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Method for preparing loratadine tablet

A technology of loratadine and tablets, which is applied in the field of drug preparation, can solve problems such as the increase of impurities, and achieve the effect of improving the dissolution rate and improving the dissolution rate

Active Publication Date: 2014-12-10
QINGDAO DOUBLE WHALE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At the same time, since loratadine is stable in an acidic environment, it is prone to hydrolysis in an alkaline environment to produce impurities. If the environment is not well controlled during the wet granulation process, the problem of increased impurities is likely to occur

Method used

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  • Method for preparing loratadine tablet
  • Method for preparing loratadine tablet
  • Method for preparing loratadine tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Drug specifications: 10mg

[0020] The formula is as follows:

[0021] Vegetarian tablet formula Proportion (weight percentage) 1000 tablets formula (g) Loratadine 9.52%10.0 Citrate 11.43%12.0 lactose 70.95%74.5 Copovidone 1.91%2.0 Crospovidone 5.24%5.5 Magnesium stearate 0.95%1.0 total 100%105

[0022] A preparation method of loratadine tablets, according to the following steps:

[0023] 1. According to the above-mentioned drug formula, add citric acid to 95% ethanol solution, stir to dissolve, and prepare an inclusion solution. The mass volume ratio of citric acid to 95% ethanol is 1:100;

[0024] 2. Pass loratadine through a 100-120 mesh sieve, put it in a boiling drying bed, spray the inclusion liquid in a boiling state, and dry at 45-55°C to prepare loratadine acidic inclusion compound ;

[0025] 3. Mix the loratadine acid inclusion compound, lactose, copovidone, crospovidone, and magnesium stearate evenly, add them to the hopper of the tablet press, and compress ...

Embodiment 2

[0027] Drug specifications: 5mg

[0028] The formula is as follows:

[0029] Vegetarian tablet formula Proportion (weight percentage) 1000 tablets formula (g) Loratadine 4.76%5.0

[0030] Citrate 5.24%5.5 lactose 81.71%85.8 Copovidone 2.10%2.2 Crospovidone 5.52%5.8 Magnesium stearate 0.67% 0.7 total 100%105

[0031] A preparation method of loratadine tablets, according to the following steps:

[0032] 1. According to the above drug formula, add citric acid to 95% ethanol solution, stir to dissolve, and prepare an inclusion solution. The mass volume ratio of citric acid to 95% ethanol is 0.5:100;

[0033] 2. Pass loratadine through a 100-120 mesh sieve, put it in a boiling drying bed, spray the inclusion solution in a boiling state, and dry at 45-55°C to prepare loratadine acidic inclusion compound ;

[0034] 3. Mix the loratadine acid inclusion compound, lactose, copovidone, crospovidone, and magnesium stearate evenly, add them to the hopper of the tablet press, and compre...

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Abstract

The invention relates to a method for preparing a loratadine tablet. The tablet is prepared from the components by weight percent of 1-15% of loratadine, 1-15% of citric acid, 56-90% of lactose, 1.5-3% of copovidone, 3.75-10.5% of polyvinylpolypyrrolidone, and 0.5-1.0% of magnesium stearate. The preparation method is operated according to the following steps of: adding citric acid to 95% of ethanol solution; stirring and dissolving to prepare inclusion solution; screening loratadine, and putting in a boiling drying bed; spraying the inclusion solution under a boiling state; drying at 45-55 DEG C to prepare an inclusion compound; evenly mixing the loratadine acid inclusion compound, lactose, copovidone, polyvinylpolypyrrolidone and magnesium stearate and then tabletting. By adopting the formula of the drug and the preparation method thereof, the dissolution rate of the tablet under a weak acid environment or a neutral environment can be significantly improved; the content of impurity is reduced; the hardness and the molding property of the tablet are improved; and the loratadine tablet is especially suitable for the sufferer with too little gastric juice secretion or the suffer with an anaphylactic disease with too little gastric juice secretion caused by iatrogenic property.

Description

Technical field: [0001] The invention relates to a preparation method of loratadine tablets, belonging to the technical field of medicine preparation. Background technique: [0002] Allergy is also called allergic reaction. Modern medicine calls this reaction an antigen-antibody reaction. Histamine is one of the important mediators of type I allergic reactions. About 10%-45% of the general population in the world have allergic diseases, and the incidence is increasing. Approximately 200 million people in my country suffer from allergic diseases. The WHO has listed allergic diseases as a "key disease for research and prevention in the 21st century." With the change of human living environment and the increase of allergens, the incidence of allergic diseases is on the increase. The number of allergic people in our country is also increasing, especially the increasing curve of the number of allergic seasonal changes is very obvious. The prevention and treatment of allergic disease...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K47/12A61K47/32A61K31/4545A61P37/08
Inventor 耿仕霞李存福倪志伟杨洵斐胡艳芬
Owner QINGDAO DOUBLE WHALE PHARMA
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