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Montelukast sodium compound

A technology of montelukast sodium and hydrate, applied in the field of medicine, can solve the problems of multiple impurities, unfavorable drug quality control and the like

Active Publication Date: 2016-10-05
TIANJIN HANRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0013] In the research process, repeat the method of above-mentioned patent document, the montelukast sodium that obtains all has bigger hygroscopicity, is unfavorable for medicine quality control; In addition, the montelukast sodium that obtains often contains more impurity, for Pharmaceutical quality must be purified, but removing these impurities is challenging

Method used

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Examples

Experimental program
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Effect test

Embodiment 1

[0057] In the reaction flask, add 10 grams of montelukast sodium and 110ml of nitromethane-ethanol-water (8:2:0.2) mixture, heat to 61℃-64℃, stir for 20 minutes, and filter while hot , 38℃-40℃, keep it for 3 hours, then cool down, keep it at 17℃-21℃ for 9 hours, filter, and dry to obtain the above-mentioned montelukast sodium three hemihydrate crystals with a purity of 99.94%. Measured by Karl Fischer method, it contains 9.40% (weight percentage) of water.

[0058] Elemental analysis results:

[0059] Actual measured value (calculated value), C: 62.64 (62.63), H: 6.32 (6.31), N: 2.08 (2.09), Cl: 5.26 (5.28).

[0060] The content of sodium was determined by sodium atomic absorption spectrometry, and the result showed: 3.41% (theoretical amount 3.43%).

[0061] The X-ray diffraction pattern of the crystal is shown in figure 1 . Instrument model and measurement conditions: Rigaku D / max 2500 diffractometer; CuKa 40Kv 100mA; 2θ scanning range: 0-50 ° .

Embodiment 2

[0063] Tablets containing montelukast sodium hydrate

[0064] Prescription: Montelukast sodium hydrate 4.41g, lactose 195g, 45g PEG-4000, 18g magnesium stearate, 48g croscarmellose sodium, appropriate amount of distilled water, made into 1000 tablets.

[0065] Process: PEG-4000 and montelukast sodium hydrate are pulverized together, passed through an 80-mesh sieve, mixed with other materials and then made of soft material with distilled water, and granulated by 16-mesh sieve, placed in a drying oven at 40-45°C, A 16-mesh sieve is granulated, magnesium stearate is added to the dry granules and mixed, and then compressed.

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Abstract

The invention belongs to the technical field of medicine, and specifically relates to a montelukast sodium hydrate and a preparation method thereof. The provided montelukast sodium hydrate has a high purity and good stability, and thus will not obviously absorb water and gain weights even in a damp environment. The invention also relates to an application of the montelukast sodium hydrate in preparation of drugs for treating asthma and / or seasonal allergic diseases.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to montelukast sodium hydrate and a preparation method thereof. The invention also relates to the use of this montelukast sodium hydrate composition to treat asthma and / or seasonal allergies. Background technique [0002] Bronchial asthma is the most common chronic respiratory disease, and its incidence is on the rise globally. Asthma is also the most common chronic disease in children. In the United States, 5 million children under the age of 18 suffer from asthma. The prevalence of childhood asthma in my country is about 2%. The survey of the current status of bronchial asthma treatment shows that many asthma patients do not [0003] With reasonable treatment, the patient's symptoms have not been effectively controlled. [0004] Bronchial asthma is a chronic inflammatory disease of the airway involving a variety of inflammatory cells. Cysteinyl leukotriene is one of the most ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D215/18A61K31/47A61P11/06A61P37/08
CPCC07D215/18
Inventor 严洁李轩
Owner TIANJIN HANRUI PHARMA
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