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Ezetimibe and simvastatin preparation

A technology of simvastatin and ezetimibe, applied in the field of pharmaceutical preparations, can solve the problems of complex degradation process and unstable active ingredients, and achieve the effects of reducing oxidation reaction, enhancing antioxidant effect and protecting stability

Inactive Publication Date: 2017-07-11
CHONGQING HUAPONT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The high-temperature oxidative degradation process of simvastatin is complicated. In addition to the main degradation impurities, there are many other oxidative degradation impurities. Therefore, the active ingredients of ezetimibe and simvastatin preparations are unstable.

Method used

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  • Ezetimibe and simvastatin preparation
  • Ezetimibe and simvastatin preparation
  • Ezetimibe and simvastatin preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Embodiment 1 The preparation of ezetimibe and simvastatin

[0035] (1) Raw material ratio:

[0036]

[0037] (2) Preparation method:

[0038] Add tert-butyl-4-hydroxyanisole, propyl gallate, and DL-tartaric acid into a certain proportion of alcohol aqueous solution to make a wetting agent. Mix ezetimibe, simvastatin, lactose, microcrystalline cellulose, and croscarmellose sodium evenly, add wetting agent to granulate, dry, then add magnesium stearate, mix evenly, and press into tablets .

Embodiment 2

[0040] (1) Raw material ratio:

[0041]

[0042] (2) Preparation method:

[0043] Add tert-butyl-4-hydroxyanisole, propyl gallate, and DL-tartaric acid into a certain proportion of alcohol aqueous solution to make a wetting agent. Mix ezetimibe, simvastatin, lactose, microcrystalline cellulose, and croscarmellose sodium evenly, add wetting agent to granulate, dry, then add magnesium stearate, mix evenly, and press into tablets .

Embodiment 3

[0045] (1) Raw material ratio:

[0046]

[0047] (2) Preparation method:

[0048] Add tert-butyl-4-hydroxyanisole, propyl gallate, and DL-tartaric acid into a certain proportion of alcohol aqueous solution to make a wetting agent. After mixing ezetimibe, simvastatin, lactose, microcrystalline cellulose and croscarmellose sodium evenly, adding a wetting agent to granulate, and drying. Then add magnesium stearate, mix evenly and compress into tablets.

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PUM

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Abstract

The invention belongs to the field of medicinal preparations, and especially relates to a medicinal preparation containing ezetimibe and simvastatin drug effect components. The ezetimibe and simvastatin preparation comprises an effective dosage of ezetimibe, an effective dosage of simvastatin, a composite antioxidant and pharmaceutically acceptable auxiliary materials; and the composite antioxidant comprises t-butyl-4-hydroxyanisole, propyl gallate and DL-tartaric acid. The active components of the preparation are ezetimibe and simvastatin, and have synergistic effects when used for preventing and treating hyperlipidemia and atherosclerotic; and the composite antioxidant is added to effectively and greatly enhance the oxidation resistance, so the product preparation with good stability is finally prepared.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to pharmaceutical preparations containing ezetimibe and simvastatin medicinal ingredients. Background technique [0002] Hyperlipidemia refers to excessive blood lipid levels, which is one of the main causes of coronary heart disease and stroke, and can directly cause some diseases that seriously endanger human health, such as atherosclerosis, coronary heart disease, pancreatitis, etc. With the improvement of living standards and the aging of my country's population, there are more and more people suffering from hyperlipidemia. [0003] Regarding the diagnostic criteria of hyperlipidemia, there is no unified method both internationally and domestically. In the past, it was considered that the plasma total cholesterol concentration> 5.17mmol / L (200mg / dl) could be defined as hypercholesterolemia, and the plasma triacylglycerol concentration> 2.3mmol / L (200mg / dl) was r...

Claims

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Application Information

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IPC IPC(8): A61K31/397A61K31/366A61K9/20A61K47/14A61K47/12A61K47/10
CPCA61K31/397A61K9/2013A61K9/2018A61K9/2054A61K31/366A61K47/10A61K47/12A61K47/14A61K2300/00
Inventor 李倩黄龙梅刘春芝
Owner CHONGQING HUAPONT PHARMA
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