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目的研究葛根素自微乳给药系统的处方工艺。方法通过溶解度试验、油和表面活性剂配伍试验,以及伪三元相图的绘制,筛选葛根素自微乳的处方组成;通过粒径、载药量和自微乳化时间优化了葛根素自微乳处方;并对葛根素自微乳的理化性质和稳定性进行了考察。结果葛根素自微乳处方中油相为中链甘油三酯(19.0%)、油酸(19.0%),表面活性剂为聚山梨酯80(19.0%)、聚氧乙烯蓖麻油(19.0%),助表面活性剂为1,2-丙二醇(19.0%),葛根素(5.0%)。自微乳化后粒径为(17.28±0.24)nm,自微乳化时间小于120 s;室温留样6个月,该自微乳性状、质量分数、粒径和自微乳化时间均无明显变化。结论所制备的葛根素自微乳粒径小、稳定性好,符合良好自微乳制剂的要求。
Objective To study the prescription of puerarin self-microemulsion system. Methods The composition of the puerarin self-microemulsion was screened through the solubility test, the compatibility test of the oil and the surfactant, and the pseudo-ternary phase diagram. The particle size, drug loading and self-microemulsification time were optimized. Milk prescription; and puerarin self-microemulsion physical and chemical properties and stability were investigated. Results The oily phase of puerarin microemulsion was medium chain triglyceride (19.0%), oleic acid (19.0%), surfactant polysorbate 80 (19.0%) and polyoxyethylene castor oil (19.0% Cosurfactants are 1,2-propanediol (19.0%), puerarin (5.0%). After self-microemulsification, the particle size was (17.28 ± 0.24) nm, the self-microemulsification time was less than 120 s, and the sample was kept at room temperature for 6 months. No significant changes were observed in the self-microemulsification, mass fraction, particle size and self- Conclusion The prepared puerarin self-microemulsions have small particle size and good stability, which is in line with the requirements of good self-microemulsion formulations.