Nitrendipine tablet and preparation method thereof

A technology of nitrendipine and nitrendipine tablets, applied in the field of nitrendipine tablets and its preparation, can solve the problems of difference in curative effect, influence on blood pressure, large difference in quality and curative effect, etc.

A technology of nitrendipine and nitrendipine tablets, applied in the field of nitrendipine tablets and its preparation, can solve the problems of difference in curative effect, influence on blood pressure, large difference in quality and curative effect, etc.

CN108743553AInactive Publication Date: 2018-11-06HEBEI SAIKE PHARMA
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  • Nitrendipine tablet and preparation method thereof
  • Nitrendipine tablet and preparation method thereof
  • Nitrendipine tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Embodiment 1: Nitrendipine Tablets

[0045] Prescription composition (1000 tablets)

[0046]

[0047] Preparation:

[0048] ① Micronization treatment of raw material medicine: micronization treatment of the raw material drug of nitrendipine to obtain more than 90% of the micropowder with a particle size of no more than 6 microns, and set aside;

[0049] ② Pretreatment of auxiliary materials: Microcrystalline cellulose, lactose, sodium carboxymethyl starch, and magnesium stearate are respectively passed through a 160-mesh sieve for use; the adhesive povidone K30 is dissolved in 50ml of 50% ethanol solution to prepare a viscous Mixture solution, spare;

[0050] ③ Mixing of raw and auxiliary materials: Using the method of equal increase, mix nitrendipine, microcrystalline cellulose, lactose, and part of sodium carboxymethyl starch (2 / 3 of the total amount) evenly;

[0051] ④ Soft material granulation: Add the powder in step ③ to the binder solution, stir, and prepare s...

Embodiment 2

[0054] Embodiment 2: Nitrendipine Tablets

[0055] Prescription composition (1000 tablets)

[0056]

[0057] Preparation:

[0058] ① Micronization treatment of raw material medicine: micronization treatment of the raw material drug of nitrendipine to obtain more than 90% of the micropowder with a particle size of no more than 6 microns, and set aside;

[0059] ② Pretreatment of auxiliary materials: microcrystalline cellulose, lactose, sodium carboxymethyl starch, and magnesium stearate are sieved through 160 meshes respectively, and used for later use; the adhesive povidone K30 is dissolved in 50ml of 55% ethanol solution to prepare adhesive agent solution, spare;

[0060] ③ Mixing of raw and auxiliary materials: Using the method of equal increase, mix nitrendipine, microcrystalline cellulose, lactose, and part of sodium carboxymethyl starch (2 / 3 of the total amount) evenly;

[0061] ④ Soft material granulation: add the powder in step ③ to the binder solution, stir to pr...

Embodiment 3

[0064] Embodiment 3: Nitrendipine Tablets

[0065] Prescription composition (1000 tablets)

[0066]

[0067] Preparation:

[0068] ① Micronization treatment of raw material drug: micronization treatment of nitrendipine raw material drug to obtain more than 90% of the micropowder with a particle size of no more than 6 microns, and set aside;

[0069] ② Pretreatment of auxiliary materials: microcrystalline cellulose, lactose, sodium carboxymethyl starch, and magnesium stearate are sieved through 160 meshes respectively, and used for later use; the adhesive povidone K30 is dissolved in 50ml of 60% ethanol solution to prepare adhesive agent solution, spare;

[0070] ③ Mixing of raw and auxiliary materials: Using the method of equal increase, mix nitrendipine, microcrystalline cellulose, lactose, and part of sodium carboxymethyl starch (2 / 3 of the total amount) evenly;

[0071] ④ Soft material granulation: add the powder in step ③ to the binder solution, stir to prepare soft ...

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Abstract

The invention provides a nitrendipine tablet and a preparation method thereof. The nitrendipine tablet is prepared from nitrendipine, lactose, microcrystalline cellulose, sodium carboxymethyl starch,a binding agent, magnesium stearate and the like. Through control of the particle size of raw materials, selection of concentration of a binding agent povidone K30 and a solvent precipitant ethanol, control of the parameters of the drying temperature, the tabletting pressure and the like, the quality of the nitrendipine tablet is stable, but also the requirement is conformed, meanwhile, the dissolution curve in four media is consistent with a raw research product, and the situation that the nitrendipine tablet has the same efficacy with the raw research product is guaranteed.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a nitrendipine tablet and a preparation method thereof. Background technique [0002] Nitrendipine is a second-generation dihydropyridine calcium channel antagonist, which has the advantages of strong antihypertensive effect, long-lasting drug effect, stable antihypertensive effect, and few adverse reactions, so it is widely used in the treatment of hypertension. Nitrendipine is a poorly soluble drug of BCS Ⅱ class, and its solubility in water is extremely low, about 1.9~2.1 micrograms / ml (37°C). Nitrendipine tablets begin to decrease in systolic blood pressure 30 minutes after oral administration, and diastolic blood pressure begins to decrease after 60 minutes. The antihypertensive effect It is the largest in 1-2 hours and lasts for 6-8 hours. The drug was first listed in the Federal Republic of Germany by Bayer in April 1985. [0003] [0004] At present, nearly ...

Claims

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Application Information

Patent Timeline
06 Nov 2018
Publication
CN108743553A
IPC
A61K9/20; A61K47/32; A61K47/10; A61K31/4422; A61P9/12
CPC
A61K9/2013; A61K9/2027; A61K31/4422; A61P9/12
Inventors
李新联; 王朝晖