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Artemisine solid lipid nano-particles and preparing method thereof

A technology of solid lipid nanometer and artemisinin, which is applied in the field of new pharmaceutical dosage forms and their preparation, can solve the problems of low biological potency, only bioavailability, and allergic reactions of patients.

Inactive Publication Date: 2010-06-16
BEIJING WBL PEKING UNIV BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] Studies have shown that oral administration of artemisinin to animals has a strong first-pass effect, compared with intramuscular injection of its oil suspension, the bioavailability is only 30%, and the biological potency is low
At the same time, since artemisinin and its fat-soluble derivatives are insoluble in water, polyoxyethylene castor oil and absolute ethanol (50:50) should be used as solubilizing carriers when they are used as injection preparations clinically, which has resulted in the release of histamine. Patients with severe allergic reactions and toxic side effects

Method used

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  • Artemisine solid lipid nano-particles and preparing method thereof
  • Artemisine solid lipid nano-particles and preparing method thereof
  • Artemisine solid lipid nano-particles and preparing method thereof

Examples

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Effect test

Embodiment 1

[0077] Weigh 80 g of glyceryl monostearate and place it in a water bath at 75°C until glyceryl monostearate melts. Weigh 5 g of artemisinin, and dissolve artemisinin in glycerol monostearate oil phase. In addition, 8 g of Poloxamer 407 was weighed as an emulsifier and dissolved in water at the same temperature. Mix the oil phase dissolved in artemisinin with the water phase, heat and stir at 500rpm for 20 minutes to form a coarse milk; use a high-pressure milk homogenizer to homogenize the coarse milk 10 times to obtain an ultra-fine emulsion, and quickly cool the ultra-fine emulsion to 2°C to obtain artemisinin solid lipid nanoparticles. The average particle size is about 210nm, see the particle size distribution diagram figure 1 , it can be seen from the figure that the particle size distribution is very narrow.

Embodiment 2

[0079] Weigh 100g of stearic acid, 5g of artemisinin, and 2g of soybean lecithin for injection, put stearic acid and soybean lecithin into a water bath at 73°C until stearic acid and soybean lecithin melt, and then add artemisinin Add and stir to dissolve the artemisinin in the molten stearic acid to form an oil phase. In addition, weigh about 20g of poloxamer F68, dissolve it in water at the same temperature, then mix the oil phase with the water phase, keep the temperature, and stir at 800rpm for about 30 minutes to form a rough milk; ultrasonically treat the thick milk for 10 minutes , and then rapidly cooled to 3°C to obtain artemisinin solid lipid nanoparticles. The average particle size is about 443.5nm, see the particle size distribution diagram figure 2 , it can be seen from the figure that the particle size distribution is very narrow.

Embodiment 3

[0081] Weigh 80 g of glyceryl monostearate and place it in a water bath at 75±5°C until glyceryl monostearate melts. Weigh 5.6 g of artemisinin, and dissolve artemisinin in glycerol monostearate oil phase. In addition, 8 g of Poloxamer 407 was weighed as an emulsifier and dissolved in water at the same temperature. Mix the oil phase in which artemisinin is dissolved with the water phase, heat and stir at 500rpm for 20 minutes to form a rough milk; use a high-speed stirrer to process the thick milk at 10000rpm for 10 minutes, and then use ultrasonic treatment for 10 minutes to obtain Ultrafine emulsion, cooling the ultrafine emulsion to 2°C rapidly to obtain artemisinin solid lipid nanoparticles. The average particle size is about 367.7nm, see the particle size distribution diagram image 3 , it can be seen from the figure that the particle size distribution is very narrow.

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Abstract

The invention discloses artemisine solid lipid nano-particles and a preparing method thereof. The artemisine solid lipid nano-particle is prepared from 100 parts of lipid substrate, 1-10 parts of artemisine and 1-80 parts of emulsifying agent. The preparing method comprises the following steps of: heating the lipid substrate to a fused state, and adding a proper amount of artemisine to dissolve; adding the emulsifying agent into water or oil to dissolve, mixing oil phase in which artemisine is dissolved and oil phase or water phase in which the emulsifying agent is dissolved, emulsifying and cooling to prepare the nano-particles. The nano-particles increase the targeting function of the artemisine on cancer cells, inhibit the growth of the cancer cells, simultaneously reduce the toxic and side effect on the normal cells of human body, and increase the anticancer effect of the artemisine, therefore, an artemisine novel preparation with obvious therapeutic effect and little toxic and side effect is provided.

Description

field of invention [0001] The invention relates to a new drug dosage form and a preparation method thereof, in particular to an artemisinin solid lipid nanoparticle and a preparation method thereof. Background technique [0002] Artemisinin, extracted from the Artemisia annua plant of the Compositae family, is an antimalarial drug developed by Chinese scientists in the 1970s and has been widely used around the world in recent years. Artemisinin is currently the only traditional Chinese medicine whose molecular structure can be described and has a miraculous effect on the treatment of malaria. It is the first traditional Chinese medicine product that is truly recognized worldwide. With the in-depth study of artemisinin and its derivatives, the anticancer effect of artemisinin and its derivatives has been discovered. A large number of experimental studies at home and abroad have shown that artemisinin and its derivatives have the effect on a variety of animal and human tumor c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/127A61K31/365A61K31/366A61P35/00
Inventor 段震文郭树仁钟杰
Owner BEIJING WBL PEKING UNIV BIOTECH
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