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Acarbose solid sustained-release preparation and preparing method thereof

A technology of acarbose and sustained-release preparations, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., and can solve the problems of short duration of drug effect, impaired liver and kidney function, It is easy to forget to take or miss a dose, etc., so as to avoid peak and valley phenomena, reduce toxic and side effects, and stabilize blood drug concentration.

Inactive Publication Date: 2009-12-23
QINGDAO HANHE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because it is a common preparation, the drug release is too fast, the blood drug concentration is too high immediately, and the blood drug concentration is too low after short-term metabolism. would make the duration of the drug effect too short
In addition, patients need to take it more than three times a day, which is extremely inconvenient, and it is easy to forget to take and miss a dose, which will affect the curative effect.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Acarbose solid sustained-release preparation (acarbose sustained-release tablet), prepared from the following raw materials in weight ratio:

[0025] Acarbose 150g

[0026] Hypromellose 50g

[0027] Hydroxyethylcellulose 30g

[0028] Sodium Carboxymethyl Cellulose 40g

[0029] Stearic acid 50g

[0030] Calcium hydrogen phosphate 100g

[0031] Starch 80g

[0032] Lactose 70g

[0033] Microcrystalline Cellulose 120g

[0034] 10% polyvinylpyrrolidone solution 700g

[0035] Magnesium Stearate 15g

[0036]

[0037] The preparation method is as follows:

[0038] 1) Pulverize acarbose and various pharmaceutical excipients, pass through a 100-mesh sieve, and store them separately for later use;

[0039] 2) Weighing the slow-release retarder, the spare acarbose in step 1) and the filler in the pharmaceutical excipients in proportion, and fully mixing them;

[0040] 3) Mix the raw materials uniformly in step 2), ...

Embodiment 2

[0042] Acarbose solid sustained-release preparation (acarbose sustained-release tablet), prepared from the following raw materials in weight ratio:

[0043] Acarbose 200g

[0044] Hypromellose 70g

[0045] Sodium Carboxymethyl Cellulose 30g

[0046] Stearic acid 50g

[0047] Calcium hydrogen phosphate 150g

[0048] Lactose 130g

[0049] Microcrystalline Cellulose 140g

[0050] Magnesium Stearate 15g

[0051] The preparation method is as follows:

[0052] 1) Pulverize acarbose and various pharmaceutical excipients, pass through an 80-mesh sieve, and store them separately for later use;

[0053] 2) Weighing the slow-release retarder, the spare acarbose in step 1) and the filler in the pharmaceutical excipients in proportion, and fully mixing them;

[0054] 3) The uniformly mixed raw materials in step 2) were mixed with a lubricant and then sent to a tablet machine for direct compression to form an acarbose sustained-release tablet with a tablet weight of 785 mg.

Embodiment 3

[0056] Acarbose solid sustained-release preparation (acarbose sustained-release capsule), prepared from the following raw materials in weight ratio:

[0057] Acarbose 50g

[0058] Hypromellose 35g

[0059]Sodium Carboxymethyl Cellulose 15g

[0060] Calcium hydrogen phosphate 60g

[0061] Dextrin 90g

[0062] Lactose 70g

[0063] 10% polyvinylpyrrolidone solution 70g

[0064] Magnesium Stearate 5g

[0065]

[0066] The preparation method is as follows:

[0067] 1) Pulverize acarbose and various pharmaceutical excipients, pass through a 50-mesh sieve, and store them separately for later use;

[0068] 2) Weighing the slow-release retarder, the spare acarbose in step 1) and the filler in the pharmaceutical excipients in proportion, and fully mixing them;

[0069] 3) Mix the raw materials uniformly in step 2), make a soft material with an aqueous solution of polyvinylpyrrolidone, then wet granulate, then dry at a...

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Abstract

The invention discloses an acarbose solid sustained-release preparation which is prepared by pulverizing and mixing acarbose, sustained release retarder and pharmaceutic excipient, palletizing and then filling in capsules or tabletting by a tabletting machine. The acarbose solid sustained release preparation completely meets the requirement of sustained release. In vitro test indicates that the release rate of the preparation is 20-40 percent after two hours, 40-65 percent after four hours, and over 75 percent after eight hours.

Description

technical field [0001] The invention relates to a solid slow-release preparation of oral drug acarbose for treating type II diabetes and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Acarbose (acarbose) was successfully developed by Bayer in 1990 and was launched in European and American countries in 1994 for the treatment of type 2 diabetes. The trade name was Glucobay, and in the following year, acarbose entered the Chinese market with the trade name "Bai Tang Ping". The dosage form is ordinary tablet, and the dosage is 50mg / tablet and 100mg / tablet. Dosage: Oral three times a day, 50-100mg each time, individual patients can increase to three times a day, 200mg each time. [0003] Acarbose belongs to the class of α-glucosidase inhibitors. It is a complex oligomeric four-carbon sugar that can competitively inhibit the α-glucosidase of small intestinal intestinal brush border cells, delaying the hydrolysis...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K9/16A61K31/7036A61K47/44A61K47/42A61K47/40A61K47/38A61K47/36A61K47/34A61K47/32A61P3/10A61K47/10
Inventor 孙桂荣吴立明
Owner QINGDAO HANHE PHARMA
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