through 3-4 times. Granulate, granulate with a 60-mesh sieve to obtain an appropriate amount of dry granules;

[0033] 4. Add dry granules and magnesium stearate to the three-dimensional mixer, mix for 20 minutes until uniform, add to the hopper of the tablet press, and press into ta...

Embodiment 2

[0036] Drug specification: 20mg

[0037] The formula is as follows:

[0038] Vegetarian Tablet Formula

Ratio (weight percent)

Formula quantity for 1000 tablets (g)

Omeprazole

25.00％

20.00

Micropowder silica gel

3.13％

2.50

lactose

60.12％

48.10

Copovidone

2.50％

2.00

Crospovidone

7.00％

5.60

Sodium Octadecyl Fumarate

1.50％

1.20

Magnesium stearate

0.75％

0.60

total

100％

80

[0039] Preparation method: The drug formula is the same as above.

[0040] 1. Omeprazole raw material is micronized, mixed with micropowder silica gel and passed through a 200-mesh sieve; Magnesium fatty acid passed through a 100-mesh sieve, set aside;

[0041] 2. Mix the raw and auxiliary materials except magnesium stearate for 60 minutes, and mix well;

[0042] 3. Put the uniformly mixed material into the dry granulator for granulation, the filling speed frequency ...

Embodiment 3

[0046] Drug specification: 40mg

[0047] The formula is as follows:

[0048] Vegetarian Tablet Formula

Ratio (weight percent)

Formula quantity for 1000 tablets (g)

Omeprazole

45.45％

40.00

Micropowder silica gel

5.68％

5.00

lactose

36.21％

31.86

Copovidone

2.05％

1.80

Crospovidone

7.95％

7.00

Sodium Octadecyl Fumarate

1.75％

1.54

Magnesium stearate

0.91％

0.80

[0049] total

100％

88

[0050] Preparation method: The drug formula is the same as above.

[0051] 1. Omeprazole raw material is micronized, mixed with micropowder silica gel and passed through a 200-mesh sieve; Magnesium fatty acid passed through a 100-mesh sieve, set aside;

[0052] 2. Mix the raw and auxiliary materials except magnesium stearate for 60 minutes, and mix well;

[0053] 3. Put the uniformly mixed material into the dry granulator for granulation, the filli...

Technical field:

[0001] The invention relates to a preparation method of omeprazole enteric-coated tablets, belonging to the technical field of medicine preparation. Background technique:

[0002] The localized defect of the endometrial tissue in the part of the digestive tract that contacts the gastric juice, including the lower part of the esophagus and the first segment of the gastroduodenum, is usually called gastric ulcer and duodenal ulcer, collectively called peptic ulcer, and erosive gastritis can be Evolve into ulcer disease, motherland's medicine claims epigastric pain. In terms of epidemiology, peptic ulcer is a common disease, and its incidence rate varies greatly in different periods and regions, and the total incidence rate accounts for about 10-20% of the 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...

Examples

Embodiment 1

[0026] Drug specification: 10mg

[0027] The formula is as follows:

[0028]

[0029] Preparation method: The drug formula is the same as above.

[0030] 1. Omeprazole raw material is micronized, mixed with micropowder silica gel and passed through a 200-mesh sieve; Magnesium fatty acid passed through a 100-mesh sieve, set aside;

[0031] 2. Mix the raw and auxiliary materials except magnesium stearate for 60 minutes, and mix well;

[0032]3. Put the uniformly mixed material into the dry granulator for granulation, the filling speed frequency is 10 Hz, the granulation speed frequency is 30 Hz, the granulation pressure is 2-3 MPa, the size of the granulation screen is about 30 mesh, and pass through 3-4 times. Granulate, granulate with a 60-mesh sieve to obtain an appropriate amount of dry granules;

[0033] 4. Add dry granules and magnesium stearate to the three-dimensional mixer, mix for 20 minutes until uniform, add to the hopper of the tablet press, and press into ta...

Embodiment 2

[0036] Drug specification: 20mg

[0037] The formula is as follows:

[0038] Vegetarian Tablet Formula

Ratio (weight percent)

Formula quantity for 1000 tablets (g)

Omeprazole

25.00％

20.00

Micropowder silica gel

3.13％

2.50

lactose

60.12％

48.10

Copovidone

2.50％

2.00

Crospovidone

7.00％

5.60

Sodium Octadecyl Fumarate

1.50％

1.20

Magnesium stearate

0.75％

0.60

total

100％

80

[0039] Preparation method: The drug formula is the same as above.

[0040] 1. Omeprazole raw material is micronized, mixed with micropowder silica gel and passed through a 200-mesh sieve; Magnesium fatty acid passed through a 100-mesh sieve, set aside;

[0041] 2. Mix the raw and auxiliary materials except magnesium stearate for 60 minutes, and mix well;

[0042] 3. Put the uniformly mixed material into the dry granulator for granulation, the filling speed frequency ...

Embodiment 3

[0046] Drug specification: 40mg

[0047] The formula is as follows:

[0048] Vegetarian Tablet Formula

Ratio (weight percent)

Formula quantity for 1000 tablets (g)

Omeprazole

45.45％

40.00

Micropowder silica gel

5.68％

5.00

lactose

36.21％

31.86

Copovidone

2.05％

1.80

Crospovidone

7.95％

7.00

Sodium Octadecyl Fumarate

1.75％

1.54

Magnesium stearate

0.91％

0.80

[0049] total

100％

88

[0050] Preparation method: The drug formula is the same as above.

[0051] 1. Omeprazole raw material is micronized, mixed with micropowder silica gel and passed through a 200-mesh sieve; Magnesium fatty acid passed through a 100-mesh sieve, set aside;

[0052] 2. Mix the raw and auxiliary materials except magnesium stearate for 60 minutes, and mix well;

[0053] 3. Put the uniformly mixed material into the dry granulator for granulation, the filli...

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