Montelukast sodium chewable tablet and preparation method thereof

A technology of montelukast sodium and chewable tablets, which is applied in the field of chewable tablets containing montelukast sodium and its preparation, can solve the problems not related to the dissolution of montelukast sodium chewable tablets, and achieve uniform and bright appearance , quality controllable, high bioavailability effect

Inactive Publication Date: 2015-03-11
FUJIAN HUAHAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Neither of the above two patents involves the dissolution of montelukast sodium chewable tablets

Method used

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  • Montelukast sodium chewable tablet and preparation method thereof
  • Montelukast sodium chewable tablet and preparation method thereof
  • Montelukast sodium chewable tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] The composition of the prescription is the same as that of the reference example.

[0046] The specific preparation method is the same as that of the reference example, except that the adhesive preparation process is changed to medicinal anhydrous ethanol.

Embodiment 2

[0048] Determination of disintegration time

[0049] Take reference example, embodiment 1 and 6 samples of Singulair (batch number: 100101) on the market, and measure the disintegration of montelukast sodium chewable tablets with reference to the disintegration time limit test method (Chinese Pharmacopoeia 2010 edition two appendix XA). solution time.

[0050] Table 1 Disintegration time test results

[0051]

[0052] It can be seen from Table 1 that the sample using 95% ethanol as solvent has a longer disintegration time.

Embodiment 3

[0054] Determination of dissolution

[0055] Avoid light operation. Take this product, according to the dissolution test method (Chinese Pharmacopoeia 2010 edition two appendix XC third method), with 0.5% sodium lauryl sulfate aqueous solution, water, 0.1mol / L hydrochloric acid solution and phosphate buffer of pH6.8 200ml of solution is the dissolution medium, and the rotating speed is 100 revolutions per minute. Operate according to the law. Take an appropriate amount of solution at 2, 5, 10, 15, 30, and 45 minutes respectively, filter, and take the subsequent filtrate as the solution for the test; An appropriate amount of the reference substance of surstatin sodium was accurately weighed, dissolved in the mobile phase and quantitatively diluted to make a solution containing 20 μg per 1 ml as the reference substance solution. Measure according to the method under the content determination item, respectively take 6 tablets of each sample of the reference example and Example 1...

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Abstract

The invention belongs to the technical field of medicines and particularly relates to a montelukast sodium chewable tablet and a preparation method thereof. The montelukast sodium chewable tablet provided by the invention is composed of montelukast sodium, a diluting agent, a lubricating agent, a binding agent, a disintegrating agent, a coloring agent, a sweetening agent and a corrigent. A preparation process of the montelukast sodium chewable tablet adopts absolute ethyl alcohol as a solvent to prepare the binding agent and then the binding agent is mixed with powder of other raw materials and auxiliary materials to carry out wet-method granulation. After being dried, wet grains are mixed with the corrigent and the lubricating agent and then a mixture is tabletted. According to the montelukast sodium chewable tablet prepared by using the process method provided by the invention, the color and the luster of the appearance of the tablet are uniform and bright, the stability is good, the disintegrating speed is high and the bioavailability is high.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a chewable tablet containing montelukast sodium and a preparation method thereof. Background technique [0002] Montelukast sodium is the sodium salt of Montelukast. Due to its unique chemical structure, its oral bioavailability, clinical efficacy and safety are superior to previous similar drugs, and it is currently the best-selling asthma drug in the world. . In 1998, the Montelukast sodium film-coated tablets of Merck & Co., Ltd. were approved by the US FDA for marketing. So far, the dosage forms of Montelukast sodium that have been on the market include granules, chewable tablets, and orally disintegrating tablets. Montelukast sodium chewable tablets are more suitable for children with asthma and allergic rhinitis. [0003] The Chinese patent with publication number CN101365450A discloses the composition and preparation method of a stable pharmaceutical preparatio...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/47A61K47/10A61P11/06A61P11/02A61P37/08
Inventor 蒋维吴晨辉许向前
Owner FUJIAN HUAHAI PHARMA
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