Felodipine propranolol hydrochloride compound preparation and preparation method thereof

A technology of dipine propranolol hydrochloride compound and preparation, which is applied in the field of felodipine propranolol hydrochloride compound preparation and its preparation, and can solve problems such as reduction

Pending Publication Date: 2022-07-08
NKD PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There may be a reflex increase in heart rate during the first week of treatment, but this effect decreases over time

Method used

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  • Felodipine propranolol hydrochloride compound preparation and preparation method thereof
  • Felodipine propranolol hydrochloride compound preparation and preparation method thereof
  • Felodipine propranolol hydrochloride compound preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0081] The present embodiment provides the compound preparation of felodipine and propranolol hydrochloride, and its prescription is as follows:

[0082]

[0083] Preparation:

[0084] 1) Inner layer granulation: add propranolol hydrochloride, anhydrous lactose, hydroxypropyl cellulose and silicon dioxide into the wet mixing granulator according to the granulation formula and content in the above table, stir for 10min, add purified Water granulation; granules are dried at 50°C.

[0085]2) Outer layer granulation: add granulation formula and content according to the above table, granulate hypromellose (K100M), hypromellose (E50), hypromellose, felodipine, microcrystalline cellulose, gallic Propyl acrylate, micropowder silica gel and polyoxyethylene hydrogenated castor oil are mixed evenly, then sodium stearyl fumarate is added, and granulated;

[0086] 3) Take the particles in step 1) and use a 5mm flat oblique punching sheet.

[0087] 4) Take part of the granules in step...

Embodiment 2-3

[0090] The present embodiment provides the compound preparation of felodipine and propranolol hydrochloride, and its prescription is as follows:

[0091]

[0092] Preparation:

[0093] 1) Inner layer granulation: add propranolol hydrochloride, anhydrous lactose, and silicon dioxide to the wet mixing granulator according to the granulation formula and content in the above table, stir for 10 min, and add purified water to granulate; Dry at 50°C.

[0094] 2) Outer layer granulation: add granulation formula and content according to the above table, granulate hypromellose (K100M), hypromellose (E50), hypromellose, felodipine, microcrystalline cellulose, gallic Propyl acrylate, micropowder silica gel and polyoxyethylene hydrogenated castor oil are mixed evenly, then sodium stearyl fumarate is added, and granulated;

[0095] 3) Take the particles in step 1) and use a 5mm flat oblique punching sheet.

[0096] 4) Take part of the granules in step 2) and fill it into the die, add ...

Embodiment 4

[0099] The compound preparation of felodipine and propranolol hydrochloride, the difference between its prescription and Example 1 is only that the propyl gallate in the prescription is replaced with the same amount of butyl ether, and the preparation method is the same as that of Example 1.

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Abstract

The invention relates to a felodipine propranolol hydrochloride compound preparation and a preparation method thereof. The felodipine propranolol hydrochloride compound preparation comprises an inner layer and an outer layer, wherein the active ingredient of the inner layer is propranolol hydrochloride; the active ingredient of the outer layer is felodipine; and the outer layer is wrapped outside the inner layer. The felodipine and propranolol hydrochloride are combined for use, so that the antihypertensive effect can be achieved, and propranolol hydrochloride can resist the effect of heart rate increase caused by long-term administration of felodipine.

Description

technical field [0001] The present invention relates to a compound preparation of felodipine and propranolol hydrochloride and a preparation method thereof. Background technique [0002] With the continuous development of hypertension-related research, its diagnosis and treatment concepts are also constantly updated. The overall cardiovascular risk treatment strategy states that the goal of hypertension treatment is to minimize the overall risk of cardiovascular events and death. To achieve this goal, the treatment strategy includes both the reduction of blood pressure itself and the reversal of all relevant risk factors. Many large clinical trials have shown that the benefits of high blood pressure mainly come from the reduction of blood pressure itself, so reaching the target blood pressure is the key to achieve the above goals. There is increasing evidence that a major determinant of risk reduction is the BP goal achieved with antihypertensive therapy. ESH / ESC 2007 hyp...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/38A61K47/26A61K47/04A61K9/28A61K31/4422A61K31/138A61P9/12G01N30/02
CPCA61K9/209A61K9/2054A61K9/2018A61K9/2009A61K9/2806A61K31/4422A61K31/138A61P9/12G01N30/02A61K2300/00
Inventor 陶秀梅李婧怡张超
Owner NKD PHARMA CO LTD
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