Preparation method of miglitol sustained release tablet

Abstract

The invention provides a preparation method of a miglitol sustained release tablet. The preparation method comprises the following steps of: I, adding miglitol, Na-montmorillonite and an acidity regulator into deionized water, and stirring uniformly to obtain a mixed solution; II, stirring the mixed solution, performing ion exchange on the miglitol and the Na-montmorillonite, and filtering, washing, drying, smashing and sieving in sequence to obtain a main material; and III, mixing the main material and auxiliary materials uniformly, and tableting to obtain the miglitol sustained release tablet. A preparation process of the method is simple, special equipment and process are not required, and the method is suitable for large-scale batch production. Specific to the defects of the conventional miglitol medicament administration way, a method for compounding the Na-montmorillonite and the miglitol is adopted, so that the in-vivo release rate of the miglitol is lowered, the utilization ratio of a miglitol medicament is increased remarkably, and the taking compliance of a patient is enhanced greatly.

Description

technical field

[0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of miglitol sustained-release tablets. Background technique

[0002] At present, with the development of economy in our country, people's material living standards have been greatly improved, and diet and living habits are more diversified. While people enjoy delicious food, few people pay attention to the matching of dietary structure. At the same time, due to social work The pressure is increasing, and many people lack effective physical exercise. Therefore, in recent years, diseases caused by people's long-term improper diet and improper living habits have gradually increased. The most prominent diseases include type II diabetes, type II diabetes Chronic non-communicable diseases are on the rise. So far, the number of diabetic patients in the world has risen to more than 230 million people, and it is estimated that the number of diabetic pati...

Examples

Embodiment 1

[0050] The preparation method of the Miglitol sustained-release tablet of the present embodiment comprises the following steps:

[0051] Step 1, adding miglitol with a mass purity of 99.99%, sodium montmorillonite with a mass purity of 98% and an acidity regulator into deionized water, and stirring to obtain a mixed solution with a pH value of 3; The concentration of Miglitol in the mixed solution is 1.0g / L, and the concentration of Na-montmorillonite is 5.0g / L; The acidity regulator is 8% hydrochloric acid in mass percent concentration;

[0052] Step 2. Stir the mixed solution described in step 1 at a temperature of 40° C. and a stirring rate of 120 r / min for 1.5 h to carry out ion exchange between miglitol and sodium-based montmorillonite, and then ion-exchange the The mixed solution is sequentially filtered, washed until neutral, dried at 50°C for 6 hours, pulverized by a pulverizer, and passed through a 100-mesh sieve to obtain a main material with a particle size not grea...

Embodiment 2

[0057] The preparation method of the Miglitol sustained-release tablet of the present embodiment comprises the following steps:

[0058] Step 1, adding miglitol with a mass purity of 99.95%, sodium montmorillonite with a mass purity of 96% and an acidity regulator into deionized water, and stirring to obtain a mixed solution with a pH value of 2; The concentration of Miglitol in the mixed solution is 0.8g / L, and the concentration of Na-montmorillonite is 4.5g / L; Described acidity regulator is the hydrochloric acid that mass percent concentration is 10%;

[0059] Step 2. Stir the mixed solution described in step 1 at a temperature of 50° C. and a stirring rate of 80 r / min for 2 h to carry out ion exchange between miglitol and sodium-based montmorillonite, and then mix the ion-exchanged The solution is sequentially filtered, washed until neutral, dried at 60°C for 5 hours, pulverized by a pulverizer, and passed through a 120-mesh sieve to obtain the main material with a particle...

