Study Of Xiaoyuzhitong Spray And Its Therapeutic Basis

"Honghua xiyao"(2006F12010) ,a powder of traditional Chinese medicine, is made by PLA No.254 hospital .It has been used for 20 years to treat traumatic injuries, and pain due to wind-dampness. Because of its disadvantages such as inconvenient application method and carries due to aged dosage form, low bioavailability, slow effect and so on, new dosage form (Xiaoyuzhitong Spray) is developed on the base of the original prescription in the paper.The results of preparation procedure show that the contents of HSYA and kaempferide in Carthamus tinctorius, imperatorin in Angelica dahurica, oleanolic acid in Clematis chinensis are higher in extract of alcohol than those in extract of water. Moreever, the analgesic effect of spray made by alcohol extract is conspicuous. Hence, alcohol is used as extraction solvent in the new praeparatum. Percolate technology in preparation procedure is optimized by utilizing orthonal design method. Optimal extraction technology conditions are 50% alcohol, soak time 48h, percolate speed 5mL/min, 6 times of percolate. Quality control standard of spray is established. Carthamus tinctorius, Angelica dahurica, Angelica sinensis and Ligusticum chuanxiong are detected by TLC and the content of hydroxyl safflower yellow pigment (HSYA) is monitored by HPLC. Its term of validity is one year in room temperature (25°C) .Pharmacodynamic action experiment shows that spray on pain perception due to heat stimulation is definite antagonistic effect and spray in analgesic effect corresponds to Yunnan white powder aerosol. Spray has definite anti-acute inflammation activity. Spray in anti-inflammatory effect corresponds to Yunnan white powder aerosol and Fluocinolone. The result of skin acute toxicity, skin stimulus, skin allergic experiments and others show that the spray is a safe preparation for external use due to its low toxicity.In addition, therapeutic basis of spray is studied preliminarily in the paper. The hydroxyl safflower yellow pigment (HSYA) is the most important effective component in Carthamus tinctorius. The results show that in vitro hypoxia-induced nerve cell damage in the body and a short focal cerebral ischemia-reperfusion injury HSYA has a neuroprotective effect, it attributes protective effect of HSYA to suppressing partly inflammation response induced by the focal ischemia-reperfusion injury and suppressing pro-inflammatory cytokines effects.