| LuTai soft capsule mainly by the Lycium barbarum,lutai composed of two crude drugs. It has the effectiveness of'nourishing blood, strengthening the spleen and replenishing qi, regulates menstruation dispelling the cold". The topic of my research is " Studies on the HPLC fingerprinting and the content determination of LuTai soft capsules". Designed by HPLC method to study lutai soft capsules, is to determine the chromatographic conditions, to establish a total fingerprint patterns and the content determination to study is thus to control the whole Lutai soft capsule quality. 1.Literature ReviewLycium barbarum is a valuable medicine beneficial traditional with nourishing liver and kidney, the benefits of a smart head and lungs cough, anti-aging and other effects. Lutai in medicine has the effect of Kidney yang and germ tonic. Along with herbal health functions authorized level rising, the study of the two high-profile drug and its preparation is also greatly enhanced the development potential.Chromatographic fingerprinting is a comprehensive and quantifiable means of identification. It 's consistent with Chinese characteristics, evaluation of the current Chinese authenticity, stability and consistency of the quality control mode 2. Studies on the HPLC fingerprinting of LuTai soft capsulesIn this study, solvent extraction using the system to inspect the extraction solvent, Chosen methanol as the extraction solvent;By orthogonal experiments, determined the optimum extraction; Based fingerprint map of the wavelength of UV absorption to determine the detection wavelength was 220nm; Through a variety of mobile phase of the study to determine the acetonitrile-0.5% phosphoric acid as the mobile phase gradient elution; Through exploration and optimization of chromatographic conditions to finalize the HPLC fingerprint of chromatographic conditions of LuTai soft capsules was:Column:Kromasil C18 (5μm 100A TiANHE(?) TH 1025 250mm×4.6mm S/N:06L25514); Mobile phase:Acetonitrile-0.5% phosphoric acid, gradient elution; Column temperature:30℃; The detection wavelength:220nm; The injection volume:10μl; Run 55 minutes. Verified by methodological, precision, reproducibility and stability are good, relative retention time and relative peak height of peak area greater than 10% of the main peaks are less than 3% RSD, Similarity greater than 0.95, Meet the fingerprint requirement. In the chromatographic conditions, study the fingerprint of the 10 approved LuTai soft capsules, using similarity evaluation software, established HPLC fingerprint Total model of LuTai soft capsules, containing ten common peaks. Provide a scientific basis for LuTai soft capsules 3. Studies on the content determination of LuTai soft capsulesIn this study, chlorogenic acid as reference substance, by determination of chlorogenic acid in LuTai soft capsules, conducted a quality standard of the LuTai soft capsules. In accordance with the 2005 version of "Chinese Pharmacopoeia" requirements, in this study the chromatographic conditions was:Column:SHISEIDO CAPCELL PAK C18 (4.6mm.I.D. X 250mm,5μm); Mobile phase:Acetonitrile-0.4% phosphoric acid; Column temperature:room temperature; The detection wavelength:326nm; Flow rate:1.0ml/min; The injection volume: 10μl; Run 30 minutes. In accordance with the established chromatographic conditions testing on the chlorogenic acid standard and test solution, Verified by methodological, linearity are good, the regression equation was y= 16601 x-2431.1, r=0.9992. Precision, reproducibility, stability are also goods. Further enriched the quality control of LuTai soft capsules.In this study,by the Studies on the HPLC fingerprinting and the content determination of LuTai soft capsules. Lay the foundation for the quality control of LuTai soft capsules, effective protection of legitimate rights and interests of consumers... |
PDF Full Text Request