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Bisoprolol fumarate tablet composition and preparation method thereof

A technology for bisoprolol fumarate and bisoprolol tablets, which is applied in directions such as drug combination, pill delivery, and pharmaceutical formulation, can solve the problems of high cost, non-disintegration, and capping, and achieves qualified quality and efficacy. Stabilizing, treating hypertension and angina pectoris

Active Publication Date: 2014-06-18
CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the preparation process of dropping pills is more complicated than that of tablets, and the cost is higher
Chinese patent 200710304297.0 discloses a bisoprolol fumarate dispersible tablet and a preparation method thereof, which provides a dispersible tablet with fast disintegration and dissolution, fast dissolution and rapid effect and a preparation method thereof for clinical use, but the bisoprolol fumarate A relatively large amount of calcium hydrogen phosphate or calcium sulfate is used as a filler in the prescription of Lohr dispersible tablets. As we all know, when the amount of calcium hydrogen phosphate accounts for most of the prescription, delamination and capping may occur when the tablet is compressed under a relatively high pressure. Calcium sulfate has the characteristics of hygroscopicity, which will cause the tablet to harden and not disintegrate after absorbing water
[0005] Bisoprolol fumarate is unstable to heat and humidity, and the general method of preparing tablet or capsule in the prior art is wet method granulation and then tabletting, owing to needing to dry in oven during granulation process, makes the tablet made Or the related substances of capsules are relatively high, which seriously affects the quality of the preparation; while the dry granulation and tabletting process is relatively complicated, it is necessary to add an appropriate amount of dry binder to ensure that the hardness or friability of the tablet is qualified, and the prepared tablet Large fluctuations in dissolution and poor reproducibility

Method used

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  • Bisoprolol fumarate tablet composition and preparation method thereof
  • Bisoprolol fumarate tablet composition and preparation method thereof
  • Bisoprolol fumarate tablet composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Preparation Process:

[0031] (1) Weigh each component according to the prescribed amount, and pass bisoprolol fumarate through a 100-mesh sieve;

[0032] (2) Bisoprolol fumarate, lactose, mannitol 200SD, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and povidone were mixed uniformly by equal addition method;

[0033] (3) Add the prescribed amount of magnesium stearate to the powder mixed uniformly in step (2), and mix uniformly;

[0034] (4) Press the uniformly mixed medicinal powder in step (3) into tablets directly, and control the pressure at 1.0~3.0KN, so that the hardness of the tablet is within 40~60N.

Embodiment 2

[0036] Preparation process: same as the preparation process of Example 1, the pressure is controlled at 1.5-3.5KN, so that the hardness of the tablet is within 50-70N.

Embodiment 3

[0038] Preparation process: same as the preparation process of Example 1, the pressure is controlled at 1.0-3.0KN, so that the hardness of the tablet is within 40-60N.

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Abstract

The invention provides a bisoprolol fumarate tablet composition and a bisoprolol fumarate tablet composition preparation method with the advantages of simple process, controllable quality, and ensured product stability. With the formula and process provided by the invention, the prepared bisoprolol fumarate tablet composition has the advantages of qualified quality, and stable medicine effect. The bisoprolol fumarate tablet composition can be used for effectively treating hypertension and angina.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a bisoprolol fumarate tablet composition and a preparation method thereof. Background technique [0002] Hypertension and angina pectoris are the most common cardiovascular diseases in the world today and the leading causes of death and disability in adults. In recent years, with the progress of society, the improvement of people's living standards and the continuous acceleration of the pace of work, the number of patients with hypertension has increased significantly. The prevalence rate of hypertension and angina pectoris has also increased significantly in China, and my country has become one of the countries with the most serious harm of these two diseases in the world. Hypertension can cause damage to the heart, brain, kidney and other organs, seriously threatening human health and life. [0003] Bisoprolol fumarate is a highly cardioselective beta 1 Receptor bl...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/205A61K31/138A61K47/26A61P9/12A61P9/10
Inventor 王颖
Owner CHENGDU EASTON BIOPHARMACEUTICALS CO LTD