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Medicine composition of mosapride citrate and preparation method of same

A technology of mosapride citrate and a composition is applied in the field of pharmaceutical compositions containing mosapride citrate, and achieves the effects of good thermal stability and good masking of bitter taste

Active Publication Date: 2017-07-14
JIANGSU HANSOH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, due to the bitter taste of mosapride, it needs to be coated
[0005] However, the inventors found after coating the plain tablets containing mosapride citrate (Comparative Example 1 below), the prepared coated tablets were seriously degraded at high temperatures (40°C and 60°C).

Method used

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  • Medicine composition of mosapride citrate and preparation method of same
  • Medicine composition of mosapride citrate and preparation method of same
  • Medicine composition of mosapride citrate and preparation method of same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0076] Embodiment 1 (sample 4)

[0077] [Table 7] Chip composition

[0078]

[0079]

[0080] ▲When necessary, use lactose as an adjusting component to change tablet weight.

[0081] [Table 8] Composition of film coating aqueous solution

[0082]

[0083] ▲Purified water accounts for about 90% (w / w) of the film coating aqueous solution.

[0084] The plain tablet (core tablet) containing mosapride citrate was prepared according to the composition ratio shown in the above table [7].

[0085] Dissolve 10 g of hypromellose in 40 g of purified water to obtain a binder solution. The prepared binder solution was added to the mixture containing mosapride citrate (5.29g), lactose (51.91g), starch (32.4g) and low-substituted hydroxypropyl cellulose (9.5g). Granulated by method, dried and sieved through a 30-mesh sieve, and blended with low-substituted hydroxypropyl cellulose (9g), magnesium stearate (1.3g) and silicon dioxide (0.6g). Then the obtained granules are pressed ...

Embodiment 2

[0087] Embodiment 2 (sample 5)

[0088] [Table 9] Chip composition

[0089]

[0090] ▲When necessary, use lactose as an adjusting component to change tablet weight.

[0091] [Table 10] Composition of film coating aqueous solution

[0092]

[0093] ▲Purified water accounts for about 90% (w / w) of the film coating aqueous solution.

[0094] The plain tablet (core tablet) containing mosapride citrate was prepared according to the composition ratio shown in the above table [9].

[0095] 15 g of hypromellose was dissolved in 40 g of purified water to obtain a binder solution. The prepared binder solution was added to the wet mixture containing mosapride citrate (5.29g), lactose (46.91g), starch (32.4g) and low-substituted hydroxypropyl cellulose (9.5g) Granulated by method, dried and sieved through a 30-mesh sieve, and blended with low-substituted hydroxypropyl cellulose (9g), magnesium stearate (1.3g) and silicon dioxide (0.6g). Then the obtained granules are pressed int...

Embodiment 3

[0097] Embodiment 3 (sample 6)

[0098] [Table 11] Chip composition

[0099]

[0100] ▲When necessary, use lactose as an adjusting component to change tablet weight.

[0101] [Table 12] Composition of film coating aqueous solution

[0102]

[0103] ▲Purified water accounts for about 90% (w / w) of the film coating aqueous solution.

[0104] The plain tablet (core tablet) containing mosapride citrate was prepared according to the composition ratio shown in the above table [11].

[0105] 45g of purified water was added to the mixture containing mosapride citrate (5.29g), lactose (61.91g), starch (32.4g) and low-substituted hydroxypropyl cellulose (9.5g) for wet granulation, After drying, pass through a 30-mesh sieve to sieve and blend low-substituted hydroxypropylcellulose (9g), magnesium stearate (1.3g) and silicon dioxide (0.6g). Then the obtained granules are pressed into a plain tablet with a hardness of 3-10 kg using a punching film with a diameter of 6.5 mm.

[01...

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Abstract

The invention provides a medicine composition containing mosapride citrate and a preparation method of same. In particular, the medicine composition contains the mosapride citrate and a plasticizer. The medicine composition has high preparation stability, can mask the bitter taste of the mosapride citrate well and also improves dissolution behavior of the mosapride citrate in different mediums.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing mosapride citrate and a preparation method. The pharmaceutical composition of the present invention is used for functional dyspepsia accompanied by heartburn, belching, nausea, vomiting, early satiety, upper abdominal distension and other gastrointestinal symptoms; it can also be used for gastroesophageal reflux disease, diabetic gastroparesis and some gastric Resect patients with gastric dysfunction. Background technique [0002] Mosapride citrate (I), the chemical name is (±)-4-amino-5-chloro-2-ethoxy-N-[[4-(4-fluorobenzyl)-2-morpholine Base] methyl] benzamide dihydrate citrate, a selective serotonin 4 (5-HT 4 ) receptor agonist, by stimulating 5-HT of cholinergic interneurons and myenteric plexuses in the gastrointestinal tract 4 receptors, promote the release of acetylcholine, thereby enhancing gastrointestinal motility, improving gastrointestinal symptoms in patients with function...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K47/10A61K47/44A61K31/5375A61P1/14A61P1/04A61P1/00
CPCA61K9/282A61K31/5375
Inventor 董礼王小雷孙运栋黄玉超
Owner JIANGSU HANSOH PHARMA CO LTD
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