Study On The Quality Standards Of Weitengning Capsule

Objective: To establish the Quality Standards of Weitengning Capsule.Methods: TLC was used to identify the Intermediate A, and verify the inclusion ofIntermediate A.GC was used to determine the determination of cineole in Intermediate A,Method of GC was developed to establish the fingerprints of Intermediate A with the peakof cineole as reference.(2) TLC was used to identify the Intermediate B;UV was used todetermine the determination of total flavonoids in Intermediate B.HPLC was used todetermine the determination ofpinostrobin in Intermediate B; Method of HPLC wasdeveloped to establish the fingerprints of Intermediate B with the peak of Pinostrobin asreference.(3) TLC was used to identify the Weitengning Capsule;GC was used to determinethe determination of cineole in Weitengning Capsule. UV was used to determine thedetermination of total flavonoids in Weitengning Capsule.HPLC was used to determine thedetermination of pinostrobin in Weitengning Capsule; Method of GC was developed toestablish the fingerprints of Weitengning Capsule with the peak of cineole asreference;Method of HPLC was developed to establish the fingerprints of WeitengningCapsule with the peak of Pinostrobin as reference.Results:（1）TLC was used to identify Weitengning Capsule and the Intermediates:(1)The cineole as reference;Lindera refLexa Hemsl.as the control herbs;Developing solvent:n-hexane-ethyl acetate (7:1);Chromogenic agent:5%vanillin sulfuric acid solution.(2)Thepinostrobin as reference;Lindera refLexa Hemsl.as the control herbs;Developingsolvent:petroleum ether-acetone(3:1);Chromogenic agent:1%AlCl3ethanol solution; UVdetection wavelength:365nm.（2）GC was used to determine the determination of cineole in Intermediate A andWeitengning Capsule,as well as to establish the fingerprints of Intermediate A andWeitengning Capsule with the peak of cineole as reference. The analysis was carried out ona Agilent HP-5.capillary column(320μm×0.25μm,30.0m).The temperature of FID detectorwas set to240℃;The temperature programm was follows:65℃for threeminutes;3℃/min,65℃â†'85℃;1℃/min,85℃â†'90℃;3℃/min,90℃â†'99℃;0.2℃/min,99℃â†'100℃;5.0℃/min,100℃â†'200℃; and then retained the temperature at200℃for threeminutes.The regression equation was Y=2941.7X+61.89（R=0.9992）,in the range of0.108μg～0.542μg good linear relationship.the average recovery of Intermediate A was 99.82%,RSD=1.74%（n=6）;the average recovery of Weitengning Capsule was99.22%,RSD=2.13%（n=6）.（3）UV was used to determine the determination of total flavonoids in Intermediate Band Weitengning Capsule with Pinostrobin as reference.Determined by UV detectionwavelength was286nm, the regression equation Y=71.51x+0.0426（R=0.9992）, at0.002mg/ml～0.016mg/ml range, good linear relationship.the average recovery rate ofIntermediate B was100.63%,RSD=2.17%（n=6）;the average recovery rate of WeitengningCapsule was100.77%,RSD=1.77%（n=6）.（4）HPLC was used to determine the determination of Pinostrobin in Intermediate Band Weitengning Capsule,as well as to establish the fingerprints of Intermediate A andWeitengning Capsule with the peak of Pinostrobin as reference.The analysis was carried outon a Waters Symmetry C18(4.6mm×250mm,5μm), with mobile phase consisting ofMeOH-H2O (25%~100%),with gradient elution at the flow rate of1.0ml/min. Thedetection wavelength was297nm, the column temperature was30℃.The regression equationwas Y=3E+06X-15263（R=0.9994）,in the range of0.10μg～2.00μg good linearrelationship.the average recovery of Intermediate A was100.63%，RSD=2.17%（n=6）;theaverage recovery of Weitengning Capsule was100.77%，RSD=1.77%（n=6）.（5）Under stable conditions, to prepare the11batches of samples for analysis.GCfingerprint marks the14peaks,11batches of Intermediate A met the degree fingerprints allover0.992;11batches of Weitengning Capsule met the degree fingerprints all over0.985.HPLC fingerprint marks the12peaks,11batches of Intermediate B met the degreefingerprints all over0.999;11batches of Weitengning Capsule met the degree fingerprintsall over0.986,indicating that the enrichment process stable and controllable. Identified byone of seven components identified.Conclusion: TLC and the methods of content determination of Weitengning Capsuleand Intermediates are preliminarily obtained,and Fingerprints provide the basis for qualitycontrol of Weitengning Capsule and Intermediates.This study show that The qualityofWeitengning capsule is stable,The method of quality control can be simply operated andhave good reproducibility.This provides theoretical basis for quality control and guaranteesthe quality and security in clinical medicine.