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目的制备同时含有丹参酮及丹酚酸的静脉注射剂。方法以丹参脂溶性成分丹参酮ⅡA和水溶性成分丹酚酸B作为指标性成分,水溶性提取物与脂溶性提取物质量比10∶1,以中链油作为油相,大豆磷脂作为主要乳化剂,分别将水溶性成分溶于水相,脂溶性成分溶于油相,采用高压均质法制备丹参双相载药亚微乳注射液。结果制剂的外观呈棕褐色,粒径(200±50)nm,zeta电位在-20~-40 mV之间;30 min旋转水浴灭菌后,制剂外观无明显变化,zeta电位略有升高;指标性成分测定结果显示,水溶性成分85%分布在水相中,脂溶性成分90%分布在油相中。结论制备丹参双相载药亚微乳是可行的;脂溶性成分与水溶性成分分别存在于与其性质相适应的油相和水相中。
Objective To prepare an intravenous injection containing both tanshinone and salvianolic acid. Methods Tanshinone ⅡA and water-soluble salvianolic acid B of Salvia miltiorrhiza were used as index components, the mass ratio of water-soluble extract to fat-soluble extract was 10:1, medium oil as oil phase and soybean phospholipid as main emulsifier , Dissolving the water-soluble component in the water phase and the fat-soluble component in the oil phase, respectively, and preparing the Danshen biphasic drug-loading submicroemulsion injection by a high-pressure homogenization method. Results The appearance of the preparation was tan, the particle size was (200 ± 50) nm and the zeta potential was between -20 ~ -40 mV. After sterilized in a rotary water bath for 30 min, the appearance of the preparation did not change significantly and the zeta potential increased slightly. The results showed that 85% of the water-soluble components were distributed in the water phase and 90% of the fat-soluble components were distributed in the oil phase. Conclusion The preparation of Danshen double-phase drug-loaded submicroemulsion is feasible. The fat-soluble and water-soluble components exist in oil phase and water phase, respectively.