心脉通软胶嚢制备工艺及芦丁含量测定方法的确立

Preparation Technology of Xinmaitong Soft Capsule and Determination of Rutin Content

为了确立心脉通软胶囊的制备工艺和其中各成分含量的测定方法,我们采用正交试验法对心脉通软胶囊的处方进行了研制,并采用高效液相色谱法对心脉通软胶囊中芦丁的含量进行了测定。结果显示,心脉通软胶囊的内容物以大豆油为基质,蜂蜡为助悬剂,司盘80为润湿剂。确定了心脉通软胶囊内容物的最佳处方。芦丁的线性范围为26.8~268.0μg/m L(r=0.999 8),样品平均加样回收率(n=9)为99.0%,RSD为1.17%。研究表明,所制得的软胶囊制备工艺稳定,质量可控,适于工业生产,含量测定结果准确,重现性好,可用于心脉通软胶囊的质量控制。

To establish the preparation technology and the method for content-measuring of Xinmaitong soft capsule, the prescription of Xinmaitong soft capsule was developed by orthogonal test. The content of rutin in Xinmaitong soft capsule was determined by high performance liquid chromatography（HPLC）. The result showed that the contents of Xinmaitong soft capsule were as follows： soybean oil as substrate, beeswax as suspending agent and Span 80 as wetting agents. The best prescription of the content of Xinmaitong soft capsule was thus confirmed. The linear ranges of rutin were 26.8~268.0 μg/m L（r=0.999 8）, the average recovery rate was 99.0%（n=9）, and RSD was 1.17%. This research indicated that the soft capsule prepared by this study had stable process and controllable quality, which was suitable for industrial production. The method for content determination was accurate and reproducible, which could be used for quality control of Xinmaitong soft capsule.