Study On The Preparation Technology And Quality Standard Of Houxue Gel Patch

Objective: To optimize the extraction process of various ingredients in the optimal prescription,determine the best prescription of prescription,choose the best concentration of azone promoting infiltration agent,and obtain the huoxue gel patch.To establish a quality standard for houxue gel patch and investigate preliminary stability,guarantee quality and safety of drugs.Methods: First investigate the extraction process of various pieces of prescription,based on the comprehensive index weight of volatile oil by steam distillation extraction method and volatile oil of cinnamaldehyde content,to optimize the extraction process of volatile oil of cinnamon,Angelica sinensis and Zanthoxylum bungeanum Maxim by orthogonal test.Based on the comprehensive index of the content of hydroxy safflower yellow A and the paste rate,to optimize the water extraction process of Carthamus tinctorius by orthogonal test.Based on the comprehensive index of the content of imperatorin and isoimperatorin and paste rate,to optimize extraction process of angelica root and acanthopanax bark.Then encase the volatile oil by the ?-cyclodextrin,based on the comprehensive index of the yield and inclusion rate of the inclusion compound,to optimize the optimum inclusion process of volatile oil by orthogonal test.To select houxue gel patch substrate by single factor method,based on the comprehensive index of comprehensive sensory score and holding capacity,to optimize the optimum ratio of matrix by methods central composite design.To determine the best concentration of azone promoting infiltration agent based on the cumulative infiltration by external transdermal absorption test.Last establish a quality standard for houxue gel patch and investigate the stability of 3 months.Results: The extraction process of volatile oil of cinnamon,Angelica sinensis and Zanthoxylum bungeanum Maxim is to add 8 times water,soak the pieces for1 hour and heat 6 hours to extrate the volatile oil.The water extraction process of Carthamus tinctorius is to heat three times,soak for 2 hours with the 6 times water for the first time,heating 30 min,add 4 times water the second and the third times,each heating 30 min.The extraction process of angelica root and acanthopanax bark is to heat 3 times by 80%ethanol,add 7 times for the first time and 5 times for the second time,each heating 45 min.The inclusion process of volatile oil is add the volatile oil into the solution of 1:1 with anhydrous ethanol,then add 7 times ?-cyclodextrin and heated 1 hours at the temperature of 50 ?.The rate of polyacrylic acid,sodium hydroxide,sodium carboxymethyl cellulose,glycerin,azone is 0.39:0.078:0.61:6.34:0.36.Make the quality standard of houxue gel patch,and determine its stability is good within 3 months.Conclusion: Through the optimization of extraction technology and forming process of houxue gel patch,to obtain houxue gel patch with good stability and reliable product quality.