当归提取物软膏剂的工艺处方研究

Study on ointment formulation design of extracts from Radix angelicae sinensis

中药当归提取物的有效成分中包括丰富的黄酮类物质,经皮给药后具有清除表皮细胞自由基、抗细胞衰老等生物活性。针对上述特点,将当归提取物制备成油包水(W/O)型软膏剂,并对相关处方工艺进行了筛选,以期得到性质稳定、肤感良好的制剂。首先通过超声提取法提取当归中的黄酮类组分,并将其浓缩制备成提取物浸膏;然后,以外观均一性、涂抹延展性、离心稳定性及耐寒耐热性的综合评分作为考察指标,对油相比例、乳化剂及辅助乳化剂的处方剂量进行正交设计以筛选出软膏剂的最优处方。本软膏剂的处方中以羊毛脂-凡士林-硬脂酸(质量比例为1∶3∶4)作为复合油相,Span-60作为乳化剂,Tween-80作为辅助乳化剂,优选处方下,复合油相、Span-60以及Tween-80的质量比例分别为35.0%、4.0%以及4.5%,制备得到的油包水(W/O)型软膏剂稳定性良好,为后期进一步应用奠定了基础。

Flavonoid ingredients are abundant in effective extracts from Radix angelicae sinensis with bioactivities of anti-aging and scavenging free radicals through topical administration.Aiming at these characteristics,ointment was prepared for extracts from Radix angelicae sinensis with water-in-oil(W/O)type.At the same time,orthogonal screening was used in formulation selection in order to obtain stable ointment formulation with preferred skin-feeling.In this investigation,flavonoid ingredients were acquired through ultrasonic extraction firstly.Afterwards,comprehensive scoring of homogeneity,extensibility,centrifugal stability and cold/heat resistance was set as the evaluation indicator to obtain the optimal proportion of oil phase,emulsifier and coemulsifier.In this ointment formulation,Span-60 and Tween-80 were used as emulsifier and coemulsifier respectively,and lanolin/vaselin/stearic were used as muti-compositional oil phase with quality ratio of 1∶3∶4.After prepared under the optimal formulation,in which the mass percentage of oil phase,Span-60 and Tween-80 were 35.0%,4.0% and 4.5%respectively,stable ointment was acquired in oil-in-water type.This study provides the basis for further application of Radix angelicae sinensis extracts ointment.