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L-amlodipine benzene sulfonate tablet and preparation process thereof

A kind of technology of levamlodipine besylate and levamlodipine besylate, applied in the field of levamlodipine besylate tablets and preparation technology thereof, can solve the problems of cumbersome types of auxiliary materials, complicated procedures, high cost of tablets, etc. The effect of high dissolution performance, simple preparation process and high stability

Active Publication Date: 2012-10-03
上海禾丰制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] There are many types of excipients used in the existing disclosed technology and are cumbersome. The cost of preparing tablets is relatively large, the procedure is complicated, and the tablets contain more impurities. At present, there is no document disclosing fewer excipients but still maintaining high dissolution performance and high Preparation method of stable levamlodipine besylate tablets

Method used

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  • L-amlodipine benzene sulfonate tablet and preparation process thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Embodiment 1, the screening of levamlodipine besylate tablet prescription

[0063] ①Dry powder compression

[0064] In the early trial production process, it was considered that the raw materials and auxiliary materials were evenly mixed and then directly pressed into tablets, but due to the poor fluidity of the powder, it could not fall into the hopper naturally. Therefore, the prescription process is selected as wet granulation followed by tablet compression.

[0065] ②Selection of adhesive

[0066] In the selection process of the binder, adding 5% hypromellose solution as the binder, the disintegration time of the prepared tablet is greatly prolonged, ranging from 10 to 12 minutes, which is likely to affect the quality of the finished product. Dissolution. Afterwards, 15% alcohol was used as a wetting agent for granulation, and the obtained tablets were bright and white, with excellent friability and disintegration. Therefore, 15% alcohol was used as a wetting ...

Embodiment 2

[0075] Embodiment 2, one of preparation technology of levamlodipine besylate tablet

[0076] Each 10,000 tablets of levamlodipine besylate contains:

[0077] Levoamlodipine Besylate 34.66g

[0078] Microcrystalline Cellulose 350g

[0079] Calcium Sulfate 350g

[0080] Hypromellose 90g

[0081] Magnesium Stearate 8g.

[0082] The preparation method of the levamlodipine besylate tablet described in the present embodiment comprises the following steps:

[0083] (1) Weigh 34.66g of levamlodipine besylate, 350g of microcrystalline cellulose, 350g of calcium sulfate, 90g of hydroxypropyl cellulose, and 8g of magnesium stearate;

[0084] (2) Pass microcrystalline cellulose, calcium sulfate and hydroxypropyl cellulose through a 60-mesh sieve, and mix well;

[0085] (3) Levoamlodipine besylate passes through a 80-mesh sieve, diffuses in grades in the mixture obtained in step (2), puts it into a wet mixing granulator, and stirs for 10 to 20 minutes;

[0086] (4) Add an appropri...

Embodiment 3

[0097] Embodiment 3, the second of preparation process of levamlodipine besylate tablet

[0098] Each 10,000 tablets of levamlodipine besylate contains

[0099] Levoamlodipine Besylate 34.66g

[0100] Microcrystalline Cellulose 280g

[0101] Calcium sulfate 280g

[0102] Hypromellose 72g

[0103] Magnesium Stearate 6.4g

[0104] The preparation method of the levamlodipine besylate tablet described in the present embodiment comprises the following steps:

[0105] (1) Weigh 34.66g of levamlodipine besylate, 280g of microcrystalline cellulose, 280g of calcium sulfate, 72g of hydroxypropyl cellulose, and 6.4g of magnesium stearate;

[0106](2) Pass microcrystalline cellulose, calcium sulfate and hydroxypropyl cellulose through a 60-mesh sieve, and mix well;

[0107] (3) Levoamlodipine besylate passes through a 80-mesh sieve, diffuses in grades in the mixture obtained in step (2), puts it into a wet mixing granulator, and stirs for 10 to 20 minutes;

[0108] (4) Add an app...

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Abstract

The invention discloses an L-amlodipine benzene sulfonate tablet which contains fewer auxiliary materials, but can keep higher dissolution performance and higher stability, and a preparation process of the L-amlodipine benzene sulfonate tablet. Per 10000 L-amlodipine benzene sulfonate tablets contain 34.66g of L-amlodipine benzene sulfonte, 280-420g of microcrystalline cellulose, 280-420g of calcium sulfate, 72-108g of hydropropylcellulose and 6.4-9.6g of magnesium stearate. The L-amlodipine benzene sulfonate tablet contains fewer auxiliary materials and is particularly free of lactose in the formula, is simple in preparation process, contains fewer related substances, but can keep higher dissolution performance and higher stability; and microcrystalline cellulose and calcium sulfate are used as filling agents, hydropropylcellulose is used as the adhesive and disintegrant, and magnesium stearate is used as the lubricant, and the formula is free of lactose, so that the tablet is also suitable for the patients suffering from lactose intolerance disease.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a levamlodipine besylate tablet and a preparation process thereof. Background technique [0002] Cardiovascular disease is the leading cause of death worldwide. With the increase of cardiovascular disease, reducing the rate of cardiovascular disease and mortality has become an increasingly urgent major public health problem. At present, an average of 17.5 million people die from cardiovascular diseases and strokes worldwide each year, accounting for 1 / 3 of all deaths. It is estimated that by 2020, the number of deaths due to cardiovascular diseases will reach 25 million worldwide. Statistical results predict that the number of hypertensive patients in the world may increase by 60% in the next 20 years, among which the growth rate in developing countries and regions will be more significant, reaching 80%, and that in developed countries will increase by about 24%. [0003] Amlodipine is t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4422A61P9/12A61P9/10
Inventor 施建国张裕吴雯君
Owner 上海禾丰制药有限公司
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