A kind of sustained-release dry suspension of mosapride and preparation method thereof

The technology of dry suspension and mosapride citrate, which is applied in the field of slow-release dry suspension of mosapride and its preparation, can solve the problems of complicated process, reduced production efficiency, low release degree and the like, To achieve the effect of simple preparation process, high production efficiency and improved taste

Active Publication Date: 2021-07-02
南京百思福医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] CN101816639B, CN105769872A, etc. disclose a variety of common dosage forms of mosapride citrate that can dissolve quickly, but they still need to be administered multiple times a day, and the patient's compliance is poor
However, its release rate in the simulated intestinal fluid (pH6.8) at 24 hours was lower than 40%, indicating that mosapride citrate could not be effectively released and absorbed in the intestinal tract
CN102335154A, CN103356498A disclose a kind of mosapride citrate sustained-release tablet, but its in vitro release test is carried out in 0.1mol / L hydrochloric acid, so it cannot be proved that the sustained-release preparation in the invention can Effective release and absorption, its slow release effect in vivo is difficult to guarantee
However, the literature only examines the release of the sustained-release preparation in water, so it is not possible to determine whether it can achieve a better release in the intestinal tract
CN 105832671 A, CN 106511280 A, etc. disclose slow-release dry suspensions of various drugs, but the preparation process requires multiple fluidized bed coatings, the process is cumbersome and may reduce production efficiency, and realizes the technology of large-scale industrial production more difficult

Method used

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  • A kind of sustained-release dry suspension of mosapride and preparation method thereof
  • A kind of sustained-release dry suspension of mosapride and preparation method thereof
  • A kind of sustained-release dry suspension of mosapride and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] a. Prescription and preparation method of mosapride citrate immediate-release granules

[0062] components Weight (g) Mosapride citrate composition 150 lactose 150

[0063] Preparation Process:

[0064] Put mosapride citrate and sodium carboxymethyl starch in a ratio of 1:2 into a pulverizer, pulverize for 20 minutes, collect the composition, pass through an 80-mesh sieve, and set aside. Mix the co-pulverized composition obtained above with the prescribed amount of lactose, use 50% (w / w) ethanol solution as a binder to make a soft material, and adopt wet granulation or extrusion spheronization to granulate. The wet granules were dried in a fluidized bed for 30 minutes, and the dry granules with a particle size between 40 mesh and 60 mesh sieve were collected to obtain mosapride citrate immediate-release granules.

[0065] b. Prescription and preparation method of mosapride citrate sustained-release granules

[0066] components ...

Embodiment 2

[0076] a. Prescription and preparation method of mosapride citrate immediate-release granules

[0077] components Weight (g) Mosapride citrate composition 150 microcrystalline cellulose 130

[0078] Preparation Process:

[0079] The preparation method of the composition of mosapride citrate and sodium carboxymethyl starch is the same as embodiment one. Take the prescribed amount of mosapride citrate composition and mix with microcrystalline cellulose, use 5% (w / w) povidone K30 aqueous solution as the binder to make soft material, adopt wet granulation or extrusion spheronization . The wet granules were dried in a fluidized bed for 30 minutes, sieved and sized, and the dry granules with a particle size between 40 mesh and 60 mesh were collected to obtain the mosapride citrate immediate-release granules.

[0080] b. Prescription and preparation method of mosapride citrate sustained-release granules

[0081] components Weight (g) M...

Embodiment 3

[0093] a. Prescription and preparation method of mosapride citrate immediate-release granules

[0094] components Weight (g) Mosapride citrate composition 150 starch 160

[0095] Preparation Process:

[0096] The preparation method of the composition of mosapride citrate and sodium carboxymethyl starch is the same as embodiment one. Take the prescribed amount of mosapride citrate composition and mix it with starch, use water as a binder to make a soft material, and adopt wet granulation or extrusion spheronization to granulate. The wet granules were dried in a fluidized bed for 30 minutes, sieved and sized, and the dry granules with a particle size between 40 mesh and 60 mesh were collected to obtain the mosapride citrate immediate-release granules.

[0097] b. Prescription and preparation method of mosapride citrate sustained-release granules

[0098] components Weight (g) Mosapride citrate composition 300 starch 160 s...

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Abstract

The invention discloses a sustained-release dry suspension of mosapride and a preparation method thereof. The dry suspension comprises suspending granules and mosapride combined sustained-release granules uniformly dispersed in the suspending granules. Suspending granules include suspending agents, fillers, sweeteners and binders. Mosapride combination sustained-release granules are composed of two kinds of granules with different drug release characteristics in proportion. The mosapride slow-release dry suspension prepared by the invention can release medicine continuously for 12 hours, has good suspending effect, good medication compliance of children and patients with dysphagia, simple preparation process, and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of sustained-release preparations, and in particular relates to a sustained-release dry suspension of mosapride and a preparation method thereof. Background technique [0002] Mosapride, chemical name 4-amino-5-chloro-2-ethoxy-N-[[4-(4-fluorobenzyl)-2-morpholinyl]methyl]benzamide, is A highly selective 5-HT4 receptor agonist, the main site of action is the stomach and duodenum, and its adverse reactions are few. It is mainly used clinically for chronic gastritis, functional dyspepsia, reflux esophagitis and surgery. Relief of a range of gastrointestinal symptoms. After oral administration, mosapride is rapidly absorbed from the gastrointestinal tract, and the plasma concentration reaches its peak in 0.5~1h, with a short half-life of 1.4~2h, so the drug has a short duration of action. The current commercially available product contains 5 mg of mosapride citrate, which needs to be taken 3 times a day. There...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/5375A61K47/38A61K47/36A61P1/04A61P1/14A61P1/00A61K9/14
CPCA61K9/0002A61K9/146A61K9/1652A61K9/5084A61K31/5375
Inventor 李学明王永禄李杨王栋陈卫任浩刘坤堂刘吉伟
Owner 南京百思福医药科技有限公司
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