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Method for preparing voglibose particles

A technology of voglibose and granules, which is applied in the field of medicine and biology, can solve the problems of small voglibose dose, difficulty in ensuring content uniformity, and large fluctuations in granule content, so as to reduce labor intensity and improve manpower Resource utilization, low fragility effect

Inactive Publication Date: 2018-10-12
SHANDONG XINHUA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] Due to the small dose of voglibose, it is difficult to ensure the uniformity of its content by ordinary methods, and the content of granules fluctuates greatly (such as greater than 5%)

Method used

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  • Method for preparing voglibose particles
  • Method for preparing voglibose particles
  • Method for preparing voglibose particles

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0065] Embodiment 1 Preparation of voglibose granules

[0066] prescription:

[0067]

[0068] Process:

[0069] (1) the hydroxypropyl cellulose (U.S. Ashland company, Klucel TM , LXF model) dissolved in purified water (self-made, the same below), uniformly dispersed as solution A;

[0070] (2) Take solution A, add the prescribed amount of voglibose (Shanghai Tianwei Biopharmaceutical Co., Ltd., pharmaceutical grade, the same below), and evenly disperse it as solution B;

[0071] (3) Lactose (U.S. Foremost Farms USA company, pharmaceutical grade, 312 model, passed through a 100-mesh sieve before use, the same below) and starch (Weifang Shengtai Pharmaceutical Co., Ltd., pharmaceutical grade, 200 mesh, below) The same), add it into a one-step granulator (Chongqing Kexu Pharmaceutical Machinery Manufacturing Co., Ltd., LBL-30 fluidized bed granulation coating machine, the same below), mix for 30min, and control the fan frequency: 20Hz~30Hz.

[0072] (4) Take the solution ...

Embodiment 2

[0074] The preparation of embodiment 2 voglibose granules

[0075] prescription:

[0076]

[0077] Process:

[0078] (1) Take 2.0 kg of ethanol (Xuzhou Xiangjiu Liquor Industry Co., Ltd., pharmaceutical grade, concentration is 95%, V / V, the same below), add purified water 18.0 kg, and prepare 10% ethanol liquid (W / W) .

[0079] (2) the hydroxypropyl cellulose (U.S. Ashland company, Klucel TM , EXF model) dissolved in 10% ethanol solution (W / W), uniformly dispersed as solution A;

[0080] (3) Take solution A, add the prescribed amount of voglibose, and evenly disperse it as solution B;

[0081] (4) Take the prescribed amount of lactose and starch, add it to the one-step granulator, mix for 25 minutes, and control the fan frequency: 20Hz-30Hz.

[0082] (5) Take the solution B and spray it into the one-step granulator containing the above materials in the way of top spray granulation. Control the fan frequency to 20-30Hz, set the air inlet temperature to 55-80°C, spray p...

Embodiment 3

[0084] The preparation of embodiment 3 voglibose granules

[0085] prescription:

[0086]

[0087] Process:

[0088] (1) Take 8.0 kg of ethanol, add 12.0 kg of purified water, and prepare 40% ethanol solution (W / W).

[0089] (2) the hydroxypropyl cellulose (U.S. Ashland company, Klucel TM , ELF model) dissolved in 40% ethanol solution (W / W), uniformly dispersed as solution A;

[0090] (3) Take solution A, add the prescribed amount of voglibose, and evenly disperse it as solution B;

[0091] (4) Take the prescribed amount of lactose and starch, add it to the one-step granulator, mix for 15 minutes, and control the fan frequency: 20Hz-30Hz.

[0092] (5) Take the solution B and spray it into the one-step granulator containing the above materials in the way of top spray granulation. Control the fan frequency at 20-30Hz, the air inlet temperature at 40-80°C, the spray pressure at 0.15-0.25Mpa, and the peristaltic pump speed at 80rpm.

[0093] (6) After spraying the above s...

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Abstract

The invention provides a method for preparing voglibose particles. The particles are prepared through a one-step prilling process,the friability is low,and the roundness is good. Voglibose can be dissolved out fast,the content uniformity is good,and the voglibose particles are suitable for being further prepared into capsules,tables (including dispersible tablets and orally disintegrating tablets)and granules. According to the preparation idea,the voglibose is added into a polar solvent containing a water-soluble adhesive,and the mixture is sprayed into a one-step pelletizer containing a diluent and a disintegrating agent in a top spraying prilling mode. The preparation method is easy to operate,the labor intensity is reduced,and the preparation method is suitable for large-scale production.

Description

technical field [0001] The invention relates to a preparation method of voglibose granules, belonging to the field of medicine and biology. Background technique [0002] Diabetes mellitus is an endocrine and metabolic disorder, a chronic disease characterized by hyperglycemia caused by insulin secretion and utilization disorders. According to the statistics of the International Diabetes Federation (IDF), as of 2015, there are 415 million diabetic patients (prevalence rate of 8.8%) and 318 million pre-diabetic patients (prevalence rate of 6.7%) worldwide. Without intervention, by 2040 there will be 642 million people with diabetes and 481 million people with prediabetes. Of these, 46.5% of the 415 million diabetics were undiagnosed. 5.1 million people die from diabetes-related diseases every year, accounting for 8.39% of the total deaths. According to the forecast of the World Health Organization (WHO), the global medical expenditure on diabetes will reach 53 billion US do...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K9/20A61K31/133A61K47/38A61K47/32A61P3/10
CPCA61K9/1652A61K9/1694A61K9/2027A61K9/2054A61K31/133A61P3/10
Inventor 黎红汪洋徐豪杰
Owner SHANDONG XINHUA PHARMA CO LTD
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