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Medicinal composition for stabilizing delotadine in preparation

A technology of desloratadine and its composition, which is applied in the direction of drug combination, pharmaceutical formula, medical preparations containing active ingredients, etc., can solve the problems of affecting the quality of drugs, cumbersome operation, high cost, etc., and is suitable for large-scale industrial production , shorten the synthesis route, simplify the effect of operation

Inactive Publication Date: 2004-12-08
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, if monosaccharides and disaccharides, especially lactose, are not used in the prescription of pharmaceutical compositions, it will bring a lot of inconvenience to large-scale industrial production and affect the quality of medicines.
In addition, the use of isolation coating or making microcapsules can only partially increase the stability of raw materials, and the operation is cumbersome and the cost is high
In addition, during the test, we found that even if monosaccharides and disaccharides, especially lactose, are not added to the preparation prescription, the prepared preparation will produce a brownish-red substance, which is difficult to preserve for a long time
[0005] CN 02128998.0 also discloses another preparation method for stabilizing desloratadine (DCL) in the preparation, mainly utilizing the amino group in the DCL molecule to react with the corresponding organic acid or inorganic acid to generate a water-soluble compound salt, thereby increasing The solubility of DCL is ensured, but this method first needs to prepare DCL and acid salts into pure products through complicated processes such as decolorization, concentration, and crystallization, and then mix them with lactose and other pharmaceutical excipients to make various dosage forms. Increased the synthesis process of raw materials

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 4

[0052] Make 1000 bags

[0053] Granule preparation process:

[0054] Dry the raw and auxiliary materials in advance and pass through a 100-mesh sieve for later use. Mix the prescription amount of excipients thoroughly first. Add the raw material drug to the excipients by increasing dilution method, and mix well 2-3 times each time to ensure that the drug and the excipients are fully mixed. Add 30% ethanol containing an appropriate amount of sodium metabisulfite to the mixture to make a soft material, pass through a 20-mesh sieve, dry in a ventilated oven at 55°C for 2 hours, pass the dry particles through a 16-mesh sieve, measure the content of intermediates, and fill it into bags .

[0055] name

Desloratadine

5g

Calcium hydrogen phosphate

40g

microcrystalline cellulose

10g

Sodium carboxymethyl starch

10g

Thioglycerol

0.75g

Magnesium stearate

8g

3...

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PUM

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Abstract

A composite medicine in which desloratadine is stabilized features that after desloratadine is mixed with medicinal auxiliaries, an antioxidizing agent is added to the mixture.

Description

technical field [0001] The present invention relates to a method for making the antihistamine 8-chloro-6,11-dihydro-11-(4-piperidinylidene)-5H-benzo[1,2-b]pyridine, known as dirol A stable pharmaceutical composition of hedidine (DCL) in formulation. Background technique [0002] Desloratadine (DCL), the active metabolite of loratadine, is a non-sedative antihistamine without central and nervous system side effects, such as drowsiness and anticholinergic effects. 1 Receptor antagonist, animal experiments show that DCL antagonizes H 1 The effect of the receptor is 2.5 to 4 times that of loratadine, so the dosage is reduced and the side effects are milder. The most important thing is that DCL shows a decongestant effect in the treatment of seasonal and allergic rhinitis, which is different from most other antihistamines. At the same time, it has been reported that DCL is more active in tumor promotion than loratad Desloratadine (DCL) is 5 to 7 times lower than loratadine, so...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4545A61P37/08
Inventor 任晓文马晋邹美香
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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