Reseach Of Shenshao Jieyin Foam

Shenshao Jieyin Foam is a kind of preparation composed of traditional Chinese Medicine (TCM). The uppository is prepared by extracts from four kinds of TCM which include lightyellow Sophora Root, Densefruit Pittany Root-bark, Dandelion, and Radix Paeoniae Rubra. The preparation is used to cure vaginitis. The clinical observation shows it has remarkably effect on the symptom caused by vaginitis, for example Pruritus Vulvae, burning pain, leucorrhea increasing and so on.The aim of this experiment is to study the preparation procedure and the quality control standards of Shenshao Jieyin Foam. Selecting foam as the preparation foam, we study the dissertation including preparation procedure, quality control standards and stability research. The results are as follows:A. The extraction procedure:Studying the water extraction technics of four kinds of TCM by testing extract content and content of Matrine and Oxymatrine. Selecting water amount, decoction times and decoction time as investigating factors, we studied the optimum preparation procedure by orthogonal text. As a result,we established the process conditions.B. The preparation procedure:We studied the usage amount of dressing and other aspects by The Single-factor Research in detail.Then the foam preparation procedure was established.C. The quality standards study:Densefruit Pittany Root bark, Dandelion and Radix Paeoniae Rubra were identified by TLC. The results showed that the spots on the chromatograms were reproducibility, clear, characteristic withing no interference by negative materials. The methods are considerable to control the standards of Shenshao Jieyin Foam.The content of Matrine and Oxymatrine was 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 Matrine and Oxymatrine was no less than 1.45mg per bottle.D. The stability research:We studied the preparation appearance, the pH, the load difference, the spray text, the distinction, the content and the microorganism limit items by using the normal temperature test and the acceleration test. The normal temperature test and the acceleration test are both tested for 3 months. The results not obviously changed, showing the stability of the foam was good.E. acute toxicity test:The result of Shenshao Jieyin Foam showed the Foam was safe.The results suggested that the preparation procedure of Shenshao Jieyin Foam was reasonable in technics, good in stability and controllable in quality. The study provided much pharmaceutical document for the declaration of Shenshao Jieyin Foam.