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目的研制丹参酮ⅡA自纳米乳来增加药物的溶出率。方法采用伪三元相图法,以乳剂外观、粒径、Zeta电位为指标优选处方,采用HPLC测定丹参酮ⅡA,考察其药剂学特性。结果优选处方为Tween80-PEG400-MCT(31∶62∶7),载药量1.5 mg·m L-1,平均粒径42.63±1.80 nm,多分散系数PDI为0.16±0.037,Zeta电位为-12.35±0.96 m V。以0.5%Tween80为溶出介质,丹参酮ⅡA自纳米乳在1.5 h时的累积释药量即可达载药量的55%。结论丹参酮ⅡA自纳米乳可显著提高药物的溶出速率。
Objective To develop tanshinone ⅡA nanoemulsion to increase the dissolution rate of drugs. Methods Pseudo ternary phase diagram method was used to determine the appearance and size of the emulsion and Zeta potential as the optimal prescription. Tanshinone ⅡA was determined by HPLC and its pharmacological properties were investigated. Results The optimal prescription was Tween80-PEG400-MCT (31:62:7), the drug loading was 1.5 mg · mL-1, the average particle size was 42.63 ± 1.80 nm, the PDI was 0.16 ± 0.037 and the Zeta potential was -12.35 ± 0.96 mV With 0.5% Tween80 as the dissolution medium, the cumulative release amount of tanshinone ⅡA nanoemulsion at 1.5 h reached 55% of the drug load. Conclusion Tanshinone Ⅱ A self-nanoemulsion can significantly improve the drug dissolution rate.