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Prucalopride succinate capsule and preparation method thereof

A technology of prucalopride and capsules, which is applied in the field of prucalopride succinate capsules and its preparation, achieving the effects of rapid disintegration, fewer types of excipients, and guaranteed drug stability

Inactive Publication Date: 2018-06-19
PEKING UNIV FOUNDER GRP CO LTD +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Prucalopride succinate is currently available in tablets, and the quality of the preparations still needs to be improved. In order to meet the needs of clinical applications, prescriptions with better dissolution and more stable quality are needed

Method used

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  • Prucalopride succinate capsule and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment 1 prucalopride succinate capsules and preparation method thereof

[0025] See Table 1 for the prescription of prucalopride succinate capsules.

[0026] Table 1

[0027] Element

weight percentage

dose

prucalopride succinate

1％

100mg

lactose monohydrate

25％

2500mg

microcrystalline cellulose

50％

5000mg

Croscarmellose Sodium

15％

1500mg

Colloidal silica

6％

600mg

Magnesium stearate

3％

300mg

[0028] Preparation:

[0029] ① Pretreatment of raw and auxiliary materials: the raw materials are micronized, and the auxiliary materials are passed through an 80-mesh sieve for use;

[0030] ②Premix: Weigh prucalopride succinate, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and colloidal silicon dioxide according to the prescription quantity, and mix to obtain a uniform premix;

[0031] ③Total blending: Add magnesium stearate to the above prem...

Embodiment 2

[0034] Embodiment 2 prucalopride succinate capsules and preparation method thereof

[0035] See Table 2 for the prescription of prucalopride succinate capsules.

[0036] Table 2

[0037] Element

weight percentage

dose

prucalopride succinate

1％

100mg

lactose monohydrate

35％

3500mg

Microcrystalline Cellulose PH101

40％

4000mg

Croscarmellose Sodium

15％

1500mg

Colloidal silica

6％

600mg

Magnesium stearate

3％

300mg

[0038] Preparation:

[0039] ① Pretreatment of raw and auxiliary materials: the raw materials are micronized, and the auxiliary materials are passed through an 80-mesh sieve for use;

[0040] ②Premix: Weigh prucalopride succinate, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and colloidal silicon dioxide according to the prescription quantity, and mix to obtain a uniform premix;

[0041] ③Total blending: Add magnesium stearate to the abov...

Embodiment 3

[0044] Embodiment 3 prucalopride succinate capsules and preparation method thereof

[0045] See Table 3 for the prescription of prucalopride succinate capsules.

[0046] table 3

[0047] Element

weight percentage

dose

prucalopride succinate

1％

100mg

lactose monohydrate

20％

2000mg

microcrystalline cellulose

55％

5500mg

Croscarmellose Sodium

15％

1500mg

Colloidal silica

6％

600mg

Magnesium stearate

3％

300mg

[0048] Preparation:

[0049] ① Pretreatment of raw and auxiliary materials: the raw materials are micronized, and the auxiliary materials are passed through an 80-mesh sieve for use;

[0050] ②Premix: Weigh prucalopride succinate, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and colloidal silicon dioxide according to the prescription quantity, and mix to obtain a uniform premix;

[0051] ③Total blending: Add magnesium stearate to the above prem...

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Abstract

The invention provides a prucalopride succinate capsule and a preparation method thereof. The capsule is prepared from substances in parts by weight as follows: 0.5-2 parts of prucalopride succinate,70-80 parts of filler, 10-20 parts of a disintegrant, 4-8 parts of a glidant and 2-5 parts of a lubricant. Raw and auxiliary materials are pretreated and mixed, a capsule shell is filled directly withthe mixture finally, and the capsule is prepared. The formula is reasonable in design, the preparation process is simple, and the product is stable and reliable in quality and high in bioavailabilityand has great market development prospect.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a prucalopride succinate capsule and a preparation method thereof. Background technique [0002] Prucalopride succinate, English name Prucalopride Succinate, chemical name: 4-amino-5-chloro-2,3-dihydro-N-[1-(3-methoxypropyl)-4-piperidine Base] -7-benzofuran carboxamide succinate, molecular formula: C 18 h 26 ClN 3 o 3 ·C 4 h 6 o 4 , molecular weight: 485.96. For the treatment of chronic constipation in adult female patients that is not adequately relieved by laxatives. [0003] Prucalopride succinate is currently available in tablets, but the quality of the preparation still needs to be improved. In order to meet the needs of clinical application, a prescription with better dissolution and more stable quality is needed. Contents of the invention [0004] The object of the present invention is to provide a prucalopride succinate capsule w...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K47/38A61K31/4525A61P1/10
CPCA61K9/4866A61K31/4525
Inventor 易崇勤谢小飞姚定丽邹明琛
Owner PEKING UNIV FOUNDER GRP CO LTD
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