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Montelukast sodium and levocetirizine hydrochloride gastrointestinal capsule pharmaceutical composition

A technology of levocetirizine hydrochloride and montelukast sodium hydrochloride, which is applied in the field of medicine to achieve the effects of increasing yield, reducing market risk, and solving poor stability

Inactive Publication Date: 2015-03-25
TIANJIN SONGRUI MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0040] The object of the present invention is to provide montelukast sodium levocetirizine hydrochloride gastrointestinal type capsule pharmaceutical composition, which can overcome the deficiencies in the prior art and effectively solve the compound prescription of montelukast sodium and levocetirizine hydrochloride. Stability and clinical drug safety and other issues

Method used

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  • Montelukast sodium and levocetirizine hydrochloride gastrointestinal capsule pharmaceutical composition
  • Montelukast sodium and levocetirizine hydrochloride gastrointestinal capsule pharmaceutical composition
  • Montelukast sodium and levocetirizine hydrochloride gastrointestinal capsule pharmaceutical composition

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Embodiment 1

[0088] The formula for making 1000 capsules is as follows:

[0089]

[0090] Preparation Process:

[0091] 1) Take the prescribed amount of levocetirizine hydrochloride and microcrystalline cellulose, pass through an 80-mesh sieve, and use 8% gelatin solution as a binder, extrude and spheronize, prepare 20-30-mesh pellets, and dry at 50±5°C When the water content is less than 3%, levocetirizine hydrochloride gastric-soluble pellets are obtained;

[0092] 2) Mix montelukast sodium and micropowder silica gel evenly in the prescribed amount, use 8% hydroxypropyl cellulose solution as a binder, and sucrose round pellets to obtain montelukast sodium pellets. Dissolve methacrylic acid copolymer type C, talcum powder, and triethyl citrate in sodium hydroxide aqueous solution, enteric-coated to increase the weight by 15%, and dry to less than 3% moisture to obtain montelukast sodium enteric-coated pellets ;

[0093] 3) Calculate the filling amount of levocetirizine hydrochloride ...

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Abstract

The invention provides a montelukast sodium and levocetirizine hydrochloride gastrointestinal capsule pharmaceutical composition, and can overcome the deficiency of the existing technology and effectively solve the problems of stability and the safety of clinical medication of the montelukast sodium and levocetirizine hydrochloride compound. The pharmaceutical composition achieves the purpose of simultaneous absorption of the montelukast sodium and levocetirizine hydrochloride in different parts, and can play a better synergistic therapeutic effect; through prescription screening and optimization, the montelukast sodium and levocetirizine hydrochloride gastrointestinal capsule pharmaceutical composition is provided; and the preparation ensures the stability of the drug during production and storage. A preparation method of the pharmaceutical composition is provided, and the method is simple and feasible, and applicable to industrial scale production through pilot-plant test.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a montelukast sodium levocetirizine hydrochloride gastrointestinal type capsule pharmaceutical composition. Background technique [0002] Levocetirizine is the R-enantiomer of cetirizine and is the active ingredient of cetirizine. The affinity of levocetirizine to the histamine H1 receptor is 2 times higher than that of cetirizine and about 30 times higher than that of the S-enantiomer (dexetirizine). [0003] Generic name: levocetirizine hydrochloride; [0004] English name: Levocetirizine Dihydrochloride; [0005] Chemical name: (R)-(-)-2-[2-[4-[(4-chlorophenyl)benzyl]-1-piperazinyl]ethoxy]acetic acid dihydrochloride; CAS registration No.: 130018-87-0; [0006] Molecular formula: C 21 h 25 ClN 2 o 3 2HCl; [0007] Molecular weight: 461.82; [0008] Specifications: Most of the specifications are 5mg. The dosage forms are all oral preparations, including tablets, granules, caps...

Claims

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Application Information

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IPC IPC(8): A61K31/495A61K9/52A61K9/16A61P9/12A61P3/10A61P3/06A61K31/47
Inventor 张昊
Owner TIANJIN SONGRUI MEDICAL TECH
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