Study On Preparation Technology,quality Standard And Skin Safety Evaluation Of Knee And Arthra Lgia HerbaL Paste

Objective: The preparation technology of Knee and ArthraLgia HerbaL Paste was studied,its quality standard was established,and the preliminary stability and skin safety were evaluated.Method:(1)By steam distillation,prescription medicines volatile oil extraction rate index,the best extraction process preferably by single factor experiments Volatile Oil(2)The extraction effect was evaluated with the content of Ferulic acid,Ligustilide,Colchicine and the extract yield.The main influential factors of extraction technics included the liquid-solid ratio,extraction time and ethanol volume fraction.The optimal extraction technics of Knee and ArthraLgia herbal paste was selected by central composite design—response surface method.(3)Effects of using single factor experiments to study the appearance of an ointment,spreadability,centrifugation,cold and heat stability of the comprehensive evaluation,the optimal filter forming process.(4)TLC method for Knee and ArthraLgia HerbaL Paste the prescription of angelica,colchicum,angelica dahurica,asarum,dried ginger and other medicines for qualitative identification respectively,using HPLC method for Knee and ArthraLgia HerbaL Paste of ferulic acid,Ligustilide and the colchicine content were determined,and establish its quality standard(5)The stability of Knee and ArthraLgia HerbaL Paste was preliminarily studied by referring to the relevant regulations under the ointment of Chinese pharmacopoeia(2015).Three batches of Knee and ArthraLgia HerbaL Paste samples were selected under extreme conditions of high temperature and high humidity and accelerated test conditions to observe whether there were significant changes in their properties,identification and content determination.(6)As a model for animal experiment,rabbits,guinea pigs were observed Knee and ArthraLgia HerbaL Paste to the stimulation of rabbit skin and damaged skin group complete response,and guinea pig skin allergic reaction experiments.(7)Animal experimental model of guinea pigs to study Knee and ArthraLgia HerbaL Paste skin hydrating and moisturizing effect Result:(1)Knee and ArthraLgia HerbaL Paste in the best extraction technology for volatile oil soaked the medicine 2 h,with 12 times theamount of water extraction of 6 h(2)the optimal ethanol extraction process is to add 11 times of 55% ethanol for two times of reflux extraction.(3)the best molding process was the blank matrix(lanolin: vaseline =2:1)and the ointment ratio was 1:1.(4)A TLC method for the identification of angelica sinensis,colchicine,angelica dahurica,asarum and zingiberensis in the preparation was established.A HPLC method for the determination of ferulic acid,ligustilide and colchicine in the preparation was established.The chromatographic conditions of Angelica sinensis were as follows(Diamonsil C18(2)4.6 mm × 250 mm,5 ?m),mobile phase B was methanol,mobile phase A was 0.1%phosphoric acid aqueous solution,and the gradient phase elution procedure was used to adjust the mobile phase B in time.Volume percentage: 0 to 15 min,5% to 35% B;15 to 30 min,35% to 70% B;30 to 40 min,70% to 95% B.flow rate : 1 mL/min,column temperature:30?,injection volume :10 ?L,and the detection wavelength was at 325 nm.The chromatographic conditions of colchicine are chromatography column(Diamonsil C18(2)4.6mm × 250 mm,5?m),mobile phase: methanol-water(45:55),detection wavelength:353nm,flow rate :1mL/min,column temperature :40?,injection volume :10?L.(5)Three group of samples in high temperature and high humidity in extreme conditions,no change character,identification,sample content declined,accelerated test conditions within 6 months,the character,identification and content determination results compared with 0 month has no obvious change,suggests that knee bi paste the good stability during the stability test.(6)external application of Knee and ArthraLgia HerbaL Paste has no irritation on intact or damaged skin of rabbits.And after external use did not appear redness,oedema and other allergic phenomena.(7)the optimal interval of administration of Knee and ArthraLgia HerbaL Paste is 4 hours,and Knee and ArthraLgia HerbaL Paste has a certain hydration and moisturizing effect.Conclusion: Knee and ArthraLgia HerbaL Paste production process is reasonable and feasible.The established quality standard is simple,rapid and accurate,which can effectively monitor the quality of the preparation and has certain guiding significance.The result of stability experiment shows that Knee and ArthraLgia HerbaL Paste has good stability and is suitable to be placed in a cool and dry place.Experimental study on skin safety evaluation of Knee and ArthraLgia HerbaL Paste shows that it is a safe and non-irritating topical preparation with the functions of moisturizing,moisturizing and keeping warm.