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Glipizide solid dispersion and preparation method thereof, glipizide solid dispersion tablet containing glipizide solid dispersion and preparation method thereof

A technology of solid dispersion and glipizide, which is applied in the direction of medical preparations of non-active ingredients, pharmaceutical formulas, active ingredients of sulfonylurea, etc., can solve the difficulties of large-scale production, poor stability of solid dispersions, grinding methods, etc. Low efficiency and other issues, to achieve the effects of no time-consuming cost, increased solubility and stability, and high Gibbs free energy

Pending Publication Date: 2021-03-23
NINGXIA MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among them, the solid dispersion prepared by the melting method has poor stability, the grinding method has low efficiency, and it is difficult to realize large-scale production, while the solvent evaporation method avoids high heat and the preparation process is simple.

Method used

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  • Glipizide solid dispersion and preparation method thereof, glipizide solid dispersion tablet containing glipizide solid dispersion and preparation method thereof
  • Glipizide solid dispersion and preparation method thereof, glipizide solid dispersion tablet containing glipizide solid dispersion and preparation method thereof
  • Glipizide solid dispersion and preparation method thereof, glipizide solid dispersion tablet containing glipizide solid dispersion and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] The preparation method of Example 1 includes the following steps:

[0068] (1) Weigh the raw material according to the formulation of the gyridazine solid dispersion described above, placing the Glielpyrazine, a unit carrier, and the binary vector to the beaker, resulting in a mixture, spare;

[0069] (2) Pour the solvent into the beaker of the mixture into the temperature of 20 ° C, the power is 40 kHz, and the power is stirred at a rate of 120 r / min; in the temperature of 55 ° C, the rotational speed is 80 rpm, rotation 40min The solid matter is obtained; wherein the solvent is mixed by a volume ratio of dichloromethane and methanol to obtain a mass of 1: 1 of the solvent is 6 times that of the total mass of the 1-membered vector and the binary vector.

[0070] (3) The solid material was placed in a vacuum drying tank at 25 ° C for 24 h, pulverized, 60 mesh sieve to obtain a gyropyrazine solid dispersion.

Embodiment 3

[0071] The preparation method of Example 3: Unlike Example 1, step (2) is: pouring the solvent into the beaker in the mixture at a temperature of 35 ° C, the power is 40 kHz, and the speed is 140 r / min. Ultrasound was stirred for 2 min; rotating at a temperature of 55 ° C, the rotation speed was 65 rpm, and the solid material was evaporated, to obtain a solid material; wherein the solvent was mixed by a volume ratio of dichloromethane and methanol. The volume of the solvent was Glops Zhenzine, one dollar carrier and the total mass of the binary vector.

[0072] Example 2, 4, 5, 6: Unlike Example 1, the step (2) is: pouring the solvent in a beaker in the mixture at a temperature of 25 ° C, the power is 40 kHz, and the speed is Ultrasound was stirred at 130R / min for 4 min; the temperature was stirred at a temperature of 50 ° C and a rotational speed of 70 rpm, and the solid material was obtained; wherein the solvent was mixed by a volume ratio of dichloromethane and methanol; so...

Embodiment 34

[0114] Example 34 Gullirazine solid dispersion sheet, Glielpyrazine (raw material pill) and the reference preparation Manduibao dissolution under pH 6.0. The results show that the Gullirazine solid dispersion has increased the dissolution of the raw material tablets; and the reference preparation Mandi Bao compared to F2 factor> 50, the dissolution has similarity (see Figure 9 ).

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Abstract

The invention discloses a glipizide solid dispersion and a preparation method thereof, a glipizide solid dispersion tablet containing the glipizide solid dispersion and a preparation method thereof. The glipizide solid dispersion is prepared from glipizide, a unitary carrier and a binary carrier. The preparation method comprises the following steps of: weighing raw materials, and mixing to obtaina mixture; pouring a solvent into the mixture, performing ultrasonic stirring, and performing rotary evaporation to obtain a solid substance; and drying the solid substance, crushing, and sieving to obtain the glipizide solid dispersion. The preparation method of the glipizide solid dispersion tablet comprises the following steps of: weighing raw materials; premixing the glipizide solid dispersion, a filling agent, a disintegrating agent and a flow aid; and then adding a lubricating agent, mixing and stirring, and tabletting to obtain the glipizide solid dispersion tablet. The glipizide soliddispersion tablet prepared from the glipizide solid dispersion can improve the solubility of a medicine, and can also improve the stability and bioavailability.

Description

Technical field [0001] The present invention relates to the technical field of pharmaceutical preparations, and more particularly to a genirazine solid dispersion and a preparation method and a gyridine solid dispersion sheet comprising therethrough. Background technique [0002] Glipizide, the chemical name is 5-methyl-N- [2- [4 [[(cyclohexyl) carbonyl] amino] sulfonyl] phenyl] ethyl] -pyrazine formamide, The molecular formula of Glithine is c 21 Hide 27 N 5 O 4 S, the molecular weight is 445.54, which has the chemical structure: [0003] [0004] Glipizide is a second-generation sulfonylurea oral hypoglycemic drug, which is a first-line treatment of non-insulin-dependent diabetes. The main mechanism is to specifically bind to the sulfonylurea receptor on the β-cell membrane. K + Channel is closed, causing membrane potential changes, CA 2+ Channel opening, cytotracic CA 2+ Increased insulin secretion. Glithine can effectively reduce blood glucose concentration and maintain its...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K47/10A61K47/18A61K47/32A61K47/34A61K9/20A61K47/36A61K47/26A61K47/38A61K47/12A61K47/04A61K31/64A61P3/10
CPCA61K9/146A61K9/145A61K9/2095A61K9/2027A61K9/2031A61K9/2059A61K9/2018A61K9/2054A61K9/2013A61K9/2009A61K31/64A61P3/10
Inventor 刘艳华于双雨毕嘉威刘金霞杨嘉玉朱溶月刘璐
Owner NINGXIA MEDICAL UNIV
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