Lacidipine dispersible tablet and preparation method thereof

A technology of lacidipine and dispersible tablets, which is applied in the field of medicine, can solve problems such as easy agglomeration, enhanced hygroscopicity, and unfavorable storage, and achieve the effects of short disintegration time, enhanced compliance, and improved bioavailability

Inactive Publication Date: 2011-07-27
佟兵 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, ultrafine pulverization requires a lot of energy consumption, and the hygroscopicity of the drug increases with the increase of the specific surface area of

Method used

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  • Lacidipine dispersible tablet and preparation method thereof
  • Lacidipine dispersible tablet and preparation method thereof
  • Lacidipine dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] The present embodiment provides the prescription and preparation method thereof of preparing 2000 lacidipine dispersible tablets (specification is: lacidipine 4mg / sheet) as follows:

[0026] Plus prescription:

[0027]

[0028]

[0029] The preparation method is as follows:

[0030] 1) Pass the main ingredient and various auxiliary materials through a 100-mesh sieve for later use.

[0031] 2) Put sodium carboxymethyl starch, microcrystalline cellulose, and crospovidone into an oven and bake at 90°C for one hour.

[0032] 3) Weigh 8 g of lacidipine, 56 g of povidone K30, and 200 g of crospovidone respectively.

[0033] 4) Put lacidipine and povidone in a large beaker first, put them in a water bath at 80°C and stir evenly. Pour in 320ml of absolute ethanol, stir until it is completely dissolved, and stir for another 3 minutes if there is no solid matter.

[0034] 5) Pour all the crospovidone into the above-mentioned beaker at one time, and stir vigorously quic...

Embodiment 2

[0052] This embodiment provides a preferred process for establishing the preparation method of the present invention, including the following aspects:

[0053] (1) Differences in performance of products prepared before and after drying of auxiliary materials

[0054] Two parts (A and B) of the main drug and various auxiliary materials were respectively passed through a 100 mesh sieve for subsequent use, and two parts of the auxiliary materials sodium carboxymethyl starch, microcrystalline cellulose, and crospovidone were weighed respectively, and the A part was put into Bake in an oven at 90°C for one hour, and part B is not dried. Follow-up operations are performed with reference to Example 1 of the invention. The test results of the prepared dispersible tablets are as follows:

[0055]

A (drying accessories)

B (undried accessories)

dispersion

Compliance

did not qualified

hardness

4.8

5.3

disintegrate

2 minutes

5 m...

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Abstract

The invention relates to a lacidipine dispersible tablet and a preparation method thereof. The lacidipine dispersible tablet provided by the invention comprises the following components in parts by weight: 1 part of lacidipine, 5-12 parts of adhesives, 25-35 parts of disintegrating agents and 5-10 parts of diluents. The preparation method of the lacidipine dispersible tablet comprises the following steps of: (1) mixing the lacidipine and the adhesives, adding absolute ethyl alcohol and heating and stirring to complete dissolution; and (2) adding the disintegrating agents to the mixture obtained in the step (1), uniformly mixing, sieving and drying by blowing. The lacidipine dispersible tablet provided by the invention has the advantages of reasonable components, short disintegrating time, rapid medicine dissolution, rapid absorption and capability of improving medicine bioavailability, and the preparation process of the lacidipine dispersible tablet is simple and easy for enforcement and capable of realizing scale production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a lacidipine dispersible tablet and a preparation method thereof. Background technique [0002] Lacidipine (Lacidipine) is a third-generation calcium antagonist, its chemical name is: (E)-4-[2-[3-(carboxy tert-butyl)-3-oxo-1-propenyl]phenyl ]-1,4-dihydro-2,6-dimethyl-3,5-pyridine-diethyl carboxylate, molecular formula: C26H33NO6, molecular weight: 455.59, the structural formula is as follows: [0003] [0004] As a new dihydropyridine calcium antagonist, lacidipine has strong vascular selectivity, diuretic and antioxidative effects, and has no significant effect on the cardiac conduction system and myocardial contractility. Oral absorption of lacidipine is rapid, with a half-life of about 8 hours at the first administration, and a half-life of up to 15 hours at a steady state, but the binding time at the receptor site is long, so the drug effect lasts up to 24 ho...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4422A61K47/38A61P9/12
Inventor 佟兵于杨
Owner 佟兵
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