Compound antihypertensive drug combination preparation containing furosemide and spirolactone and preparation method of compound antihypertensive drug combination preparation

A technology of furosemide and spironolactone, which is applied to the compound antihypertensive drug combination preparation containing furosemide and spironolactone and the field of preparation thereof, can solve the problems of low bioavailability, etc. The effect of increased surface area

Inactive Publication Date: 2016-06-22
KANGYA OF NINGXIA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The present invention aims to provide a compound antihypertensive drug combination preparation containing furosemide and spironolactone and a preparation method thereof, to solve the problem of low bioavailability of the compound antihypertensive drug combination preparation containing furosemide and spironolactone in the prior art technical problem

Method used

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  • Compound antihypertensive drug combination preparation containing furosemide and spirolactone and preparation method of compound antihypertensive drug combination preparation
  • Compound antihypertensive drug combination preparation containing furosemide and spirolactone and preparation method of compound antihypertensive drug combination preparation
  • Compound antihypertensive drug combination preparation containing furosemide and spirolactone and preparation method of compound antihypertensive drug combination preparation

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preparation example Construction

[0036] According to a typical embodiment of the present invention, a preparation method of the above compound antihypertensive drug combination preparation is provided. The preparation method comprises the following steps: S1, respectively superfinely pulverizing furosemide and spironolactone so that their particle diameters D90 are respectively below 12 μm, and uniformly mixing the pulverized furosemide and spironolactone to obtain mixed powder A; S2, Mix mixed powder A with filler, 60% disintegrant and solubilizer evenly, add binder and appropriate amount of solvent to prepare soft material, then granulate and dry; S3, the granules after step S2 are dried After granulation, add the remaining disintegrant and lubricant, mix evenly, and compress the tablet to obtain the tablet core; S4, coat the tablet core, and obtain the compound antihypertensive drug combination preparation after drying.

[0037]In the present invention, the crude drug is ultrafinely pulverized so that its ...

Embodiment 1

[0043]

[0044] Coating solution:

[0045]

[0046] Preparation Process:

[0047] ①Ultrafinely pulverize furosemide and spironolactone, the particle size D90 of which is less than 12 μm, then mix evenly and set aside;

[0048] ②Weigh the prescribed amount of lactose, microcrystalline cellulose, poloxamer and 7.2g of low-substituted hydroxypropyl cellulose and mix them with the two main ingredients evenly, add 50% ethanol solution to make soft material, and pass through a 20-mesh sieve to granulate ;

[0049] ③ Dry the wet granules in an oven at 60°C for 1.5 to 2 hours, and take the dried granules and pass them through a 20-mesh sieve for granulation;

[0050] ④Take the dry granules, add the prescribed amount of magnesium stearate and 4.8g of low-substituted hydroxypropyl cellulose, mix well, and punch the tablets with 8mm shallow concaves to obtain plain tablets;

[0051] ⑤Place the beaker with 50% ethanol solution on a magnetic stirrer, slowly add Opadry (295F620027)...

Embodiment 2

[0054]

[0055] Coating solution:

[0056]

[0057]

[0058] Preparation Process:

[0059] ① Pulverize furosemide and spironolactone, the particle size D90 of which is less than 12 μm, then mix evenly and set aside;

[0060] ② Weigh the prescription amount of lactose, microcrystalline cellulose, Tween 80 and 6.0 g of prescription amount of carboxymethyl starch sodium and mix with the two main ingredients, add water to make soft material, and pass through a 20-mesh sieve to granulate;

[0061] ③ Dry the wet granules in an oven at 60°C for 1.5 to 2 hours, and take the dried granules and pass them through a 20-mesh sieve for granulation;

[0062] ④Take the dry granules, add the prescribed amount of magnesium stearate and 4.0 g of sodium starch glycolate, mix well, and punch the tablets with 8 mm shallow concaves to obtain plain tablets;

[0063] ⑤Place the beaker with 50% ethanol solution on a magnetic stirrer, slowly add Opadry (295F620027) into the constantly stirrin...

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Abstract

The invention discloses a compound antihypertensive drug combination preparation containing furosemide and spironolactone and a preparation method thereof. Wherein, the compound antihypertensive drug combination preparation includes a tablet core and a coating, and the tablet core includes the following components based on the total weight of the core in the photo: 10% to 40% of furosemide, 20% to 50% of spironolactone, and 2% of solubilizer ~4%, filler 10%~60%, disintegrant 4%~8%, lubricant 0.5%~1% and binder 0.1%~2%.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a compound antihypertensive drug combination preparation containing furosemide and spironolactone and a preparation method thereof. Background technique [0002] Furosemide, white or off-white crystalline powder; soluble in acetone, slightly soluble in ethanol, insoluble in water; belongs to strong diuretic, is a high-efficiency diuretic acting on the ascending branch of Heinz loop. It is clinically used to treat edema disease, liver cirrhosis, hypertension, congestive heart failure, hyperkalemia and hypercalcemia, dilutional hyponatremia, hypersecretion of antidiuretic hormone and acute drug poisoning, etc. , can prevent acute renal failure and the clinical situation where diuretics are not effective and diuretics are urgently needed. But the disadvantage is that it can cause blood electrolyte disturbance, especially for K + The impact is obvious. [0003]...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/585A61K9/36A61K47/20A61K47/38A61P9/12A61K31/341
CPCA61K31/341A61K9/2013A61K9/2059A61K9/2866A61K31/585
Inventor 韩丽娟杨亚军
Owner KANGYA OF NINGXIA PHARMA
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