Study On Preparation Process And Quality Standards Of Anti-cancer Compound Particles

Objective:This topic is mainly on the research work of clinical proved recipe andmanufacture granules to overcome traditional decoction’s defects such as difficult todecoction, large doses and not easy to save and carry. It’s purpose is give full play toadvantages such as portable, easy to preserve of granules and provides a theoretical basisfor the further development of the preparation.Methods:1.Study the preparation technology of anticancer granule, make literatureresearch on medicinal materials of the prescription, use easy industrialized alcoholextraction and water extraction respectively according to medicinal materials’ polarity,select the optimal process with orthogonal design.2.The thin-layer chromatography ofastragalus, donkey hide gelatin, atractylodes has been built in quality control, the contentof oridonin and astragaloside were determined by HPLC.3.Investigate on initial stabilityof compound anticancer granule. Investigate the character, moisture, granularity, thecontent of oridonin and astragaloside of the prescription at ambient temperature snd40℃±2℃,the relative moisture at75%±5%. the results indicate that the stability ofcompound anticancer granule is preferably.Results and conclusion:1.This experiment chose the content of oridonin andastragaloside for the evaluation index, the extract condition of rabdosia rubescens throughorthogonal design optimization, eight times amount ethanol reflux extraction three timesof one hour and the Astragalus,Atractylodes, Gynostemma eight times amountwater reflux extraction three times of one and a half hours. The relative density ofextraction solution was concentrated to1.25（20℃）, then decompression drying andgranulation. The preparation technology is certified safe, reliable and repeatabilitythrough pilot plant test of three batches of samples.2.The thin-layer chromatography of astragalus, donkey hide gelatin, atractylodes has been built, the result indicate that testsample’s spectrum, medicinal materials and standard control on a color spectrum revealthe same color spots corresponds to the location while the negative control not reveal spot.The experiment confirmed that this method can be used to identify Chinese medicinalcrop preparation with advantages such as convenient, reliable, sensitive, specificity，repeatable.3.The content of Rabdosia rubescens (oridonin) and astragalus’(astragaloside)effective ingredients were determined by HPLC. The regression equation of oridonin isY＝565.95X-57.39，r=0.9997，the linear range is0.3004～1.5020μg and astragaloside’sY＝60.441X-43.487，r=0.9996，the linear range is2.722～16.332μg. Experiments showthat the method is simple, reliable and sensitive, basically achieve the purpose ofpreparation’s quality control, is safe and effective.