Study On Preparation And Quality Control Of Compound Minoxidil Gel

Objective:To prepare the compound minoxidil gel and establish the quality control standard and carried out the satability studies.Methods:The method for in vitro percutaneous penetration test was established.And the methods for the content determination of in vitro percutaneous penetration test was established.Based on the single factor investigation,cumulative permeation amount as an dinicator,using orthogonal design method optimize and determine the prescription of compound monoxide gel. The optimum preparation process was determined by single factor and orthogonal test by investigate the key points of the process which are the preparation method of gel base, method of neutralization and the drug dissolution method. Establish the quality control standard for quality control of the 3 batches of samples.Stability tests were carried out to investigate the rationality of packaging materials and to predict the effective period of compound gel.Result:Optimum formuation contained 2%minoxidil,0.025%tretinon,10%glycerinum, 15%butanediol,1%azone the gel base is 1% carbomer solution.Mix the minoxidil, Tretinon,glycerinum,butanediol and azone add appropriate amount of ethanol then using ultrasonic dissolving method at 60℃ for 15 min.Quality standard items include traits, identification, examination and content determination. Content determination and related substances examination are all used HPLC. Content detection method can simultaneously detect two kinds of drugs.The linear ranges were 4~320μg/ml for minoxidil and 0.05~4.00 μg/ml for tretionin.Using impact factor test,accelerated test and long-term test to carried out stability studies.All the indexes of compound minoxidil gel found no significant change.Conclusion:The formulation was reasonable and the qulity of the compound gel is controllable.The quality of samples is stable and the packaging is reasonable.