The Compound Silymarin Pill Preparation And Quality Standards

Fu Fang Yi Gan Ling Tablet is a kind of traditional Chinese medicine developed on the bases of silymarin, and its main ingredients are silybum extracts and Fructus schisandrae chinensis extracts. These two components supplement each other efficientlyf which achieved good clinic results of stabilizing lever cell membrane, enhancing microsome enzyme activity of lever cells, decreasing ALT rapidly and supportively, and improving lever function roundly. In clinical field, Fu Fang Yi Gan Ling is reputable and in good favor of patients. However, the silymarin (the extracted effectiveness of silybum) in Fu Fang Yi Gan Ling Tablet is difficult to be absorbed by human body, which prevents the substantive betaken in clinics.We produced it in the form of dropping pill, Fu Fang Yi Gan Ling drop-pill, which improves the absorption in human body. Drop-pillis a new solid medicament developed rapidly in recent years, and the advantages of it are quicker releasing to body, higher biological utilization, easier manufacturing, less production process, and shorter production cycle, etc. However, at the present time, the development of drop-pill limited by agent-carrier and cooler conditions therefore, we studied the production process systematically. Different extraction conditions were studied, and total flavonoids content was used as productivity index. Orthogonal experiment method was used to prioritize the production condition of extraction and purification, which provides the scientific evidence for bulk production. Different spray-dryer conditions to the dry content of extracts by ethol from schisandrae were also studied.The influence of different carrier on the rate of dissolution of Fu Fang Yi Gan Ling drop-pill was studied as well, as is described in Chapter 4, and PEG6000 was chosen as the carrier material. IR scanning experiment was used in the study, and the result shows the medicine presents in the dispersion in the form of amorphism. Different ratios of medicine and carrier were studied, and based on the research of solid dispersion, L₉(3⁴) orthogonal experiment design was applied to optimize and screen prescription.In the quality study, TLC was performed distinguishably with clear chromatographic marks and good degree of separation. HPLC was used to quantify silybin (effective ingredient in silybum) and kadsurin (effective ingredient in schisandrae) . Remarkable peak was achieved reproducibly with high recovery rate, high accuracy, high stability and easy operation, and is regarded as an effective quantity analysis method for silybin and kadsurin. Experiment was conducted to compare the new drop-pill product with plain tablet on the market, and the rate of dissolution out of body result shows that Fu Fang Yi Gan Ling enhanced the absorption of silybin significantly.