Voglibose suspension and synthesis process thereof

Abstract

The invention discloses a voglibose suspension and a synthesis process thereof. The formula of the voglibose suspension comprises voglibose, hydroxypropyl methyl cellulose, purified water, calcium stearate, lauryl sodium sulfate and a solvent. The synthesis process comprises the following steps: step 1, preparation work; step 2, preparing a liquid medicine; step 3, sieving treatment; 4, mixing the medicinal powder; step 5, preparing suspension liquid; step 6, mixing liquid medicine; and step 7, packaging and storing. The voglibose suspension is designed, purified water is heated to dissolve voglibose and hydroxypropyl methyl cellulose, calcium stearate and polydextrose are added after the voglibose and the hydroxypropyl methyl cellulose are dissolved, and the calcium stearate can promote gastrointestinal motility so as to promote absorption of a patient to the medicine; hydroxypropyl methyl cellulose has thickening and polymerization effects and can prolong the drug effect time, and polydextrose can generate special physiological metabolism to relieve diarrhea caused by metabolic disorder after entering a human body.

Description

Technical Field

[0001] The invention relates to the technical field of voglibose, in particular to a voglibose suspension and a synthesis process thereof. Background Art

[0002] Voglibose is used to treat the symptoms of increased blood sugar after meals in diabetes. After oral administration, it can competitively and antagonistically inhibit disaccharide hydrolases in the body, thereby delaying the digestion and absorption of carbohydrates to improve postprandial hyperglycemia. It is mostly used in people with hyperglycemia and diabetes.

[0003] However, some patients may experience diarrhea due to metabolic problems after taking voglibose due to slow absorption of the drug, which results in the drug's efficacy not taking effect in time and the drug's efficacy lasting too short. Summary of the invention

[0004] The object of the present invention is to provide a voglibose suspension and a synthesis process thereof to solve the problems raised in the above background technology.

[0005] To achieve the above object, the present invention provides the following technical solution: a voglibose suspension, comprising: voglibose, hydroxypropyl methylcellulose, purified water, calcium stearate and sodium lauryl sulfate, wherein the mass percentages of the components are 25% to 35% of voglibose, 6% to 12% of hydroxypropyl methylcellulose, 40% to 55% of purified water, 5% to 8% of calcium stearate, 5% to 3% of mannitol, 1% to 3% of p-aminobenzoic acid, 3% to 6% of polydextrose and 2% to 5% of sodium lauryl sulfate.

[0006] As a further technical solution of the present invention, the mass percentages of the components are: 31% voglibose, 10% hydroxypropyl methylcellulose, 44% purified water, 1% p-aminobenzoic acid, 3% sodium lauryl sulfate, 5% calcium stearate, 3% polydextrose and 3% mannitol.

[0007] A synthesis process of voglibose suspension, comprising step 1, preparation; step 2, preparation of drug solution; step 3, screening; step 4, drug powder mixing; step 5, preparation of suspension; step 6, drug solution mixing; step 7, packaging and storage;

[0008] In the above step 1, prepare the required materials;

[0009] In the above step 2, a voglibose solution is prepared;

[0010] In the above step 3, the drug powder is sieved to remove impurities therein;

[0011] Wherein in the above step 4, the sifted powder is evenly mixed;

[0012] Wherein in the above step 5, other materials are used to prepare the suspension;

[0013] Wherein in the above step 6, the drug solution is mixed with the suspension;

[0014] In the above step 7, the stirred suspension is packaged and stored in an environment away from direct sunlight and moisture.

[0015] As a further technical solution of the present invention, in the step 1, materials, tools and environment for preparing the voglibose suspension are prepared, including a blender, a sieve, a container, voglibose, hydroxypropyl methylcellulose, purified water, p-aminobenzoic acid, sodium lauryl sulfate, calcium stearate, polydextrose and mannitol, and an environment is selected to avoid direct sunlight.

