| Objective:Ershiwuwei Ercha pill which can chubi, diminish inflammation, relieve pain, is a traditional Tibetan medicine prescription, included in the Health Department of the People’s Republic of China drug standards? Tibetan Book1. In this study, improve the quality standards of Ershiwuwei Ercha pill to achieve effective quality control.Method:To establish a TLC method for the identification of Casssia, Piper Longum, Woody, Thistles; Investigated moisture, weight variation, dissolution time, heavy metals. To establish a high performance liquid chromatography (HPLC) method for determination of limited quantity of toxic components Aconitine. To determine contents of catechin, epicatechin by HPLC, and then the methodology study was promoted.For the first time, to determine six kinds of ingredients of Ershiwuwei Ercha pills by a new method of quantitative analysis of multi-components by single marker(QAMS). To calculate relative correction factor(RCF) for Gallic acid, Catechin, Gentiopicroside, Costunolide, Dehydrocostus lactone relative to Piperine as an internal content. And then evaluate this method of durability and adaptability evaluation of system. To posite chromatographic peaks of Gallic acid, Catechin, Gentiopicroside, Costunolide, Dehydrocostus lactone by comparing the methods of the relative difference of the retention time and the relative retention value. To determine contents of piperine in Ershiwuwei Ercha pills by external standard method, and then calculate contents of other constituents through RCF. And caculate the contents of other constituents through external standard method, then compare this method with external standard method.Result:The TLC identification methods of Cassia, piper longum, Woody, Thistles have good specificity and repeatability. And each of the test with the corresponding reference or the reference drug with the same color spots in the same location under the same chromatographic conditions. The TLC spots were quite clear and the blank test showed no interference.The limited quantity of Aconitine was determined by HPLC, the linear regression equation is Y=989736.5x+757.10, the correlation coefficient r was0.9999, the linear range is0.02992-0.2244μg, the average recovery is102.2%and RSD is2.21%（n=6).The limited quantity of Catechin was determined by HPLC, the linear regression equation is Y=738457.70x+7961.25, the correlation coefficient r was0.9997, the linear range is0.036~1.800μg, the average recovery is98.75%and RSD is1.67%(n=6). The limited quantity of Epicatechin was determined by HPLC, the linear regression equation is Y=641223.65x+11740.32, the correlation coefficient r was0.9999, the linear range is0.039~1.950μg, the average recovery is96.73%and RSD is0.77%(n=6). To determine the contents of six compositions in Ershiwuwei Ercha pills by QAMS method at the same time. The RCF relative to Piperine of Gallic acid, Catechin, Gentiopicroside, Costunolide, Dehydrocostus lactone were2.26、11.91、6.779、3.688、5.897。A small change in the chromatographic conditions to the composition of relative correction factor has no obvious influence. The contents of Gallic acid, Catechin, Gentiopicroside, Piperine, Costunolide, Dehydrocostus lactone by QAMS method and the external standard method have no obvious influence. The relative difference of retention time for Gallic acid, Catechin, Gentiopicroside was-66.76、-47.48、-38.81, and RSD was2.72%、2.44%、1.72%, respectively; and different instruments and chromatographic columns of the relative retention value for Costunolide, Dehydrocostus lactone was1.05、1.07, and RSD was0.71%、0.77%, respectively.Conclusion:Experimental results show that the proposed quality standards are controllable for the agents, fully and effectively and determination of six components of the quantitative analysis of multi-components by single marker method, accurate, fast, simple and inexpensive. |
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