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Indacaterol tablets and preparation method thereof

A technology for indacaterol and preparations, applied in the field of indacaterol-containing tablets and its preparation, can solve the problems of undisclosed inclusion of indacaterol and no reminder of the proportion of components of pharmaceutical preparations, etc., to achieve The effect of content uniformity

Inactive Publication Date: 2014-06-04
熊妲妮
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, none of the existing literature discloses the inclusion of indacaterol filler Adhesive and lubricant Indacaterol tablet pharmaceutical preparations, also did not give any hints about the proportion of components of its pharmaceutical preparations

Method used

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  • Indacaterol tablets and preparation method thereof
  • Indacaterol tablets and preparation method thereof
  • Indacaterol tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Indacaterol tablets are prepared from the following medicinal components:

[0028]

[0029] Preparation

[0030] Indacaterol and lactose are finely powdered at a ratio of 1:20, and set aside; prepare a PVP K90 aqueous solution with a concentration of 15%, and set aside; weigh the prescribed amount of indacaterol, lactose, and starch and mix evenly, add PVP K90 aqueous solution to granulate , dry, add the corresponding prescription amount of magnesium stearate and mix evenly, measure the content of the mixture, calculate the weight of the tablet, and compress the tablet to get final product.

[0031] The prepared indacaterol sheet has the following characteristics:

[0032] Content uniformity inspection: qualified. Disintegration time limit inspection: it disintegrates completely within 5 minutes, and the disintegration phenomenon is the same as that of the original preparation.

Embodiment 2

[0034] Indacaterol tablets are prepared from the following medicinal components:

[0035]

[0036] Preparation

[0037] Indacaterol and lactose are finely powdered at a ratio of 1:20, and set aside; prepare a PVP K90 aqueous solution with a concentration of 15%, and set aside; weigh the prescribed amount of indacaterol, lactose, and starch and mix evenly, add PVP K90 aqueous solution to granulate , dry, add the corresponding prescription amount of magnesium stearate and mix evenly, measure the content of the mixture, calculate the weight of the tablet, and compress the tablet to get final product.

[0038] The prepared indacaterol sheet has the following characteristics: content uniformity inspection: qualified. Disintegration time limit inspection: complete disintegration within 5 minutes.

Embodiment 3

[0040] Indacaterol tablets are prepared from the following medicinal components:

[0041]

[0042] Preparation

[0043] Indacaterol and lactose are finely powdered at a ratio of 1:20, and set aside; prepare a PVP K90 aqueous solution with a concentration of 15%, and set aside; weigh the prescribed amount of indacaterol, lactose, and starch and mix evenly, add PVP K90 aqueous solution to granulate , dry, add the corresponding prescription amount of magnesium stearate and mix evenly, measure the content of the mixture, calculate the weight of the tablet, and compress the tablet to get final product.

[0044] The prepared indacaterol sheet has the following characteristics: content uniformity inspection: qualified. Disintegration time limit inspection: complete disintegration within 5 minutes.

[0045] The specific values ​​of the dissolution curve are shown in Table 1.

[0046] Table 1 each embodiment sample stripping curve value

[0047]

[0048]It can be seen from th...

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PUM

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Abstract

The invention belongs to the field of medical technology, and particularly discloses indacaterol tablets and a preparation method thereof. In the invention, active ingredients including indacaterol and lactose are subjected to micropowder treatment, and povidone K90 is added into the prescription as an adhesive to obtain the tablets. By adopting the method, the content uniformity of the obtained preparation meets the requirements, a new option is provided to COPD (chronic obstructive pulmonary disease) patients with different illness characteristics, and the needs for treating asthma and COPD are met to the greatest degree.

Description

field of invention [0001] The invention belongs to the field of medicines, and in particular relates to tablets containing indacaterol and a preparation method thereof. Background of the invention [0002] Indacaterol is a bronchodilator that belongs to the long-acting inhaled β2-adrenergic receptor agonist (LABA) class and is suitable for the maintenance treatment of adult patients with chronic obstructive pulmonary disease (COPD). It takes effect in 5 minutes and lasts for 24 hours. Indacaterol is produced by Swiss Novartis Pharmaceuticals and has been listed in more than 70 countries and regions around the world since 2009; it was approved by the State Food and Drug Administration in June 2012 to be listed in China. It is the first LABA approved for the treatment of COPD in my country class of single preparations. Clinical trials have shown that taking indacaterol once a day can cause bronchodilation for more than 24 hours, and its bronchodilation time is longer than tha...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4704A61K47/26A61P11/08
Inventor 熊妲妮翟萍孙文娟程志娟薛红
Owner 熊妲妮
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