Embodiment 3

[0064] The preparation method of the Miglitol sustained-release tablet of the present embodiment comprises the following steps:

[0065] Step 1, adding Miglitol with a mass purity of 99.9%, sodium montmorillonite with a mass purity of 97% and an acidity regulator into deionized water, and stirring to obtain a mixed solution with a pH value of 4; The concentration of Miglitol in the mixed solution is 0.8g / L, and the concentration of Na-montmorillonite is 4.5g / L; Described acidity regulator is the hydrochloric acid that mass percent concentration is 5%;

[0066] Step 2. Stir the mixed solution described in step 1 at a temperature of 20° C. and a stirring rate of 150 r / min for 2 h to carry out ion exchange between miglitol and sodium montmorillonite, and then mix the ion exchanged solution The solution is sequentially filtered, washed until neutral, dried at 60°C for 5 hours, pulverized by a pulverizer and passed through a 60-mesh sieve to obtain the main material with a particle...

technical field

[0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of miglitol sustained-release tablets. Background technique

[0002] At present, with the development of economy in our country, people's material living standards have been greatly improved, and diet and living habits are more diversified. While people enjoy delicious food, few people pay attention to the matching of dietary structure. At the same time, due to social work The pressure is increasing, and many people lack effective physical exercise. Therefore, in recent years, diseases caused by people's long-term improper diet and improper living habits have gradually increased. The most prominent diseases include type II diabetes, type II diabetes Chronic non-communicable diseases are on the rise. So far, the number of diabetic patients in the world has risen to more than 230 million people, and it is estimated that the number of diabetic pati...

Examples

Embodiment 1

[0050] The preparation method of the Miglitol sustained-release tablet of the present embodiment comprises the following steps:

[0051] Step 1, adding miglitol with a mass purity of 99.99%, sodium montmorillonite with a mass purity of 98% and an acidity regulator into deionized water, and stirring to obtain a mixed solution with a pH value of 3; The concentration of Miglitol in the mixed solution is 1.0g / L, and the concentration of Na-montmorillonite is 5.0g / L; The acidity regulator is 8% hydrochloric acid in mass percent concentration;

[0052] Step 2. Stir the mixed solution described in step 1 at a temperature of 40° C. and a stirring rate of 120 r / min for 1.5 h to carry out ion exchange between miglitol and sodium-based montmorillonite, and then ion-exchange the The mixed solution is sequentially filtered, washed until neutral, dried at 50°C for 6 hours, pulverized by a pulverizer, and passed through a 100-mesh sieve to obtain a main material with a particle size not grea...

Embodiment 2

[0057] The preparation method of the Miglitol sustained-release tablet of the present embodiment comprises the following steps:

[0058] Step 1, adding miglitol with a mass purity of 99.95%, sodium montmorillonite with a mass purity of 96% and an acidity regulator into deionized water, and stirring to obtain a mixed solution with a pH value of 2; The concentration of Miglitol in the mixed solution is 0.8g / L, and the concentration of Na-montmorillonite is 4.5g / L; Described acidity regulator is the hydrochloric acid that mass percent concentration is 10%;

[0059] Step 2. Stir the mixed solution described in step 1 at a temperature of 50° C. and a stirring rate of 80 r / min for 2 h to carry out ion exchange between miglitol and sodium-based montmorillonite, and then mix the ion-exchanged The solution is sequentially filtered, washed until neutral, dried at 60°C for 5 hours, pulverized by a pulverizer, and passed through a 120-mesh sieve to obtain the main material with a particle...

Embodiment 3

[0064] The preparation method of the Miglitol sustained-release tablet of the present embodiment comprises the following steps:

[0065] Step 1, adding Miglitol with a mass purity of 99.9%, sodium montmorillonite with a mass purity of 97% and an acidity regulator into deionized water, and stirring to obtain a mixed solution with a pH value of 4; The concentration of Miglitol in the mixed solution is 0.8g / L, and the concentration of Na-montmorillonite is 4.5g / L; Described acidity regulator is the hydrochloric acid that mass percent concentration is 5%;

[0066] Step 2. Stir the mixed solution described in step 1 at a temperature of 20° C. and a stirring rate of 150 r / min for 2 h to carry out ion exchange between miglitol and sodium montmorillonite, and then mix the ion exchanged solution The solution is sequentially filtered, washed until neutral, dried at 60°C for 5 hours, pulverized by a pulverizer and passed through a 60-mesh sieve to obtain the main material with a particle...

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