[0016] As a further technical solution of the present invention, in the step 2, hydroxypropyl methylcellulose is slowly poured into purified water above 80° C. and then put into a stirrer at a stirring speed of 60 to 80 r / min for 5 to 10 minutes. After the stirring is completed, the hydroxypropyl methylcellulose solution is placed aside to cool. After the hydroxypropyl methylcellulose is swollen, dissolved and defoamed, voglibose is added to dissolve and stirred at a stirring speed of 50 to 60 r / min for 5 to 10 minutes. After the stirring is completed, it is placed in a container for standby use.

[0017] As a further technical solution of the present invention, in the step three, the prepared sodium lauryl sulfate and calcium stearate are placed into a sieve with a pore size of 0.5 mm to 0.8 mm for filtration, and after filtration, are placed in a container to avoid moisture.

[0018] As a further technical solution of the present invention, in the step 4, the filtered sodium lauryl sulfate and calcium stearate are put into a blender according to the formula ratio and stirred at a stirring speed of 20 to 40 r / min for 5 to 10 minutes.

[0019] As a further technical solution of the present invention, in the step 5, the powders of polydextrose and mannitol are added to purified water at 60°C to 70°C and then poured into a blender for stirring at a speed of 40 to 60 r / min for 10 to 20 minutes.

[0020] As a further technical solution of the present invention, in the step five, after the stirring is completed, the powder stirred in the step four is poured into the solution and stirred again with the polydextrose solution at a stirring speed of 80 to 90 r / min for 5 to 10 minutes. After the stirring is completed, the powder is put into a container and set aside to cool.

[0021] As a further technical solution of the present invention, in step six, the polydextrose solution prepared in step five and the voglibose solution prepared in step two are put into a mixer in proportion, the stirring speed is 70-80 r / min, stirring for 5 minutes, and after the stirring is completed, p-aminobenzoic acid is added and stirring is continued for 10-15 minutes, and the stirring speed remains unchanged.

[0022] Compared with the prior art, the present invention has the following beneficial effects: the present invention is designed with a voglibose suspension, wherein the voglibose and hydroxypropyl methylcellulose are dissolved by heating purified water, and calcium stearate and polydextrose are added after the voglibose and hydroxypropyl methylcellulose are dissolved; calcium stearate can promote the patient's absorption of the drug by promoting gastrointestinal motility, hydroxypropyl methylcellulose has thickening and polymerization effects and can prolong the drug effect time, and polydextrose can produce special physiological metabolism after entering the human body and is used to relieve diarrhea caused by metabolic disorders. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 The present invention is a flow chart of the method. DETAILED DESCRIPTION

[0024] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0025] See also Figure 1 , a technical solution provided by the present invention:

[0026] Example 1

[0027] A voglibose suspension comprises: voglibose, hydroxypropyl methylcellulose, purified water, calcium stearate and sodium lauryl sulfate, wherein the mass percentages of the components are: 31% of voglibose, 10% of hydroxypropyl methylcellulose, 44% of purified water, 1% of p-aminobenzoic acid, 3% of sodium lauryl sulfate, 5% of calcium stearate, 3% of polydextrose and 3% of mannitol.

[0028] A synthesis process of voglibose suspension, comprising step 1, preparation; step 2, preparation of drug solution; step 3, screening; step 4, drug powder mixing; step 5, preparation of suspension; step 6, drug solution mixing; step 7, packaging and storage;

[0029] In the above step 1, materials, tools and environment for preparing voglibose suspension are prepared, including a blender, a sieve, a container, voglibose, hydroxypropyl methylcellulose, purified water, p-aminobenzoic acid, sodium lauryl sulfate, calcium stearate, polydextrose and mannitol, and an environment is selected to avoid direct sunlight;

[0030] In the above step 2, hydroxypropyl methylcellulose is slowly poured into purified water above 80° C. and then put into a stirrer at a stirring speed of 60 to 80 r / min for 5 to 10 minutes. After the stirring is completed, the hydroxypropyl methylcellulose solution is placed aside to cool. After the hydroxypropyl methylcellulose is swollen, dissolved and defoamed, voglibose is added to dissolve and stirred at a stirring speed of 50 to 60 r / min for 5 to 10 minutes. After the stirring is completed, it is placed in a container for standby use;

