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Acarbose tablets and preparation method thereof

A technology of acarbose and acarbose, which can be used in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. Eligibility, poor fluidity of acarbose, etc., to achieve the effect of stable and controllable product quality, control of disintegration degree and microbial limit, and ease of subsequent processing

Active Publication Date: 2013-09-25
HAINAN HULUWA PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Disadvantages of this method: acarbose has poor fluidity, even if lubricant is added, its fluidity cannot be improved well, and the main drug and auxiliary materials are mixed and pressed into tablets. The raw material of acarbose is relatively light, and the auxiliary materials After mixing directly, and then compressing the tablets, there will be large differences in the tablets, and even unqualified phenomena, and powder spraying will occur during the tableting process, which cannot guarantee the eligibility of the tablet weight
The effect of wet granulation and high-speed stirring granulation is not good, it is easy to cause unqualified tablet quality after tableting, and it is difficult to sieve and granulate.

Method used

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  • Acarbose tablets and preparation method thereof
  • Acarbose tablets and preparation method thereof
  • Acarbose tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040]Acarbose 50.0g Microcrystalline Cellulose 13.0 Starch 63.0g

[0041] Sodium starch glycolate 4.2g Silicon dioxide 7.0g Magnesium stearate 0.7g

[0042] Acarbose, microcrystalline cellulose, starch, sodium starch glycolate, silicon dioxide, and magnesium stearate were respectively pulverized through a 100-mesh sieve, and set aside.

[0043] Put acarbose, microcrystalline cellulose, starch and 2 / 3 carboxymethyl starch sodium into the mixer, start the machine and mix evenly to obtain a premix; put the above premix into GZL series dry roller compaction granules In the machine, the roller pressure is 40 Pa, the pressing roller speed is 20 rpm, and the mixture transmission speed is 60 rpm, start the machine, pass through a 20-mesh sieve after granulation, and then get the granules; mix the above granules with stearic acid Magnesium, silicon dioxide, and the remaining sodium starch glycolate were added into a multidirectional mixer and mixed for 30 minutes, and the resulting m...

Embodiment 2

[0045] Acarbose 80.0g Microcrystalline Cellulose 18.0g Starch 94.0g

[0046] Sodium starch glycolate 6.3g Silicon dioxide 10.5g Magnesium stearate 1.05g

[0047] Acarbose, microcrystalline cellulose, starch, sodium starch glycolate, silicon dioxide, and magnesium stearate were respectively pulverized through a 100-mesh sieve, and set aside.

[0048] Put acarbose, microcrystalline cellulose, starch and 2 / 3 carboxymethyl starch sodium into the mixer, start the machine and mix evenly to obtain a premix; put the above premix into GZL series dry roller compaction granules In the machine, the roller pressure is 20 Pa, the pressing roller speed is 17 rpm, and the mixture transmission speed is 45 rpm, the machine is started, and the granules are discharged through a 20-mesh sieve to obtain granules; the above granules are mixed with stearic acid Magnesium, silicon dioxide, and the remaining sodium starch glycolate were added into a multidirectional mixer and mixed for 30 minutes, and...

Embodiment 3

[0050] Acarbose 100.0g Microcrystalline Cellulose 26.0g Starch 126.0g

[0051] Sodium starch glycolate 8.4g Silicon dioxide 14g Magnesium stearate 1.4g

[0052] Acarbose, microcrystalline cellulose, starch, sodium starch glycolate, silicon dioxide, and magnesium stearate were respectively pulverized through a 100-mesh sieve, and set aside.

[0053] Put acarbose, microcrystalline cellulose, starch and 2 / 3 carboxymethyl starch sodium into the mixer, start the machine and mix evenly to obtain a premix; put the above premix into GZL series dry roller compaction granules In the machine, the roller pressure is 50 Pa, the pressing roller speed is 22 rpm, and the mixture transmission speed is 80 rpm, start the machine, pass through a 20-mesh sieve after granulation, and then get the granules; mix the above granules with stearic acid Magnesium, silicon dioxide, and the remaining sodium starch glycolate were added into a multidirectional mixer and mixed for 30 minutes, and the resultin...

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Abstract

The invention discloses acarbose tablets and a preparation method thereof. The preparation method comprises the following steps of: uniformly mixing acarbose, microcrystalline cellulose, starch and 2 / 3 of carboxymethyl starch sodium to form a premix; pelletizing and granulating the premix through a dry process to obtain particles; and uniformly mixing the particles, 1 / 3 of carboxymethyl starch sodium, magnesium stearate and silicon dioxide, tabletting the mixture by a tablet press to obtain the acarbose tablets. According to the tablets prepared by dry-process palletizing and tabletting methods, the hardness and stability of the tablets are effectively improved and the problems of unaccepted disintegration time and unaccepted microorganisms are solved; as a result, the quality of the tablets is improved; and besides, the preparation method is simple in process flow, capable of saving energy source and cost, and suitable for industrial production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an acarbose tablet and a preparation method thereof. Background technique [0002] Diabetes Mellitus (DM) is a group of metabolic diseases characterized by chronic elevated blood glucose (referred to as blood sugar) levels, which is caused by defects in insulin secretion and / or action. Long-term carbohydrate, fat, and protein metabolic disorders can cause multi-system damage, leading to chronic progressive lesions, functional decline, and failure of tissues and organs such as eyes, kidneys, nerves, heart, and blood vessels. Severe metabolic disorders can occur in severe illness or stress, such as diabetic ketoacidosis (DKA), hyperglycemia and hyperosmolar state, etc. The disease reduces the quality of life of patients, shortens the life expectancy, and increases the mortality rate. It has become the third largest non-communicable disease that seriously endangers human ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/7036A61K47/36A61P3/10
Inventor 刘全国陈克领
Owner HAINAN HULUWA PHARMA GRP CO LTD
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