Montelukast sodium chewable tablet and preparation method thereof
A technology of montelukast sodium and chewable tablets, which is applied in the field of medicine, can solve the problems of safety risks, ethanol is volatile and explosive, and unfavorable to industrialization, so as to reduce the cost of medication, increase the dissolution rate, and avoid potential safety hazards.
- Summary
- Abstract
- Description
- Claims
- Application Information
AI Technical Summary
Problems solved by technology
Method used
Image
Examples
preparation example Construction
[0036] The preparation method of the montelukast sodium chewable tablet of one embodiment, the method comprises the following steps:
[0037] S1: Mixing montelukast sodium, the first binder and water to obtain a montelukast sodium solution.
[0038] In the present invention, montelukast sodium is [R-(E)]-1-[[[1-[3-[2-(7-chloro-2-quinoline) vinyl]phenyl-3-[ The Chinese product name of 2-(1-hydroxy-1-methylethyl)phenyl]propyl]sulfur]methyl]cyclopropane sodium acetate, the English product name is Montelukast sodium, and the CAS number is 151767-02-1. Molecular formula is C 35 h 35 ClNNaO 3 S, the structural formula is:
[0039]
[0040] In one embodiment, the concentration of montelukast sodium in the montelukast sodium solution is 40 μg / mg-70 μg / mg. If the concentration of the montelukast sodium solution is too low, it will be unfavorable for subsequent granulation due to excessive water content; if the concentration is too high, the uniformity of the active ingredients ...
Embodiment 1
[0076] The preparation process of the montelukast sodium chewable tablet of the present embodiment is as follows:
[0077] (1) Mix 5.2 mg of montelukast sodium, 5.2 mg of hydroxypropyl cellulose and 93.6 mg of water in the dark at 25°C to obtain 104.0 mg of montelukast sodium solution;
[0078] (2) Mannitol 194.8 mg, microcrystalline cellulose 60 mg, hydroxypropyl cellulose 9 mg, croscarmellose sodium 9 mg, aspartame 3 mg, cherry essence 3 mg and iron oxide red 3 mg were wet granulated Mix evenly in the machine, and the condition parameters of the wet granulator are stirring 240rpm, cutting 1800rpm, and time 5min to obtain 281.8mg of premixed excipients; add the montelukast sodium solution in step (1) to the wet granulation within 2h of preparation Mix with the above-mentioned premixed auxiliary materials in the machine, and carry out wet granulation under the conditions of stirring 240 rpm and cutting 1800 rpm, and the granulation time is 5 minutes to obtain wet granules;
...
Embodiment 2
[0082]The preparation process of the montelukast sodium chewable tablet of this example is roughly the same as that of Example 1, the difference is that the step (1) of this example is: at 25°C in the dark, 5.2mg of montelukast sodium, 5.2 mg of povidone was mixed with 75.8 mg of water to obtain a solution of 86.2 mg of montelukast sodium.
PUM
| Property | Measurement | Unit |
|---|---|---|
| Hardness | aaaaa | aaaaa |
Abstract
Description
Claims
Application Information
Login to View More