[0031] In the above step 3, the drug powder is sieved to remove impurities therein, and the prepared sodium lauryl sulfate and calcium stearate are placed on a sieve with a pore size of 0.5 mm to 0.8 mm for filtration. After filtration, the mixture is placed in a container to avoid moisture;

[0032] In the above step 4, the sieved powder is evenly mixed, and the filtered sodium lauryl sulfate and calcium stearate are put into a blender according to the formula ratio and stirred at a stirring speed of 20 to 40 r / min for 5 to 10 minutes;

[0033] In the above step 5, the powder of polydextrose and mannitol is added to purified water at 60°C to 70°C and poured into a mixer for stirring at a speed of 40 to 60 r / min for 10 to 20 min. After the stirring is completed, the powder stirred in step 4 is poured into the solution and stirred again with the polydextrose solution at a speed of 80 to 90 r / min for 5 to 10 min. After the stirring is completed, the powder is placed in a container and set aside to cool.

[0034] In the above step 6, the polydextrose solution prepared in step 5 and the voglibose solution prepared in step 2 are put into a blender according to a proportion, the stirring speed is 70-80 r / min, stirring for 5 minutes, after the stirring is completed, p-aminobenzoic acid is added and stirring is continued for 10-15 minutes, and the stirring speed remains unchanged;

[0035] In the above step 7, the stirred suspension is packaged and stored in an environment away from direct sunlight and moisture.

[0036] Example 2

[0037] A voglibose suspension comprises: voglibose, hydroxypropyl methylcellulose, purified water, calcium stearate and sodium lauryl sulfate, wherein the mass percentages of the components are: 35% of voglibose, 6% of hydroxypropyl methylcellulose, 40% of purified water, 2% of p-aminobenzoic acid, 3% of sodium lauryl sulfate, 6% of calcium stearate, 4% of polydextrose and 4% of mannitol, and the preparation process is the same as that of Example 1.

[0038] Example 3

[0039] A voglibose suspension comprises: voglibose, hydroxypropyl methylcellulose, purified water, calcium stearate and sodium lauryl sulfate, wherein the mass percentages of the components are: 27% of voglibose, 9% of hydroxypropyl methylcellulose, 45% of purified water, 1% of p-aminobenzoic acid, 2% of sodium lauryl sulfate, 7% of calcium stearate, 5% of polydextrose and 4% of mannitol, and the preparation process is the same as that of Example 1.

[0040] The specific composition ratios of each embodiment are shown in the following table:

[0041]

[0042]

[0043] Based on the above, the advantages of the present invention are: the present invention is designed to solve the problems of slow absorption, failure of the drug to take effect in time, short drug effect time and possible diarrhea after taking voglibose by adding hydroxypropyl methylcellulose, calcium stearate and polydextrose, wherein calcium stearate can accelerate gastrointestinal motility and better absorb the drug properties, hydroxypropyl methylcellulose has thickening properties and can also slow down the release rate of the drug properties, avoid excessive waste of the drug properties and effectively prolong the drug effect time, and polydextrose can produce special physiological metabolic functions after entering the human body, which can alleviate the problem of diarrhea caused by physiological metabolic disorders after taking drugs.

[0044] It will be apparent to those skilled in the art that the invention is not limited to the details of the exemplary embodiments described above and that the invention can be implemented in other specific forms without departing from the spirit or essential features of the invention. Therefore, the embodiments should be considered exemplary and non-limiting in all respects, and the scope of the invention is defined by the appended claims rather than the foregoing description, and it is intended that all variations falling within the meaning and scope of the equivalent elements of the claims be included in the invention. Any reference numeral in a claim should not be considered as limiting the claim to which it relates.

