Study On The Quality Standard Of Extract Of Rupixiao

The complex Chinese herbal formula Rupixiao was an effective medical prescription. It was composed of fifteen kinds of herbs, including antler, notoginseng radix, paeoniae radix, and so on. The tablet formula of Rupixiao was absorbed in Pharmacopoeia of the People's Republic of China (2005) I . It was used to treat hyperplasia of mammary glands. In this article, the quality control of extract of Rupixiao has been studied in order to ensure its safety and effectiveness.The main active constitutents of extract of Rupixiao were polysaccharides, flavonoids and saponins. In this article, total polysaccharides, total flavonoids and total saponins were determined by UV-Vis spectrophotometry and peoniflorin was determined by HPLC. In addition, pretreatment of the samples and color reaction conditions have been optimized.In the assay of total polysaccharides, glucose was used as a reference substance. Concentrated sulfuric acid and phenol were used to perform color reaction. The method was validated to be sensitive, accurate and has a good linearity. After carefulcomparison, water was selected as solvent. The samples were pretreated by supersonic for 20min. The reproducibility of the method was good and the practice was simple, so the established method could be used for quality control. According to the contents of three batches of samples, the total polysaccharides calculated in glucose (C₆H₁₂O₆) in extract of Rupixiao should not less than 15.0%.In the assay of total flavonoids, rutin was used as a reference substance. Sodium nitrite, aluminum nitrate and sodium hydroxide were used as chromogenic agents in this experiment. The accuracy and linearity of the method were good. The results of the stability test indicated that the time for practice was long enough. The constituents in extract of Rupixiao were complicated, so the results of determination were not satisfactory without any pretreatment. According to the nature of flavonoids, polyamide was used to gather and purify them. The method was validated to be suitable for assay because of its good accuracy. According to the contents of three batches of samples, the total flavonoids calculated in rutin (C₂₇H₃₁O₁₆) in extract ofRupixiao should not less than 1.0%.In the assay of total saponins, ginsenoside Rgi was used as a reference substance. Perchloric acid, vanillin and glacial acetic acid were used as chromogenic agents in this study. The colorable reaction conditions were optimized. The selected method was sensitive and accurate. Extraction using n-butanol was selected as the pretreatment method. The method was validated to have good reproducibility and have no interference in the chromatography of UV-Vis spectrum, so it could be used for assay. According to the contents of three batches of samples, the total saponins calculated in ginsenoside Rgi (C43H74O13) in extract of Rupixiao should not less than 1.4%.Peoniflorin in extract of Rupixiao was determined by HPLC. The linearity, precision, stability, reproducibility and recovery of the method were validated to be good. According to the contents of three batches of samples, the peoniflorin (C23H28O11) in extract of Rupixiao should not less than 0.20%.In this study, polysaccharides, flavonoids and saponins in extract of Rupixiao were identified by colorable reactions after proper pretreatment. Severn kinds of medicinal herb were identified by TLC, such as notoginseng, rhapontici radix and paeoniae radix.In addition, loss on drying, microorganism and some other indexes of extract of Rupixiao were examined. After the initial study of quality control of extract of Rupixiao, the stability of the extract was studied. The results indicated that extract of Rupixiao was stable within 12 months in the test condition.The method of quality control in this article was accurate and simple. It could be used for quality control of extract of Rupixiao and its preparations.