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Gliclazide tablet (II) and preparation method thereof

A technology for gliclazide tablets and tablet compression, which is applied in the field of gliclazide tablets and its preparation, and can solve the problems of slow release speed of gliclazide sustained-release tablets, inability to stop taking medicine immediately, delayed drug effect, etc. , to achieve the effect of preventing hypoglycemia side effects, significant effect, and improving compliance

Active Publication Date: 2013-05-01
浙江华润三九众益制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The technical problem to be solved by the present invention is to overcome the fact that the gliclazide dispersible tablets in the prior art need to be taken many times, and the fast absorption of active pharmaceutical ingredients will cause the medicine to reach a very high blood drug concentration in the body in a short time, which is extremely serious. It is easy to cause hypoglycemia, or the release rate of gliclazide sustained-release tablets is slow and the drug effect is delayed after drug withdrawal, and once hypoglycemia occurs, it cannot be solved by stopping the drug immediately. The blood concentration of gliclazide in the body maintains an appropriate concentration for a long time, is not easy to cause hypoglycemia, greatly improves the compliance of taking medicine, and the gliclazide tablet (II) with moderate frequency of taking medicine and its preparation method

Method used

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  • Gliclazide tablet (II) and preparation method thereof
  • Gliclazide tablet (II) and preparation method thereof
  • Gliclazide tablet (II) and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0030] components mg / tablet Grecht 40 Hydroxypropyl Methyl Cellulose (K15M) 10 Sodium carboxymethyl starch 5 starch 42 PVP K30 2 Magnesium stearate 1 total weight 100

[0031] Preparation method: sieve gliclazide, hydroxypropyl methylcellulose, sodium carboxymethyl starch, and starch respectively, dry mix for 10 minutes, add the binder povidone ethanol solution to make a soft material, granulate, and dry , granulated, added with magnesium stearate, mixed evenly, compressed into tablets, ready to be obtained.

[0032] The Gliclazide Tablets (II) prepared in this example were tested for drug release according to the method of Gliclazide Tablets (II) recorded in Part II of the Chinese Pharmacopoeia 2010 Edition, and the results were recorded in the following table:

[0033] time (hours) Cumulative percent of drug released 1 41.4％ 2 64.7％ 3 79.3％ 4 87.8％ 5 ...

Embodiment 2

[0035] components mg / tablet Grecht 40 Hydroxypropyl Methyl Cellulose (K15M) 5 Sodium carboxymethyl starch 4 pregelatinized starch 40 microcrystalline cellulose 10 Magnesium stearate 1 total weight 100

[0036] Preparation method: sieve gliclazide, hydroxypropyl methylcellulose, sodium carboxymethyl starch, pregelatinized starch and microcrystalline cellulose respectively, dry mix for 20 minutes, add magnesium stearate and mix evenly, directly Tablets, ready to use.

[0037]The gliclazide tablet (II) prepared by the present embodiment is carried out drug release assay as described in Example 1:

[0038] time (hours) Cumulative percent of drug released 1 38.5％ 2 67.2％ 3 82.1％ 4 89.4％ 5 95.3％ 6 99.5％

Embodiment 3

[0040]

[0041] Preparation method: sieve gliclazide, hydroxypropyl methylcellulose, sodium carboxymethyl starch and dextrin respectively, dry mix for 10 minutes, add binder povidone ethanol solution to make soft material, granulate, Dried, granulated, added magnesium stearate, mixed evenly, compressed into tablets, and obtained.

[0042] The gliclazide tablet (II) prepared by the present embodiment is carried out drug release assay as described in Example 1:

[0043] time (hours) Cumulative percent of drug released 1 40.8％ 2 68.1％ 3 83.0％ 4 89.2％ 5 94.9％ 6 100.4％

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Abstract

The invention discloses a gliclazide tablet (II) and a preparation method thereof; the formula of the gliclazide tablet (II) contains 30-60% of gliclazide, 30-60% of filler, 1-10% of release regulator and 2-20% of framework material, wherein the percent is the mass percent of various components in the total weight of the gliclazide tablet (II); the filler is one or more of mannitol, sorbierite, xylitol, lactose, cane sugar, glucose, starch, dextrin, pre-gelatinized starch and microcrystalline cellulose; the release regulator is one or more of sodium carboxymethyl starch, crospovidone, hydroxypropyl cellulose and microcrystalline cellulose; the framework material is one or more of hydroxypropyl methyl cellulose, ethyecellulose, Carbomer, algin and stearic acid; and the gliclazide tablet (II) further contains lubricant. After the gliclazide tablet (II) is taken, the itnernal gliclazide blood concentration is kept properly for a long time; hypoglycaemia is difficult to result; the medicine taking compliance is greatly increased; and the medicine taking time is proper.

Description

technical field [0001] The invention relates to a gliclazide tablet (II) and a preparation method thereof. Background technique [0002] Gliclazide is currently a relatively commonly used product on the market for the treatment of type 2 diabetes, and it also has the effect of preventing vascular complications. [0003] In order to quickly control blood sugar, Xu Jun et al. developed Gliclazide Dispersible Tablets (Shi Zhen Guoyi Guoyao, 2007, 18(11): 2671-2672), which can quickly disintegrate into Uniform viscous suspension has the characteristics of convenient administration, fast absorption, and high bioavailability. Also because it can quickly disintegrate into a uniform viscous suspension and absorb quickly, it also causes the drug to be released in a short period of time. The body reaches a very high blood concentration, and it is very easy to cause hypoglycemia. In addition, it also has the disadvantage of taking more times (generally three times a day) every day. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/64A61K47/38A61K47/36A61K47/32A61P3/10A61P9/00
Inventor 朱菊红金鑫周旭早王旦
Owner 浙江华润三九众益制药有限公司
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