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Pharmaceutical composition containing mosapride citrate

A technology of mosapride citrate and composition, which is applied in the field of pharmaceutical compositions containing mosapride citrate, and can solve the problems of increased related substances, unstable storage, and decreased dissolution rate, etc.

Active Publication Date: 2016-05-11
CHENGDU KANGHONG PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In order to solve the problems of long-term storage instability of existing mosapride citrate preparations, decrease of dissolution rate, increase of related substances, etc., the invention provides a pharmaceutical composition containing mosapride citrate. The drug contains lactose and other pharmaceutically acceptable excipients, and the mass ratio of lactose to water in the pharmaceutical composition is ≥19.0, preferably ≥54.2, most preferably ≥60.0; wherein the lactose is anhydrous lactose;

Method used

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054]

[0055]

[0056] The auxiliary materials in the above prescription are vacuum-dried, the drying temperature is 60°C, and the drying time is 1 hour. Mix anhydrous lactose, disperse once through a 50-mesh sieve, and form mixture 1; add crospovidone XL-10, low-substituted hydroxypropyl cellulose, and micropowder silica gel to mixture 1, disperse once through a 50-mesh sieve, and form mixture 2; Stearic acid was added to mixture 2, blended, discharged, tabletted, and double-aluminum packaged to make 1000 tablets in total. Detect the dissolution rate of the finished product and the content of related substances. Then, under the condition of 60°C / 75%RH, an accelerated test was carried out for 1 month. The inspection results are as follows:

[0057] Table 6

[0058]

Embodiment 2

[0060]

[0061] The excipients in the prescription are vacuum-dried, the drying temperature is 60°C, and the drying time is 1 hour. Lactose water was mixed, dispersed once through a 50 mesh sieve, and became mixture 1; crospovidone XL-10, low-substituted hydroxypropyl cellulose, and micropowder silica gel were added to mixture 1, and dispersed once through a 50 mesh sieve to become mixture 2; Add stearic acid into mixture 2, total blend, discharge, tabletting, adopt double aluminum packaging, make 1000 tablets altogether. Detect the dissolution rate of the finished product and the content of related substances. Then, under the condition of 60°C / 75%RH, an accelerated test was carried out for 1 month. The inspection results are as follows:

[0062] Table 7

[0063]

Embodiment 3

[0065]

[0066] The auxiliary materials in the above prescription are vacuum-dried, the drying temperature is 60° C., and the drying time is 1 hour. After drying, under the condition that the ambient humidity is 45% RH, mosapride citrate, microcrystalline cellulose PH105 and Mix β-anhydrous lactose, disperse once through a 50-mesh sieve, and form mixture 1; add low-substituted hydroxypropyl cellulose and micropowder silica gel to mixture 1, disperse once through a 50-mesh sieve, and form mixture 2; mix mixture 2, Discharging, sub-packaging, and packaging in aluminum-plastic bags, a total of 1,000 bags are made. Detect the dissolution rate of the finished product and the content of related substances. Then, under the condition of 60°C / 75%RH, an accelerated test was carried out for one month. The inspection results are as follows:

[0067] Table 8

[0068]

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Abstract

The invention relates to a pharmaceutical composition containing mosapride citrate. The pharmaceutical composition contains lactose and other pharmaceutically acceptable accessory materials. Through strict control of a mass ratio of lactose to water in the pharmaceutical composition, mosapride citrate long-term storage stability is greatly improved and related substance generation and increasing risk is reduced. The pharmaceutical composition provides guarantee for clinical drug safety and effectiveness.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a pharmaceutical composition containing mosapride citrate. Background technique [0002] Mosapride Citrate (MosaprideCitrate) is a selective 5-HT 4 Receptor agonists belong to the third generation of gastric motility drugs, mainly used for the treatment of functional dyspepsia (FD) and gastroesophageal reflux disease. The drug can significantly improve symptoms such as sourness and heartburn in FD patients, and can accelerate gastric emptying and promote gastric and duodenal motility. At present, there are many mosapride citrate preparations on the market, such as the imported drug "Gasiqing" produced by the original research company Sumitomo Pharmaceutical Co., Ltd. of Japan, and the mosapride citrate produced by the domestic generic company Lunan Beite Pharmaceuticals Tablets "Kuaili", Mosapride Citrate Dispersible Tablets "Xinluona" produced by Kanghong Pharmaceuti...

Claims

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Application Information

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IPC IPC(8): A61K31/5375A61K47/26A61P1/14A61P1/04
Inventor 柯潇郑强朱绪
Owner CHENGDU KANGHONG PHARMA GRP
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