Indapamide slow-release hypertension pill and preparation method thereof

A technology for indapamide and antihypertensive tablets, which is applied in the field of indapamide sustained-release antihypertensive tablets and its preparation, can solve the problem of damage to the sustained-release function of hypromellose, drugs that do not meet the quality standards for regularization, and product quality Instability and other problems, to avoid the sudden release of the drug effect, reduce the economic burden, and achieve the effect of gentle and long-lasting antihypertensive effect

Inactive Publication Date: 2015-09-16
HUBEI HUIRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the process of wet granulation, factors such as the amount of binder added, the effect of drying temperature on the quality of the drug, the drying time, the number of granules, and the amount of fine powder should be considered. Moreover, the functional group hydroxypropoxy and water have produced gelation. As a result, the sustained-release function of part of the hypromellose is consumed and destroyed, and the sudden release is too large, and the release control fails. , and because some factors need to rely on empirical judgment, it may cause unstable product quality, large differences between batches and other defects

Method used

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  • Indapamide slow-release hypertension pill and preparation method thereof
  • Indapamide slow-release hypertension pill and preparation method thereof
  • Indapamide slow-release hypertension pill and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Based on the above, the framework materials are selected as hypromellose RT4000 and hypromellose RT5, the disintegrating material is microcrystalline cellulose, the diluent is lactose, the lubricant is magnesium stearate, and the weight of each component The percentages are: indapamide, 0.75 parts; hypromellose RT4000, 25 parts; hypromellose RT5, 23.75 parts; microcrystalline cellulose, 10 parts; lactose, 40 parts; magnesium stearate, 0.5 Copies.

[0027] Hypromellose RT4000 and hypromellose RT5 are used as the backbone material. RT4000 / 5 represents its viscosity model. It contains two main functional groups, namely methoxy and hydroxypropoxy. The oxy group is a hydrophobic group, which is resistant to corrosion and has a slow release effect. The hydroxypropoxy group is a hydrophilic group that quickly forms a gel layer after contact with water, which can inhibit the burst release of the drug. Lactose plays a role of diluting in the prescription, and has good compressibil...

Embodiment 2

[0029] Based on the above, the framework materials used are hypromellose RT4000 and hypromellose RT5, the disintegrating material is microcrystalline cellulose, the diluent is lactose, the lubricant is magnesium stearate, and the weight of each component The percentages are: indapamide, 0.75 parts; hypromellose RT4000, 28.75 parts; hypromellose RT5, 15 parts; microcrystalline cellulose, 5 parts; lactose, 50 parts; magnesium stearate, 0.5 Copies.

Embodiment 3

[0031] Based on the above, the framework materials used are hypromellose RT4000 and hypromellose RT5, the disintegrating material is microcrystalline cellulose, the diluent is lactose, the lubricant is magnesium stearate, and the weight of each component The percentages are: indapamide, 0.75 parts; hypromellose RT4000, 30 parts; hypromellose RT5, 25 parts; microcrystalline cellulose, 8 parts; lactose, 35.75 parts; magnesium stearate, 0.5 Copies.

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Abstract

The invention discloses an indapamide slow-release hypertension pill and a preparation method thereof. The indapamide slow-release hypertension pill comprises the following components in parts by weight: 0.75 part of indapamide, 40-55 parts of a framework material, 5-10 parts of a disintegration material, 40-50 parts of a diluent and 0.5 part of a lubricant. The indapamide slow-release hypertension pill is prepared by using a direct powder tabletting method which comprises the following steps: pretreating main materials and assistant materials, premixing the assistant materials, performing equivalent progressive increase mixing on the materials, tabletting, and coating. By adopting the indapamide slow-release hypertension pill disclosed by the invention, burst release can be relatively well inhibited, thorough later release can be ensured, the hypertension effect can be relatively stable and long-lasting, the production cost is reduced as a domestic framework material is adopted, and due to the adoption of a direct dry powder tabletting process, the phenomenon of too intense burst release caused by gelatinization of functional groups and water when a wet granulation method is adopted can be prevented, the pill can be prepared according to the formula ratio, the product quality can be relatively stable, and the in-batch product difference can be reduced.

Description

Technical field [0001] The invention relates to the field of sustained-release drugs, in particular to an indapamide sustained-release antihypertensive tablet and a preparation method thereof. Background technique [0002] Indapamide sustained-release tablets is an antihypertensive drug used for cardiovascular and cerebrovascular diseases, because it can significantly improve the effect of antihypertensive effect, the safety ratio, and the use of low-dose antihypertensive drugs and diuretics as recommended by international professional guidelines. The medication requirements for compression therapy are widely used in clinical practice. At present, the matrix materials of indapamide sustained-release tablets produced in China are all imported raw materials in order to meet the standards of sustained-release and antihypertensive. Therefore, the price is expensive and consumption is increased. The financial burden of the person. [0003] The currently used preparation process is wet ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/404A61K47/38A61P9/12
Inventor 刘明胜艾卫涛陈守平
Owner HUBEI HUIRUI PHARMA
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