ABSTRACT
OBJECTIVE:To establish the method for content determination of cantharidin in Lytta caraganae,and to use the result as the extract screening evidence of L. caraganae source material. METHODS:Ultrasonic extraction method was used to extract cantharidin from L. caraganae using acetone as solvent. HPLC method was adopted to determine the content of cantharidin. The determination was performed on C18column with mobile phase consisted of methanol-water(23:77)at flow rate of 1.0 mL/min. The detection wavelength was set 230 nm,the column temperature was set at 35 ℃,and sample size was 10 μL. The content of cantharidin in L. caraganae was determined and compared with the results of content determination by the method stated in Chinese Pharmacopeia(using chloroform as extraction solvent). RESULTS:The liner range of cantharidin were 0.2-1.0 mg/mL (r=0.998 8)with average methodology recovery rates of 101.1%(RSD=1.7%,n=6). The average content of cantharidin in L. caraganae was 0.932%(n=3),while the content of cantharidin was 0.793%(n=3)determined by the method stated in Chinese Pharmacopeia. Both were higher than the requirement of Chinese Pharmacopeia that the content of cantharidin in scource material of cantharidin was higher than 0.35%. CONCLUSIONS:Established method is accurate and reliable for the content determination cantharidin in L. caraganae. The content of cantharidin is up to the standard of Chinese Pharmacopeia,and can be used as source material for exacting cantharidin.
ABSTRACT
Objective To improve the quality of clinical biochemistry laboratory by quality indicators of pre-analytical,analytical,post-analytical phase and the whole process.Methods Analytical Phase:The Sigma values of items were calculated,applying the equation Sigma =(TEa％-Bias％)/CV％.Total allowable error (TEa) is from analyticalal specification defined in WS/T403-2012 of China,Bias％ is from the evaluation results of National Center for Clinical Laboratory (NCCL) trueness verification PT series and CV％ is from internal quality control data during the last 6 months in our lab.Normalized Sigma metrics plot was made to evaluate the analysis performance and the quality control strategies were designed accordingly.The quality goal indexes (QGI) were also calculated to propose improvement measures for items below 6 Sigma.Quality indicators of pre-,post-analytical and whole analytical phase,such as quality of specimen,critical value notification,critical value notification in time,TAT of hs-cTnT,TAT of emergency biochemical items,rewrite of laboratory reports and unacceptable performance in EQA-PT were measured in Sigma metrics too.The Sigma metrics changes before and after taking improvement measures were compared to conform the effectiveness.Results The average Sigma value of 17 biochemical tests was 5.29,of which 8 items (UA,K,ALP,CK,AMY,AST,TG,Na) achieved excellent to world class level (≥ 5 Sigma),6 items (LDH,Cre,TC,ALT,Mg,Glu) achieved marginal to good level (5 ＞ Sigma ≥ 3),BUN performed poorly (3 ＞ Sigma ≥ 2),Ca,TP performed unacceptably (Sigma ＜ 2) with serious quality defects.The Sigma values of unacceptable specimen,critical value notification,critical value notification in time,unacceptable turn around time (TAT) of hs-cTnT,unacceptable turn around time (TAT) of emergency biochemical items,rewrite of laboratory reports,unacceptable performance in EQA-PT were 4.17,3.60,2.75,1.72,3.27,4.52,3.33 respectively,rising to 4.30,4.30,2.90,2.45,3.75,4.80,3.60 accordingly after improvement.Conclusions Sigma metrics is potentially an ideal approach for clinical biochemistry laboratories management,which is helpful to find out problems,put forward improvement measures,and confirm the effectiveness,so as to achieve the purpose of continuous quality improvement.