Voglibose tablet and preparation method thereof

A technology of voglibose and sugar tablets, which is applied in the field of oral preparations containing voglibose and its preparation, can solve the problem of difficulty in realizing large-scale industrial production, reducing the absorption rate of voglibose, and affecting the production of voglibose. Glibose curative effect and other issues, to achieve the effect of fewer steps, improved bioavailability, and rapid dissolution

Inactive Publication Date: 2021-04-09
SUZHOU CHUNGHWA CHEM & PHARMA IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although voglibose has good water solubility, its disintegration is slow due to its crystal form of matrix-arranged needles. At present, the in vitro dissolution rate of ordinary tablets is only about 83% in 30 minutes, and its dissolution rate is relatively poor. , affecting the curative effect of voglibose to varying degrees
[0004] Both patents CN 108309946 A and CN 110101671 A disclose a method for preparing voglibose tablets, but the addition of surfactant polysorbate 80 may cause irritation to the gastrointestinal tract, and at the same time, many types of auxiliary materials are used. And the preparation process is complex, it is difficult to realize large-scale industrial production
Patent CN 101219127A discloses a preparation method of voglibose capsules, but the swelling rate of the capsule shell of the preparation is slow, which will inevitably reduce the absorption rate of voglibose in the body

Method used

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  • Voglibose tablet and preparation method thereof
  • Voglibose tablet and preparation method thereof
  • Voglibose tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Raw materials Prescription amount (g) Voglibose 10 Copovidone VA64 25 Croscarmellose Sodium 2 porous starch 40 Sodium stearyl fumarate 1

[0028] Preparation:

[0029] Weigh the raw materials and copovidone VA64 according to the prescription amount, heat and melt the extrusion at 151°C through a hot-melt extruder, crush the extrudate, pass through a 80-mesh sieve, and mix with the prescription amount of croscarmellose sodium , porous starch, and sodium stearyl fumarate are mixed evenly, and the tablet hardness is controlled to 30N, and the tablets are directly pressed.

Embodiment 2

[0031] Raw materials Prescription amount (g) Voglibose 5 Copovidone S630 10 Carmellose Calcium 1 porous starch 25 Magnesium stearate 0.5

[0032] Preparation:

[0033] Weigh the raw materials and copovidone S630 according to the prescription amount, heat and melt the extruded product at 151°C through a hot-melt extruder, crush the extrudate, pass through a 80-mesh sieve, and mix with carmellose calcium, porous starch, stearin The magnesium acid is mixed evenly, and the tablet hardness is controlled to be 30N, and the tablets are directly compressed.

Embodiment 3

[0035] Raw materials Prescription amount (g) Voglibose 5 Copovidone VA64 15 Hydroxypropyl starch 1 porous starch 34 talcum powder 0.5

[0036] Preparation:

[0037] Weigh the raw materials and copovidone VA64 according to the prescription amount, heat and melt the extruded product at 151°C through a hot-melt extruder, crush the extrudate, pass through a 80-mesh sieve, and mix with hydroxypropyl starch, porous starch, and talc powder Uniform, controlled tablet hardness 30N, direct tablet compression.

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a voglibose-containing tablet and a preparation method thereof. The tablet is composed of 20-50% of a voglibose solid dispersion, 0.5-5% of a disintegrating agent, 30-60% of a filling agent and 0.5-2% of a lubricating agent, wherein the voglibose solid dispersion is prepared by uniformly mixing voglibose and copovidone, and performing heating melt extrusion through a hot melt extruder. The tablet provided by the invention has the advantages of rapid disintegration, rapid dissolution, high bioavailability, simple preparation process and few steps, and is beneficial to industrial large-scale production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a pharmaceutical preparation for treating diabetes, in particular to an oral preparation containing voglibose and a preparation method thereof. Background technique [0002] Voglibose is an α-glucosidase inhibitor developed by Takeda Pharmaceutical Company in Japan for the treatment of elevated postprandial blood glucose in diabetes. The drug competitively inhibits disaccharide hydrolase in the small intestine, prevents the degradation of disaccharides into monosaccharides, and delays the digestion and absorption of sugars, thereby improving postprandial hyperglycemia. Unlike sulfonylureas, voglibose does not stimulate β cells to secrete insulin, so it can reduce the harmful effects of postprandial hyperinsulinemia, reduce insulin resistance, and is beneficial to the prevention and treatment of metabolic syndrome such as cardiovascular complications; It is ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/133A61K47/36A61K47/32A61K47/38A61P3/10
CPCA61K31/133A61K9/2095A61K9/2027A61K9/2059A61K9/2054A61P3/10
Inventor 邱月琴
Owner SUZHOU CHUNGHWA CHEM & PHARMA IND
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