Study On Ziziphi Spinosae Semenand Candidate Standard Pieces Preparation Technical Specification

Under the situation that it is difficut to perfectly describe the characteristic attributes of processed Traditional Chinese Medicine decoction pieces with chemical reference substance,standard herbs,and standard extracts.Candidate standard pieces will be applyed in quality evaluation and control,comprehensive information expression,exclusive information expression,Processing information expressio-n.This subject research on Ziziphi spinosae Semen candidate standard pieces preparation technical specification.AIM To study the harvesting and processing of raw medicinal materials,processing technology,homogenization technology,qual-ity evaluation and control,fingerprint spectrum,and stability study.And providing a scientific basis and for a complete set for Ziziphi spinosae Semen candidate standard pieces preparation technical specification.METHODS 1 According to the survey of genuine producing area and then gather the information of the base resource,the place of origin,harvest season,and considerations.Enterprise was processing produce Ziziphi spinosae Semen and fried Ziziphi spinosae Semen based on the practical experience and regulations.2 Preparing different sizes of decoction pieces powder pretreatmented by different pretreatment.Multi-index Co-mprehensive Evaluation on the homogenization by basises including observing the character,measuring the size distribution by sieving method,measuring the Color characteristics parameters by colorimeter,calculating E* ab and RSD,adopt-ing the analysis method of MBSD and PCA measured by NIRS.3 To improve quality evaluation and control such studying were completed including trait,differential,examination,content determination by microscope,colorimeter,HPLC,and TLC.4 Establishing the fingerprint by HPLC-DAD,HPLC-ELSD,GC-MS.5 Stabili-ty study was completed by drug comprehensive stability test chamber.RESULTS The genuine producing area of Ziziphi spinosae Semen is Xingtai,Heibei pr-ovince,and come from Ziziphus jujuba Mill.var.spinosa(Bunge)Hu ex H.F.Chou.The fruit completly mature during September to October.Removing the pulp and collectting seeds after harvest so that the raw herbal materials sample could be prepared.Ziziphi spinosae Semen medicinal pieces could be prepared by purifying.Fried Ziziphi spinosae Semen medicinal pieces could be prepared in the condition of 170 ℃ and 80 seconds by fried medicine.The homogenizati-on candidate standard pieces could be prepared by high speed grinder,which smash three times(20 s each time)and then sift out by 65 mesh sieve,collectin-g all the powder and then blending by 50 mesh sieve.Established the HPLC-D AD,HPLC-ELSD,GC-MS finger-print and mutual mode of the candidate standar-d pieces of crude and processed Ziziphi spinosae Semen,determined the conten-ts of Spinosin,Jujuboside A,Jujuboside B,betulinic acid,and betulin,character,E*ab,and TLC condition.The candidate standard pieces must be sealed packaging by brown borosilicate penicillin bottle with 1 gram each vial.The candidate standard pieces should be stockpiled in a cool,dark place away from moisture.Effe-ctive period of The candidate standard pieces provisionally stipulate for 2years.