Angelica Formula Granule Quality Standards Standardized

The study on standardization of quality standard for Danggui Concen--trated Granule is one of the State level important items. Under the guidance of theories of Traditional Chinese Medicine and Pharmacy, according to the related law, this thesis has made a comprehensive and systematic study on this project.Danggui concentrated granule is made from Danggui Slice. By adopting different experiment methods including orthogonal experiment, the optimal preparation process have been obtained as follows: Isolate volatile oil from Danggui Slice by distillation for 3 hours with 10 portions water, collect the volatile oil and coat it by B-CD, store the coated volatile oil and the aqueous solution for further use. Decoct the residue with 8 portions water for 1 hour, filter, and combine the filtrate with the above aqueous solution, concentrate to a thin extract with a relative density of 1.06(80℃), spray drying. Add the above coated volatile oil and a quantity of dextrin, mix well, dry granulation.Efforts on quality standard have mainly been put into identification and determination. Methods for TLC identification have been established, meanwhile, the content of 70% ethanol-soluble estractives and ferulic acid have been determined. It contains 70% ethanol-soluble estractives not less than 65%, and ferulic acid (C₁₀H₁₀O₄) not less than 1.5 mg per bag.The preliminary stability test has been fulfilled according to the quality standard and the guidance of related rules, which indicates that the packed granule was stable in 3 months. Furthermore, HPLC fingerprint and GC identification methods are studied to a certain extent.Results of pharmacodynamics and acute toxicity indicate that Danggui concentrated granule is safe and effective compared with Danggui slice.All the experiments mentioned above prove that the preparation technique is reasonable and practicable, the standard is controllable, and the finished product is safe and effective as well as stable.