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A kind of pharmaceutical composition containing mosapride citrate

A mosapride citrate and composition technology, applied in the field of pharmaceutical compositions containing mosapride citrate, can solve the problems of unstable storage of pharmaceutical preparations, long production cycle, complicated preparation process, etc.

Active Publication Date: 2021-09-07
CHENGDU KANGHONG PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In order to solve the problems of unstable long-term storage of the existing pharmaceutical preparations containing mosapride citrate, complex preparation process, harsh preparation conditions or storage and packaging conditions, long production cycle and high production cost, the present invention provides A kind of pharmaceutical composition containing mosapride citrate, described pharmaceutical composition contains mosapride citrate, reducing sugar and magnesium stearate, the preparation method of described pharmaceutical composition comprises the following steps:

Method used

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  • A kind of pharmaceutical composition containing mosapride citrate
  • A kind of pharmaceutical composition containing mosapride citrate
  • A kind of pharmaceutical composition containing mosapride citrate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0097]

[0098]

[0099] The preparation method is:

[0100] 1) The formulation amount of spray-dried lactose and magnesium stearate are thoroughly mixed to obtain a mixture, the standby;

[0101] 2) the formulation amounts Mosapride thoroughly mixed with the other pharmaceutically acceptable excipients, to obtain a mixture containing drug use;

[0102] 3) Take a mixture of drug-containing mixture was thoroughly mixed, the material, tableting, the use of PVC bag, 1000 were made. For finished product testing and dissolution matter content. Then were 20 days limit accelerated test and 3 months conventional accelerated testing investigated substances and dissolution of situations, acceleration condition: limit acceleration: 60 ℃ ± 2 ℃ / RH = 90% ± 5%, the conventional acceleration: 40 ℃ ± 2 ℃ / RH = 75% ± 5%.

[0103]

Embodiment 2

[0105]

[0106] The preparation method is:

[0107] 1) The formulation amount of spray-dried lactose and magnesium stearate are thoroughly mixed to obtain a mixture, the standby;

[0108] 2) the formulation amounts Mosapride mixed with polyethylene glycol 4000, to obtain the drug-containing mixture, standby;

[0109] 3) The drug-containing mixture is a mixture thoroughly mixed and granulated with a solution of hydroxypropyl cellulose in ethanol was added a prescribed amount, screening, PVC packaging. Finished product testing dissolution, content uniformity and the content of related substances, and were 20 days limit accelerated test and 3 months conventional accelerated testing investigated substances and dissolution of situations, acceleration condition: limit acceleration: 60 ℃ ± 2 ℃ / RH = 90% ± 5%, the conventional acceleration: 40 ℃ ± 2 ℃ / RH = 75% ± 5%. Study results are as follows:

[0110]

Embodiment 3

[0112]

[0113]

[0114] The preparation method is:

[0115] 1) The formulation amount of spray-dried lactose and magnesium stearate are thoroughly mixed to obtain a mixture, the standby;

[0116] 2) the formulation amounts Mosapride hydroxypropyl methylcellulose and thoroughly mixed to obtain a mixture containing drug use;

[0117] 3) Take a mixture of drug-containing mixture was thoroughly mixed, the material, tableting, the use of PVC bag, 1000 were made. For finished product testing and dissolution matter content. Then were 20 days limit accelerated test and 3 months conventional accelerated testing investigated substances and dissolution of situations, acceleration condition: limit acceleration: 60 ℃ ± 2 ℃ / RH = 90% ± 5%, the conventional acceleration: 40 ℃ ± 2 ℃ / RH = 75% ± 5%. Study results are as follows:

[0118]

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Abstract

The invention discloses a pharmaceutical composition containing mosapride citrate. The composition contains mosapride citrate, reducing sugar, magnesium stearate and other pharmaceutical excipients. Magnesium fatty acid is premixed and then mixed with mosapride citrate and other pharmaceutical excipients, and the process of granulating or tableting effectively solves the problem of long-term storage of the mosapride citrate composition. The technical problems of high substance content and low dissolution rate have significantly improved the long-term stability, safety and effectiveness of the mosapride citrate composition packaged in conventional PVC packaging materials.

Description

Technical field [0001] The present invention belongs to the field of pharmaceutical preparations, particularly relates to a pharmaceutical composition comprising mosapride citrate. Background technique [0002] Mosapride citrate (Mosapride Citrate) is a selective 5-HT4 receptor agonist, a third generation gastric motility, for the treatment of functional dyspepsia (FD) and gastroesophageal reflux disease. The drug not only can significantly improve symptoms in patients with FD ache, heartburn, and can accelerate gastric emptying, stomach and duodenum promote sports, but does not affect gastric acid secretion, no extrapyramidal side effects, well tolerated. With growing public concern about drug safety, adverse reactions of many drugs and drug related substances decompose, and therefore pay attention to the degradation of drugs, reduce the content of related substances, it has become a key link in drug quality control, for patients drug safety is important. Since Mosapride drug it...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/5375A61K47/26A61K47/38A61P1/14A61P1/04
Inventor 柯潇高波田密
Owner CHENGDU KANGHONG PHARMA GRP
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