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Voglibose tablet with high dissolution rate and preparation method thereof

A technology for voglibose and tablets, which is applied in the field of voglibose tablets and its preparation, and can solve the problems of increasing the risk of adverse reactions, affecting the curative effect of voglibose, and the types and dosage of excipients. , to increase the dissolution surface area, ensure a high degree of dispersion, and improve the dissolution performance

Pending Publication Date: 2022-07-29
SUZHOU CHUNGHWA CHEM & PHARMA IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the in vitro dissolution rate of ordinary tablets is only about 83% in 30 minutes, and its dissolution rate is relatively poor, which affects the efficacy of voglibose to varying degrees.
The absorption of the drug mainly depends on the dissolution rate of the drug. Although the existing tablet preparation technology disclosed in the above patents has achieved certain beneficial effects, there are still some deficiencies, such as complex preparation process, many types and dosage of excipients, which will increase the adverse effects. The risk of reaction, and other defects that are not suitable for large-scale industrial production such as high equipment requirements

Method used

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  • Voglibose tablet with high dissolution rate and preparation method thereof
  • Voglibose tablet with high dissolution rate and preparation method thereof
  • Voglibose tablet with high dissolution rate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Example 1: Preparation of Voglibose Tablets

[0023] The voglibose solid dispersion of the present embodiment is composed of voglibose raw materials and carrier materials PEG-4000 and PEG-6000 according to the weight ratio of 1:1:0.5; the formulation of tablet accessories is as follows:

[0024]

[0025] Preparation Process:

[0026] (a) Dissolving: disperse the carrier materials PEG-4000 and PEG-6000 in 42% (V / V) ethanol, ultrasonicate until dissolved, and then add voglibose to obtain a mixed solution;

[0027] (b) Spray drying: spray drying the mixed solution in step (a), and the spray drying process conditions are: the inlet air volume is 40-60 m 3 / h, the inlet air temperature is 50-70°C, the spray speed is 8-10g / min, the atomization pressure is 0.3-0.5MPa, and the outlet air temperature is 45-55°C to obtain voglibose solid dispersion powder;

[0028] (c) preparation of solid preparation: take the solid dispersion of voglibose prepared in step (b), add adjuvant...

Embodiment 2

[0029] Example 2: Preparation of Voglibose Tablets

[0030] The voglibose solid dispersion of this embodiment is composed of voglibose raw materials and carrier materials PEG-4000 and PEG-6000 according to the weight ratio of 1:0.5:0.5; the tablet formulation is composed as follows:

[0031]

[0032] Preparation Process:

[0033] (a) Dissolving: disperse the carrier materials PEG-4000 and PEG-6000 in 60% (V / V) ethanol, ultrasonicate until dissolved, and then add voglibose to obtain a mixed solution;

[0034] (b) Spray drying: spray drying the mixed solution in step (a), and the spray drying process conditions are: the inlet air volume is 40-60 m 3 / h, the inlet air temperature is 50-70°C, the spray speed is 8-10g / min, the atomization pressure is 0.3-0.5MPa, and the outlet air temperature is 45-55°C to obtain voglibose solid dispersion powder;

[0035] (c) preparation of solid preparation: take the solid dispersion of voglibose prepared in step (b), add adjuvant lactose T8...

Embodiment 3

[0036] Example 3: Preparation of Voglibose Tablets

[0037]The voglibose solid dispersion of the present embodiment is composed of the voglibose raw material and the carrier material polyvinyl alcohol MXP according to the weight ratio of 1:2; the composition of the tablet auxiliary material is as follows:

[0038]

[0039] Preparation Process:

[0040] (a) dissolving: disperse the carrier material polyvinyl alcohol MXP in 50% (V / V) ethanol, ultrasonicate until dissolved, and then add voglibose to obtain a mixed solution;

[0041] (b) Spray drying: spray drying the mixed solution in step (a), and the spray drying process conditions are: the inlet air volume is 40-60 m 3 / h, the inlet air temperature is 50-70°C, the spray speed is 8-10g / min, the atomization pressure is 0.3-0.5MPa, and the outlet air temperature is 45-55°C to obtain voglibose solid dispersion powder;

[0042] (d) preparation of solid preparation: take the solid dispersion of voglibose prepared in step (b), a...

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Abstract

The invention discloses a voglibose tablet capable of being quickly dissolved out and a preparation method of the voglibose tablet, and belongs to the technical field of pharmaceutical preparations. According to the voglibose tablet, firstly, a solid dispersion of voglibose and a carrier material is prepared by adopting a solvent method and a spray drying technology, and then the solid dispersion is uniformly mixed with a filling agent, a disintegrating agent and a lubricating agent and is directly tableted. According to the voglibose tablet prepared by the method, the dissolution rate and the content uniformity are improved, meanwhile, the quality is stable and controllable, and the voglibose tablet is suitable for industrial large-scale production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a rapidly dissolving voglibose tablet and a preparation method thereof. Background technique [0002] Diabetes is a series of clinical syndromes caused by absolute or relative insufficiency of insulin in the body. The main clinical manifestations of diabetes are polydipsia, polyuria, polyphagia and weight loss, as well as high blood sugar and high urine sugar. Improper treatment can also cause many serious complications, such as cardiovascular disease, retinopathy, chronic renal failure, etc. . [0003] At present, the drugs on the market for the treatment of diabetes are mainly sulfonylureas, biguanides and α-glucosidase inhibitors. However, sulfonylureas are easy to cause persistent hypoglycemia, biguanides can cause severe gastrointestinal reactions and liver and kidney damage, while α-glucosidase inhibitors have fewer adverse reactions except...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/133A61K47/32A61K47/10A61P3/10
CPCA61K31/133A61K9/2095A61K9/2027A61K9/2031A61P3/10
Inventor 郑佳智马晓华
Owner SUZHOU CHUNGHWA CHEM & PHARMA IND
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