The Preparation Technology And Quality Evaluation Of Compound Subing Transdermal Patch

Compound su bing preparation has the functions of inducing aromatic resuscitation,regulating qi and relieving pain.It can be used for treating coronary heart disease,angina pectoris,myocardial infarction,chest distress,etc.This subject made it into transdermal preparation,optimized the preparation technology and established the quality evaluation method.Taking single factor and orthogonal experiments to optimize the ultrasonic extraction process of storax,the optimal extraction process was determined as follows:ultrasonic 25 min,solvent 12 times,ultrasonic power 50 khz and extraction time 1 time.The extraction rate of cinnamic acid under this extraction process is high,stable and feasible.The prescription and technology of compound su bing transdermal preparation were determined by single factor investigation and orthogonal experiment,and the optimal preparation technology was determined as follows:weighing the same weight 2.1 g of storax and borneol,4 g of RL 100 pressure sensitive adhesive,2 g of dibutyl sebacate,0.28 g of succinic acid and 3%of azone,and the patch quality met the requirements.The prescription of delayed-release transdermal preparation is 3g RL 100 pressure sensitive adhesive dissolved in solvent,and magnetically expanded and evenly coated on the drug storage layer.the prepared transdermal patch can achieve controlled release effect with controlled release time in 3 hours,which meets the design requirements.The patch preparation process is simple and feasible,and can be used for production.We studied the pharmacokinetics of compound su bing transdermal preparation in vivo.The results Cmax of delayed release transdermal patch was 1.006 ?g/ml,AUC(0-t)of area under drug time curve was 4.168,MRT of average residence time in vivo was 8.052,VRT of average residence time was 15.056,and half-life t1/2z was 10.211 h eliminated.Comparing with gastric perfusion group,transdermal drug retention time in vivo is longer and bioavailability is lower than that in gastric perfusion group,but its characteristics of slow release and long-term release provide more possibilities for clinical drug selection.The quality evaluation method of compound su bing transdermal preparation was studied,the appearance,adhesion and weight differences of the preparation met the requirements,and the in vitro release rate could reach 70%within 12 hours.the established quality evaluation method can effectively control the quality of the preparation and can be used for the quality inspection of the preparation.