Study On The Preparation Technology And Quality Control Of Shi-zhen-kang Gel

ObjectiveOptimum selection of the best extractive method of egg yolk oil,in order to provide high quality material for preparations.Optimized the composition of prescription and preparation technology of Shi-zhen-kang gel.Not only established a standard for quality control of the gel,but also explored its transdermal permeability preliminary.Method(1)Using acid value,iodine value,saponification value,peroxide value and the like as indexs,with the contents of water,volatiles,fatty oil and phosphorus,evaluated the quality of egg yolk oil with different extraction methods.(2)Using the appearance of the preparation,viscosity,coating performance,pH value,centrifugal stability,heat and cold-resistant stability as the quality control indexs,and using single factor experiment with Topis comprehensive evaluation method and orthogonal experiment,selected the best composition of prescription and preparation technology of Shi-zhen-kang gel.(3)Using Thin Layer Chromatography(TLC),built the identification methods of matrine,oxymatrine,borneol,egg yolk oil.Using High Performance Liquid Chromatography(HPLC),built the determination method of matrine and oxymatrine.And established a standard for quality control of Shi-zhen-kang gel.(4)Explored the transdermal permeability preliminary of Shi-zhen-kang gel by experiment of transdermal diffusion.Results(1)The phosphorus content of egg yolk oil is higher by mechanical pressing.This kind of oil has good quality,without residual solvent and shin irritation.(2)Carbopol 940 has been selected as the gel matrix by single factor experiment.The best preparation technology of Shi-zhen-kang gel was determined by single factor experiment and orthogonal test.The result showed that the amount of oil phase(egg yolk oil)as 20%,water phase(glycerol:water)as 10%:60%,emulsifier(polysorbate 80)as 4%,co-emulsifier(1,2-propylene glycol)as 3%.(3)Built the methods to identify matrine,oxymatrine,borneol,?sitosterol and phosphatidyl choline both from the egg yolk oil by TLC.Built a method to determine the content of matrine and oxymatrine at the same time by HPLC.(4)The cumulative penetration,percutaneous rate and storage ability of Shi-zhen-kang gel is higher than the Shi-zhen-kang oil.Conclusion(1)Considering the result of quality control and drug safty,that the egg yolk oil which extracted by mechanical pressing was a suitable drug material for Shi-zhen-kang gel.(2)Selected the best composition of prescription and preparation technology of Shi-zhen-kang gel.The gel not only has good appearance,suitable viscosity and coating performance,but also overcomes the disadvatage of easily polluted clothes by the original oil.(3)Established the method of HPLC which is simply,accurate and available for determination simultaneously the contents of matrine and oxymatrine.(4)The percutaneous and storage abilities of Shi-zhen-kang gel is better than Shi-zhen-kang oil.