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Solid oral preparation and preparation method thereof

A solid and preparation technology, which is applied in the field of pharmaceutical preparations and can solve the problems that the stability of preparations has not been studied.

Inactive Publication Date: 2016-10-12
麦丽芳
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this dry process only considers the dissolution performance of the preparation, but does not study the stability of the preparation

Method used

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  • Solid oral preparation and preparation method thereof
  • Solid oral preparation and preparation method thereof
  • Solid oral preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048]

[0049] 1. Use a double-cone dryer to dry the moisture content of the auxiliary materials to about 1.0% (80°C);

[0050] 2. Pass microcrystalline cellulose, highly substituted hydroxypropyl cellulose, crospovidone, silicon dioxide, and magnesium stearate through a 40-mesh sieve for later use, and weigh and prepare materials according to the prescription quantity;

[0051] 3. Take the prescribed amount of crospovidone, high-substituted hydroxypropyl cellulose and 1 / 2 of the prescribed amount of microcrystalline cellulose and mix evenly to obtain mixed powder A;

[0052] 4. Take the prescribed amount of bulk drug (water content 5.0%, Karl Fischer method), silicon dioxide, and 1 / 2 of the prescribed amount of microcrystalline cellulose and mix uniformly to obtain mixed powder B;

[0053] 5. Add the mixed powder A to the mixed powder B, and add the prescribed amount of magnesium stearate for mixing to obtain the total mixed powder;

[0054] 6. The blended powder is prep...

Embodiment 2

[0058]

[0059]

[0060] The compound 1 solid oral preparation was prepared by the same method as in Example 1 by using the compound 1 bulk drug with a water content of 4.8% (Karl Fischer method).

[0061] Adopt Opadry (Opadry) coating material, use 70% hydrous ethanol as the coating solution of solvent preparation content 8% to carry out spray coating to the obtained plain tablet, control weight gain between 2%~4%, enter air The temperature is 40-60°C, and the drying time is 60 minutes.

[0062] The water content of the obtained solid oral preparation was detected by Karl Fischer method to be 5.3%.

Embodiment 3

[0064]

[0065] The compound 1 solid oral preparation was prepared by the same method as in Example 1 by using the compound 1 bulk drug with a water content of 5.1% (Karl Fischer method).

[0066] Adopt Opadry (Opadry) coating material, use 70% hydrous ethanol as the coating solution of solvent preparation content 8% to carry out spray coating to the obtained plain tablet, control weight gain between 2%~4%, enter air The temperature is 40-60°C, and the drying time is 120 minutes.

[0067] The water content of the obtained solid oral preparation was detected by Karl Fischer method to be 4.1%.

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Abstract

The present invention provides a stable solid oral preparation. By controlling the water content within a specific range, the solid oral preparation has the characteristics of high storage stability, which is more in line with industrialization than the preparations disclosed in the prior art. production and clinical use.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a solid oral preparation that can be used for the treatment of heart failure and other cardiovascular diseases and a preparation method thereof. Background technique [0002] Heart failure (referred to as heart failure) is a group of complex clinical syndromes due to any structural or functional abnormality of the heart that leads to impaired ventricular filling or ejection ability. The main clinical manifestations of heart failure are dyspnea and fatigue (limited exercise tolerance), and fluid retention (pulmonary congestion and peripheral edema). Heart failure is the severe and terminal stage of various heart diseases with a high incidence rate and is one of the most important cardiovascular diseases today ("Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2014"). [0003] Since 2005, due to the prevalence of cardiovascular disease risk factors, th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/41A61K31/216A61K9/20A61K47/38A61P9/04A61P9/12A61P9/00A61P3/10A61P9/06A61P9/10A61P11/00A61P13/12A61P17/00A61P9/14A61P25/06A61P25/28A61P27/06
CPCA61K31/41A61K9/2054A61K9/2095A61K31/216
Inventor 许文杰叶冠豪植建琼邓运
Owner 麦丽芳
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