Study On The Quality Standard Of Tongqiao Erlong Pills

Object iveTongqiao Erlong pills is made up of12Chinese herbal medicines such as Radix Gentianae, Radix Scutellariae, Fructus Gardeniae, Aloe, Radix Angelicae Sinensis, Indigo Naturalis, Radix Bupleuri, Costus Root with effect of purging liver-fire and relaxing the bowels.It is used for the treatment of intense fire in liver, Deafness, tinnitus, Earache, and so on. The existing quality standard of Tongqiao Erlong Pills is written in the first Drug Standard of the Health Ministry. However, It is difficult to control the quality of Tongqiao Erlong pills completely due to the lacking of the qualitative and quantitative control methods of components in the medicine. The purpose of this research is to improve the quality standard of Tongqiao Erlong pills and control the quality effectively.MethodsUse the thin-layer chromatography(TLC) to carry on the qualitative distinction of Costus Root, Radix Angelicae Sinensis, Radix Scutellariae, Fructus Gardeniae, Radix Bupleuri, Radix Gentianae, Aloe, Indigo Naturalis in the preparation.Taking gentiopicrin as the target, A reversed-phase high performance liquid chromatography (HPLC) method was developed to determine Radix Gentianae in the preparation. HPLC analytical method was carried out by using a Diamonsil C18column(4.6mm×250mm,5um)and a mixture of acetonitrile-water (15:85) as the mobile phase. The detection wavelength was set at275nm. Taking baicalin as the target, A reversed-phase HPLC method was developed to determine Radix Scutellariae in the preparation. HPLC analytical method was carried out by using a Diamonsil C18column(4.6mmX250mm,5um)and a mixture of acetonitrile-0.2%phosphoric acid (26:74) as the mobile phase. The detection wavelength was set at278nm. ResultsIn the identification, the sample displayed the same spots which were vivid and with high resolution as the reference substance did in the Chromatography, while the negative sample did not.In the essay, the liner ranges of gentiopicrin was0.24-2.7μg, liner regression equation was Y=20.375X-0.7398, r=0.9999. The RSD of precision, repeatability and recovery were less than3%. We finally determined that gentiopicrin (C16H20O9) should not be less than1.5mg pergrams of Tongqiao Erlong pills; the liner ranges of baicalin was0.45-3.15μ g, liner regression equation was Y-39.403X-0.2359, r=0.9998. The RSD of precision, repeatability and recovery were less than3%. We finally determined that baicalin (C21H18O11) should not be less than12mg pergrams of Tongqiao Erlong pills.ConclusionThe TLC methods for identification and the HPLC assay methods were simple, sensitive, specific, repeatable and accurate. These analysis method can be applied to the quality control of preparation.