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Isosorbide mononitrate tablet and preparation method thereof

A technology of isosorbide dinitrate and lactose, applied in the field of isosorbide mononitrate tablets and preparation thereof, can solve the problems of insignificant improvement effect of mixed powder fluidity, poor fluidity of mixed powder, poor mixing uniformity, etc. Uniformity, fast dissolution rate, small difference in tablet weight

Pending Publication Date: 2022-04-08
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Aiming at the problem that the raw material of isosorbide mononitrate is needle-like crystal and the fluidity of the mixed powder is poor, resulting in the difference in tablet weight and poor mixing uniformity in the subsequent tableting process, the inventor first adjusted the amount of lubricant and added lubricant After a large number of tests, it was found that the above measures had no obvious effect on improving the fluidity of the mixed powder.

Method used

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  • Isosorbide mononitrate tablet and preparation method thereof
  • Isosorbide mononitrate tablet and preparation method thereof
  • Isosorbide mononitrate tablet and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0052] Embodiment 1: Isosorbide mononitrate tablet

[0053] Prescription composition 1000 tablets

[0054] Element Weight (g) isosorbide mononitrate 20 Colloidal silica 244FP 2 microcrystalline cellulose 110 lactose 40 Carboxymethyl Starch Sodium 10 Magnesium stearate 2

[0055] Preparation Process:

[0056] Take the prescription amount of isosorbide mononitrate and silicon dioxide, mix and pulverize, mix microcrystalline cellulose, isosorbide mononitrate silicon dioxide mixed powder, carboxymethyl starch sodium, lactose, sieve the mixed powder and mix again, It is then mixed with magnesium stearate, compressed into tablets, and obtained.

Embodiment 2

[0057] Embodiment 2: Isosorbide mononitrate tablet

[0058] Prescription composition 1000 tablets

[0059] Element Weight (g) isosorbide mononitrate 20 Colloidal silica 244FP 2 microcrystalline cellulose 105 lactose 35 Carboxymethyl Starch Sodium 10 Magnesium stearate 2

[0060] Preparation process: adopt the preparation method of embodiment 1.

Embodiment 3

[0061] Embodiment 3: Isosorbide mononitrate tablet

[0062] Prescription composition 1000 tablets

[0063] Element Weight (g) isosorbide mononitrate 20 Colloidal silica 244FP 2 microcrystalline cellulose 175 lactose 35 Carboxymethyl Starch Sodium 10 Magnesium stearate 2

[0064] Preparation process: adopt the preparation method of embodiment 1.

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Abstract

The invention belongs to the technical field of medicine oral solid preparations, and provides a method for preparing isosorbide mononitrate tablets by a powder direct compression method. According to the preparation method, a powder direct compression process is adopted, raw materials and auxiliary materials are mixed and then are directly compressed to obtain the isosorbide mononitrate tablet, granulation and drying are not needed, the preparation process is simple and easy to implement, time and energy are saved, the production cost is remarkably reduced, and the prepared isosorbide mononitrate tablet is high in finished product yield, high in disintegration and dissolution speed, good in stability and suitable for commercial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical oral solid preparations, and relates to an isosorbide mononitrate tablet and a preparation method thereof. Background technique [0002] Isosorbide mononitrate, an organic nitrate, is a vasodilator that affects both blood vessels and veins. The mechanism of action is the same as that of nitroglycerin, but the action time is longer. Stimulate guanylate cyclase by releasing nitric oxide (NO), increasing cyclic guanosine monophosphate (cGMP) and dilating blood vessels. Mainly dilate peripheral veins to store blood in the periphery, reduce blood return to the heart, reduce left ventricular end-diastolic pressure and diastolic coronary blood flow resistance; dilate peripheral arterioles, reduce peripheral resistance and blood pressure, and reduce myocardial oxygen consumption; Dilate coronary arterioles, redistribute blood flow in myocardial ischemic area, and relieve angina pectoris. Its exp...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/36A61K47/38A61K47/04A61K47/26A61K31/34A61P9/10A61P9/04
Inventor 徐颖郭洪涛
Owner SHANDONG NEWTIME PHARMA