Manidipine hydrochloride tablet for treating hypertension and preparation method thereof

A technology of manidipine hydrochloride and manidipine hydrochloride, which is applied in the directions of medical preparations without active ingredients, medical preparations containing active ingredients, and pill delivery, etc., can solve the problems of low bioavailability and low dissolution rate.

Active Publication Date: 2020-07-07
佛山德芮可制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The main purpose of the present invention is to overcome the problems of low dissolution rate and low bioavailability of existing manidipine hydrochloride tablets, and provide a higher manidipine hydrochloride tablet with dissolution rate

Method used

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  • Manidipine hydrochloride tablet for treating hypertension and preparation method thereof
  • Manidipine hydrochloride tablet for treating hypertension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] The preparation of manidipine hydrochloride tablet

[0024] (1) 25g polyethylene glycol 6000 is melted;

[0025] (2) 10 g of manidipine hydrochloride, 0.5 g of sodium lauryl sulfonate and 60 g of lactose are pulverized to an average particle size of 10 μm, and then mixed with molten polyethylene glycol 6000 by an electrostatic powder spray gun;

[0026] (3) After raising the temperature of the material mixed in step (2) to 125°C, stir at a speed of 250r / min for 1-2min, cool down to 75°C, add 0.9g of magnesium stearate and stir for 30 minutes at a speed of 80r / min , then transfer the material to a drying oven, dry at 80° C. for 6 to 8 hours, and compress the dried material into tablets to obtain 1000 manidipine hydrochloride tablets.

Embodiment 2

[0028] The preparation of manidipine hydrochloride tablet

[0029] (1) Polyethylene glycol 6000 of 37.5g is melted;

[0030] (2) 10 g of manidipine hydrochloride, 3.1 g of sodium lauryl sulfonate and 62.5 g of lactose are pulverized to an average particle size of 30 μm, and then mixed with molten polyethylene glycol 6000 by an electrostatic powder spray gun;

[0031] (3) After raising the temperature of the mixed material in step (2) to 120°C, stir at 240r / min for 1-2min, cool down to 75°C, add 0.6g of magnesium stearate and stir for 30 minutes at 100r / min , then transfer the material to a drying oven, dry at 80° C. for 6 to 8 hours, and compress the dried material into tablets to obtain 1000 manidipine hydrochloride tablets.

Embodiment 3

[0033] The preparation of manidipine hydrochloride tablet

[0034] (1) 30g polyethylene glycol 6000 is melted;

[0035] (2) 10 g of manidipine hydrochloride, 0.2 g of sodium lauryl sulfonate and 80 g of lactose are pulverized to an average particle size of 20 μm, and then mixed with molten polyethylene glycol 6000 by an electrostatic powder spray gun;

[0036] (3) After raising the temperature of the mixed material in step (2) to 130°C, stir at a speed of 280r / min for 1-2min, cool down to 85°C, add 1g of magnesium stearate and stir for 30 minutes at a speed of 80r / min, The material is then transferred to a drying oven, dried at 60° C. for 6 to 8 hours, and the dried material is compressed into tablets to obtain 1000 manidipine hydrochloride tablets.

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Abstract

theThe invention discloses a Manidipine dihydrochloride tablet for treating hypertension and a preparation method thereof. The tablet contains Manidipine dihydrochloride, sodium dodecanesulphonate, polyethylene glycol 6000, lactose and magnesium stearate. The preparation method comprises the following steps: (1) fusion of polyethylene glycol 6000 is carried out; (2) Manidipine dihydrochloride, sodium dodecanesulphonate and lactose are crushed, and then the materials and fused polyethylene glycol 6000 mixed by a powder injection apparatus; (3) the materials mixed in the step (2) are heated to 120-150 DEG C, stirring is carried out at a rotating speed of 220-280 r / min for 1-2 minutes, cooling is carried out for 75-85 DEG C, magnesium stearate is added and stirring is carried out for 30 minutes, materials are transferred to a drying box, drying is carried out, and materials are dried and pressed into tablets in order to obtain the Manidipine dihydrochloride tablet. The invention providesthe Manidipine dihydrochloride tablet for treating hypertension, the tablet has higher dissolution rate, the dissolution rate of the tablet reaches 98.2% or above, the preparation method is stable andreliable, and the method is suitable for industrialized production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a manidipine hydrochloride tablet for treating hypertension and a preparation method thereof. Background technique [0002] Hypertension is one of the most common cardiovascular diseases in the world today. The current drug treatment of hypertension is based on the use of different drug classes, including angiotensin converting enzyme inhibitors, angiotensin receptor blockers, diuretics, beta -Receptor blockers and calcium channel blockers. Manidipine hydrochloride is a third-generation lipophilic calcium channel antagonist. It is a dihydropyridine antihypertensive drug developed by Japan Takeda Pharmaceutical Co., Ltd. in 1990. This product is selective to blood vessels, can inhibit the voltage-dependent influx of calcium ions in smooth muscle cells, and cause systemic vasodilation, thereby reducing blood pressure. Pharmacological and toxicological experim...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K47/20A61K47/10A61K47/26A61K31/496A61P9/12
CPCA61K9/2013A61K9/2018A61K9/2031A61K9/2095A61K31/496
Inventor 黄逸斌孙益东耿志
Owner 佛山德芮可制药有限公司
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