Studies On The Quality Standard Of Ru Jiling Capsule

Ru Jiling capsule is the national basic drugsthe national basic drugs.There are 3 manufacturers of Ru Jiling capsule in China,there are 3 approval number.Problems found in the process of inspectio and evaluation:(One)Quality standards are not uniform,each enterprise to implement different quality biao.(Two)Standard defects.Hesperidin identification,separation effect is poor.The problems due to the standard,we conducted a for exploratory research;establish the TLC identification method for icariin,paeoniflorin,protocatechuic aldehyde,bupleurum root,Caulis Spatholobi,method is specific,the spots were clear.HPLC methods were established for the determination of icariin and paeoniflorin content,can be used as the quality standard of Ru Jiling capsule product quality control.Part one Studies on the methods to identify the Ru Jiling Capsule by TLCObjective: To establish a series of TLC methods to identify traditional Chinese medicinal herb in Ru Jiling Capsule in order to provide one guideline for product quality control.Methods:(1)Choose items for identification.(2)Choose the control articles for identification.(3)Optimization of the extraction method:different extraction methods,extraction solvents of different solvent composition and extration time were tested,for optimization of the effective extraction of test components from Ru Jilin Capsule,further more avoidance interference.(4)Optimization of the thin layer chromatographic conditions: the thin layer chromatographic conditions such as static phase,composition and proportion of developing agent were tested for optimization of the chromatographic conditions.(5)Select appropriate colouration or examine conditions in order to make out the speckle clearly.(6)The test of selectivity: negative control samples were analyzed to evaluate the selectivity of the developed method.Results:(1)List the items of identification of Epimedium Salvia miltiorrhiza,Radix Paeoniae Rubra,Bupleurum,lignum millettiae,and Green Tangerine Peel into the quality standard of Ru Jiling Capsule.Choose reference substance such as icariin,protocatechuic aldehyde,paeoniflorin,formononetin,hesperidin;reference medicinal herb such as Bupleurum and Caulis spatholobi.We didn't list the items of identification of vaccariae semen,dodder seed and rhizoma cyperi into the quality standard of Ru Jiling Capsule,because there was not any characteristic speckle in thin layer chromatogram during attempt.(2)The established method was applied for identification of salvia miltiorrhiza,Radix Astragali,Radix Angelicae Sinensis,Radix Paeoniae Rubra,Rhizoma Atractylodis Macrocephalae,and radix bupleuri in Ru Jiling Capsule.The result showed that the spots of the test solution were in the same position as those of the reference solution,without the interference of other chemical components originated from the coexisting herbs.Conclusion: The developed methods were proved to be accurate,sensitive and convenient,and can be used for the identification of Ru Jiling Capsule,which provided some guideline for qulity control.Part two Studies on the methods to determination of Ru Jiling Capsule by HPLCObjective: To establish a series of reversed phase high performance liquid chromatography methods for determination of the key chemical components in Ru Jiling Capsule,for ensure the safety,efficiency and qulity controllability of the product.Methods:(1)Choose items for determination.(2)Select the effective extraction of test components from Ru Jiling Capsule.(3)Choose appropriate chromatographic column,and adjust the formulation,proportion flow rate in order to separate the peaks of test components well.(4)Validated the methodology.(5)The established methods were applied for determination of icariin and peoniflorin in Ru Jiling Capsule of different production batches.Results:(1)List the items of determination of icariin,peoniflorinpeoniflorin into the quality standard of Ru Jiling Capsule,which is grounded upon the prescription,technology and studies material base of traditional Chinese herbal.(2)Optimization of the extraction method.For determination icariin Ru Jiling Capsule,was extracted with 70% ethanol by a sonifier for 30 min.For determination peoniflorin the preparation was extracted with methanol by a sonifier for 30 min.(3)The chromatographic condition: The HPLC system was performed on a C18 analytical column.The mobile phases for determination of icariin,,and peoniflorin were 0.075mol/L phosphoric acid solution(adjusted to pH 4.5 with three ethylamine)-acetonitrile(80:20),acetonitrile-water(15:85),separately.The detector for determination of icariin and peoniflorin was UV,and the wavelengthes were set at 270 nm,230 nm separately.(4)Validated the methodology: The calibration curves of icariin and peoniflorin showed good linearity at the ranges of 0.207~4.136?g,0.238~4.752?g and the average recoveries were100.0%,99.85%,with RSD of 2.2%,0.95% respectively.The reproducibilities of thses methods were good with RSD of 1.1%,2.0%.Conclusion: A series of reversed phase high performanceliquid chromatography methods for the determination of icariin and peoniflorin in the compound preparation of Ru Jiling Capsule were established.The developed methods were sensitive,precise,accurate and selective and can be applied for determination of the key chemical components in Ru Jiling Capsule for efficient quality control.