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Preparation method of voglibose capsule

A technology for voglibose and capsules, which is applied in the field of pharmaceutical preparations, can solve the problems of poor voglibose content uniformity, low dissolution rate, poor voglibose content uniformity and the like, and achieves inhibition of crystallization. Phenomenon, good uniformity, good dissolution and effect of content uniformity

Active Publication Date: 2022-07-05
SHANDONG WEIFANG PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Dispersible tablets and capsules obtained in this patent have low dissolution rate and poor voglibose content uniformity
[0007] As can be seen from the above, the current voglibose oral preparations still have problems such as low dissolution rate and poor content uniformity of voglibose

Method used

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  • Preparation method of voglibose capsule
  • Preparation method of voglibose capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Embodiment 1: a kind of preparation method of voglibose capsules

[0033] Include the following steps:

[0034] 1. Preparation of the original drug solution

[0035] Add voglibose to deionized water, after the dissolution is complete, add 20 polyglycerol monostearate, polyvinyl pyrrolidone, polyethylene glycol 15-hydroxystearate, oat beta glucan in turn, stir After the dissolution is complete, the micropowder silica gel is slowly added, and after the addition is completed, it is fully stirred to be in a state of suspension to obtain the original drug solution;

[0036] The molecular weight of the polyvinylpyrrolidone is 8800g / mol;

[0037] The molecular weight of the polyethylene glycol 15-hydroxystearate is 963.2 g / mol;

[0038] The molecular weight of the oat beta glucan is 10530g / mol;

[0039] The particle size of the micropowder silica gel is 5 microns, and the specific surface area is 270 m 2 / g;

[0040] The mass ratio of described voglibose, deionized water...

Embodiment 2

[0049] Embodiment 2: a kind of preparation method of voglibose capsules

[0050] Include the following steps:

[0051] 1. Preparation of the original drug solution

[0052] Add voglibose to deionized water, after the dissolution is complete, add 20 polyglycerol monostearate, polyvinyl pyrrolidone, polyethylene glycol 15-hydroxystearate, oat beta glucan in turn, stir After the dissolution is complete, the micropowder silica gel is slowly added, and after the addition is completed, it is fully stirred to be in a state of suspension to obtain the original drug solution;

[0053] The molecular weight of the polyvinylpyrrolidone is 6000g / mol;

[0054] The molecular weight of the polyethylene glycol 15-hydroxystearate is 963.2 g / mol;

[0055] The molecular weight of the oat beta glucan is 6300 g / mol;

[0056] The particle size of the micropowder silica gel is 3 microns, and the specific surface area is 150 m 2 / g;

[0057] The mass ratio of described voglibose, deionized water...

Embodiment 3

[0066] Embodiment 3: a kind of preparation method of voglibose capsules

[0067] Include the following steps:

[0068] 1. Preparation of the original drug solution

[0069] Add voglibose to deionized water, after the dissolution is complete, add 20 polyglycerol monostearate, polyvinyl pyrrolidone, polyethylene glycol 15-hydroxystearate, oat beta glucan in turn, stir After the dissolution is complete, the micropowder silica gel is slowly added, and after the addition is completed, it is fully stirred to be in a state of suspension to obtain the original drug solution;

[0070] The molecular weight of the polyvinylpyrrolidone is 10000g / mol;

[0071] The molecular weight of the polyethylene glycol 15-hydroxystearate is 963.2 g / mol;

[0072] The molecular weight of the oat beta glucan is 12000 g / mol;

[0073] The particle size of the micropowder silica gel is 8 microns, and the specific surface area is 360 m 2 / g;

[0074] The mass ratio of described voglibose, deionized wat...

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Abstract

A preparation method of voglibose capsules belongs to the field of pharmaceutical preparations and comprises five steps of preparation of original liquid medicine, coating drying, micronization, freeze drying and capsule filling. The voglibose capsule with high dissolution rate and good voglibose content uniformity is prepared, the dissolution rates in 5 minutes, 15 minutes and 30 minutes are respectively 53.8 to 55.9 percent, 93.6 to 96.7 percent and 99.9 to 100 percent, and the voglibose content uniformity is 0.35 to 0.43; according to the voglibose capsule preparation and the preparation method thereof, the polyvinylpyrrolidone and the superfine silica powder are added into the voglibose aqueous solution, and the rapid evaporation operation of coating drying is matched, so that the crystallization phenomenon in the voglibose precipitation process is inhibited, the voglibose in an amorphous powder state is obtained, and the final capsule preparation has excellent dissolution rate and content uniformity.

Description

technical field [0001] The invention relates to a preparation method of voglibose capsules, belonging to the field of pharmaceutical preparations. Background technique [0002] Voglibose is an α-glucosidase inhibitor, and its mechanism of action is to competitively inhibit maltase, isomaltase, glycosidase, etc. Glucose formation is reduced, thereby delaying the digestion and absorption of starch and sucrose, lowering blood sugar, and especially controlling postprandial hyperglycemia. The hypoglycemic effect of voglibose is stable and does not stimulate the secretion of insulin. There is no postprandial hyperinsulinemia, and hypoglycemia is not easy to occur. [0003] As a hypoglycemic drug, voglibose has a strict method of use and must be taken orally before meals to be effective. [0004] To control the blood sugar level after meals, to achieve this goal, voglibose must have the characteristics of rapid disintegration, high dissolution rate, and good content uniformity. ...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/133A61K47/32A61K47/04A61K47/14A61P3/10
CPCA61K31/133A61K9/4808A61K9/4866A61K9/485A61P3/10
Inventor 孙路路李金姑赵娜谭新孙园园周青青
Owner SHANDONG WEIFANG PHARMA FACTORY
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