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Manidipine hydrochloride oral quick release preparation and preparation method thereof

A technology of manidipine hydrochloride and manidi hydrochloride, which is applied in pill delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve the problems of poor drug stability of liquid preparations, affecting full absorption of drugs, and slow drug dissolution. Achieve the effect of good disintegration performance, convenient taking and fast absorption speed

Inactive Publication Date: 2012-03-21
YANGTZE RIVER PHARMA GRP BEIJING HAIYAN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the full absorption of the drug is often affected by the slow disintegration and dissolution of the drug; at the same time, when the dose is large and more drugs need to be taken at one time, it often brings troubles to the elderly, children and patients with dysphagia
In this case, oral solutions, suspensions and emulsions are superior, but liquid preparations have disadvantages such as poor drug stability and inconvenient storage and transportation.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] prescription:

[0068] Composition Weight percentage content

[0069] Manidipine Hydrochloride 15%

[0070] Croscarmellose Sodium 6%

[0071] Povidone (1% aqueous solution) 1%

[0072] Magnesium Stearate 0.5%

[0073] The rest is mannitol added to 100%

[0074] Preparation:

[0075] Firstly crush the above materials respectively through a 100-mesh sieve, mix manidipine hydrochloride, mannitol, and croscarmellose sodium evenly, use 1% PVP aqueous solution as a binder, make a soft material, and pass through a 20-mesh sieve. Granules, dried at 80°C, granulated into 20 meshes, added with magnesium stearate, mixed evenly, and compressed into tablets.

Embodiment 2

[0077] prescription:

[0078] Composition Weight percentage content

[0079] Manidipine Hydrochloride 15%

[0080] Sodium Starch Carboxymethyl 7%

[0081] Povidone (2% aqueous solution) 1%

[0082] Micronized silica gel 0.5%

[0083] The rest is mannitol plus 100%

[0084] Preparation:

[0085] First above-mentioned materials are pulverized respectively through 100 mesh sieves, manidipine hydrochloride, mannitol, and carboxymethyl starch sodium are mixed evenly, and 2% PVP aqueous solution is used as binder, soft material is made, and granulated through 24 mesh sieves, 80 Dry at ℃, granulate at 24 mesh, add micro-powder silica gel, mix evenly, and press into tablets.

Embodiment 3

[0087] prescription:

[0088] Composition Weight percentage content

[0089] Manidipine Hydrochloride 15%

[0090] Crospovidone 6%

[0091] Hypromellose (5% aqueous solution) 1%

[0092] Magnesium Stearate 0.5%

[0093] The rest is lactose added to 100%

[0094] Preparation:

[0095] First crush the above materials respectively through a 100-mesh sieve, mix manidipine hydrochloride, lactose, and crospovidone evenly, use 5% hydroxypropyl methylcellulose solution as a binder, make a soft material, and pass through a 28-mesh sieve Granulate, dry at 60°C, granulate at 28 mesh, add magnesium stearate, mix evenly, and tablet.

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PUM

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Abstract

The invention relates to a manidipine hydrochloride oral quick release preparation and a preparation method thereof, wherein the manidipine hydrochloride oral quick release preparation cures hypertension, can be quickly disintegrated and released, and includes oral fast dissolving tablets, oral disintegrating tablets and dispersible tablets. The manidipine hydrochloride oral quick release preparation comprises medicinal active ingredient manidipine hydrochloride and excipients, according to the weight percentage, the manidipine hydrochloride occupies 0.1swung dash95%, and the pharmaceutical excipients occupy 5swung dash99.9%. The manidipine hydrochloride oral quick release preparation is prepared through the method, the preparation formulation range of the manidipine hydrochloride is expanded, the manidipine hydrochloride oral quick release preparation has reasonable formula, good disintegration performance, no oral grit taste and discomfort tastes, a simple preparation technology and quick absorption rate, so the pharmaceutical bioavailability and blood medicine solubility can be improved, accordingly, the curative effect for curing hypertension is improved, the preparation is convenient to take, has good tastes, can be quickly disintegrated with saliva in the oral cavity, so convenience is brought to the old or patients who have the difficulty in swallowing medicines and have inconvenience in taking water.

Description

technical field [0001] The invention relates to a rapidly disintegrating and releasing manidipine hydrochloride oral immediate-release preparation for treating hypertension and a preparation method thereof, comprising an orally dissolving tablet, an orally disintegrating tablet and a dispersible tablet. Background technique [0002] Hypertension is one of the most common cardiovascular diseases in the world today. Epidemiological studies show that there are currently 600 million hypertensive patients in the world, and the prevalence of hypertension is about 10%, and that in some developed countries in Europe and America is 20%. According to the latest statistical results released by the Ministry of Health on October 12, 2004, the prevalence rate of hypertension among residents aged 18 and over in my country is 18.8%, and it is estimated that there are more than 160 million patients nationwide. Compared with 1991, the prevalence rate increased by 31%, and the number of patie...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/46A61K31/496A61K47/32A61K47/34A61K47/36A61K47/38A61K47/42A61P9/12
Inventor 宋志涛周津梅肖慧石和鹏侯鹏
Owner YANGTZE RIVER PHARMA GRP BEIJING HAIYAN PHARMA
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