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A kind of prucalopride succinate tablet composition

A technology of prucalopride and succinic acid, which is applied in the directions of drug combination, pill delivery, medical preparations of inactive ingredients, etc., can solve the problems of accelerated reaction, toxic substances, and laxatives are not completely satisfied, and achieves drug use. High safety, uniform content and reasonable prescription

Active Publication Date: 2017-02-22
HEBEI RENHE YIKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The treatment of chronic constipation usually uses more laxatives, but laxatives cannot effectively improve the symptoms of constipation. A study in 2008 showed that although 16% to 40% of patients with constipation used laxatives, the symptoms still persisted. , no significant difference compared to patients not using laxatives
A 2007 web-based survey showed that 47% of patients were not completely satisfied with laxatives, 82% due to poor efficacy and 16% due to safety
[0004] The molecular structure of prucalopride succinate contains amino groups, and there is lactose in the existing prucalopride succinate tablets (Lilo, Janssen Pharmaceutica N.V. company) auxiliary materials, and amino groups and reducing sugars can produce Melamine German reaction, the reaction can be carried out at room temperature (20-25°C), and the reaction is accelerated in the presence of moisture. This reaction can produce toxic substances, which is not conducive to health

Method used

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  • A kind of prucalopride succinate tablet composition
  • A kind of prucalopride succinate tablet composition
  • A kind of prucalopride succinate tablet composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～6

[0037] Embodiment 1~6 prucalopride succinate tablet

[0038] Prescription (unit: g):

[0039]

[0040] Note: in embodiment 1-3, the weight ratio of mannitol and crospovidone is 5:1.

[0041] Preparation Process:

[0042] According to the prescription of Example 1-6 respectively, prucalopride succinate, mannitol, crospovidone, and binder were mixed evenly, added pure water to make soft material, passed through a 14-20 mesh sieve for granulation, and 50 Dry at -80°C, granulate, add lubricant (or lubricant and glidant), mix well, and compress into tablets.

Embodiment 7

[0043] Embodiment 7 prucalopride succinate tablet stability experiment

[0044] Utilize the prucalopride succinate tablet of the present invention prepared in Examples 1-6 and the commercially available product "Lilo", carry out long-term stability experiment (25 ℃, 60%RH), press the following inspection method, measure related substances .

[0045] Chromatographic conditions and system suitability test use octadecyl bonded silica gel as filler; use 25mmol / L ammonium acetate aqueous solution containing 0.2% diethylamine as mobile phase A; use acetonitrile-isopropanol (80:20) It is mobile phase B; carry out linear gradient elution according to the table below; the detection wavelength is 275nm, the flow rate is 1.0ml / min; the column temperature is 35°C. The number of theoretical plates should not be less than 5000 based on the prucalopride succinate peak.

[0046]

[0047]Determination method gets the sample prepared by embodiment 1-6 appropriate amount, grinds finely, acc...

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Abstract

The invention provides a prucalopride succinate tablet composition and a preparation method thereof. The prucalopride succinate tablet contains prucalopride succinate, mannitol, crospovidone and the like. The prucalopride succinate tablet has the advantages that a Maillard reaction is not generated; the tablet can be prepared via a wet granulation method; the tablet is high in stability and the like.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to an oral solid preparation of prucalopride succinate. Background technique [0002] Chronic constipation has become a global chronic public health problem. Constipation is especially common in women and the elderly. It not only seriously affects the quality of life of patients, but may also induce other serious diseases, such as anorectal disorders, fecal ulcers and hepatic ulcers. encephalopathy, etc., and increase the risk of cardiovascular events, the danger cannot be ignored. The treatment of chronic constipation usually uses more laxatives, but laxatives cannot effectively improve the symptoms of constipation. A study in 2008 showed that although 16% to 40% of patients with constipation used laxatives, the symptoms still persisted. , with no significant difference compared with patients not using laxatives. A 2007 web-based survey showed that 47% of patients were not completely sati...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K47/32A61K47/10A61K47/38A61K47/26A61K31/4525A61P1/10
Inventor 刘淑景
Owner HEBEI RENHE YIKANG PHARMA
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