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Digoxin micro tablet and preparation method thereof

A technology for digoxin and symplectic microtablets, which is applied in the field of preparing digoxin microtablets, can solve the problems of inability to meet the requirements of individualized medicine, inability to achieve precise administration, inability to conveniently divide doses, etc., and achieve an ideal drug release rate , flexible and accurate dosing, reducing the effect of high local blood concentration

Inactive Publication Date: 2018-07-10
COSCI MED TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Existing digoxin dosage forms cannot meet the requirements of individualized medication, cannot be conveniently and accurately divided into doses, and cannot achieve precise drug administration
In addition, when the existing pharmaceutical dosage form is taken, due to the excessive volume of the dosage form, the compliance of taking the medicine is poor for patients who are inconvenient to swallow the tablet

Method used

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  • Digoxin micro tablet and preparation method thereof
  • Digoxin micro tablet and preparation method thereof
  • Digoxin micro tablet and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0023]

[0024]

[0025] The preparation process is as follows: put digoxin, microcrystalline cellulose 102, lactose Flowlac100 and HPMC E3 in the pot of the wet granulator, turn on the paddle for 10 minutes of initial mixing, after the mixing is completed, turn on the paddle and spray purified water at the same time Wet granulation; continue to granulate for 2 minutes after the purified water is sprayed; then wet granulate the obtained wet granules, and then put them into a fluidized bed for drying. After drying, the granules undergo dry granulation; After the magnesium stearate is uniformly mixed, the mixed material is transferred to a high-speed rotary tablet press for tabletting with a diameter of 2 mm to obtain finished tablets.

Embodiment 2

[0027] name

[0028] Preparation process: Put digoxin, microcrystalline cellulose 102, lactose Flowlac100 and HPMC E3 in a multiphase mixer for uniform mixing, then add magnesium stearate and mix for 3 minutes, and transfer the mixture to a high-speed rotary tablet press Perform tablet compression with a diameter of 2 mm to obtain finished tablets.

Embodiment 3

[0030] Digoxin

[0031]Preparation process: After mixing digoxin, microcrystalline cellulose 102 and sodium carboxymethyl starch evenly, the mixture is added to a dry granulator to obtain suitable dry granules; after the granules are uniformly mixed with calcium stearate, The mixed materials were transferred to a high-speed rotary tablet press for tableting with a diameter of 2 mm to obtain finished tablets.

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Abstract

The invention discloses a novel digoxin preparation and a method of preparing the novel digoxin preparation. Digoxin, a bonding agent, a filling agent and the like are used as raw materials, and through methods such as dry granulation tablet compression, wet granulation tablet compression and top jet fluidized bed granulation tablet compression, the novel digoxin preparation with good compressibility is prepared. According to the novel digoxin preparation, for patients who need to take a precise amount of medicine, a small dose of medicine can be applied to the patients multiple times, particularly for people with large individual metabolism difference, counting can be conducted during medicine taking, for people who have difficulty in taking common preparations, the adaptability of medicine taking can be improved, the adopted method is simple, the raw materials are easily obtained, and industrial production is facilitated.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to digoxin microtablets and a method for preparing digoxin microtablets. Background technique [0002] Digoxin is a medium-acting cardiac glycoside drug purified from Digitalis chinensis. Digoxin was approved by the US Food and Drug Administration in 1998 for the clinical treatment of chronic heart insufficiency and was later approved by the US Food and Drug Administration. It is clearly recommended and currently clinically mainly used for various congestive heart failure, atrial fibrillation and arrhythmia. The biggest problem with the clinical use of cardiac glycosides is that the safety range is small, and the effective dose is close to the toxic dose. Once digoxin is poisoned, new arrhythmias, poor appetite or nausea, vomiting, lower abdominal pain, abnormal weakness, electrolyte imbalance, etc. will appear. Systemic reactions such as mental depression or c...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/7048A61K47/38A61K47/36A61K9/22A61P9/04A61P9/06
CPCA61K9/2054A61K9/2059A61K9/5084A61K31/7048A61K9/2077A61K9/2018A61K9/205A61P9/04A61P9/06
Inventor 谷雨田崔一民李焕谢瑞强刘质净牛秀丽
Owner COSCI MED TECH CO LTD
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