Study On Quality Standard For Bushenqiangshen Tablets

Objective:To improve the quality standard of Bushenqiangshen tablets.Methods:1.To establish a new TLC identification method for semen Cuscuta and Ligustrum lucidum in Bushenqiangshen tablets.2.A new ICP-AES method for the determination of heavy metals in Pb,Cd,Hg and As of Bushenqiangshen tablets was established.3.A HPLC method for the determination of icariin and privet glycosides in Bushenqiangshen tablets was established.Results:1.The TLC identification method of effective component Cuscuta chinensis was determined.The Cuscuta chinensis in Bushenqiangshen tablets was treated by petroleum ether and ethanol,and the residue was extracted by ethanol.The extract was used as the sample solution,and the toluene-ethyl acetate-formic acid?5:5:3?was used as the developer.The silica gel G plate was selected for the experiment.The specific shift value was 0.6.The method has clear color,good specificity and no interference in negative.In addition,the TLC identification method of Ligustrum lucidum was also determined.Oleanolic acid in tonifying kidney and strengthening body tablets was extracted by trichloromethane,filtered,steamed,and the residue was dissolved in methanol solution as the test solution.The experiment was carried out with silica gel G plate as thin layer plate and petroleum ether-acetone-ammonia test solution.?7:5:0.5?as the developer,the specific shift value is 0.5.The method has obvious spots,good specificity and no interference in the negative.2.The microwave digestion technology combined with ICP-AES was determined.At the same time,the limits of heavy metal impurities Pb,Cd,Hg and As in Bushenqiangshen tablets were examined.The detection limit of heavy metal Pb at 220nm wavelength was 20 ng/mL,and the linear relationship was good in the range of 66-5000 ng/mL,r=0.9998.The recovery rate of sample addition was 98%and RSD was2.3%?n=6?.The detection limit of Cd at 214 nm wavelength was 2 ng/mL,and the linear relationship is good in the range of 5-5000 ng/mL,r=0.9999,the recovery rate of adding samples was 87%,RSD=1.2%?n=6?.The detection limit of Hg at 184 nm wavelength was 17 ng/mL,and the linear relationship was good in the range of 57-5000 ng/mL,r=0.9995,the recovery rate of adding samples was 87%,RSD=2.5%?n=6?.The detection limit of As at 189 nm was 40 ng/mL.The linear relationship was good in the range of 133-5000 ng/mL,r=0.9998.The recovery of As was 99%and RSD was 1.5%,respectively?n=6?.The method was simple,efficient,wide linear range,less reagent and less pollution.3.A new method for the determination of icariin in Bushenqiangshen tablets by high performance liquid chromatography was established.The extract was extracted by 50%ethanol solution and the extract was used as the sample solution.The chromatographic conditions were as follows:detection wavelength was 270 nm;Waters Symmetry C18 column?200×4.6 mm,5 micron?,column temperature was35?;acetonitrile-water?30:70?was mobile phase.The linear relationship was good in the range of 10-161?g/mL,r=0.9999,and the sample was recovered.The recovery rate was 98%and RSD was 2.2%?n=6?.This method was accurate,specific,simple and efficient.A method for determining the content of Ligustrum lucidum in Bushenqiangshen tablets by HPLC was established.The extract was extracted by ultrasound with 50%ethanol solution as the sample solution.The chromatographic conditions were as follows:detection wavelength 224 nm;Agilent C₁₈?250×4.6 mm,5?m?;column temperature 35?;methanol:water?45:55?as mobile phase;the linear relationship was good in the range of 20-179 ng/mL,r=0.9999;the average recovery was 97%after sample addition,RSD was 1.5%;the method was accurate,precise and had a wide linear range.Conclusion:The TLC method for identification of Cuscuta chinensis and Ligustrum lucidum in Bushenqiangshen tablets,ICP-AES method for determination of heavy metal impurities such as Pb,Cd,Hg and As,supplemented the HPLC method for determination of icariin and Ligustrum lucidum,which provided experimental basis for quality control and improvement of Bushenqiangshen tablets.