Pharmaceutical Study On Sanhu Tongfeng Granules

Objective: Sanhu Tongfeng Granules is a prove clinical effective recipe which hadbeen used several years by First Affiliated Hospital of Guangxi Medical College. It consistsof12traditional Chinese medicines include of Rhizoma Polygoni Cuspidati, Radix etRhizoma Achyranthes, Herba Taraxaci, Herba Desmodii, etc. It has potent activity of stasisdredge collaterals and scattered stasis analgesic for treatment of Rheumatoid Arthrids, hasstable clinical efficacy. This research was based on clinical soup dosage and processedstudy, by prescription analysis and dosage from selecting and prepared Sanhu Tongfenggranules. The research dealed with preparation process study, quality standard study andpreliminary stability in order to research a safety, convenience, and effective new medicinewhich basic curative effect remained, provide a scientific basis for the further developmentof a hospital preparation.Methods:(1) Study of water-extraction technology: Extraction technology were optimized byL9(34) orthogonal design method, with consideration: the amount of water, the times ofextraction and time length of extraction. HPLC was used to quantitative by using thecontent of Polydatin and Emodin as the index, determine the optimum water-extractionmethod.(2) Study of purification technology: Extraction technology were optimized by L9(34)orthogonal design method, with consideration: the liquid relative density, the concentrationof ethanol and time length of precipitation. HPLC was used to quantitative by using thecontent of Polydatin and Emodin as the index, determine the optimum purificationtechnology method.(3) Study of concentration technology: The contents of Polydatin and Emodin wereused as index to determine the optimum concentration conditions.(4) Study of formulation technology: Formalizing properties, hygroscopicity,flowability and dissolubility was used as index to investigate the formulation technique. (5) Study of quality standard: A variety of traditional Chinese medicines in this SanhuTongfeng Granule were identified by TLC, and the content of paeoniflorin was determinedby HPLC.(6) Study of preliminary stability: We examine long term stability and acceleratedstability of Sanhu Tongfeng Granule in the aspects of properties, TLC, the determination ofthe content etc for6months, respectively.Results:(1) The optimum condition of water-extraction:10times water, extracted60min for2times.(2) The optimum condition of purification: Liquid relative density is1.10, theconcentration of ethanol is60%, and precipitation for12hours.(3) The optimum condition of concentration:60?at-0.08~-0.10MPa.(4) The optimum condition of formulation: Extract is concentrated to a relative densityof1.32~1.35, mixed with proper amount of lactose, made of soft material, pelletizing,drying, forming.(5) The optimum condition of the method TLC and the HPLC method of Polydatinand Emodin, and the creation of a draft standard of granules.(6) That the above parameters were not changed significantly indicates a good stabilityof the preparation.Conclusions: The preparation procedure is reasonable and feasible, the qualitystandard can be used effectively for the quality control and the product quality is stability,has broad application prospects. The results of this study provides the guarantee for theproducts to enlarge production and preclinical basic research? it also provides theexperimental basis for scientific production.