Preparation And Quality Artemisinin Ointment

Purpose:In this paper, basic theories of Traditional Chinese medicine as a guide, combined with modern pharmaceutical knowledge to determine the bast formulation of Artemisinin ointment preparation process. Through a comprehensive standardized study, provided feasibility analysis for clinical application.Method:1.In this paper,O/W ointment is determined as this prescription.We made score standard with appearance index,pH index and stability index for ointment, to screened out Triethanolamine and Sodium dodecyl sulfate as emulsifier.And we made score standard Artemisinin ointment with sensory index and experiment index, to determine the optimal formulation and process parameter.2.According to the preparation general rule to the traditional Chinese medicine ointments request of Chinese Pharmacopoeia2010edition, We carried on the corresponding project inspection on the basis of experimental results.And we researched the quality standard of Artemisinin ointment, the method was established for determining the content of Artemisinin by High Performance Liquid Chromatography (HPLC).Use Waters XTerra(?) MS C18(4.6mm×250mm,5u m)Column,the mobile phase consisted of methanol:distilled water(65:35),the detected wavelength was set at210nm.3. We inspected preliminary stability of Artemisinin ointment, include stability test at impact factor experiment,and acceleration test.The indexes include appearance,spreadability, pH and the content of Artemisinin.4.In this study,we use isolated rat skin ointment for transdermal experiment,to explore the feasibility in clinical use.Result:1.The best preparation process:take Stearic acid8g, Vaseline8g, Lanolin3g, Liquid paraffin3.2g, Borneo12.5g,Vegetable oil lOg and Artemisinin powder4g, heated to85℃,stir well at the same time, as the oil phase. Weigh Glycerinl2g, Ethylparaben0.06, Triethanolamine0.26ml, Sodium dodecyl sulfate0.28g, distilled water, heated to75℃～85℃after all dissolved.The oil phase was slowly added to the water phase,400rpm constant stirring to completely emulsified, condensation, aliquot. The Artemisinin ointment prepared under this method is and it can be stored in different climatic temperature.2.Artemisinin ointment is the milky white semi-solid substances, the paste is fine and smooth, the quality of it is stable.The method was established for determining the content of Artemisinin by HPLC, the standard curve is y=1091.9x—36.847(r2=0.9994), the range of emodin was20～200μg/ml. The methodological study results meet the requirements, it can effectively control the quality of Artemisinin ointment. The content of Artemisinin can not be less than37.76μg/g.3.The result of preliminary stability test shows,this product is instable in glare and high temperature, so it should be stored in the dark and cool place. Also we can study from the humidity experiments and accelerated test, the quality of thie product is stable and humidity-resistant, its validity period can be tentatively scheduled for two years.4.Within24hours,the result was stable,24h average cumulative infiltration volume Artemisinin is Q24=16.64μg/cm2.This result suggests that the method established in vitro percutaneous test is accurate and stable and it apply to vitro transdermal experimental study.