| Hongjingtian Soft Capsule is a kind of soft capsule which contains Rhodiola of theeffective components by supercritical Carbon Dioxide. The preparation is used to improvehypoxia tolerance.The aim of this experiment is to study the preparation procedure and the quality controlstandards of Hongjingtian Soft Capsule. Selecting soft capsule as the preparation foam, westudied the dissertation including preparation procedure, quality control standards andstability research. The results are as follows:A. Technology of extracting concretes from the Rhodiola with supercritical carbondioxide: Studying the supercritical carbon dioxide extraction technics by testing extractcontent and content of Salidroside. Selecting extraction pressure, temperature and time asinvestigating factors, we studied the optimum preparation procedure by orthogonal text. As aresult,we established the process conditions.B. The preparation procedure: We studied the usage amount of dressing and otheraspects in detail. Then the soft capsule preparation procedure was established.C. The quality standards study: The content of Salidroside was determined by HPLC.The results showed that the linearity, stability, precision, reproducibility and recovery wereall satisfactory. The total content limits was regulated: the total content of Salidroside was noless than1.28mg per grain.D. The stability research: We studied the preparation appearance, the spray text, theload difference, the distinction, the content and the microorganism limit items by using thenormal temperature test and the acceleration test. The tacceleration tes test and the normaltemperature are both tested for3months. The results did not obviously changed, showing thestability of the foam was good.The results suggested that the preparation procedure of Hongjingtian Soft Capsule wasreasonable in technics, good in stability and controllable in quality. The study provided much pharmaceutical document for the declaration of Hongjingtian Soft Capsule. |