Complex The Fang Lingzhi Particle Technology And Quality

Fufang Lingzhi Granule, an effective medical prescription being used to supporting the healthy energy and strengthening body resistance in clinical application, is developed to be a modern preparation aimed at reinforcing the human body's immunity and inhibiting the growth of the tumor by the modern technology combined with pharmacodynamics screening test in this study. The inhibition rate of Fufang Lingzhi Granule toward S180 tumor cell is above 40% in pharmacodynamics test. The dosage form and modern production process of the prescription were studied in detail on the guidance of pharmacodynamic and pharmaceutical theory. A scientific quality control method was established to evaluate the safety and efficiency of the prescription.In the process of the preparation, volatile oil was extracted by water boiling combined with steam distillation method, and theβ-cyclodextrin inclusion technology was used to improve the stability of the volatile oil; The technology process was established based on the result of the pharmacodynamic screening test; the conditions of the preparation process was determined according to the volatile oil-β-cyclodextrin inclusion complex's thermal stability, the moisture content of the extract and the medicine; moreover, the scale-up study from the experimental conditions of the small test was preformed and a successful transition between above two of the quality conditions.The two kinds of the ingredient, the total triterpenold acids and the Ferulic acid composition was chosen as the indicator. Quantitative standards were established by based on high performance liquid chromatography and the UV spectra method, and the quantitative analyses of the medicine were established with the combination methods of Microscopy, TLC, and GC. The developed quality control methods mentioned above made an assurance for the drug production and its quality. Furthermore, the suability of the preparation was studied systematically.