Preclinical Pharmaceutical Study On Radix Dolichosae Total Saponin Capsules Of Dai Ethnic Medicine

Radix Dolichosae are the dried root of Dolichos tenuicaulis(Baker)Craib and Dolichos appendiculatus Hand.-Mazz,in leguminosae.It has the functions of hemostasis,myogensis,anti-inflammatory and analgesia,it is mainly used for treat rheumatic pain,bruises,fractures,etc.On the basis of previous research,a systemtic study was cayyied out on the draft standards for Radix Dolichosae,processing technology of wheat bran fried Radix,preparation process of total saponin capsules,quality standard of total saponins capsules in accordance with the relevant application requirements of the Chinese Medicine Class 5 new drugs in Annex 1 of the “Administrative Measures for Drug Registration”(Bureau Order No.28).So as to provide scientific reference for the preclinical pharmaceutical research of Radix Dolichosae total saponin capsules.In terms of draft standard for medicinal materials:formulated a qualitative identification methods for medicinal materials with obvious traits and microscopic features,and clear TLC spots;established limited indicators such as moisture,total ash,acid-insoluble ash,water-soluble extract,alcohol soluble extract in medicinal materials.Determined there batches of medicinal materials and found that heavy metals and aflatoxin met the limits.Only one bath of phoxim exceeds the standard in 70 pesticide residues,and others were not exceeded.The purity of self-made doliroside B reference product was more than 98.0%.The content limit of doliroside B should not be lower than 3.0% in Radix Dolichosae.Processing technology of wheat bran fried Radix:the orthogonal experiment design was used to optimize the wheat bran process;TLC and HPLC were used to compare the chemical composition before and after processing.The research on anti gout inflammation of processed products was carried out.It was clear that the traditional efficacy was total saponins,the doliroside A and doliroside B was the main active ingredients.The preparation process of total saponin capsules:taking the extraction rate and purity of total saponins as the investigation indicators,the best extraction process was optimized.In the study of capsule preparation tecnology,the best small-scale preparation technology was determined based on the angle of repose ande moisture absorption rate.Fill the NO.4 capsule with a critical relative humidity(CRH)of 80.10%.On the basis of the optimized small-scale test process,the pilot scale-up study was carried out,The results showed tha the three batches of pilot data were in line with expectations and the repeatability was good.Quality standard of total saponin capsules were established by using TLC performed qualitative identification and HPLC to Quantitate determination.The result indicated that the spots of the index components were clear,the content of doliroside B in each capsule should not be less than 25 mg,and the drug should be stored in dry environment.In summary,the subject established and improved the quality standard of Radix Dolichose,explored the processing method of decoction pieces,optimized preparation process of total saponin capsules,explored the quality standard of drugs.It has laid a solid foundation for the development of Radix Dolichose into safe,effective and controllable anti-gout drug.