| Fructus Schisandra Chinensis, Schisandra Chinensis Baill plant's dry mellow fruit, can astringe the lung, nourish the kidney, promote the production of body fluid to quench thirst, tranquilize the mind and so on in Traditional Chinese Medicine theroy and treat hepatitis, liver and gall's calculus and asthma in modern clinic. At the beginning of 1970's, some clinical reports showed that Fructus Schisandra Chinensis has efficiency in lowering abnormal SGPT level of patients suffering from chronic hepatitis. Lignans were regarded as the most bioactive ingredients in pharmacological trials. Thus, by determining lignans in Fructus Schisandra Chinensis and its preparations, we can not only give one guideline for their quality control, but also provide a reference for reasonable administration in clinic. However, at present, no paper has investigated deeply the total level of lignans, so in this study, a method was established to assay Deoxyschizandrin and Schisandrin B in order to express the level of lignans indirectly. In China, Hugan Tablet and Weiganfutai Tablet are two categories of medicine containing Fructus Schisandra Chinensis as the main component to treat liver disease. But the standards to control their quality do not react comprehensively to the level of lignans extracted. It is necessary to develop a method to improve that. Objective: To establish a reversed-phase HPLC method for determination of Deoxyschizandrin and Schisandrin B in Fructus Schisandra Chinensis, Weiganfutai Tablet and Hugan Tablet in order to provide one guideline for their quality control. Methods: ①Deoxyschizandrin and Schisandrin B from Fructus Schisandra Chinensis, Weiganfutai Tablet and Hugan Tablet were extracted with methanol through supersonic wave, then the extract solution was filtered. The continuations were diluted to a certain concentration. ②Choose appropriate chromatogram column and adjust the formulation, proportion and flow rate to separate the peaks of Deoxyschizandrin and Schisandrin B well. ③ Preparation of standard curve: Prepare a series of the reference solution, and then determine peak area under above-mentioned condition. The regression equation was obtained with the content of Deoxyschizandrin and Schisandrin B as abscissa and the relevant peak area as ordinate.④ Confirmation of the lowest detection limitation: Dilute the reference solution until the value of S/N was more than 3. The relevant concentration was the lowest detection limitation. ⑤ In the experiment of stability, transfer the sample solution from Weiganfutai Tablet to determine the relevant peak area at 0, 2, 4, 6, 8, 10 and 12 hour, respectively. ⑥ In the experiment of precision, take the same test solution, inject it into the apparatus, determine the peak areas of Deoxyschizandrin and Schisandrin B and calculate the concentrations of Deoxyschizandrin and Schisandrin B in comply with the same standard curve with the same apparatus in the same day, record the chromatograms, then calculate the precision. ⑦ In the experiment of reproducibility, prepare the sample solution and repeat in the same way, respectively. Assay the concentrations of the solutions. ⑧ In the experiment of recovery, transfer 5 shares of Weiganfutai Tablet and add the reference solution, respectively. Detect the content of Deoxyschizandrin and Schisandrin B of every sample. ⑨ The samples of Fructus Schisandra Chinensis,Weiganfutai Tablet and Hugan Tablet were analyzed under above-mentioned conditions. Results: ①The method of supersonic wave-extraction was simple, quick and stable. ②Under the conditions of this experiment, the mobile phase was acetonitrile -water- acetic acid glacial (70: 30: 0.1) at the flow rate of 1.0mL·min-1, the detection wavelength was set at 254nm, and the volume of injection was 20μL. Under the circumstance, the peaks of these samples were separated well with the resolution of no less than 1.5, the column efficiency is no less than 4000 theoretical plates, the tailing factors for the peak were from 1.12 to 1.16. ③W...
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