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Acarbose capsule and preparation method thereof

A technology of acarbose and capsules, applied in the field of medicine, can solve the problems such as the inability to improve the fluidity, the easy moisture absorption of acarbose, and the powder spraying.

Active Publication Date: 2015-04-29
HANGZHOU ZHUYANGXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Disadvantages of this method: acarbose is easy to absorb moisture and has poor fluidity. Although adding a lubricant, its fluidity cannot be improved well, and the main drug and auxiliary materials are mixed and pressed into tablets. Compared with acarbose raw materials Light, after the auxiliary materials are directly mixed, and then compressed, there will be large differences in the tablet, or even unqualified phenomena, and powder spraying will occur during the tableting process, and the qualification of the tablet weight cannot be guaranteed.
It is believed that the invention overcomes the disadvantages of inconvenient administration of existing tablets and capsules, and provides an easier-to-administer acarbose preparation that disintegrates rapidly in the oral cavity and does not require water

Method used

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  • Acarbose capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0094] Embodiment 1: Preparation of acarbose capsules

[0095] formula:

[0096] Acarbose

50mg

microcrystalline cellulose

20mg

corn starch

90mg

Modified pregelatinized starch

40mg

Sodium octadecyl fumarate

1.5mg

silica

1mg

[0097] Preparation method:

[0098] (1) Make the acarbose that crosses 80 mesh sieves through being pulverized and mix evenly with the lubricant of prescription quantity;

[0099] (2) mix the diluent and the mixed powder obtained in step (1) through pulverizing in advance and passing through an 80-mesh sieve;

[0100] (3) mixing the glidant and the mixed powder obtained in step (2) in a three-dimensional mixer for 5-10 minutes to obtain a uniform total mixture, which is used as a filler for capsules;

[0101] (4) Detect the content of the active substance in the filler, and calculate the loading amount of the filler in each capsule;

[0102] (5) Filling the obtained filler into...

Embodiment 2

[0103] Embodiment 2: preparation of acarbose capsules

[0104] formula:

[0105] Acarbose

50mg

microcrystalline cellulose

20mg

Cassava starch

87.5mg

Modified pregelatinized starch

40mg

Sodium octadecyl fumarate

1.5mg

silica

1mg

[0106] Preparation method:

[0107] (1) Make the acarbose that crosses 80 mesh sieves through being pulverized and mix evenly with the lubricant of prescription quantity;

[0108] (2) mix the diluent and the mixed powder obtained in step (1) through pulverizing in advance and passing through an 80-mesh sieve;

[0109] (3) mixing the glidant and the mixed powder obtained in step (2) in a three-dimensional mixer for 5-10 minutes to obtain a uniform total mixture, which is used as a filler for capsules;

[0110] (4) Detect the content of the active substance in the filler, and calculate the loading amount of the filler in each capsule;

[0111] (5) Filling the obtained fille...

Embodiment 3

[0112] Embodiment 3: Preparation of acarbose capsules

[0113] formula:

[0114] Acarbose

50mg

microcrystalline cellulose

15mg

Potato starch

95mg

Modified pregelatinized starch

45mg

Sodium octadecyl fumarate

1.2mg

silica

0.5mg

[0115] Preparation method:

[0116] (1) Make the acarbose that crosses 80 mesh sieves through being pulverized and mix evenly with the lubricant of prescription quantity;

[0117] (2) mix the diluent and the mixed powder obtained in step (1) through pulverizing in advance and passing through an 80-mesh sieve;

[0118] (3) mixing the glidant and the mixed powder obtained in step (2) in a three-dimensional mixer for 5-10 minutes to obtain a uniform total mixture, which is used as a filler for capsules;

[0119] (4) Detect the content of the active substance in the filler, and calculate the loading amount of the filler in each capsule;

[0120] (5) Filling the obtained filler...

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Abstract

The invention relates to an acarbose capsule and a preparation method thereof. Specifically, the capsule comprises a capsule shell and filler which is coated in the capsule shell and is in the form of powder or granule, wherein the filler consists of an active substance acarbose, a thinner, a lubricant and a flow aid; the thinner is selected from starch, dextrin, carboxymethyl starch, hydroxypropyl starch, modified starch, modified pregelatinized starch, microcrystalline cellulose, calcium phosphate, calcium hydrogen phosphate, calcium carbonate and the like and the combinations thereof; the lubricant is selected from magnesium stearate, stearic acid, polyethylene glycol with molecular weight of 4000-8000, calcium stearate, zinc stearate, octadecyl sodium fumarate and the combinations thereof. The capsule disclosed by the invention is excellent in pharmaceutical properties such as excellent stability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a pharmaceutical composition, in particular to a pharmaceutical preparation in the form of a hard capsule, in particular to a pharmaceutical composition of an Acarbose capsule. The invention also relates to a process for their preparation. The capsule of the present invention has excellent pharmaceutical properties. Background technique [0002] Diabetes Mellitus (DM) is a group of metabolic diseases characterized by chronic increase in blood glucose (referred to as blood sugar) level, 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 conditions or stress, such as diabetic ketoacid...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/7036A61K47/42A61K47/38A61K47/36A61P3/10
Inventor 李阅东唐建飞沈如杰河海珍马雯霞姚成娥张群赵福斌张婧
Owner HANGZHOU ZHUYANGXIN PHARMA
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