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Double-controlled release gliclazide sustained-release capsules and preparation method thereof

A technology for gliclazide and sustained-release capsules is applied in the field of medicine, which can solve the problems of slow drug release and slow onset of action, and achieve the effect of a simple preparation method.

Active Publication Date: 2011-05-18
桂林华信制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Most of the existing gliclazide sustained-release capsules have a shortcoming, that is, the release of the drug is slow at the beginning of a period of time after taking the medicine, and the onset of effect is slow. Simultaneous filling into the same capsule for controlled release

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] 1. ① Formula of gliclazide sustained-release pellets in 1000 capsules:

[0035] Gliclazide 20g

[0036] Microcrystalline Cellulose 30g

[0037] Lactose 60g

[0038] Hypromellose 4000cp 6g

[0039] water 30g

[0040] ② Immediate release film coating formula:

[0041] Dissolve 10 g of Gliclazide, 10 g of Eudragit RL100 and 30 g of talcum powder in 300 g of aqueous ethanol solution with a volume concentration of 95%, shake well and set aside.

[0042] Second, the preparation process:

[0043] (1) Gliclazide is pulverized to 100 mesh;

[0044] (2) Take 20g of 100-mesh gliclazide, 30g of microcrystalline cellulose, 60g of lactose, 6g of hypromellose 4000cp and mix evenly, add 30g of water as a wetting agent to make a soft material, and put it into the extrusion pellet machine Prepare pellets by extrusion at 60 rpm and spheronization at 600 rpm, and dry at 80°C for 2 hours to obtain gliclazide sustained-release pellets;

[0045] (3) Select the above-mentioned 20-mesh ...

Embodiment 2

[0050] 1. ① Formula of gliclazide sustained-release pellets in 1000 capsules:

[0051] Gliclazide 25g

[0052] Microcrystalline Cellulose 35g

[0053] Lactose 55g

[0054] Hypromellose 4000cp 8g

[0055] water 50g

[0056] ② Immediate release coating solution formula:

[0057] Dissolve 5 g of gliclazide, 15 g of Eudragit RL100 and 25 g of talcum powder in 300 g of aqueous ethanol solution with a volume concentration of 95%, shake well and set aside.

[0058] Second, the preparation process:

[0059] (1) Gliclazide is pulverized to 100 mesh;

[0060](2) Take 25g of 100-mesh gliclazide, 35g of microcrystalline cellulose, 55g of lactose, 10g of hypromellose 4000cp and mix evenly, add 50g of water as a wetting agent to make a soft material, and put it into the extrusion pellet machine Prepare pellets by extrusion at 60 rpm and spheronization at 600 rpm, and dry at 50°C for 4 hours to obtain gliclazide sustained-release pellets;

[0061] (3) Select 20 mesh gliclazide sustai...

Embodiment 3

[0066] 1. ① Formula of gliclazide sustained-release pellets in 1000 capsules:

[0067] Gliclazide 30g

[0068] Microcrystalline Cellulose 40g

[0069] Lactose 50g

[0070] Hypromellose 4000cp 5g

[0071] water 45g

[0072] ② Immediate-release film coating liquid formula:

[0073] Take 15g of gliclazide, 20g of EudragitRL100 and 30g of talcum powder and dissolve in 300g of aqueous ethanol solution with a volume concentration of 95%, shake well and set aside.

[0074] Second, the preparation process:

[0075] (1) Gliclazide is pulverized to 100 mesh;

[0076] (2) Take 30g of 100-mesh gliclazide, 40g of microcrystalline cellulose, 50g of lactose, 5g of hypromellose 4000cp and mix evenly, add 45g of water as a wetting agent to make a soft material, and put it into the extrusion pellet machine Prepare pellets by extrusion at 60 rpm and spheronization at 600 rpm, and dry at 40°C for 4 hours to obtain gliclazide sustained-release pellets;

[0077] (3) Select 20 mesh gliclazid...

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Abstract

The invention discloses double-controlled release gliclazide sustained-release capsules and a preparation method thereof. Contents filled into the sustained-release capsules are gliclazide sustained-release pellets of which surfaces are coated with quick release film coatings. Based on 1,000 capsules, the gliclazide sustained-release pellets are prepared from the following raw materials by weight: 20 to 30 grams of gliclazide, 30 to 50 grams of microcrystalline cellulose, 40 to 60 grams of lactose, 2 to 8 grams of hydroxypropyl methylcellulose 4000cp and 30 to 60 grams of water; and the quickrelease film coatings are prepared from the following raw materials by weight: 5 to 20 grams of gliclazide, 10 to 40 grams of EudragitRL100, 5 to 30 grams of talcpowder and 300 grams of ethanol at the volume concentration of 95 percent. Compared with the prior art, the capsules provided by the invention can develop the advantages of multi-unit preparations at the same time of meeting requirementson the quick response of medicaments and keeping a certain blood concentration; and the preparation method for the capsules is simple and easy to control.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a double-controlled release gliclazide sustained-release capsule and a preparation method thereof. Background technique [0002] Diabetes mellitus (DM, Diabetes Mellitus) is a metabolic disease with multiple etiologies, characterized by chronic hyperglycemia, accompanied by disorders of sugar, fat and protein metabolism caused by defects in insulin (Insulin) secretion and / or action. [0003] Gliclazide was first successfully developed by the French Servier pharmaceutical company, and its trade name is Diamicron. Diamicron has been registered and sold in more than 130 countries in the world. After the drug entered China, it received unanimous praise from doctors and experts, and now it has become the first-line oral hypoglycemic drug in my country. [0004] At present, for the treatment of non-insulin-dependent diabetes mellitus (type II), the slow-release dosage forms with glic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K9/16A61K31/64A61P3/10
Inventor 陈华兆唐世锭罗习
Owner 桂林华信制药有限公司
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