Studies On Preparation And Quality Standard Of Salt-processed Fructus Psoraleae

Traditional Chinese Medicine(TCM)dispensing grandule is a new dosage form derived from traditional herbal decoction.However,there’s no unified technical or quality specification yet,and the market is in urgent need of an improved regulatory system.Fructus Psoraleae(BGZ),a traditional type of fruit and seed medicine with the function of reinforcing kidney,strengthening yang,warming the spleen and stopping diarrhea,is commonly used after salt-processing for better efficacy and more moderated property.This paper aims to study on salt-processed Fructus Psoraleae(YBGZ)dispensing granule,based on the combination of HPLC fingerprint,chemometrics,and quantitative analysis of multi-components by single marker(QAMS).A fairly complete quality evaluation was performed for YBGZ dispensing granules,from raw material to final product.The main research works are as follows:1.An HPLC fingerprint method was built in combination with TOF-MS,and 13 common compounds were identified accordingly,namely psoralenoside(PO),isopsoralenoside(IPO),psoralen(PS),isopsoralen(IPS),neobavaisoflavone(NBF),bavachin(BC),corylin(CN),bavachromene(BCM),psoralidin(PD),isobavachalcone(IBC),bavachinin(BCN),corylifol A(CA)and bakuchiol(BK).Raw materials originated from different regions were compared through fingerprint similarity and principal component analysis(PCA).Then with PS as the internal marker,QAMS was successfully applied in quantitation of 10 compounds in BGZ,and the calculation results were proved to be highly correlated with the results determined by external standard method with no significant difference.2.Chemical constituents in Fructus Psoraleae before and after processing were compared via HPLC fingerprint,resulting in no variance of the main composition.But an obvious decline of total content of PO and IPO and a slight increase of BK were found in YBGZ,while the contents of coumarins and flavonoids remained unchanged.Simultaneously,revalidation of QAMS method was applied in 15 batches of YBGZ decoction slices,and it turned out to be a feasible and repeatable method,providing a referential quality evaluation system with multiple indicators for YBGZ decoction slices.3.15 batches of YBGZ standard decoction dried by freezing were studied,based on which the quality evaluation system of YBGZ standard decoction was built.The HPLC fingerprint was characterized with 7 commone peaks,among which,PO,IPO,PS and IPS,the main effective constituents,were selected as Q-marker,with the total content of(7.81± 1.03)%and extract transfer rate of(66.29 ±19.93)%,and the average extract yielding rate was 17.8%.All parameters range from 70%to 130%of the mean values in consideration of practical manufacturing,which were taken as the target to further investigate the extracting,concentrating,drying and preparation process.The processing technique was finally determined as:adding 8/6 BV of water,refluxing twice for 1 h each time,concentrating under 60 ℃,concentrated extract at the density of 1.05～1.10 g/mL,air inlet at(180 ± 3)℃ and flow velocity of 70～80 rpm in spray drying,soluble starch added at the ratio of 1:0.6(dry extract to excipient).Three pilot scale test results were all wthin the pramater scopes of standard decoctions.4.Chemical variances between self-made YBGZ dispensing granules and raw material,decoction slice,standard decoction and dry extract were discussed by correlation analysis of characteristic chromatogram.The main active substances,PO,IPO,PS and IPS,with good traceability,were proposed to serve as Q-marker of YBGZ dispensing granules,and evaluated quantitatively by QAMS method.In accordance with parameters of standard decoctions and actual values in terms of equal quantity,every one gram of prescription dose was equal to(5 ± 0.2)g decoction slices.The quality evaluation system of YBGZ dispensing granules was established tentatively,with an extract yielding rate of 12.5%-23.3%,total contents of Q-markers ranging from 3.5%to 10.9%,and transfer rate from 46.4%to 86.2%.