Oral tablet containing gliclazide and colesevelam hydrochloride and preparation method of oral tablet

A technology of colesevelam hydrochloride and oral tablets, which is applied in the field of medicine, can solve the problems of lack of reach and synergistic effect, and achieve good drug release, reduce the long-term risk of hyperlipidemia, and strong hygroscopicity

Active Publication Date: 2015-04-08
CHENGDU HENGRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Taking the drugs containing gliclazide and colesevelam hydrochloride separately can achieve the purpose of lowering blood sugar and blood lipids respectively, but they cannot exert the synergistic effect of the two drugs, and the effect of 1+1>2 cannot be achieved

Method used

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  • Oral tablet containing gliclazide and colesevelam hydrochloride and preparation method of oral tablet
  • Oral tablet containing gliclazide and colesevelam hydrochloride and preparation method of oral tablet
  • Oral tablet containing gliclazide and colesevelam hydrochloride and preparation method of oral tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] An oral tablet containing gliclazide and colesevelam hydrochloride, which includes an immediate-release layer and a sustained-release layer, and the sustained-release layer is provided with a coating outside;

[0038] In parts by weight, the composition of the quick-release layer is:

[0039] Colesevelam hydrochloride 500 parts,

[0040] Immediate release layer filler 150 parts,

[0041] 20 parts of disintegrant;

[0042] The composition of described sustained-release layer is:

[0043]

[0044] Wherein, the immediate-release layer filler is a composition of 100 parts of microcrystalline cellulose, 30 parts of treated agar, and 20 parts of mannitol;

[0045] The disintegrant is sodium carboxymethyl starch;

[0046] The slow-release layer filler is a composition of 70 parts of microcrystalline cellulose, 30 parts of mannitol, and 10 parts of micropowdered silica gel.

[0047] A kind of preparation method of oral tablet as above, its steps are as follows:

[0048...

Embodiment 2

[0056] An oral tablet containing gliclazide and colesevelam hydrochloride, which includes an immediate-release layer and a sustained-release layer, and the sustained-release layer is provided with a coating outside;

[0057] In parts by weight, the composition of the quick-release layer is:

[0058] Colesevelam hydrochloride 1000 parts,

[0059] Immediate release layer filler 100 parts,

[0060] 40 parts of disintegrant;

[0061] The composition of described sustained-release layer is:

[0062]

[0063] Among them, the quick-release layer filler is 40 parts of microcrystalline cellulose, 30 parts of processed agar, 15 parts of mannitol, 5 parts of micropowder silica gel, and 10 parts of magnesium stearate;

[0064]The disintegrant is a composition of 20 parts of croscarmellose sodium and 20 parts of sodium carboxymethyl starch;

[0065] The slow-release layer filler is 30 parts of microcrystalline cellulose.

[0066] A kind of preparation method of oral tablet as above...

Embodiment 3

[0075] An oral tablet containing gliclazide and colesevelam hydrochloride, which includes an immediate-release layer and a sustained-release layer, and the sustained-release layer is provided with a coating outside;

[0076] In parts by weight, the composition of the quick-release layer is:

[0077] Colesevelam hydrochloride 750 parts,

[0078] Immediate release layer filler 125 parts,

[0079] 30 parts of disintegrant;

[0080] The composition of described sustained-release layer is:

[0081]

[0082] Wherein, the immediate-release layer filler is a composition of 70 parts of lactose, 30 parts of microcrystalline cellulose, and 25 parts of mannitol;

[0083] The disintegrant is a composition of 10 parts of croscarmellose sodium and 20 parts of sodium carboxymethyl starch;

[0084] The slow-release layer filler is a combination of 20 parts of microcrystalline cellulose, 20 parts of treated agar, and 15 parts of mannitol.

[0085] A kind of preparation method of oral ta...

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Abstract

The invention discloses an oral tablet containing gliclazide and colesevelam hydrochloride and a preparation method of the oral tablet. The oral tablet comprises a quick release layer and a slow release layer, wherein a layer of coating is arranged out the slow release layer; the quick release layer comprises the following components in parts by weight: colesevelam hydrochloride, a quick release layer filling agent, and a disintegrating agent; the slow release layer comprises the following components in parts by weight: gliclazide, a slow release layer filling agent, magnesium stearate, hydroxy propyl cellulose and povidone. The preparation method of the oral tablet comprises the following steps: A preparing the quick release layer: screening various components of the quick release layer, mixing evenly, directly tabletting powder, and prepressing or carrying out once compression molding; B preparing the slow release layer; C forming the tablet: wrapping the coating outside the slow release layer, and carrying out compression molding together with the quick release layer. Compared with the prior art, the oral tablet is capable of playing a synergistic effect of medicines, achieves relatively good effects, is applied to correction of metabolic syndrome of patients with diabetes, and is beneficial to reduction of hyperlipidemia long-term risk of the patients with diabetes.

Description

technical field [0001] The invention relates to the field of medicine, in particular to an oral tablet containing gliclazide and colesevelam hydrochloride and a preparation method thereof. Background technique [0002] Gliclazide biguanide hypoglycemic drugs can increase the concentration of insulin by stimulating pancreatic β cells, so as to achieve the purpose of hypoglycemic. Colesevelam hydrochloride, as a non-absorbable polymer lipid-lowering drug, can bind to bile acid in the intestine and significantly reduce the reabsorption of the latter, and the depletion of bile acid will increase the conversion of cholesterol into bile acid. Therefore, colesevelam hydrochloride can be used to reduce the concentration of cholesterol. It can reduce the concentration of low-density cholesterol (LDL-C) by 15%-18%, and increase the concentration of high-density lipoprotein (HDL-C) by 3%. [0003] At present, the medical field has not used colesevelam hydrochloride and gliclazide to p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/785A61K9/24A61P3/10A61P3/06A61K31/64
Inventor 朱德其沈桦
Owner CHENGDU HENGRUI PHARMA
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