Study On Preparation Technology And Preliminary Pharmacodynamic Of Compound Chrysanthemum Indicum Lotion

The experienced prescription on compound chrysanthemum indicum is a kind of prescription used within a hospital in Xi'an,which consists of chrysanthemum indicum,dandelion,violae herba and Patrinia villosa Juss,and has its own unique advantages for external use.The prescription consists mainly of chrysanthemum indicum,dandelion and other anti-heat,detoxification and dampness drugs.Its main purpose is to clean wounds and control infections.In clinic,it is mainly used in the treatment of infectious skin diseases,and has achieved certain curative effects.The main purpose of this research is to make the experienced prescription on compound chrysanthemum indicum into a stable external lotion,so as to make its clinical application more convenient,and to investigate its preliminary pharmacodynamics,explore its mechanism of action and main adverse reactions,to provide data support for clinical safe use.It is hoped that the traditional Chinese medicine-compound chrysanthemum indicum lotion will become the main drug for the treatment of bacterial dermatoses,playing to the unique advantages of traditional Chinese medicine preparations in the clinical treatment of bacterial infectious skin diseases,reduce the dependence on antibiotics for the treatment of bacterial dermatoses,and thus slow down the occurrence of bacterial resistance.The main research contents are as follows:(1)Research on the preparation process of compound chrysanthemum indicum lotion.Based on the analysis of single factor experiments,the content of buddleoside and the yield of dry extract in the prescription of compound chrysanthemum indicum lotion were determined by HPLC.The main factors affecting the extraction were optimized by response surface methodology.The optimum extraction parameters were obtained as follows: decocting time for 50 min,adding water for 12 times and extracting times for 2 times.The filtrate wasmerged and concentrated after decocting twice,adding the preservative sodium benzoate and potassium sorbate,mixing,filling and sterilization.The experimental results showed that there was no significant difference(p > 0.05),indicating that the optimized preparation process had good reproducibility and high stability,which could be used as a reference for industrial production.(2)Quality control research.The properties,PH value and microbial limit of compound chrysanthemum indicum lotion were examined with reference to the Chinese Pharmacopoeia(2015 edition),and the results were in accordance with the provisions of the pharmacopoeia.TLCwas used to qualitative identification for chrysanthemum indicum and dandelion in the prescription of compound chrysanthemum indicum lotion.The results showed that the chromatogram of compound chrysanthemum indicum lotion showed the same color fluorescence spot in the same position with the control product of chrysanthemum indicum and dandelion.The buddleoside content of compound chrysanthemum indicum lotion was determined by HPLC with good specificity and stability,and the results showed that there was no significant difference(p >0.05).Finally,it was established that the content of buddleoside in compound chrysanthemum indicum lotion was not less than 95 ug/mL.(3)Research on antimicrobial activity and its mechanism.The MIC of compound chrysanthemum indicum lotion against Staphylococcus aureus,Escherichia coli and Proteus vulgaris was determined by double broth dilution method,of which drug concentration were 31.25 mg/mL,62.5 mg/mL and 125mg/mL,respectively.The antimicrobial activity experiment combined with antibiotic Mopirocin showed that the compound chrysanthemum indicum lotion could effectively reduce the drug concentration of Mopirocin against Staphylococcus aureus,Escherichia coli and Proteusvulgaris.Antibacterial mechanism experiment by measuring electrical conductivity,nucleic acid,protein and alkaline phosphatase(AKP)of Staphylococcus aureus medium,The results showed that there was a significant difference between the compound chrysanthemum indicum lotion group and control group with the sterile pure water(p<0.01),which illustrated that compound chrysanthemum indicum lotion could effectively destroy cell wall and cell membrane integrity in Staphylococcus aureus.(4)Skin irritation test.Healthy rats were used as experimental subjects to investigate the skin irritation toxicity of compound chrysanthemum indicum lotion.The adverse reactions of compound chrysanthemum indicum lotion on skin were evaluated through the irritation toxicity experiments on normal and damaged skin of rats.The main experimental contents included acute skin toxicity test,skin allergy test,acute skin irritation test and skin irritation test with multiple administration.The results showed that there were no reversible inflammatory symptoms such as erythema,edema,exudation,congestion,eruption and chromatosis in the skin of rats,indicating that the compound chrysanthemum indicum lotion was safe and non-irritating to human skin.