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Pharmaceutical composition containing pravastatin sodium fenofibrate liposome and preparation method thereof

A technology of pravastatin sodium and fenofibrate, applied in the pharmaceutical composition containing pravastatin sodium fenofibrate liposome and its preparation field, can solve the problem of low bioavailability and easy formation of fenofibrate Problems such as lactone and low bioavailability

Inactive Publication Date: 2017-09-15
海南欣莱医药科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0026] The problem to be solved by the present invention is to overcome the defects of the prior art and provide a pharmaceutical composition comprising pravastatin sodium fenofibrate liposomes and a preparation method thereof, in order to solve the stability of pravastatin sodium in gastric acid problem, low bioavailability problem, and easy to form lactone problem when heated, and also solves the problem of low bioavailability of fenofibrate, providing a stable composition with low level of impurities and / or degradation products, said Impurities and / or degradation may occur during the preparation and / or subsequent storage of the composition

Method used

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  • Pharmaceutical composition containing pravastatin sodium fenofibrate liposome and preparation method thereof
  • Pharmaceutical composition containing pravastatin sodium fenofibrate liposome and preparation method thereof
  • Pharmaceutical composition containing pravastatin sodium fenofibrate liposome and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0097] Embodiment 1: Preparation of pravastatin sodium fenofibrate liposome

[0098] Name of raw material

Dose 1 (mg)

Dose 2 (mg)

Dose 3 (mg)

Dose 4(mg)

Pravastatin Sodium

40.00

40.00

40.00

40.00

Fenofibrate

40.00

80.00

160.00

320.00

Hydrogenated Soy Lecithin

100.00

100.00

100.00

100.00

Hydrogenated egg yolk lecithin

100.00

100.00

100.00

100.00

cholesterol

200.00

200.00

200.00

200.00

total

480.00

520.00

600.00

760.00

[0099] Preparation:

[0100] (1) Dissolve 1 part of pravastatin sodium, 1-8 parts of fenofibrate, 2.5 parts of hydrogenated soybean lecithin, 2.5 parts of hydrogenated egg yolk lecithin, and 5 parts of cholesterol in 25 parts of absolute ethanol, mix well, and record volume, filtered, evaporated to remove absolute ethanol to prepare phospholipid film, and dried in vacuum;

[0101] (2) Add a phosphate buffer solution wit...

Embodiment 2

[0103] Embodiment 2: Preparation of pravastatin sodium fenofibrate liposome

[0104] Name of raw material

Dose 1 (mg)

Dose 2 (mg)

Dose 3 (mg)

Dose 4(mg)

Pravastatin Sodium

40.00

40.00

40.00

40.00

Fenofibrate

40.00

80.00

160.00

320.00

Hydrogenated Soy Lecithin

140.00

140.00

140.00

140.00

Hydrogenated egg yolk lecithin

140.00

140.00

140.00

140.00

cholesterol

280.00

280.00

280.00

280.00

total

640.00

680.00

760.00

920.00

[0105] Preparation:

[0106] (1) Dissolve 1 part of pravastatin sodium, 1-8 parts of fenofibrate, 3.5 parts of hydrogenated soybean lecithin, 3.5 parts of hydrogenated egg yolk lecithin, and 7 parts of cholesterol in 30 parts of absolute ethanol, mix well, Record the volume, filter, evaporate and remove absolute ethanol to prepare a phospholipid film, and dry it in vacuum;

[0107] (2) Add a phosphate buffer with a pH v...

Embodiment 3

[0109] Embodiment 3: the preparation of pravastatin sodium fenofibrate liposome

[0110]

[0111]

[0112] Preparation:

[0113] (1) Dissolve 1 part of pravastatin sodium, 2-16 parts of fenofibrate, 1-8 parts of hydrogenated soybean lecithin, 1-8 parts of hydrogenated egg yolk lecithin, and 2-16 parts of cholesterol in 20 parts of absolute ethanol In, mix evenly, record the volume, filter, evaporate and remove absolute ethanol to prepare a phospholipid film, and vacuum dry;

[0114] (2) Add phosphate buffer with a pH value of 7.6, soak for 1.5 hours, stir at high speed, and after 10 minutes, slowly add povidone K30 dissolved in the same phosphate buffer with a concentration of 0.50 mg / ml dropwise solution, and make up the buffer to the original volume;

[0115] (3) Filtrate the liposome suspension with a microporous membrane with a diameter of 0.8 μm, and freeze-dry the obtained filtrate to obtain pravastatin sodium fenofibrate liposomes.

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Abstract

The invention relates to a medicine composition containing a pravastatin sodium fenofibrate liposome and a preparation method of the medicine composition. The medicine composition comprises a pravastatin sodium fenofibrate liposome and at least one pharmaceutically acceptable vector, wherein the pravastatin sodium fenofibrate liposome comprises pravastatin sodium, fenofibrate, phospholipid and cholesterol. The medicine composition prepared by the pravastatin sodium fenofibrate liposome not only satisfies the requirements of Chinese Pharmacopoeia and has the advantages of faster dissolution, faster medicine efficacy, high bioavailability, good stability as well as worth of being widely promoted and applied when being compared with the common pravastatin sodium fenofibrate medicine composition.

Description

technical field [0001] The invention relates to a pharmaceutical composition comprising pravastatin sodium fenofibrate liposome and a preparation method thereof, wherein the pharmaceutical composition is composed of pravastatin sodium fenofibrate liposome and at least one pharmaceutical The above-mentioned carrier is acceptable, wherein the pravastatin sodium fenofibrate liposome is composed of pravastatin sodium, fenofibrate, phospholipid and cholesterol, and belongs to the technical field of medicine. Background technique [0002] Cardiovascular disease has become the first cause of death in urban and rural populations in my country. Cardiovascular disease in China is characterized by a high incidence of stroke and a low incidence of coronary heart disease. However, the incidence and mortality of coronary heart disease have gradually increased in the past 20 years; In large cities with rapid economic development, such as Beijing, the monitoring results show that the inciden...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/127A61K9/48A61K31/22A61K31/366A61K47/32A61K47/26A61K47/20A61P3/06A61K31/216
Inventor 邝少轶张丽林学良
Owner 海南欣莱医药科技股份有限公司
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