Research On The Qualitative And Quantitative Standard For Fei Lao Granule

Abstract:Fei Lao Granule, which is being studied at the Affiliated Hospital of Luzhou Medical University, is a pure Chinese Medicinal compounded preparation for the treatment of pulmonary tuberculosis(TB).Objective:To establish the quality standard of Fei Lao Granule, qualitative and quantitative analysis of Fei Lao Granule were studied, which can be used as part of the main indications of quality standard of Fei Lao Granule.Method:According to the requirements of technology for new Chinese Medicinal compounded preparation studying,methods were established as follows:①Thin-layer chromatography was used for qualitative of Rhizoma Bletillae, Radix Scutellariae, Houttuynia cordata Thunb, Radix Ranunculus Ternati, Radix Astragali, Radix Pesudostellariae, Radix Ophiopogonis, Stemonaceae, Schisandra chinensis (Turcz.) Baill in the recipe. Conditions of abstracting,purifying and chromatographic system are to be acquired through experimentations, and qualitative identifications of Fei Lao Granule established.②A RP-HPLC method is to be developed for determination of assay of Baicalin in Fei Lao Granule. Conditions of abstracting, purifying and chromartographic system are to be acquired through experimentations. The method established is to be tested in linearity, precision, recovery, accuracy, etc. Content limitation of Baicalin will be acquired by the results of determination of six batches of Fei Lao Granule.Results:①Radix Scutellariae and Schisandra chinensis (Turcz.) Baill were separately identified in the sample by TLC, and the spots were clear and concentrated. Qualitative identified of adix Scutellariae and Schisandra chinensis (Turcz.) Baill were placed in the qualitative standard of Fei Lao Granule.②Chromatographic system:The analytical column was a Phenomenex C18(4.6mm×250mm,5um) column. The mobile phase was acetonitrile-0.1% Orthophosphoric acid(30:70). The flow rate was 1,0 ml/min, and the UV detection wavelength was 280 nm. The linearity was good in the range of 0.0193-0.0963mg/ml(r=0.9993).There are no peaks in the vicinity of the peak of Baicalin in the blank sample. Detection is stable within 24h. The average recovery method was 97.78%(n=6).The precisions are 0.406%(within-day)and 0.25%(between-day).A sensitive, simple and accurate method was developed for the determinations of Baicalin. Content limitation of Baicalin (C21H18O11) in 1g Fei Lao Granules was 2.0mg/g. Conclusion:Qualitative identifications of Radix Scutellariae and Schisandra chinensis (Turcz.) Baill and quantitative analysis of Baicalin can be used as the quality control of Fei Lao Granule.