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A kind of prucalopride succinate tablet and preparation method thereof

A technology of prucalopride and succinic acid, which is applied in the direction of pharmaceutical formulations, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., can solve the problem of low stability and prucalopride succinate tablets Weak stability and other problems, to achieve the effect of good stability, flexible medication time, and simple production process

Active Publication Date: 2020-03-24
JUMPCAN PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] On the other hand, the quality of stability has an important impact on the curative effect of prucalopride succinate tablets, and the stability of the currently disclosed prucalopride succinate tablets is relatively weak
For example, Chinese patent application CN201410654611 discloses a silicon dioxide-free prucalopride succinate pharmaceutical composition. This compound can effectively relieve chronic constipation but has low stability. Therefore, improving its stability has always been an issue in the art goals pursued by people

Method used

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  • A kind of prucalopride succinate tablet and preparation method thereof
  • A kind of prucalopride succinate tablet and preparation method thereof
  • A kind of prucalopride succinate tablet and preparation method thereof

Examples

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Effect test

Embodiment 1

[0048] Embodiment 1 A kind of prucalopride succinate tablet tablet and preparation method thereof

[0049] Formula: by weight: 1 part of prucalopride succinate (calculated as prucalopride), 70 parts of lactose, 10 parts of microcrystalline cellulose, 10 parts of sodium carboxymethyl starch, 1 part of silicon dioxide, hard 0.2 parts of magnesium fatty acid, 3 parts of Opadry, 12 parts of laminin, and 24 parts of trehalose. Preparation:

[0050] (1) Pulverize the prucalopride succinate in the formula dosage through an 80-mesh sieve to obtain powder A; pass the lactose in the formula dosage through a 80-mesh sieve to obtain powder B;

[0051] (2) Place the microcrystalline cellulose in the formula dosage, powder A and powder B obtained in step (1) in a wet mixing granulator, adjust the stirring speed to 150r / min, and mix for 18min to obtain material A;

[0052] (3) Sodium carboxymethyl starch, laminin, trehalose and the mixed material A obtained in step (3) are placed in the bl...

Embodiment 2

[0055] Embodiment 2 A kind of prucalopride succinate tablet and preparation method thereof

[0056] Formula: by weight: 1 part of prucalopride succinate (calculated as prucalopride), 100 parts of mannitol, 15 parts of povidone, 15 parts of sodium carboxymethyl starch, 1.1 parts of silicon dioxide, talc 0.55 parts of powder, 4 parts of Opadry, 15 parts of laminin, and 25 parts of trehalose.

[0057] Preparation method: The difference from Example 1 is that the raw materials are different, the air inlet temperature in step (5) is 55° C., and the material temperature is 40° C.; the rest are the same as in Example 1.

Embodiment 3

[0058] Embodiment 3 a kind of prucalopride succinate tablet and preparation method thereof

[0059] Formula: by weight: 1 part of prucalopride succinate (calculated as prucalopride), 110 parts of lactose, 18 parts of sucrose, 20 parts of sodium carboxymethyl starch, 1.2 parts of silicon dioxide, 0.6 parts of micronized silica gel , 5 parts of Opadry, 18 parts of laminacin, 26 parts of trehalose.

[0060] Preparation method: The difference from Example 1 is that the raw materials are different, the inlet air temperature in step (5) is .60°C, and the material temperature is 45°C; the rest are the same as in Example 1.

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Abstract

The invention provides prucalopride succinate tablets and a preparation method thereof. The prucalopride succinate tablets contain prucalopride succinate, microcrystalline cellulose, laminine, mycoseand the like. The invention further discloses a preparation method of the prucalopride succinate tablets. With the adoption of the prucalopride succinate tablets and the preparation method thereof, the prucalopride succinate tablets can be better in stability, high in bioavailability, low in toxicity and more flexible to use, product equality can be uniform, stable and controllable, besides, the production technology is simple, the production cost is low, and the prucalopride succinate tablets are suitable for industrialized production.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a prucalopride succinate tablet and a preparation method thereof. Background technique [0002] With the change of people's diet structure and the impact of many aspects such as psychological and social factors, constipation has become one of the important factors affecting the quality of life of modern people. Epidemiological surveys in Beijing, Xi'an and other regions in my country show that the incidence of chronic constipation is 6.1%-9.2%. A survey in the United States shows that 20% of healthy people are troubled by constipation, and constipation is also associated with colon cancer, cardiovascular and cerebrovascular diseases. And related to the occurrence of senile dementia. Therefore, in recent years, research on chronic constipation has made great progress. [0003] Chronic constipation is a common disease that may seriously affect the quality of human life, and chronic constip...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/36A61K31/4525A61K47/38A61K47/36A61K47/26A61P1/10
Inventor 曹龙祥田刚李昌龙韦明元陈丽蔡虎
Owner JUMPCAN PHARMA GRP
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