Policosanol-containing solid dispersion, controlled release tablet and preparation method thereof

A solid dispersion and policosanol technology, which is applied in the field of policosanol preparations, can solve the problems of low patient compliance, achieve the effects of prolonging the release time, improving dispersion and solubility, and reducing the frequency of administration

Active Publication Date: 2022-02-18
湖北中古生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Currently, existing tablets usually need to be taken twice a day, resulting in low patient compliance

Method used

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  • Policosanol-containing solid dispersion, controlled release tablet and preparation method thereof
  • Policosanol-containing solid dispersion, controlled release tablet and preparation method thereof
  • Policosanol-containing solid dispersion, controlled release tablet and preparation method thereof

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preparation example Construction

[0045] Some embodiments of the present invention provide a method for preparing a controlled-release tablet containing policosanol as described above, comprising the following steps:

[0046] mixing policosanol, surfactant, carrier material, binder and solvent to obtain a drug-containing solution; the drug-containing solution, filler and lubricant are wet granulated to obtain drug-containing layer particles;

[0047] Provide booster layer particles and coating material solutions respectively;

[0048] Compressing the drug-containing layer granules and the booster layer granules to obtain a double-layer tablet core;

[0049] The double-layer tablet core is coated with the coating material solution, and then punched to obtain a controlled-release tablet containing policosanol.

[0050] Wherein, the specific types and dosages of the active ingredients of the drug and each auxiliary material are as described in the previous prescription. In a specific embodiment of the present i...

Embodiment 1

[0069] Tablet core drug-containing layer prescription:

[0070]

[0071]

[0072] Preparation process of drug-containing layer granules:

[0073] (1) Weigh the prescribed amount of soybean lecithin and polyethylene glycol 6000, respectively add them into the prescribed amount of acetone under stirring, disperse evenly and slowly raise the temperature to 50°C.

[0074] (2) Weigh the prescribed amount of policosanol, add it into the solution in (1) under stirring, and keep stirring until the policosanol dissolves to obtain a drug-containing solution.

[0075] (3) Continue heating the drug-containing solution in (2) to obtain a light yellow solid after the acetone volatilizes. After the solid is pulverized at low temperature, pass through a 100-mesh sieve.

[0076] (4) Weighing the prescribed amount of polyvinylpyrrolidone, adding it to the prescribed amount of ethanol, stirring and dissolving to obtain a binder solution.

[0077] (5) Weigh the lactose and polyoxyethylene...

Embodiment 2

[0094] Tablet core drug-containing layer prescription:

[0095]

[0096]

[0097] Preparation process of drug-containing layer granules:

[0098] (1) Weigh the prescribed amount of sucrose ester, polyethylene glycol and polyvinylpyrrolidone, respectively add them to the prescribed amount of ethanol under stirring, disperse evenly and slowly heat up to 70°C.

[0099] (2) Weigh the prescribed amount of policosanol, add it into the solution in (1) under stirring, and keep stirring until the policosanol dissolves to obtain a drug-containing solution.

[0100] (3) Take the sodium chloride and polyoxyethylene of prescription quantity, place in the fluidized bed granulator and mix. Add the solution in (2) into a fluidized bed granulator for granulation.

[0101] (4) Dry the granulated granules to obtain dry granules, add the prescribed amount of lubricant for mixing, and obtain drug-containing layer granules for future use.

[0102] Tablet Booster Layer Prescription:

[010...

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Abstract

The invention relates to the technical field of policosanol preparations, and provides a policosanol-containing solid dispersion, the policosanol-containing solid dispersion comprises policosanol, a surfactant and a carrier, and the surfactant is a nonionic surfactant used for auxiliary dispersion; the particle size of the solid dispersion is not greater than 5 microns. The invention provides a controlled-release tablet containing policosanol and a preparation method of the controlled-release tablet. The tablet comprises a double-layer tablet core and a controlled-release film layer wrapping the double-layer tablet core; the double-layer tablet core is composed of a drug-containing layer and a boosting layer; the drug-containing layer comprises policosanol, a surfactant, a filler, a carrier, an adhesive and a lubricant; the content of policosanol in each controlled-release tablet is more than or equal to 5mg. The particle size of policosanol in the drug can be greatly reduced, the dispersity and solubility of policosanol can be improved, the release rate of policosanol can be controlled, the release time and the medicine taking interval can be prolonged, and then the bioavailability of policosanol in a human body and the medicine taking compliance of policosanol can be improved.

Description

technical field [0001] The invention relates to the technical field of policosanol preparations, in particular to a solid dispersion containing policosanol, a controlled-release tablet and a preparation method thereof. Background technique [0002] Policosanol is a mixture of eight higher fatty alcohols, including octacosanol, which is extracted from cane wax. Through animal experiments, it was found that policosanol can reduce the serum cholesterol and low-density lipoprotein (LDL-C) levels of normal and endogenous hypercholesterolemic animals. Studies in various animal models have shown that policosanol can lower cholesterol in the liver, adipose tissue, and heart. The active ingredient drug has almost no acute toxicity when taken orally, and no genotoxicity, reproductive toxicity and carcinogenicity have been seen. [0003] Policosanol tablets were first developed by Cuba Dalma Laboratories Co., Ltd., and were approved by the Cuban Food and Drug Administration in 1991 t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/045A61K47/26A61K47/24A61K47/14A61P3/06
CPCA61K9/2866A61K9/2086A61K9/2013A61K9/2018A61K9/2031A61K31/045A61P3/06
Inventor 陶安进袁建成蔡磊
Owner 湖北中古生物制药有限公司
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