The Studies On Zicao Spray

OBJECTIVE: To prepare a new preparation of Chinese materia medica, Zicao spray, for allergic coryza.METHODS: The extraction conditions of lithospermi were optimized with the different concentrations of alcohol as extracting solvent and with the l-shikonin content as the index using orthogonal test. With 95% alcohol used as solvent, 1,2-propylene glycol as solvent and penetration enhancer, Tween-80, polyglycol as solubilizing agent, the optimum formulation of Zicao spray was selected with orthogonal test ,using the cumulative amount of l-shikonin in Zicao spray permeating the frog skin in vitro as the index. The permeation of l-shikonin across the frog skin in vitro were investigated, as well as the preliminary stability of Zicao spray. The l-shikonin content in Zicao spray was determined by high performance liquid chromatography (HPLC) to establish the tentative quality standard of the preparation. The mucosa irritation experiments and elementary pharmacodynamics tests of Zicao were also conducted.RESULTS: The optimized extraction and exaltatation conditions of lithospermi were as follows: Soaking 12h with 5 times 80% alcohol and percolating 4h with 10 times 80% alcohol,reclaiming alcohol, Mixing with 2% NaOH of 4 times medical material,sedding,coletting and mixing with HCL ,coleting and then washing the sedimentation by water to neutral and drying it up. The optimum formulation of Zicao spray consist s of 2% alcohol,20%1,2-propylene glycol and 5% polyglycol.The process of percutaneous permeation of Zicao spray in vitro across the frog skin was zero-order (r>0.99), and the kinetic equations were Q=3.5737t+30.6,r=0.9949. The results of preliminary stability experiments indicated that Zicao spray were stable and the drug content of the spray was not obviously changed at ordinary temperature during six months.The quality standard was simple, convenient and practical, which can be used for controlling the quality of Zicao spray. In addition, the results of mucosa irritation experiments and elementary pharmacodynamics tests showed that it is almost no irritation and it is effective in prevention and treatment for allergic coryza of pig cony.CONCLUSIONS: The well-chosen preparation technology of Zicao spray is reasonable and reliable,and the qualitiy control methods are practicable. It is effective to preventing and treating allergic coryza of pig cony with almost no irritation.The study results mentionged above show that it is valuable for further research and development.