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Preparation method of manidipine sustained release tablet

A sustained-release tablet, gentle technology, applied in the field of manidipine sustained-release tablets, to achieve the effect of simple preparation process and small gastrointestinal side effects

Inactive Publication Date: 2014-04-02
广西南宁科冠医药科技开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Nifedipine (30 or 60 mg daily) had no such effect

Method used

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  • Preparation method of manidipine sustained release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] The formulation of the plain tablets of manidipine sustained-release tablets is as follows: 500 mg of manidipine, 200 mg of carrageenan, 50 mg of magnesium stearate, 100 mg of citric acid, and 200 mg of lactose; the coating formulation of manidipine sustained-release tablets is as follows: carboxymethyl Sodium cellulose base 10.5mg, propylene glycol 20mg, talcum powder 9.5mg.

[0022] Preparation Process:

[0023] (1) Dissolving 100mg of carrageenan in an ethanol solution to prepare an alcohol solution; (2) Place the sieved manidipine, remaining carrageenan, citric acid, and lactose in a high-efficiency mixing granulator to fully mix , add the alcohol solution of the above-mentioned carrageenan, and mix well to obtain a soft material; (3) dry the above-mentioned soft material and add a lubricating glidant to obtain a mixed powder, which is all added to a multi-directional motion mixer, using a rotary Tablet machine tableting to obtain plain tablets; (4) preparation of ...

Embodiment 2

[0025] The formulation of the plain tablets of manidipine sustained-release tablets is as follows: 500 mg of manidipine, 300 mg of carrageenan, 20 mg of magnesium stearate, 50 mg of citric acid, and 100 mg of lactose; the coating formula of manidipine sustained-release tablets is as follows: carboxymethyl Cellulose Sodium 9.5mg, Propylene Glycol 19mg, Talc 15mg.

[0026] Preparation Process:

[0027] (1) Dissolving 100mg of carrageenan in an ethanol solution to prepare an alcohol solution; (2) Place the sieved manidipine, remaining carrageenan, citric acid, and lactose in a high-efficiency mixing granulator to fully mix , add the alcohol solution of the above-mentioned carrageenan, and mix well to obtain a soft material; (3) dry the above-mentioned soft material and add a lubricating glidant to obtain a mixed powder, which is all added to a multi-directional motion mixer, using a rotary Tablet machine tableting to obtain plain tablets; (4) preparation of coating solution: tal...

Embodiment 3

[0028] The release research of embodiment 3 manidipine sustained-release tablets

[0029] Tablets prepared by direct compression of the tablet (specification 50 mg) prepared in Example 1 of the present invention and manidipine (see figure 1 In Comparative Example 1) for comparison.

[0030] Release test method: Take the tablet (50 mg specification) prepared in Example 1 and the tablet (50 mg specification) prepared by direct compression of manidipine respectively, according to the release test method (Chinese Pharmacopoeia 2010 edition two appendix XD first method), use 900ml of distilled water as solvent, rotate at 50 rpm, operate according to law, after 1, 4, and 8 hours, take 10ml of the solution, filter it through a 0.8um filter immediately, and add 10ml of solvent in time, and accurately measure the filtrate Appropriate amount, quantitatively diluted with distilled water to a solution containing about 16ug per 1ml, according to the spectrophotometric method (Chinese Phar...

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Abstract

The invention relates to a manidipine sustained release tablet for treating hypertension, belonging to the technical field of a Western medicine preparation. The manidipine sustained release tablet consists of a tablet and a coating, and is characterized in that the tablet comprises the following components according to the total weight percentage of the sustained release tablet: 30-70 parts of manidipine, 10-30 parts of carrageenan, 1-10 parts of a lubrication glidant, 5-15 parts of citric acid and 1-20 parts of a sweetening agent; the coating comprises the following components in 100 parts by total weight of the sustained release tablet: 0.5-3 parts of sodium carboxymethylcellulose, 0.5-5 parts of propylene glycol and 0.5-2 parts of the lubrication glidant. The tablet provided by the invention has the advantages of slow release, small side effects on stomachs and intestines, and no bitter taste.

Description

technical field [0001] The invention belongs to the technical field of western medicine preparations, in particular to a manidipine sustained-release tablet for treating senile dementia. Background technique [0002] Manidipine is a lipophilic, third-generation dihydropyridine calcium channel blocker, CA registration number 89226-75-5, molecular formula C35H38N4O6 2HCl, molecular weight 683.62, highly selective for vascular smooth muscle , thus significantly inducing peripheral vasodilation with minimal cardioinhibition. In addition, manidipine did not significantly affect norepinephrine levels, suggesting that it does not affect the sympathetic nervous system. The effects of this drug are gradual but long-lasting and can be taken only once a day. Manidipine can dilate the output and input arteries of the kidney, which has certain benefits to the kidney, but its effect on the kidney is not related to its antihypertensive effect. Oral once-daily manidipine is effective and...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/28A61K31/496A61P9/12
Inventor 杨建国梁梦雪
Owner 广西南宁科冠医药科技开发有限公司
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