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Roflumilast tablets as well as preparation method and detection method thereof

A technology of roflumilast tablets and roflumilast, which is applied in the field of western medicine and can solve the problems of poor fluidity and compressibility, slow dissolution rate of starch, slow dissolution rate of tablets, etc.

Active Publication Date: 2013-03-06
GUIZHOU XINBANG PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the high viscosity of PVP K90, the agglomeration is not easy to disperse when preparing the solution, and it takes a certain time to dissolve. The dissolution rate of the tablet made by using PVP K90 is slow, and the fluidity and compressibility are deviations; in the case of povidone as a binder Under this condition, the dissolution rate of starch is slow, which will also affect the fluidity and compressibility
[0006] In addition, currently there is no set of strict and reliable quality testing standards for roflumilast preparations

Method used

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  • Roflumilast tablets as well as preparation method and detection method thereof
  • Roflumilast tablets as well as preparation method and detection method thereof
  • Roflumilast tablets as well as preparation method and detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0543] Embodiment 1: each tablet preparation is to use 0.5mg roflumilast as raw material drug, add 100mg lactose, 80mg pregelatinized starch, 10mg povidone K30 and 0.5mg magnesium stearate, and add acetone, ethanol, purified water made as a solvent. Pass lactose and pregelatinized starch through a 60-mesh sieve, and add them to a multi-functional coating granulator; stir roflumilast with acetone, ethanol, and purified water, and then add povidone K30 to make roflumilast Roflumilast solution, lactose, and pregelatinized starch were granulated using fluidized bed spray granulation equipment, dried, and granulated; adding magnesium stearate after passing through a 100-mesh sieve and mixing evenly; tableting, Roflumilast tablets are obtained after coating.

Embodiment 2

[0544] Embodiment 2: each tablet preparation is to use roflumilast 0.5mg as raw material drug, add 150mg lactose, 120mg pregelatinized starch, 30mg povidone K30 and 2.6mg magnesium stearate, and add acetone, ethanol, purified water made as a solvent. Pass lactose and pregelatinized starch through a 60-mesh sieve, and add them to a multi-functional coating granulator; stir roflumilast with acetone, ethanol, and purified water, and then add povidone K30 to make roflumilast Roflumilast solution, lactose, and pregelatinized starch were granulated using fluidized bed spray granulation equipment, dried, and granulated; adding magnesium stearate after passing through a 100-mesh sieve and mixing evenly; tableting, Roflumilast tablets are obtained after coating. Wherein, preparation process parameter is:

[0545] (1) Granulation process parameters: fan flow rate 35 ~ 120m 3 / h, peristaltic pump speed 6±2rpm, atomization pressure 0.2±0.02MPa, inlet air temperature 75±10℃, material te...

Embodiment 3

[0551] Embodiment 3: each tablet preparation is to use 0.5mg roflumilast as raw material drug, add 138.5mg lactose, 100mg pregelatinized starch, 20mg povidone K30, 1mg magnesium stearate, and add 0.02mL acetone, 0.2mL Ethanol, 0.13mL purified water as solvent. Pass lactose and pregelatinized starch through a 60-mesh sieve, and add them to a multi-functional coating granulator; stir roflumilast with acetone, ethanol, and purified water, and then add povidone K30 to make roflumilast Roflumilast solution, lactose, and pregelatinized starch were granulated using fluidized bed spray granulation equipment, dried, and granulated; adding magnesium stearate after passing through a 100-mesh sieve and mixing evenly; tableting, Serve immediately after coating. Wherein, the specific preparation method is as follows:

[0552] 1. Pretreatment of raw and auxiliary materials: pass lactose and pregelatinized starch through a 60-mesh sieve, weigh the above auxiliary materials in 3 equal parts,...

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Abstract

The invention provides roflumilaste tablets as well as a preparation method and a detection method thereof. The roflumilaste tables are prepared by adopting 0.5mg roflumilast as crude drugs, adding 100mg to 150mg of lactose, 80mg to 120mg of pregelatinized starch, 10mg to 30mg of povidone K30 and 0.5 to 2.6mg of magnesium stearate and adopting acetone, ethanol and pure water as solvent. Aiming at the weaknesses of the prior art, the formula and the preparation process of the roflumilast tablets are optimized, so that a remarkable effect for treating diseases such as chronic obstructive pulmonary disease (COPD) is obtained, a systematic, complete and valid component discrimination and content determination method is established, the quality of the medicine can be effectively controlled, and the clinical effect of the roflumilast tablets can be guaranteed.

Description

technical field [0001] The invention relates to a roflumilast tablet and a preparation method and a detection method thereof, belonging to the technical field of western medicine. Background technique [0002] Chronic obstructive pulmonary disease (COPD for short) is a preventable and treatable disease characterized by airflow limitation, which is not fully reversible and develops progressively. Abnormal inflammatory response to noxious particles. COPD mainly involves the lungs, but it can also cause systemic (or extrapulmonary) adverse effects. COPD is also often closely related to heart failure and metabolic syndrome, and the existence of these chronic comorbid diseases may further aggravate the clinical manifestations of COPD. As a chronic inflammatory disease of the airways and lungs, chronic obstructive pulmonary disease has become one of the leading causes of common diseases and deaths worldwide. [0003] Roflumilast is a phosphodiesterase 4 inhibitor used as an adj...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/44A61P11/00G01N30/88
Inventor 张观福
Owner GUIZHOU XINBANG PHARMACEUTICAL CO LTD
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