Study On The Preparation Of Arnebia Euehroma (royle) Johnst Extracts Liposomes Cream

Objective: To prepare the Arnebia euehroma (Royle) Johnst extracts liposomes (L-AEE), evaluate the dissolution profile and safety to skin. Methods: (1) The thin film dispersion method, reverse phase evaporation vesicle method, ethanol injection-extrude method, ether injection method and melting methods were used to prepare the L-AEE, respectively, to compare the reliability of different preparing methods with the indexes of entrapment efficiency, shapes and the distribution of particle size.(2) On the bases of single factor testing , the orthogonal design was adopted to select the prepare method to optimize the technology and formulation of L-AEE.(3) Under the condition of preparing technology optimized, the indexes of quality controlling to L-AEE such as entrapment efficiency, pH value, shapes, the distribution of particle size, Zeta-potential, superficial electricity, dissolution rate and stability were observed, respectively.(4) Through the test of centrifuge, hot bearing, cool bearing and coefficient of stability(KE), physical appearance to select the base of the cream; The permeation of the cream were observed using the accumulated amount of drug as indexes through the present membrane; the acute toxicity, irritation and the allergy reaction on normal and damaged skin were tested after spread the cream on the back of rabbit or cavia cobaya that hairs were cut off. Results:(1) Compare the different methods of preparation comprehensively, the ethanol injection-extrude method was more suitable to prepare the L-AEE.(2) The parameters of L-AEE prepared under the formulation and preparation condition optimized were as follows: the average concentration of drug was (0.084±0.003)g.g-1; the average entrapment efficiency defined were (81.98%±2.14)%; the average particle size were (297.58±6.41)nm; the pH value was 6.94±0.04; the drug-loaded particles were observed with spherical shapes, uniform size, and mostly single unilateral vesicles under the transmission electric microscope; the Zeta-potential was (-59.24±1.51) mV with negative electric(.3)The L-AEE showed quite stable being stored at 4℃in refrigerator for 60 d.(4)The O/W type of formula on the L-AEE cream showed uniform in content ,fine in appearance and easy to spread, there were no any irritation, allergic and toxicity on the skin after single and multi administrated to normal and damaged skin. Conclusion: The ethanol injection-extrude method was suitable to prepare the L-AEE, it was quite stable being stored at 4℃in refrigerator; O/W cream showed far more fast release than that of W/O, it was safe and no evidence of irritation, allergic and toxicity.