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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.

Inactive Publication Date: 2018-11-06
HEBEI SAIKE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, nearly 180 pharmaceutical companies in my country produce nitrendipine tablets, but a large number of clinical application experience shows that the outstanding problem of nitrendipine is the large difference in quality and curative effect. This phenomenon is not only manifested in the nitrendipine tablets produced by different companies. between different batches of the same company, and even between different batches of the same company. damage to organs

Method used

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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

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IPC IPC(8): A61K9/20A61K47/32A61K47/10A61K31/4422A61P9/12
CPCA61K9/2013A61K9/2027A61K31/4422A61P9/12
Inventor 李新联王朝晖刘同梅刘九春杜蕊
Owner HEBEI SAIKE PHARMA
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