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Ranolazine sustained release tablet medicine composition and preparation method thereof

The technology of a composition and ranolazine is applied in the pharmaceutical composition of ranolazine sustained-release tablets and its preparation field, which can solve problems such as strong hygroscopicity, poor fluidity, difficult selection of excipients, unstable preparations, etc., so as to facilitate human body absorption and improve The effect of stability and simple preparation method

Active Publication Date: 2015-07-08
SICHUAN HAISCO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0017] Due to its own molecular structure, ranolazine is easy to absorb moisture, and the prepared preparation is easily unstable; when it is placed at room temperature for a certain period of time, the unsatisfactory dissolution will occur; It brings certain difficulty in operation; in addition, ranolazine is water-insoluble, but easily soluble in 0.1mol / L hydrochloric acid solution, if the formulation is not properly prescribed, it may cause its burst release in the stomach
Therefore, the ranolazine sustained-release tablets prepared in the prior art still encounter problems that need to be solved such as unstable sustained release, large fluctuations, difficult selection of auxiliary materials, unstable preparations, and easy moisture absorption.

Method used

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  • Ranolazine sustained release tablet medicine composition and preparation method thereof
  • Ranolazine sustained release tablet medicine composition and preparation method thereof
  • Ranolazine sustained release tablet medicine composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] The preparation of embodiment 1 ranolazine sustained-release tablet pharmaceutical composition

[0048] prescription:

[0049]

[0050] The preparation method is prepared according to the following steps:

[0051] (1) Weigh the ranolazine raw material according to the prescription amount, and pass it through a 60-mesh sieve;

[0052] (2) After mixing the treated ranolazine and microcrystalline cellulose evenly, fluidize in a fluidized bed;

[0053] (3) Take the prescription amount of NaOH to prepare an aqueous solution with a mass concentration of 5%, and spray it evenly on the fluidized mixture;

[0054] (4) Prepare hydroxypropyl methylcellulose into an aqueous solution with a concentration of 5% as a binder and spray it in for granulation;

[0055] (5) Take the prescribed amount of Eudragit After diluting L30D-5530% water dispersion with equal weight of water, spray it into the granulated granules to coat the granules;

[0056] (6) Dry the coated granules in ...

Embodiment 2

[0060] The preparation of embodiment 2 ranolazine sustained-release tablet pharmaceutical composition

[0061] prescription:

[0062]

[0063]

[0064] The preparation method is prepared according to the following steps:

[0065] (1) Weigh the ranolazine raw material according to the prescription amount, and pass it through a 60-mesh sieve;

[0066] (2) After mixing the treated ranolazine and microcrystalline cellulose evenly, fluidize in a fluidized bed;

[0067] (3) Take the prescription amount of NaOH to prepare an aqueous solution with a mass concentration of 5%, and spray it evenly on the fluidized mixture;

[0068] (4) Prepare polyvinylpyrrolidone into an aqueous solution with a concentration of 5% as a binder and spray it in for granulation;

[0069] (5) Take the prescribed amount of Eudragit After the L100-55 powder is dissolved in 1.5 times the weight of water, it is sprayed into the granulated granules to coat the granules;

[0070] (6) Dry the coated gra...

Embodiment 3

[0074] The preparation of embodiment 3 ranolazine sustained-release tablet pharmaceutical composition

[0075] prescription:

[0076]

[0077] The preparation method is prepared according to the following steps:

[0078] (1) Weigh the ranolazine raw material according to the prescription amount, and pass it through a 60-mesh sieve;

[0079] (2) After mixing the treated ranolazine and microcrystalline cellulose evenly, fluidize in a fluidized bed;

[0080] (3) Take the prescription amount of NaOH to prepare an aqueous solution with a mass concentration of 5%, and spray it evenly on the fluidized mixture;

[0081] (4) The neutral polyacrylate is prepared into an aqueous solution with a concentration of 5% as a binder and sprayed into it for granulation;

[0082] (5) After taking the prescribed amount of polyvinyl acetate phthalate and diluting it evenly with 1.5 times the weight of water, spray it into the granulated granules to coat the granules;

[0083] (6) Dry the coa...

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Abstract

The invention relates to a ranolazine sustained release tablet medicine composition and a preparation method thereof. The composition comprises, by weight, 50%-72% of ranolazine, 20%-25% of pH dependence binding agents, 5%-8% of non-pH-dependence binding agents, 2%-15% of microcrystalline celluloses, 0.1%-0.5% of magnesium stearate and 0.1%-0.5% of sodium hydroxide. The preparation method includes the steps of mixing, palletizing, particle wrapping, drying, tidying, tabletting, tablet core wrapping and the like. The preparation method s easy and convenient, industrialization is easily achieved, and the prepared ranolazine sustained release tablet medicine composition has the beneficial effects of being good in slow-release effect, light in tablet weight and the like.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a pharmaceutical composition of ranolazine sustained-release tablets and a preparation method thereof. Background technique [0002] Angina pectoris is a clinical syndrome caused by coronary insufficiency, myocardial acute, temporary ischemia and hypoxia. In recent years, with the continuous improvement of people's living standards and changes in living habits, angina pectoris has become one of the more common cardiovascular diseases, and the incidence rate is still rising. The incidence rate of angina pectoris is higher in the male population. According to incomplete statistics, the incidence rate of men over 50 years old is 0.2%, while the incidence rate of women is only 0.08%. The main causes are fatigue, emotional agitation, rainy weather, fullness Food and cold, acute circulatory failure, etc., the occurrence of this disease will bring a lot of trouble and inconve...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/495A61K47/38A61K47/32A61P9/10
Inventor 汪顺洪任东冯卫傅灵刘林林
Owner SICHUAN HAISCO PHARMA CO LTD
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