The Preliminary Pharmaceutical Research Of Ku Jing Ointment

Ku Jing Ointment is the preparation consists of Sophora flavescens Ait, Schizonepeta tenuifolia. It has the function of clear away heat and eliminate dampness, dispelling wind and arresting itching, mainly used for eczema and skin itching and other allergic skin diseases. With the guidance of Traditional Chinese Medicine, combined with the technology of modern preparation and topical formulations require, the Ku Jing Ointment was studied pri-clinical preliminary pharmaceutical qualities. To provide a safe, effective and convenient new preparation of traditional Chinese medicine for external use for eczema patients.The extraction process has been divided into two parts:with the extraction rate of volatile oil as the evaluation index of Schizonepeta tenuifolia, through single factor and orthogonal test to choose the optimum process conditions:10 times of water, 1h immersing, and 6h steam distillation, collection of volatile oil and extract. Sophora flavescens Ait use alcohol extract, with the "Overall Desirability" of extraction rate of K (the sum of matrine and oxymatrine) and the yield of extract as the evaluation index, the extraction times has determined as 2 times by the single factor investigation, the optimized extraction processes were screened by central composite design-response surface methodology as following:extracted 2 times with 8 times the amount of 65% ethanol,2.5h each time, collection of alcohol extract, recovering ethanol to no alcohol flavor, and combined with the water extract which had extracted the volatile oil, vacuum concentration to a relative density of 1.08 to 1.12(60℃) of the extract.The molding process of the preparation, matrix formulation were screened through literature and pre experiment. Box-Behnken design was used to optimize the best prescription ratio; Investigated the stabilization process of volatile oil and choose the microsilica gel as inclusion material; In vitro transdermal test to screene the 5% azone as transdermal enhancers. Preparation process established:Weighing the prescribed amount of stearic acid, liquid paraffin, albolene, glycerol monostearate and azone, water bath to 80℃ to melt, stir well, heat preservation, as the oil phase. Another glycerin, triethanolamine, ethylparaben. drug extract, with the right amount of distilled water, putting in the same temperature to make it dissolve, stir well, heat preservation, as the water phase. After heat half an hour, adding the water phase to the oil phase slowly, and constantly stirring. When the temperature was below 50℃. adding Schizonepeta tenuifolia volatile oil which was solidified by microsilica gel, and mixed them.In the study of preparation’s quality standard, TLC was used to identify all the herbs in the preseription. The general rules for inspection of Ointment preparation were finished. HPLC was used to content determination of matrine and oxymatrine, and individual provision standards was made with the total content of matrine and oxymatrine.The results of stability study show that the three batches of samples keep stable within 6 months, each items of three batches of sample was accordance with the quality standard. The skin irritation test investigation prove Ku Jing Ointment has no irritation to the skin and with better security for external use.