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Amlodipine benazepril impulse tablet and preparation method thereof

A technology of benazepril hydrochloride and dipinbei, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of increasing the incidence of adverse reactions, and achieve a suitable large-scale Effects of industrialized production, improvement of quality of life, improvement of drug compliance

Inactive Publication Date: 2019-04-26
SHANGHAI SUNTECH PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] According to statistics, the effective rate of treating hypertension with a single drug is only 40%. Increasing the dosage to improve the curative effect will also increase the incidence of adverse reactions

Method used

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  • Amlodipine benazepril impulse tablet and preparation method thereof
  • Amlodipine benazepril impulse tablet and preparation method thereof
  • Amlodipine benazepril impulse tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0071] Immediate-release tablet core prescription:

[0072]

[0073]

[0074] Preparation process: After fully mixing the components, immediate-release tablet cores were prepared by powder direct compression method, and a total of 2,500 immediate-release tablet cores were prepared.

[0075] Swelling Coating Recipe:

[0076] HPMC E5 130g

[0077] Absolute ethanol 2470g

[0078] Swelling coating layer coating process: prepare coating liquid according to prescription, and use pan coating method for coating. The material temperature of the coating pan is 38-45° C., the flow rate of the coating liquid is 15 g / min, the rotational speed of the coating pan is 12 rpm, and the weight gain of the coating is 10%.

[0079] Controlled release coating formulation:

[0080] Eudragit RS 100 25g

[0081] Eudragit RL 100 5g

[0082] Absolute ethanol 100g

[0083] Coating process of the controlled-release coating layer: Prepare the coating solution according to the prescription, and ...

Embodiment 2

[0086] In this example, the same prescription and process conditions as in Example 1 were used to prepare the immediate-release tablet core and the swelling coating layer, and then form the controlled-release coating layer.

[0087] Controlled release coating formulation:

[0088] Eudragit RS 100 150g

[0089] Eudragit RL 100 30g

[0090] Absolute ethanol 600g

[0091] Coating process of the controlled-release coating layer: Prepare the coating solution according to the prescription, and use the pan coating method for coating. The material temperature of the coating pan is 38-45° C., the flow rate of the coating solution is 15 g / min, the rotational speed of the coating pan is 10 rpm, and the weight gain of the coating is 12%. The drug release time lag of the prepared pulse tablet is about 9h, and the time lag is reached, and the dissolution rate of the drug is greater than 80% in 1 hour. The drug release curve in vitro is shown in figure 2 .

[0092] from figure 2 It c...

Embodiment 3

[0094] In this example, the same prescription and process conditions as in Example 1 were used to prepare the immediate-release tablet core and the swelling coating layer, and then form the controlled-release coating layer.

[0095] Controlled release coating formulation:

[0096] Eudragit RS 100 80g

[0097] Eudragit RL 100 100g

[0098] Absolute ethanol 600g

[0099] Coating process of the controlled-release coating layer: the coating solution was prepared according to the prescription, and the same coating conditions as in Example 2 were used to prepare the controlled-release coating layer. The drug release time lag of the prepared pulse tablet is about 6h, and the time lag is reached, and the dissolution rate of the drug is greater than 80% in 1 hour. The drug release curve in vitro is shown in image 3 .

[0100] from image 3 It can be seen from the figure that the prepared pulsating tablets began to exhibit obvious drug release behavior after the 6th hour, and the ...

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Abstract

The invention discloses an amlodipine benazepril impulse tablet and a preparation method thereof. The amlodipine benazepril impulse tablet comprises a rapid-release tablet core and a controlled-release coating layer, wherein the rapid-release tablet core is prepared from a main drug and a tablet core auxiliary material, and the main drug is prepared from amlodipine besylate and benazepril hydrochloride. The preparation method comprises the following steps that (1) after the main drug and the tablet core auxiliary material are uniformly mixed, the rapid-release tablet core is prepared by adopting a direct powder compression method; (2) optionally, a swelling coating layer is formed on the rapid-release tablet core prepared in the step (1); and (3), the controlled-release coating layer is formed on the rapid-release tablet core prepared in the step (1) or the swelling coating layer prepared in the step (2) so as to obtain the amlodipine benazepril impulse tablet. According to the amlodipine benazepril impulse tablet and the preparation method thereof, the drug release time lag of the amlodipine benazepril impulse tablet can reach 1-10 h, the drug is completely and rapidly released, the drug release time lag accords with the pathogenetic time rule of hypertension and adverse reaction thereof, and the compliance of a patient is better; and in addition, a preparation process is simple, and relatively good industrial application values are achieved.

Description

technical field [0001] The invention relates to an amlodipine benazepril pulse tablet and a preparation method thereof. Background technique [0002] In the past 20 years, the morbidity and mortality of cardiovascular and cerebrovascular diseases in China are still on the rise, and have become the number one killer with the highest cause of death in my country (about 40% death contribution rate). Among cardiovascular and cerebrovascular diseases, hypertension occupy the first place in the incidence rate. At present, high blood pressure poses a huge threat to the health of Chinese people and increases the economic burden. It also poses a huge challenge to medical workers. [0003] Amlodipine Besylate (Amlodipine Besylate) is a calcium ion antagonist that directly acts on vascular smooth muscle, thereby relaxing coronary vessels and systemic vessels, increasing coronary blood flow, and lowering blood pressure. Amlodipine Besylate Tablets were successfully developed by Pfizer ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4422A61K31/55A61K9/36A61K9/32A61K47/38A61K47/32A61P9/12
CPCA61K9/2059A61K9/2846A61K9/2866A61K9/2893A61K31/4422A61K31/55A61K2300/00
Inventor 刘学军牛国琴涂亮星连建豪
Owner SHANGHAI SUNTECH PHARMA
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