Studies On The Preparation Process Of Total Saponins Capsules From Nigella Glandulifera Freyn Et Sint

Objective:①To study extraction and purification of total saponins from Nigellaglandulifera Freyn et Sint and establish its quality standards;②To study preparationprocess of the anti-rheumatism capsules of total saponins from N. glandulifera.Methods:①Extracting and purifying condition of total saponins from N.glanduliferawas optimized by monofactorial tests and orthogonal experiments.②Quality standardsof total saponins from N. glandulifera were established by various chromatographictechniques, such as TLC, UV and HPLC-ELSD.③Effective dose on total Saponinsfrom N. glandulifera w as identified by pharmacodynamic screening. The preparationprocess of the total saponins capsule from N. glandulifera was determined byhydrophilicity percentage and qualified rate of particle.Results:①The optimum extracting conditions of total saponins from N. glanduliferawas that the seeds of N. glandulifera were extracted by30%ethanol at70℃for3timesand1h each time after petroleum ether degreased. The30%ethanol extracts wereextracted by saturated n-butanol (v/v:1/1), then n-butanol extracts were purified bymacroporous resin. D101resin was optimized, and the best purifying conditions was:10BV water washed impurities,5BV50%ethanol and the flow rate2BV/h, and suitable tomass production of total saponins from N. glandulifera.②The content of saponins wasmore than50%, the content of saponins A was no less than45%in T total saponins from N.glandulifera.③The effective dose of total saponins from N. glandulifera equivalent tothe human clinical dose was0.68mg/(kg·d). The optimized preparing process of the totalsaponins capsule was as follows: the proportion of total saponins and microcrystalcellulose was1:4; the adhesive used30%ethanol to5%PVP, and the dose was90%of thegross.Conclusion: The determination of extraction, purification and quality standards of totalsaponins which the content of effective constituents is more than50%and preparation of its anti-rheumatic capsules will provide science basis for developing and using thismedicinal plant.