Ezetimibe, simvastatin and nicotinic acid compound preparation and preparation method of ezetimibe, simvastatin and nicotinic acid compound preparation

A technology of ezetimibe and compound preparations, which is applied in the field of pharmaceutical preparations to achieve the effects of improving stability, simple operation, and convenient large-scale production

Inactive Publication Date: 2013-08-14
LIAONING YILING KECHUANG BIOLOGICAL MEDICAL TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, hypertensive patients are seldom able to insist on ...

Method used

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  • Ezetimibe, simvastatin and nicotinic acid compound preparation and preparation method of ezetimibe, simvastatin and nicotinic acid compound preparation
  • Ezetimibe, simvastatin and nicotinic acid compound preparation and preparation method of ezetimibe, simvastatin and nicotinic acid compound preparation
  • Ezetimibe, simvastatin and nicotinic acid compound preparation and preparation method of ezetimibe, simvastatin and nicotinic acid compound preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Example 1 : Niacin / ezetimibe / simvastatin composition

[0050] In this implementation, ezetimibe was fully mixed with Kollidon VA64, a well-water-soluble carrier, to prepare a physical mixture, which was extruded through a twin-screw hot-melt extruder (Coperion KEYATE-20). The physical mixture was first put into the feeding In the feeder, it is sent to the heater area through the double helix rotation, and the physical mixture is extruded by the high mechanical force of the double helix and the temperature in the heater area, and the extruded item (glassy shape, relatively brittle) cools down Grind it into powder with a grinder at room temperature, and pass through a 100-mesh sieve. There are four temperature options in the heater zone: respectively set to Zone1 = 120 °C, Zone2 = 130 °C, Zone3 = 130 °C, Zone4 = 130 °C; the feeding speed and twin-screw extrusion speed are set to 2Hz.

[0051] In this implementation, the tablet core was prepared by mixing niacin with cor...

Embodiment 2

[0065] Example 2 Niacin / Ezetimibe / Simvastatin Composition

[0066] Table 6 Prescription quantity

[0067]

[0068] The preparation process of embodiment 2 refers to embodiment 1.

Embodiment 3

[0070] Table 7 Prescription amount

[0071]

[0072] The preparation process of embodiment 3 refers to embodiment 1.

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Abstract

The invention belongs to the field of pharmaceutical preparations and particularly relates to a compound preparation which takes ezetimibe, simvastatin and nicotinic acid as effective components and has the effects of reducing blood pressure and blood lipid and a preparation method of the compound preparation. The compound preparation is a sustained release tablet. Aiming at the problems of poor water solubility of the ezetimibe, unstability of the simvastatin to acid and oxygen, and the like, the preparation method of the compound preparation adopts a melt extrusion technology for improving the dissolution rate of the ezetimibe, and adopts a cladding membrane technology for enhancing the stability of the simvastatin in a body so as to give full play to the efficacy of all components of the compound preparation and have the best synergy effect. The specific process comprises the steps of preparing the nicotinic acid into a tablet core as a sustained release part, spraying an isolating layer on the tablet core, then spraying the simvastatin and the ezetimibe on an outer layer of the sustained release part as a quick release layer, and then carrying out film coating on the quick release layer. The compound preparation provided by the invention is mainly applied to the treatment or prevention of diseases and indications associated with heart and cerebral vessels.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a compound preparation with ezetimibe, simvastatin and niacin as active ingredients and has blood pressure and lipid-lowering effects. Background technique [0002] Cardiovascular and cerebrovascular diseases are the main factors that threaten human life in the 21st century, and the death of cardiovascular and cerebrovascular diseases accounts for 40.8% of the deaths from chronic diseases in my country. Cardiovascular and cerebrovascular diseases are essentially vascular diseases. [0003] Clinical studies have shown that elevated levels of total cholesterol, low-density lipoprotein (LDL), and apolipoprotein can lead to atherosclerosis in humans. In addition, decreased levels of high-density lipoprotein (HDL) can also lead to atherosclerosis. Epidemiological studies have shown that the morbidity and mortality of cardiovascular diseases are directly proport...

Claims

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Application Information

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IPC IPC(8): A61K31/455A61K31/397A61K31/366A61K9/24A61P3/06A61P9/00A61P9/12A61P3/10A61P9/10
Inventor 关屹闫冬
Owner LIAONING YILING KECHUANG BIOLOGICAL MEDICAL TECH
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