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探讨以乳剂同时载药丹参脂溶性与水溶性成分的可行性,为从制剂学方面综合利用丹参药效成分提供新思路。以丹参酮ⅡA,丹酚酸B为原料,大豆磷脂与帕洛沙姆188为混合乳化剂,甘油为等渗调节剂,采用星点设计-效应面法优选处方,高速剪切法制备初乳,续以高压均质机进行匀化,制备丹参双相载药静脉乳剂,进而考察其药剂学特性与稳定性。所制得产品外观为橙黄色乳状液,平均粒径241 nm,Zeta电位-35.3 m V,其中丹参酮ⅡA载药量为0.5 g·L-1,丹酚酸B载药量为1g·L-1,长期留样稳定性良好。结果表明研制的乳剂可同时载药脂溶性成分丹参酮ⅡA,水溶性成分丹酚酸B,可为充分发挥丹参的药效奠定制剂学基础。
To explore the feasibility of simultaneous administration of fat-soluble and water-soluble components of Radix Salviae Miltiorrhizae with emulsion, and to provide new ideas for comprehensive utilization of the active ingredient of Radix Salviae Miltiorrhizae in terms of formulation. Using tanshinone ⅡA and salvianolic acid B as raw materials, soy lecithin and philoxene 188 as emulsifier and glycerol as isotonic modifier, colostrum was prepared by high-speed shearing and star-point design-response surface method. Continued with high-pressure homogenizer homogenization Preparation Danshen biphasic drug-loaded intravenous emulsion, and then investigate its pharmacological properties and stability. The obtained product was an orange-yellow emulsion with an average particle diameter of 241 nm and a Zeta potential of -35.3 mV, wherein the dosage of tanshinone IIA was 0.5 gL-1, the dosage of salvianolic acid B was 1 gL- 1, long-term retention of good stability. The results showed that the developed emulsion can simultaneously load lipid-soluble ingredients tanshinone Ⅱ A, salvianolic acid B water-soluble ingredients, can give full play to the efficacy of Salvia to lay the foundation for the formulation.