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Mosapride Citrate Sustained Release Tablets

A technology for mosapride citrate and sustained-release tablets, which is applied in the direction of digestive system, pharmaceutical formulations, drug combinations, etc., and can solve the problems that sustained-release preparations are not necessarily suitable and the preparation process is complicated.

Active Publication Date: 2016-06-08
四川健能制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The patents whose publication numbers are CN1615877, CN1911233, CN101273973 and CN101756945 respectively disclose the solution to the problem of the chemical stability of mosapride in ordinary immediate-release preparations, but these disclosed technical solutions are not necessarily suitable for the preparation of sustained-release preparations, and the preparation process will be complicated

Method used

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  • Mosapride Citrate Sustained Release Tablets
  • Mosapride Citrate Sustained Release Tablets
  • Mosapride Citrate Sustained Release Tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] 1. Prescription:

[0017] Mosapride Citrate

15g

HPMC K4M

20g

HPMC K15M

15g

Lactose

60g

80% ethanol solution

Moderate

Magnesium stearate

2g

Opadry

2g

A total of 1000 pieces were made

[0018] 2. Process steps:

[0019] Take mosapride citrate, pulverize and pass through a 100-mesh sieve, stir with lactose at a high speed in a high-speed mixer for 5 minutes, wet it with 80% ethanol, granulate, and dry at 50 °C. After drying, the moisture of the granules is controlled to be less than 0.5 %, the granules pass through a 40-mesh sieve and granulate, add HPMCK4M, HPMCK15M, and magnesium stearate to mix evenly, and then press into tablets. The prepared plain tablet is coated with Opadry, the temperature of the tablet bed is controlled at 40-45 DEG C, the atomization pressure is 0.2-0.3 MPa, and the weight gain of the coated tablet is 2-2.5%.

[0020] Determination method of releas...

Embodiment 2

[0030] 1. Prescription:

[0031] Mosapride Citrate

15g

HPMC K4M

20g

HPMC K15M

10g

Lactose

50g

80% ethanol solution

Moderate

Magnesium stearate

2g

Opadry

2g

A total of 1000 pieces were made

[0032] 2. Process steps:

[0033] With embodiment 1;

[0034] The release measurement results are as follows:

[0035] time (h)

Cumulative release %

1

9.14

2

20.14

4

35.16

6

56.88

8

78.20

12

97.24

[0036] In production, the release degrees of 10,000 and 100,000 samples prepared according to the prescription and process are as follows:

[0037]

[0038] The samples of 1000 pieces, 10000 pieces and 100000 pieces were inspected by accelerated test respectively. Accelerated conditions: temperature: 40 degrees, humidity: RH75%;

[0039] The release results are as follows:

[0040]

[0041] Chemical sta...

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Abstract

The invention discloses a mosapride citrate dehydrate sustained release tablet. The sustained release tablet comprises the following components according to a unit dose package: 15mg of citric acid mosapride, 30-50mg of sustained-release materials, 30-70mg of a stabilizer, a bonding agent, a lubricant and a coating material. The sustained release tablet has a 12-hour sustained release effect and good chemical stability.

Description

technical field [0001] The present invention relates to the technical field of pharmaceutical preparations, specifically to a mosapride citrate sustained-release tablet. Background technique [0002] Patent Publication No. WO03 / 011256A1 discloses a mosapride citrate sustained-release tablet and a preparation method thereof. The sustained-release tablet has a 24-hour sustained-release effect. Crystalline cellulose, lactose, starch, HPMCK4M, HPMCK100M, magnesium stearate, micropowder silica gel, etc. The sustained-release tablet has poor reproducibility, large differences in release between batches, poor chemical stability, and large changes in related substances during long-term storage. [0003] The patent publication number CN102335154A discloses a mosapride citrate sustained-release tablet, the sustained-release tablet has a 12-hour sustained-release effect, and the sustained-release tablet is composed of mosapride citrate, sustained-release material, Composed of diluent...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/22A61K31/5375A61K47/38A61P1/08A61P1/14
Inventor 王国华胡延贵
Owner 四川健能制药有限公司
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