Ginseng Oil Soft Capsule is a kind of soft capsule which contains panax ginseng fibril and leaves of the effective components by ultrasonic extraction method. And studied the biological activities of soft capsule.The aim of this experiment is to study the preparation procedure, the quality control standards and the physiological activity of ginseng fibril oil soft capsule and ginseng stem leaf oil soft capsule. Selecting the soft capsule as the preparation foam, we studied the dissertation including preparation procedure, quality control standards and stability research. We also studied the surveying the acute toxicity experiment, fatigue experiment, anti inebriation experiment and hypolipidemic experiment in the aspects of biological activities. The results are as follows: A.Ultrasonic extraction process.In the extract, the panaxynol and panaxydol as an index, to study the technology of ginseng fibril oil soft capsule and ginseng stem leaf oil soft capsule, and solid-liquid ratio and extraction time as factors, the optimal process. The experimental results show that the optimum extraction process of ginseng root for the solid-liquid ratiois 1:10, extraction time is 30 min; For ginseng stems and leaves, the optimum solid-liquid ratio is 1:20, extraction time is 60 min. According to the characteristics of the extract, then the soft capsule preparation procedure was established. B.The quality standards study.The quality standards study: The content of panaxynol and panaxydol were determined by HPLC. The results showed that the linearity, stability, precision, reproducibility and recovery were all satisfactory. The total content limits was regulated: The total content of panaxynol was not less than 0.06 mg per grain, and the panaxynol was not less than 0.01 mg per grain in ginseng fibril oil soft capsule. And the total content of panaxynol was not less than 0.05 mg per grain; And the panaxynol was not less than 0.003 mg per grain in ginseng stem leaf oil soft capsule. C.The stability research.We studied the high temperature experiment, high humidity, light irradiation experiment, long term test and the acceleration test. The results showing the stability of the foam was good. D.The physiological activity research.We made the acute toxicity experiment, fatigue experiment, anti inebriation experiment and hypolipidemic experiment form ginseng fibril oil soft capsule and ginseng stem leaf oil soft capsule, shown that the two drugs in reducing the human body fatigue, reducing the hangover and reducing the blood fat have a strong role.The results suggested that the preparation procedure of ginseng fibril oil soft capsule and ginseng stem leaf oil soft capsule were reasonable in technics, good in stability, controllable in quality and strong physiological activity. |