| Kuiyangling Capsule was included in the fifth book of traditional Chinese medicine prescription preparations,consisting of a total of nine herbs,they are Panax pseudoginseng?Radix Astragali?Corydalis yanhusuo?Fritillaria thunbergii?Acacia catechu?Glycyrrhiza uralensis?Sepia esculenta?Bletilla striata?Lilium brownii.This article has been studied for its quality standards,and were determined on the content of heavy metal.In the prescription,Panax pseudoginseng?Radix Astragali?and Corydalis yanhusuo was discriminated by the method of TLC,and act the TLC as the qualitative analysis.Besides the Panax pseudoginseng methods of content Determination is set up in Kuiyangling Capsule,and Ginsenoside Rg1?Ginsenoside Rb1?Notoginsenoside R1 is choosed as its index components in the experiment.The method is use of reversed-phase HPLC method,column select Welch Uitimate XB-C18,select the acetonitrile-water Solution as mobile phase,the way of gradient elution,the column temperature was set at 30?,the choice for the detection wavelength 203nm,the flow rate is set to 1mL/min,the sample volume is selected as 10?L.By the experimental results,the standard curve equation of Notoginsenoside R1 is Y=2384.6X-714.99,its R2 is 0.9998,and within the range of 15.9-159.4?g/mL,it has good linear relationship,the average recovery of sample is 95.52%,RSD was calculated to be 1.06%.The standard curve equation of Ginsenosides Rb1 is Y=2538.3X-3904.4,its R2 value is 0.9998,and within the range of 51.4?513.8?g/mL,it has good linear relationship,the average recovery of sample is 98.25%,RSD was calculated as 1.09%.The standard curve equation of Ginsenosides Rg1 was Y=2601.2X-2630.6,its R2 value is 0.9996,and within the range of 49.9?499.4?g/mL,it has good linear relationship,the average recovery of sample was 97.32%,RSD was calculated as 1.16%.This method for the content determination has the Feature of high accuracy,good repeatability,and was acted as Kuiyangling Capsules' quantitative analysis.Then moisture content determination?the load difference inspection?disintegration examination was made of the capsule,and the results are in line with relevant regulations.Qualitative and quantitative analysis method in the experiments do well as quality standards to control the quality of products,and is good for achieving the purpose of drug safety.In addition to,the heavy metal content of Pb,Cd,As,Hg,Cu,Cr were determined in the Capsule and its shell,and microwave digestion conditions were optimized.In the particular experiment,the determination of Pb and Cd selected graphite furnace atomic absorption spectrophotometry.After optimization of experimental conditions,selecting 8 mL HNO3 and 2 mL H2O2 as the digestion solution,it was allowed to stand overnight,temperature programmed 30 minutes digestion the Sample,in the experimental results,the good linear correlation of Pb is 0-20 ng/ml,the standard curve equation was y=0.0184x+0.0127(R2=0.9993),the average recovery rate of sample was 98.66%,RSD was calculated to be 2.14%;The good linear correlation of Cd is 0-2.0 ng/ml,its standard curve equation was y=0.4364x-0.0162(R2=0.9997),the average recovery rate of sample was 98.40%,RSD was calculated to be 2.06%;Cu was Determined by flame atomic absorption spectrophotometry.selecting 8 ml HNO3 and 2 ml H2O2 as the digestion solution,it was allowed to stand overnight,temperature programmed 30 minutes dige-stion the Sample,in the experimental results,the good linear correlation of Cu is 0-0.8?g/mL,the standard curve equation was y=0.0129x+0.0003(R2=0.9997),the average recovery rate of sample was 98.00%,RSD was calculated to be 2.05%;The content of As and Hg was determined by Atomic Fluorescence Spectrometry,selecting 8 ml HNO3 and 2 ml H2O2 as the digestion solution,it was allowed to stand overnight,temperature programmed 40 minutes digestion the Sample,in the experimental results,the good linear correlation of As is 0-10?g/L,the standard curve equation was y=287.65x-41.802,(R2=0.9999),the average recovery rate of sample was 97.92%,RSD was calculated to be 1.77%;The good linear correlation of Hg is 0-1.0?g/L,the standard curve equation was y=2819x+35.994,(R2=0.9995),the average recovery rate of sample was 98.15%,RSD was calculated to be 1.85%;Cr was Determined by graphite furnace atomic absorption spectrophotometry.selecting 8 ml HNO3 and 2 ml H2O2 as the digestion solution,it was allowed to stand 2 hours,temperature programmed 25minutes digestion the Sample,in the experimental results,the good linear correlation of Cr is 0-80ng/ml,the standard curve equation was y=0.0065x+0.035(R2=0.9995),the average recovery rate of sample wa-s 97.98%,RSD was calculated to be 1.80%;The heavy metals experimental methods has the feature of high accuracy and good Operability,it can provide another basis forquality control. |
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