Gliclazide sustained release tablets and preparation method thereof

A technology for gliclazide and sustained-release tablets, applied in the field of medicine, can solve the problems of unsustainable blood drug concentration of gliclazide, poor sustained-release stability of sustained-release tablets, and inability to exert drug efficacy, etc., so as to ensure drug efficacy. , The effect of stable drug effect and reducing dependence

Inactive Publication Date: 2015-12-30
NANJING REAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The existing slow-release preparations with gliclazide as the main component are mainly capsules, and there are fewer sustained-release tablets, and the slow-release stability of the existing slow-release tablets is poor

Method used

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  • Gliclazide sustained release tablets and preparation method thereof
  • Gliclazide sustained release tablets and preparation method thereof
  • Gliclazide sustained release tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-4

[0028] Gliclazide sustained-release tablets were prepared according to the ratio of raw materials in Table 1 below:

[0029] Table 1. Raw material ratio of gliclazide sustained-release tablets

[0030]

[0031] The preparation method of Gliclazide sustained-release tablet:

[0032] 1) Raw material preparation: pass gliclazide, hypromellose, and microcrystalline cellulose through a 80-mesh sieve, and pass magnesium stearate through a 20-mesh sieve for later use; mix 95% ethanol with povidone K 30 Mix evenly to make 5% povidone K by weight 30 Ethanol solution is used as a wetting agent for standby;

[0033] 2) Mixing and granulation: pour gliclazide, hypromellose and microcrystalline cellulose into a wet mixing granulator, dry mix for 5 minutes, then add a wetting agent, and wet mix for 5 minutes to make granules ;

[0034] 3) Drying: Spread the granules prepared in step 2) evenly on a baking tray with a thickness of no more than 2 cm, and send them to a hot air circulati...

Embodiment 5

[0039] According to the dissolution determination method specified in the second appendix XC of "Chinese Pharmacopoeia" in 2010, the gliclazide sustained-release tablets produced in Examples 1-4 were tested respectively, and the test results were shown in Table 2 below:

[0040] Table 2, Example 1-4 Gliclazide Sustained Release Tablets Dissolution Test Data

[0041]

[0042] Carry out accelerated test to Gliclazide Sustained-release Tablet in embodiment 1-4, measure Gliclazide (C 15 h 21 N 3 o 3 S) content, detection data is as follows table 3:

[0043] Table 3, embodiment 1-4 accelerated test detection data

[0044]

[0045]

[0046] Tables 2 and 3 show that the gliclazide sustained-release tablet of the present invention prepared by the present invention has stable components, good sustained-release effect, and can continuously maintain the blood concentration of gliclazide in the body above the effective therapeutic concentration, ensuring long-lasting drug con...

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Abstract

The invention discloses gliclazide sustained release tablets which are prepared from the following components in percentage by weight: 18.75% of gliclazide, 32-36% of hydroxypropyl methylcellulose, 40-50% of microcrystalline cellulose and the balance of magnesium stearate; the invention further discloses a preparation method of gliclazide sustained release tablets. The gliclazide sustained release tablets provided by the invention conform to provisions in the part II of China Pharmacopeia 2010, the components are stable, the slow-release effect is good, and the production cost is low.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a gliclazide sustained-release tablet and a preparation method thereof. Background technique [0002] Diabetes is a group of metabolic diseases characterized by hyperglycemia. Long-term high blood sugar causes chronic damage and dysfunction of various tissues and organs in the human body, especially the eyes, kidneys, heart, blood vessels, and nerves. Gliclazide as an effective drug ingredient for the treatment of non-insulin-dependent diabetes mellitus (type Ⅱ) has been increasingly studied by researchers. [0003] To clinically evaluate the efficacy and safety of gliclazide sustained-release preparations in patients with type 2 diabetes whose blood sugar was poorly controlled by other oral hypoglycemic agents in the past, and to explore the optimal treatment mode for type 2 diabetes. The results showed that after 16 weeks of treatment with Gliclazide Sustained Release Tablet...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/64A61K47/38A61P3/10
Inventor 时文祥于居超相文杰
Owner NANJING REAL PHARMA
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