五加五味软胶囊研制与质量评价

Study on preparation technology and quality evaluation of Acanthopanax senticosus and Schisandra chinensis soft capsule

研究五加五味软胶囊的制备工艺,并对其进行质量评价.以基质、药粉粒度、助悬剂、助溶剂以及其他辅料为单因素筛选最佳处方;以胶囊收率、扎囊现象为评价指标,以软胶囊机进料口、温度、转速等考察因素,采用正交试验筛选制备工艺,并对产品进行质量评价研究.采用豆油作为内容物基质,药粉过100目筛,助悬剂蜂蜡用量为4%,助溶剂吐温-80用量为0.5%,囊壳配比明胶∶甘油∶纯化水为1.0∶0.35∶1.0,静置24 h.制备工艺条件为进料口温度50℃,转速比1.75∶1,晾晒干燥时间6 h.制备的五加五味软胶囊囊壳呈现淡黄色,内容物呈现黄色,软胶囊均完整光洁,无黏结、变形、渗漏,偶见有囊壳破损的现象.装量差异限度在±10%,崩解时限小于60 min.五加五味软胶囊中含五味子醇甲、五味子甲素、五味子甲素和紫丁香苷的量分别为(3.66±0.03)、(0.56±0.01)、(1.67±0.01)mg/g和(1.42±0.01)mg/g.本制备工艺所得的软胶囊质量稳定可控,有利于发挥两药的协同作用,具有广阔的市场前景.

The preparation technology of Acanthopanax senticosus and Schisandra chinensis soft capsule was studied and its quality was evaluated.The best prescription was selected with matrix,particle size of drug powder,suspending agent,co-solvent and other auxiliary materials as single factor,capsule yield and capsule ligation phenomenon as evaluation index,and factors such as feed port,temperature and rotational speed of soft capsule machine were investigated.Orthogonal test was used to screen the preparation process,and the product quality evaluation was studied.The results showed that soybean oil was used as the content matrix,the powder was sifted through 100 mesh,the dosage of beeswax was 4%,the dosage of cosolvent Tween-80 was 0.5%,and the ratio of gelatin∶glycerin∶purified water was 1.0∶0.35∶1.0,and stood for 24 hours.The preparation conditions were as follows:feed temperature 50℃,rotational speed ratio 1.75,drying time 6 h.The shell color of the prepared Acanthopanax senticosus soft capsules was light yellow,and the contents were yellow.The soft capsules were all intact and clean,without adhesion,deformation,leakage,and occasional damage of the capsule shell.The limit of load difference was±10%,and the disintegration time was less than 60 min.The average contents of Schisandrin,deoxyschisandrin andγ-Schisandrin and syringin were(3.657±0.027)mg/g,(0.563±0.005)mg/g,(1.666±0.012)mg/g and(1.418±0.008)mg/g,respectively.The quality of the soft capsule obtained by this preparation process was stable and controllable,which was beneficial to give full play to the synergistic effect of the two drugs,and has a broad market prospect.