A kind of nitrendipine dispersible tablet and preparation method thereof

A technology of dispersible tablets and nitren, which is applied in the field of nitrendipine dispersible tablets and its preparation, and can solve the problems of low bioavailability, poor absorption, irregular blood pressure fluctuations, etc.

Active Publication Date: 2021-08-10
HEBEI SAIKE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, nearly 180 pharmaceutical companies in my country produce nitrendipine dispersible tablets (ordinary tablets), but a large number of clinical application experience shows that the bioavailability of nitrendipine dispersible tablets is low, which directly leads to poor absorption, which makes the blood pressure of hypertensive patients Irregular fluctuations not only affect the control of blood pressure, but also aggravate the damage to organs

Method used

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  • A kind of nitrendipine dispersible tablet and preparation method thereof
  • A kind of nitrendipine dispersible tablet and preparation method thereof
  • A kind of nitrendipine dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Embodiment 1: Nitrendipine Dispersible Tablets

[0051] Prescription composition:

[0052] components weight (g) number of copies Nitrendipine 10 10 lactose 35 35 starch 35 35 microcrystalline cellulose 52.5 52.5 Cross-linked polyvinylpyrrolidone 22 22 Magnesium stearate 2.5 2.5

[0053] Preparation:

[0054] 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;

[0055] ② Pretreatment of excipients: Microcrystalline cellulose, lactose, starch, cross-linked polyvinylpyrrolidone, and magnesium stearate are sieved through 120 sieves respectively, and set aside;

[0056] ③ Mixing of raw and auxiliary materials: using the method of equal increase, mix nitrendipine, microcrystalline cellulose, lactose, and cross-linked polyvinylpyrrolidone (3 / 5 of t...

Embodiment 2

[0062] Embodiment 2: Nitrendipine Dispersible Tablets

[0063] Prescription composition:

[0064] components weight (g) number of copies Nitrendipine 10 10 lactose 40 40 starch 40 40 microcrystalline cellulose 60 60 Cross-linked polyvinylpyrrolidone 25 25 Magnesium stearate 3 3

[0065] Preparation:

[0066] Same as Example 1

[0067] The nitrendipine dispersible tablet prepared in embodiment 2 is carried out disintegration time limit and dissolution rate inspection, and the results are as follows:

[0068] sample Disintegration time limit Dissolution Example 2 2.6 Compliance

Embodiment 3

[0069] Embodiment 3: Nitrendipine Dispersible Tablets

[0070] Prescription composition:

[0071] components weight (g) number of copies Nitrendipine 10 10 lactose 30 30 starch 30 30 microcrystalline cellulose 45 45 Cross-linked polyvinylpyrrolidone 20 20 Magnesium stearate 2 2

[0072] Preparation:

[0073] Same as Example 1

[0074] The nitrendipine dispersible tablet prepared by embodiment 3 is carried out to disintegration time limit and dissolution rate inspection, and the results are as follows:

[0075] sample Disintegration time limit Dissolution Example 3 2.4 Compliance

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Abstract

The invention provides a nitrendipine dispersible tablet and a preparation method thereof, comprising nitrendipine, lactose, microcrystalline cellulose; cross-linked polyvinylpyrrolidone, binding agent, magnesium stearate, etc. Process parameters such as disintegrating agent and adding method, selection of binder, dosage ratio of lactose, starch and microcrystalline cellulose make the prepared nitrendipine dispersible tablet easier to disintegrate, disperse and dissolve, improve absorption and bioavailability Spend.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a nitrendipine dispersible tablet and a preparation method thereof. Background technique [0002] Nitrendipine is a second-generation dihydropyridine calcium antagonist that selectively acts on vascular smooth muscle, reducing total peripheral resistance and lowering blood pressure. And can reduce myocardial oxygen consumption, has a protective effect on ischemic myocardium. It is suitable for various types of hypertension, such as primary and secondary mild and moderate hypertension, and can also be used for coronary heart disease, congestive heart failure, etc. The drug was first launched by Bayer in Federal Germany in April 1985 listed. [0003] Nitrendipine is a poorly soluble BCS class II drug with a very low solubility in water, about 1.9-2.1 micrograms / ml (37°C). Its molecular formula is as follows: [0004] . [0005] Figure 1: Nitrendipine Chemical Struc...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/4422A61K47/38A61K47/36A61K47/26A61K47/32A61P9/12
CPCA61K9/0095A61K9/2018A61K9/2027A61K9/205A61K9/2054A61K31/4422A61P9/12
Inventor 冯朝王朝辉李新联王红杰
Owner HEBEI SAIKE PHARMA
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