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A kind of technology of montelukast sodium and oral disintegrating tablet, applied in the field of montelukast sodium oral disintegrating tablet composition and preparation field
Pending Publication Date: 2022-02-18
BEIJING DO-PHARMA BIOTECH GRP CO LTD
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[0010] In the prior art, there is no disclosed technology that shows the introduction of water-soluble pigments into montelukast sodium preparation products
Method used
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Embodiment 1
[0041]
[0042] The preparation process is as follows:
[0043] 1) Weigh the gelatin, add water, stir in a water bath at 60°C to dissolve it completely, and let it cool to room temperature.
[0044] 2) Take another appropriate amount of water, weigh mannitol, pigment, sucralose, and montelukast sodium in sequence, and stir evenly.
[0045] 3) Add the product obtained in 1) to the product obtained in 2), dilute to the specified volume, and stir evenly.
[0046] 4) Degas the product obtained in 3).
[0047] 5) The product obtained in 4) is divided into tablet blister molds, placed in a freeze dryer, set to -50°C for rapid cooling, vacuum degree 0.1500mbar, duration of 90min, rising from -50°C to -30°C , keep for 150min, rise from -30°C to -15°C, keep for 90min, rise from -15°C to 0°C, keep for 20min, rise from 0°C to 20°C, keep for 20min, rise from 20°C to 35°C, keep for 20min .
[0048] 6) Take out the product and store it in an aluminum-plastic seal.
[0049] Determina...
Embodiment 2
[0053]
[0054] The preparation process is as follows:
[0055] 1) Weigh the pullulan and add it into water, stir it in a water bath at 60°C to dissolve it completely, and let it cool to room temperature.
[0056] 2) Another appropriate amount of water was taken, and the mannitol, allura red pigment, sucralose, and montelukast sodium were weighed in sequence and stirred evenly.
[0057] 3) Add the product obtained in 1) to the product obtained in 2) and dilute to the specified volume, and stir evenly.
[0058] 4) Degas the product obtained in 3).
[0059] 5) The product obtained in 4) is divided into tablet blister molds, placed in a freeze dryer, set to -50°C for rapid cooling, vacuum degree 0.1500mbar, duration of 90min, rising from -50°C to -30°C , keep for 150min, rise from -30°C to -15°C, keep for 90min, rise from -15°C to 0°C, keep for 20min, rise from 0°C to 20°C, keep for 20min, rise from 20°C to 35°C, keep for 20min .
[0060] 6) Take out the product and store ...
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technical field [0001] The invention relates to a montelukast sodium orally disintegrating tablet composition and a preparation method thereof. The orally disintegrating tablet adopts a freeze-drying process, which does not require special protection from light during the process, and the stability of montelukast sodium is fully guaranteed. It belongs to the field of medicine. Background technique [0002] With the rapid economic development and industrialization process, people are facing changes in lifestyle and environmental conditions, and asthma has become an important index disease worldwide. In recent years, the prevalence of bronchial asthma in my country is showing a rapid upward trend, and it is one of the important chronic respiratory diseases that seriously endanger people's health. Among them, montelukast sodium is an important drug in the field of anti-asthma treatment. [0003] The structure of montelukast sodium is as follows: [0004] [0005] Montelu...
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