Study On Manufacturing Technique And Quality Control Of Maluhuangxian Mixture In Medical Institution Preparation

By now western medicine has no effective remedy for ulcerative colitis(UC), while Chinese traditional medicine is comparatively advantageous to the treatment of UC because for its therapy features multi-link, multi-target, multi-channel and generality.Chinese traditional drugs in Gansu province predominate China, so applying indigenous medicinal materials to the clinics is the significant topic in the current interest in Gansu province even in the whole country.The essential component of Maluhuangxian mixture is kronopolites svenhedini indigenous to Linxia area in Gansu province. This preparation, comprising Longmalu, Scutellaria baicalensis, Hairyvein Agrimonia, Herband Bud, white peony root and Licorice, has therapeutic effect on UC. Guided by the theory of Chinese traditional medicine in combination with modern scientific technology and methods, the research project covers the systematic experiments including the preparation process and the quality standard, which lays a scientific basis on promising novelty preparation in medical institution.Research contents are listed below.Firstly, attributive analysis and identification of its medicinal materials were performed by HPLC. Our found the sources of 33 chromatographic peaks and separately identified such five index components as peoniflorin, baicalin, baicalein, wogonin and ammonium glycyrrhizinate. Over five ingredients in Maluhuangxian mixture were simultaneously by ultra performance liquid chromatography with photo-diode array detector(UPLC-DAD, which aids to subsequently controlling its quality and formulating its draft of quality standard.Secondly, study on preparation process: using baicalin and extraction ratio as indexes the optimal extraction technology is listed below. Totally add 12 times(five time, four times and three times) amount of water, decoct for 2 times, for 1.5 h each time. Three batches of pilot samples were found be stable.Thirdly, study on quality standard: white peony root and Licorice in the preparation were identified by TLC. In chromatographic spectrum test products have the same Rf value and color as reference substances, and negative control gave no interference. Extensive tests indicated the superior repeatability. A method for quantifying baicalin in the preparation by HPLC was established. Methodological survey showed its application and repeatability. Draft for quality standard was laid down according to the above results. These methods are simple, accurate and reliable to control the quality of Maluxian mixture effectively.Fourthly, stability study: affecting factor trials involving high temperature and strong radiation and long-term test for 6 months were conducted. Test indicated the products have good compatibility with package receptacles directly in contact in 6 months.