Gliclazide sustained-release capsule and preparation process thereof

A technology of gliclazide and sustained-release capsules, applied in the field of medicine, can solve the problems of many components and complexities, and achieve the effects of less toxic and side effects, high qualification rate and stable product performance

Inactive Publication Date: 2010-03-17
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

The gliclazide sustained-release capsules of this invention can treat non-insulin-dependent diabetes (type II), and are especially suitable for

Method used

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  • Gliclazide sustained-release capsule and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] 1. ① Gliclazide pellets prescription:

[0044] Gliclazide 30g

[0045] Microcrystalline Cellulose 30g

[0046] Lactose 60g

[0047] water 30g

[0048] Makes 1000 capsules

[0049] ② Preparation of sustained-release film coating solution:

[0050] Take 5g of EudragitRS100, 30g of EudragitRL100 and 30g of talcum powder and dissolve them in 1000ml of ethanol solution with a volume concentration of 95%, shake well and set aside.

[0051] Second, the preparation process:

[0052] (1) Gliclazide is pulverized to 100 mesh;

[0053] (2) Take 30g of 100-mesh gliclazide, 30g of microcrystalline cellulose, and 60g of lactose and mix evenly, add 30g of water as a wetting agent to make a soft material, and put it into an extrusion rolling pellet machine at a speed of 400 rpm Granulate and dry at 80°C for 4 hours to obtain gliclazide pellets;

[0054] (3) Select 20-mesh gliclazide pellets and put them into the coating machine, adjust the speed of the coating machine to 150 rpm...

Embodiment 2

[0059] 1. ① Gliclazide pellets prescription:

[0060] Gliclazide 30g

[0061] Microcrystalline Cellulose 35g

[0062] Lactose 55g

[0063] water 66g

[0064] Makes 1000 capsules

[0065] ② Preparation of sustained-release film coating solution:

[0066] Take 5g of EudragitRS100, 15g of EudragitRL100 and 10g of talcum powder and dissolve them in 1000ml of ethanol solution with a volume concentration of 95%, shake well and set aside.

[0067] Second, the preparation process:

[0068] (1) Crush gliclazide to 80-100 mesh;

[0069] (2) Take 30g of 80-100 mesh gliclazide, 35g of microcrystalline cellulose, and 55g of lactose, mix evenly, add 66g of water as a wetting agent to make a soft material, put it into an extrusion rolling pellet machine at 800 rpm Gliclazide pellets were obtained by granulating at a rotating speed of 100°C, and then setting the extrusion rolling machine at 40°C, and drying for 10 hours under this condition;

[0070] (3) Select 20-50 mesh gliclazide...

Embodiment 3

[0075] 1. ① Gliclazide pellets prescription:

[0076] Gliclazide 33g

[0077] Microcrystalline Cellulose 50g

[0078] Lactose 45g

[0079] water 70g

[0080] Makes 1000 capsules

[0081] ② Preparation of sustained-release film coating solution:

[0082] Take 20g of EudragitRS100, 40g of EudragitRL100 and 10g of talcum powder and dissolve them in 1000ml of ethanol solution with a volume concentration of 95%, shake well and set aside.

[0083] Second, the preparation process:

[0084] (1) Gliclazide is pulverized to 90 mesh;

[0085] (2) Take 33g of 90-mesh gliclazide, 50g of microcrystalline cellulose, and 45g of lactose and mix evenly, add 70g of water as a wetting agent to make a soft material, and put it into an extrusion rolling pellet machine at a speed of 1000 rpm Granulate, take out and dry in cold air for 10 hours in a sterile environment at 20°C to prepare gliclazide pellets;

[0086] (3) Select 20-40 mesh gliclazide pellets and put them into the coating mach...

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Abstract

The invention relates to the technical field of medicines, in particular to a gliclazide sustained-release capsule and a preparation process thereof. The content filled in the capsule is gliclazide micro-pills of which the surfaces are coated with sustained-release film coatings, and the gliclazide micro-pills are prepared from the following raw materials in portion by weight: 30 to 35 portions ofgliclazide, 30 to 50 portions of microcrystalline cellulose, 40 to 60 portions of lactose, and 30 to 70 portions of water. The sustained-release film coatings are prepared from the following raw materials in portion by weight: 5 to 20 portions of EudragitRS100, 10 to 40 portions of EudragitRL100, 10 to 40 portions of talc powder, and 1,000 portions of 95 percent ethanol solution. The method for preparing the gliclazide sustained-release capsule comprises the following steps: firstly, crushing the gliclazide; secondly, taking a proper amount of the gliclazide powder according to a gliclazide micro-pill formula to perform pelletizing so as to obtain the gliclazide micro-pills; and thirdly, coating the gliclazide micro-pills. The gliclazide sustained-release capsule can well control the in vivo release rate of the gliclazide and is safe and long-acting.

Description

(1) Technical field: [0001] The invention relates to the technical field of medicine, in particular to gliclazide sustained-release capsules and a preparation process thereof. (two) background technology: [0002] Diabetes mellitus is an endocrine and metabolic disease caused by insufficient insulin secretion and decreased sensitivity of target cells to insulin, resulting in metabolic disorders of sugar, protein, fat, water, and electrolytes. Commonly used oral hypoglycemic drugs include sulfonylureas and biguanides, among which sulfonylureas are the earliest discovered and widely used hypoglycemic drugs, and Gliclazide is the most commonly used. Gliclazide is the second-generation sulfonylurea hypoglycemic drug, and is currently the largest-selling sulfonylurea hypoglycemic drug. colored crystals. Its chemical name is 1-(3-azabicyclo[3.3.0]octyl)-3-p-toluenesulfonylurea, molecular formula: C 15 h 21 N 3 o 3 S, the structural formula is: [0003] [0004] Gliclazid...

Claims

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Application Information

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IPC IPC(8): A61K9/56A61K31/403A61P3/10
Inventor 黎炜烘唐世锭
Owner 桂林华信制药有限公司
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