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目的:制备丹参片提取物的磷脂复合物并进行口服十二指肠体外吸收评价。方法:以复合率为评价指标,结合预试验结果,采用正交试验优选影响丹参片提取物与磷脂复合效果的药物浓度、复合时间、复合温度和药脂比等因素;分别按照原工艺制备丹参片提取物并制备成磷脂复合物,对提取物和磷脂复合物采用外翻肠囊法评价改性前后在十二指肠段的吸收情况。结果:确定了以甲醇作为反应溶剂,提取物与大豆卵磷脂比例为1∶1.5,提取物的投料浓度为7.5 mg/m L,在55℃条件下复合1 h为较佳条件;基于磷脂复合物技术制备的丹参片提取物磷脂复合物肠吸收较提取物显著增加。结论:磷脂复合物技术对于丹参片的技术升级具有一定的适用性。
OBJECTIVE: To prepare phospholipid complex of Salvia miltiorrhiza tablet extract and evaluate its in vitro absorption in duodenum. Methods: Taking the compounding rate as the evaluation index and combining with the pre-test results, orthogonal test was conducted to optimize the drug concentration, compounding time, compounding temperature and drug-lipid ratio of Salvia miltiorrhiza tablet extract and phospholipid complexing effect. Tablet extract and prepared into phospholipid complex, the extract and phospholipid complexes using valgus gut method to assess the modified before and after the duodenum in the absorption. Results: The optimum conditions were methanol as the solvent, the ratio of extract to soybean lecithin was 1: 1.5, the concentration of extract was 7.5 mg / m L and the temperature was 55 ℃ for 1 h. Compared with the extract of radix salviae miltiorrhizae radix salviae miltiorrhizae prepared by the technology, the intestinal absorption of the phospholipid complex increased significantly. Conclusion: The phospholipid complex technology has some applicability to the technological upgrading of Danshen tablets.