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Benidipine hydrochloride dispersible tablet and preparation method thereof

A technology of benidipine hydrochloride and benidipine hydrochloride is applied in the field of benidipine hydrochloride dispersible tablets and their preparation, which can solve the problems of long tablet disintegration time, low bioavailability, single taking method, etc., and achieve rapid drug dissolution , the effect of high bioavailability and simple production process

Active Publication Date: 2011-12-21
SHANDONG SBOND PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Benidipine hydrochloride is almost insoluble in water, and the dosage form on the domestic market is only tablets, which take a long time to disintegrate, cause poor absorption in the body, low bioavailability, single administration methods, and are difficult for patients with dysphagia to take. This problem is especially prominent when you are older or when you take a large number of tablets at a time

Method used

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  • Benidipine hydrochloride dispersible tablet and preparation method thereof
  • Benidipine hydrochloride dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] The formula of dispersible tablets is composed of: benidipine hydrochloride 2g, microcrystalline cellulose 20g, lactose 10, pregelatinized starch 25g, super starch sodium 16g, croscarmellose sodium 23g, hypromellose 1g, Aspartame 0.5g, magnesium stearate 0.2g.

[0033] Take benidipine hydrochloride, microcrystalline cellulose, lactose, pregelatinized starch, super carmellose sodium starch, croscarmellose sodium, hypromellose, and aspartame according to the formula, sieve, mix well, Use an appropriate amount of 50% ethanol solution to make soft material, pass through a 18-mesh sieve to granulate, dry at 50°C for 4 hours, granulate through a 18-mesh sieve, add magnesium stearate, mix evenly, and press into tablets, weighing 0.1g.

Embodiment 2

[0035] The formula of dispersible tablets is composed of: benidipine hydrochloride 2g, microcrystalline cellulose 30g, lactose 15g, sodium starch glycolate 30g, croscarmellose sodium 19g, hypromellose 2g, sodium saccharin 1g, stearic acid Magnesium 1g.

[0036] Take benidipine hydrochloride, microcrystalline cellulose, lactose, carboxymethyl starch sodium, croscarmellose sodium, hypromellose, and saccharin sodium according to the formula, sieve, mix well, and use an appropriate amount of 60% ethanol solution to soften Material, passed through a 20-mesh sieve to granulate, dried at 60°C for 4 hours, granulated through a 20-mesh sieve, added magnesium stearate, mixed evenly, and pressed into tablets.

Embodiment 3

[0038] The formula of the dispersible tablet consists of: benidipine hydrochloride 2g, microcrystalline cellulose 20g, pregelatinized starch 44g, crospovidone 50g, hypromellose 3g, povidone K30 1g, aspartame 4g, Magnesium stearate 2g.

[0039] Take benidipine hydrochloride, microcrystalline cellulose, pregelatinized starch, crospovidone, hypromellose, povidone K30, and aspartame according to the formula, sieve, mix well, and add an appropriate amount of 75% ethanol Soft material made from solution, passed through a 20-mesh sieve to granulate, dried at 65°C for 4 hours, granulated through a 20-mesh sieve, added magnesium stearate, mixed evenly, and compressed into tablets.

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Abstract

The invention discloses a benidipine hydrochloride dispersing tablet, which comprises the following components in percentage by weight: 0.5-2% of benidipine hydrochloride used as an active ingredient as well as 40-62.8% of auxiliary material A, 35-55% of auxiliary material B, 1.0-5.0% of auxiliary material C, 0.5-6.0% of auxiliary material D and 0.2-5.0% of auxiliary material E used as a mixed auxiliary material. The method also discloses a preparation method of the benidipine hydrochloride dispersing tablet. The dispersing tablet disclosed by the invention has the advantages of short disintegration time, good dispersion state, rapid drug dissolution, definite curative effect, high bioavailability and convenience in administration, and can be administered by swallowing and can also be administered after being dispersed in water. The preparation process comprises production equipment and process for common tablets, and has the advantages of no need for special production process and equipment, simple production process and low cost.

Description

technical field [0001] The invention relates to a benidipine hydrochloride dispersible tablet and a preparation method thereof, belonging to the technical field of drug synthesis and preparation. Background technique [0002] Hypertension can be divided into primary hypertension and secondary hypertension. Essential hypertension accounts for about 90%, which is caused by dysfunction of blood pressure regulation under the influence of various factors; secondary hypertension accounts for about 5% to 10%. According to statistics from our country, the incidence of hypertension is as high as 27% among Chinese people aged 35 to 74, and the number of patients is close to 130 million, with an increase of more than 3 million every year. Hypertension can cause damage to the heart, brain, kidney and other organs, seriously threatening human health and life. Therefore, protecting the heart, brain, and kidneys and preventing heart failure, renal failure, and stroke have become importan...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4545A61K47/36A61K47/38A61K47/32A61P9/12
Inventor 王浩骅刘红秦昌金高恒忠刘永霞王庆生马全龙夏春梅宋金燕
Owner SHANDONG SBOND PHARMA
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