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Mosapride citrate dehydrate sustained release tablet

A technology for mosapride citrate and sustained-release tablets, which is applied to medical preparations of non-active ingredients, digestive system, organic active ingredients, etc. It can solve the problems that sustained-release preparations are not necessarily suitable and the preparation process is complicated.

Active Publication Date: 2013-10-23
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 dehydrate sustained release tablet
  • Mosapride citrate dehydrate sustained release tablet
  • Mosapride citrate dehydrate sustained release tablet

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

Appropriate amount

Magnesium stearate

2g

Opadry

2g

A total of 1000 pieces were made

[0018] 2. Process steps:

[0019] Take mosapride citrate, pulverize it and pass through a 100-mesh sieve, stir it with lactose in a high-speed mixer for 5 minutes, moisten it with 80% ethanol and granulate it, dry it at 50°C, and control the moisture content of the granules to less than 0.5 %, the granules pass through a 40-mesh sieve for granulation, add HPMC K4M, HPMC K15M, and magnesium stearate to mix evenly and then press into tablets. The prepared plain tablets are coated with Opadry, the tablet bed temperature is controlled at 40-45°C, the atomization pressure is 0.2-0.3MPa, and the weight gain of the coated tablets is 2-2.5%.

[0020] Release measurement method:...

Embodiment 2

[0030] 1. Prescription:

[0031] Mosapride citrate

15g

HPMC K4M

20g

HPMC K15M

10g

lactose

50g

80% ethanol solution

Appropriate amount

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, according to the prescription and process, the release of 10,000 and 100,000 samples of samples is as follows:

[0037]

[0038] 1000 pieces, 10,000 pieces, and 100,000 pieces of samples were respectively inspected through accelerated tests. Acceleration conditions: temperature: 40 degrees, humidity: RH75%;

[0039] The release results are ...

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PUM

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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 invention relates to the technical field of pharmaceutical preparations, in particular to a sustained-release mosapride citrate tablet. Background technique [0002] Publication number is that the patent of WO03 / 011256A1 discloses a kind of mosapride citrate sustained-release tablet and preparation method thereof, and this sustained-release tablet has 24 hours sustained-release effect, and this sustained-release tablet is made of mosapride, micro Crystalline cellulose, lactose, starch, HPMCK4M, HPMCK100M, magnesium stearate, micronized silica gel, etc. The sustained-release tablet has poor reproducibility, large release difference between batches, and poor chemical stability, and the related substances change greatly during long-term storage. [0003] The patent with publication number CN102335154A discloses a kind of mosapride citrate sustained-release tablet, which has a 12-hour sustained-release effect. The sustained-release tablet is composed ...

Claims

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Application Information

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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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