Claims

1. A voglibose suspension, comprising: Voglibose, hydroxypropyl methylcellulose, purified water, calcium stearate and sodium lauryl sulfate, characterized in that the mass percentages of the components are 25% to 35% of voglibose, 6% to 12% of hydroxypropyl methylcellulose, 40% to 55% of purified water, 5% to 8% of calcium stearate, 5% to 3% of mannitol, 1% to 3% of p-aminobenzoic acid, 3% to 6% of polydextrose and 2% to 5% of sodium lauryl sulfate.

2. A voglibose suspension according to claim 1, characterized in that: The mass percentages of the components are: 31% of voglibose, 10% of hydroxypropyl methylcellulose, 44% of purified water, 1% of p-aminobenzoic acid, 3% of sodium lauryl sulfate, 5% of calcium stearate, 3% of polydextrose and 3% of mannitol.

3. A synthesis process of voglibose suspension, comprising step 1, preparation; step 2, preparation of drug solution; step 3, screening; step 4, drug powder mixing; step 5, preparation of suspension; step 6, drug solution mixing; step 7, packaging and storage; characterized in that: In the above step 1, prepare the required materials; In the above step 2, a voglibose solution is prepared; In the above step 3, the drug powder is sieved to remove impurities therein; Wherein in the above step 4, the sifted powder is evenly mixed; Wherein in the above step 5, other materials are used to prepare the suspension; Wherein in the above step 6, the drug solution is mixed with the suspension; In the above step 7, the stirred suspension is packaged and stored in an environment away from direct sunlight and moisture.

4. The synthesis process of a voglibose suspension according to claim 3, characterized in that: In the step 1, materials, tools and environment for preparing voglibose suspension are prepared, including a blender, a screen, a container, voglibose, hydroxypropyl methylcellulose, purified water, p-aminobenzoic acid, sodium lauryl sulfate, calcium stearate, polydextrose and mannitol, and an environment is selected to avoid direct sunlight.

5. The synthesis process of a voglibose suspension according to claim 3, characterized in that: In the step 2, hydroxypropyl methylcellulose is slowly poured into purified water above 80° C. and then put into a stirrer at a stirring speed of 60 to 80 r / min for 5 to 10 minutes. After the stirring is completed, the hydroxypropyl methylcellulose solution is placed aside to cool. After the hydroxypropyl methylcellulose is swollen, dissolved and defoamed, voglibose is added to dissolve and stirred at a stirring speed of 50 to 60 r / min for 5 to 10 minutes. After the stirring is completed, the mixture is put into a container for standby use.

6. The synthesis process of a voglibose suspension according to claim 3, characterized in that: In the step three, the prepared sodium lauryl sulfate and calcium stearate are placed into a sieve with a pore size of 0.5 mm to 0.8 mm for filtration, and after filtration, are placed in a container to avoid moisture.

7. The synthesis process of a voglibose suspension according to claim 3, characterized in that: In the step 4, the filtered sodium lauryl sulfate and calcium stearate are put into a blender according to the formula ratio and stirred at a stirring speed of 20 to 40 r / min for 5 to 10 minutes.

8. The synthesis process of a voglibose suspension according to claim 3, characterized in that: In the step 5, the powders of polydextrose and mannitol are added to purified water at 60° C. to 70° C. and poured into a mixer for stirring at a stirring speed of 40 to 60 r / min for 10 to 20 minutes.

9. The synthesis process of a voglibose suspension according to claim 8, characterized in that: In the step 5, after the stirring is completed, the powder stirred in the step 4 is poured into the solution and stirred again with the polydextrose solution at a stirring speed of 80 to 90 r / min for 5 to 10 minutes. After the stirring is completed, the powder is placed in a container and set aside to cool.

10. The synthesis process of a voglibose suspension according to claim 3, characterized in that: In the step six, the polydextrose solution prepared in the step five and the voglibose solution prepared in the step two are put into a blender in proportion, the stirring speed is 70-80 r / min, stirring for 5 minutes, and after the stirring is completed, p-aminobenzoic acid is added and stirring is continued for 10-15 minutes, and the stirring speed remains unchanged.

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