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A kind of tablet containing indapamide and preparation method thereof

An indapamide and tablet technology, which is applied in the field of indapamide-containing tablets, can solve the problems of complex operation process, fluctuation of various tablet indexes, many manpower and material resources, etc., and achieves high controllability of process parameters. , The effect of easy industrial production and improving product quality

Active Publication Date: 2020-12-29
科贝源(北京)生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, most of the indapamide tablets adopt the traditional wet granulation process, such as in CN101756927A, the indapamide sustained-release tablet adopts the wet granulation process, and its prescription components are complicated, and it needs to go through pre-mixing and granulation in the preparation process. , Drying, granulation, total mixing, tableting, coating and other processes, the operation process is complicated, consumes more manpower and material resources, and the production cost is high
In addition to the wet granulation process, the powder direct compression process is also used in the preparation of indapamide sustained-release tablets, such as CN1943564A and CN104324013A, etc., in which a variety of auxiliary materials are used. Due to the density and particle size distribution of different auxiliary materials, Delamination is prone to occur during tablet compression, resulting in large fluctuations in various indicators of the tablet, which in turn affects product quality

Method used

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  • A kind of tablet containing indapamide and preparation method thereof
  • A kind of tablet containing indapamide and preparation method thereof
  • A kind of tablet containing indapamide and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022]

[0023] Preparation process: take the prescribed amount of indapamide, lactose, and microcrystalline cellulose and mix them evenly in a mixer, add 5% povidone K30 aqueous solution to make a soft material, pass through a 24-mesh sieve to granulate, and place in an oven at 60°C Dry, control the water content to 2-4%, pass through a 24-mesh sieve for granulation, add the prescribed amount of magnesium stearate, mix evenly, and press into tablets. 0.5%. The compressed tablet is coated with a film coat, and the product is obtained.

Embodiment 2

[0025]

[0026] Preparation process: Take the prescribed amount of indapamide, lactose, and microcrystalline cellulose and mix them uniformly in a mixer, add the prescribed amount of magnesium stearate and mix evenly, press into tablets, control the difference in tablet weight to be no more than 5%, and the hardness is 4~8kg, the friability is not more than 0.5%. The compressed tablet is coated with a film coat, and the product is obtained.

Embodiment 3

[0028]

[0029] Preparation process: Take the prescribed amount of indapamide and lactose and mix them evenly in a mixer, add the prescribed amount of magnesium stearate and talcum powder, mix evenly, press into tablets, control the difference in tablet weight to not more than 5%, and the hardness is 4-4. 8kg, the friability is not more than 0.5%. The compressed tablet is coated with a film coat, and the product is obtained.

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Abstract

The invention relates to a tablet containing indapamide and a preparation method thereof. The tablet is composed of a table core and a casing, wherein the table core is composed of indapamide, a direct-pressing diluent, and a lubricant. The direct-pressing diluent is selected from lactose, a lactose-microcrystalline cellulose composition, or a mixture thereof at optional ratio. The tablet containing indapamide has simple formula and simple preparation process. The preparation method can save labor intensity and raw materials, is easy to achieve in industrial production, greatly saves production cost, is high in controllability on process parameters in production, and improves product quality.

Description

technical field [0001] The invention relates to a tablet containing indapamide, which belongs to the field of pharmaceutical preparations. Background technique [0002] Hypertension is one of the most common cardiovascular diseases clinically. Indapamide is a sulfonamide derivative with an indole ring. By regulating the transmembrane transport of calcium ions, it can weaken the contraction of smooth muscle, stimulate the synthesis of prostaglandin vasodilator factors, and achieve the antihypertensive effect of regulating blood vessels. At the same time, it also has the effect of reversing the left ventricular hypertrophy of the heart. Indapamide has good antihypertensive, diuretic and calcium antagonistic effects after oral administration, and its absorption is rapid and its curative effect is reliable after oral administration. [0003] At present, most of the indapamide tablets adopt the traditional wet granulation process, such as in CN101756927A, the indapamide sustain...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/36A61K47/26A61K47/38A61K47/12A61K47/04A61K31/404A61P9/12A61P7/10
CPCA61K9/2009A61K9/2013A61K9/2018A61K9/2054A61K9/2866A61K31/404
Inventor 满艳哲张建维
Owner 科贝源(北京)生物医药科技有限公司