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微脂粒不同製程之粒徑與安定性分析

Particle size and Stability analysis of different liposome preparation

摘要


本研究以薄膜水合法/超音波震盪法及超音波震盪法/薄膜擠壓法,製備微脂粒包覆熊果素進行粒徑大小及分布值分析、安定性及安全性評估。實驗結果顯示,微脂粒包覆熊果素製備法以薄膜水合法/超音波震盪法/薄膜擠壓法之粒徑PI值0.24~0.32之間較為均勻;薄膜水合法/超音波震盪法,使用不同尺寸(10 mL/20 mL)樣品瓶震盪,在相同條件下10 mL之平均粒徑較20 mL小,但粒徑PI值較無差異;薄膜水合法/超音波震盪法在20 mL/20℃/40 mins/15W的條件下之微脂粒粒徑為53.84 nm,PdI值為0.28粒徑最小均一性最高;微脂粒包覆熊果素到了第14天其平均粒徑與PI值都有明顯差異;本實驗微脂粒包覆熊果素以10位受測者接受48 hrs之皮膚過敏測試後,證明人體皮膚不會產生過敏紅腫等現象,方可安全使用。

並列摘要


In this study, the stability and safety evaluation of liposome encapsulated arbutin were carried out by thin film hydration method / sonication method and sonication method / film extrusion method. The experimental results show that the particle size of arbutin liposome is more uniform between the PI value of 0.24~0.32. Thin film hydration method /sonication method use different sizes (10 mL / 20 mL) glass bottle shaking, under the same conditions 10 mL bottle of the particle size is smaller than the 20 mL bottle, but the particle size of the PI value is no difference. The particle size was 53.84 nm and the PdI value was 0.28 were the best under thin film hydration method / sonication method of 20 mL / 20 ℃ / 40 mins / 15W. The arbutin liposome revealed a significant difference between the average particle size and the PI value on the 14th day. The arbutin liposme treated with 10 human subjects for 48 hrs of skin allergy test, the human skin does not produce allergic swelling and other phenomena, can be safe to use.

參考文獻


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