Glipizide controlled release composition as well as preparation method thereof

A technology of glipizide and composition, applied in the field of glipizide controlled-release composition and its preparation, can solve problems such as organic solvent residues, avoid residues, reduce the probability of unqualified tablets, and be simple and easy to operate control effect

Active Publication Date: 2014-02-12
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The inventors of the present invention have conducted a large number of long-term experiments and found that the drug-containing layer uses polyoxyethylene to spray glipizide aqueous suspension in a fluidized state to granulate, and the booster layer uses polyoxyethylene to spray and granulate in a fluidized state. Suspension, sodium chloride aqueous solution and binder aqueous solution granulation overcomes the problem of viscous swelling when polyoxyethylene granules encounter water, solves the problem of mixing uniformity, and overcomes the problem of organic solvent residue at the same time

Method used

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  • Glipizide controlled release composition as well as preparation method thereof
  • Glipizide controlled release composition as well as preparation method thereof
  • Glipizide controlled release composition as well as preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] The preparation of the booster layer, the specific prescription components are as follows.

[0045]

[0046] i) Preparation of solutions and suspensions for granulation

[0047] ① Preparation of granulation suspension: Weigh purified water, add a small amount of binder (sodium carboxymethyl cellulose, hypromellose, hydroxypropyl cellulose, polyoxyethylene) while stirring, and stir until viscous The mixture is completely swollen, then add the prescribed amount of iron oxide red, stir to make the iron oxide red completely mix to form a suspension, pass through a 100-mesh sieve, then add normal temperature purified water, stir and mix, and set aside;

[0048] ② Preparation of binder solution: Weigh purified water, add remaining binder (sodium carboxymethyl cellulose, hypromellose, hydroxypropyl cellulose, polyoxyethylene) to the prescribed amount while stirring, and stir Until the adhesive is completely swollen, set aside;

[0049] ③ Preparation of sodium chloride sol...

Embodiment 2

[0057] The preparation of the drug-containing layer, the specific prescription components are as follows.

[0058]

[0059] i) Preparation of suspension for granulation

[0060] ① Preparation of binder solution: Weigh purified water, add the prescribed amount of binder (sodium carboxymethylcellulose, hypromellose, hydroxypropyl cellulose) while stirring, and stir until the binder is completely dissolved. up, spare;

[0061] ② Weigh the prescribed amount of adhesive solution in ①, and add the prescribed amount of glipizide to form a suspension while stirring. The suspension is homogenized under high pressure until the particle size of glipizide is less than 10 μm, and set aside;

[0062] ii) Weigh the prescription amount of polyoxyethylene and add it to the fluidized bed granulator, preheating;

[0063] iii) top spray granulation;

[0064] iv) After stopping the liquid spraying, dry, and the particles pass through a 24-mesh sieve;

[0065] v) Add the prescribed amount o...

Embodiment 3

[0082] Embodiment 3 Tablet comparative investigation

[0083] The granules in the prescription B of Example 1 and the prescription b of Example 2 and the mixed powders in Comparative Example 1 and Comparative Example 2 were selected respectively, and the same double-layer tablet press was used to compress the double-layer tablet with the same parameters, and the results are shown in the following table shown.

[0084] Numbering booster layer Drug-containing layer result Ⅰ Embodiment 1 prescription B Embodiment 2 prescription b There is no mixture of two layers of color, and almost no flower flakes are found. Ⅱ Comparative example 1 Comparative example 2 The colors are mixed, and the flower flakes are obvious. Ⅲ Comparative example 1 Embodiment 2 prescription b There are red spots and plaques on the surface of the white layer. Ⅳ Embodiment 1 prescription B Comparative example 2 There are white spots on the surface of the ...

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Abstract

The invention relates to a glipizide controlled release composition which consists of a double-layer tablet core and a semipermeable membrane controlled release coating membrane. The double-layer tablet core consists of a medicine containing layer and a boosting layer, wherein the medicine containing layer and the boosting layer of the composition are pelletized by a water suspension. The invention further relates to a preparation method of the glipizide controlled release composition. The preparation method comprises the following steps: pelletizing the medicine containing layer; pelletizing the boosting layer; preparing the double-layer tablet core; coating; and punching, wherein the medicine containing layer and the boosting layer are pelletized by the water suspension. The glipizide controlled release composition prepared by the preparation method provided by the invention is uniform in particle distribution, good in tabletting and forming effect, uniform in content, low in residual rate of organic solvents and good in dissolving out effect. The preparation method is simple and feasible and is favorable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a glipizide composition and a preparation method thereof, in particular to a glipizide controlled-release composition and a preparation method thereof. Background technique [0002] Glipizide is an oral hypoglycemic drug of the sulfonylurea class, which achieves its rapid hypoglycemic effect by stimulating the pancreas to secrete insulin. The effect depends on the function of islet β cells, and the extrapancreatic effect also plays a part in the mechanism of action of sulfonylurea oral hypoglycemic drugs. The extrapancreatic effect of increasing insulin sensitivity and reducing hepatic glucose production plays a role in the mechanism of action of glipizide more important in. After taking ordinary glipizide tablets, the blood sugar fluctuates greatly, and hypoglycemia is occasionally reported, and the patients take the medicine many times a day, and the compliance is poor. Contro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/44A61K8/28A61K9/24A61K31/64A61K9/28A61K47/38A61P3/10
Inventor 张志宏陈勇军刘亚英陈少华池晓雷耿佳
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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