Preparation,Quality Standards And Pharmacodynamics Study Of Traditional Chinese Medicine Compound Shufu Ointment

Eczema is an itchy and inflammatory skin disease and one of the standard clinical skin diseases.It accounts for 15% to 30% of the dermatology clinics and accounts for 58.53% of all allergic diseases.Clinically,we divide eczema into three phases: an acute phase,subacute phase,and the chronic phase according to its attack phase.Eczema is a skin inflammation reaction with evident exudative tendency caused by a variety of internal and external factors.The rash is pleomorphic,with exudation or pustules in the acute phase,and the skin is infiltrated with hypertrophy,dryness,itching,and pigmentation in the chronic phase or accompanied by branlike scale Bran scaly temper,which is a characteristic symptom.Overall,eczema is hard to cure,has a long course,and is easy to relapse.Objective: This study is to build the foundation for the research on the development of new medicine Shufu cream for the treatment of eczema,through the research on the preparation technology,quality standards,and pharmacodynamics of Shufu cream.Methods: We use orthogonal test and star-point design-response surface method to extract the effective components of traditional Chinese medicine.The yield of volatile oil,the content of oxymatrine,and the return of extract were used as indicators.The factors and levels of active ingredient extraction finally screened the optimal extraction process for the prescription.To test the molding process of the Shufu cream,we first examined the paste quality of the Shufu cream prepared from different types of ointment bases.Then,the oil phase components,emulsifier,and emulsification conditions in the cream base were preliminarily screened,and single-factor experiments were conducted respectively.We tested the forming process of the cream matrix by orthogonal test design.According to the pharmacopeia,the cream should be evaluated by the appearance characteristics,p H value,particle size,loading limit,and microbial limit.We firstly tested Shufu cream qualitatively through micro-identification of Phellodendri Chinensis Cortex and Indigo Naturalis in the preparation,thin-layer identification of nepeta,parsnip,and wolf venom.Then we detected the active ingredients of Dictamnus dasycarpus Turcz and Sophora flavescens Ait to establish the preliminary quality standard of Shufu cream.We used DNCB-sensitized KM mice to build chronic dermatitis and eczema model to do pharmacodynamic study.We observed images of mouse ear tissue sections of each group from HE staining,and measured cytokine TNF-?,IL-4 levels in serum by ELISA reagent test kit.Results: The essential oil was extracted from nepeta and windproof in the prescription.Among them,nepeta and windproof decoction were soaked for 3 hours,ten times the amount of water was added,and the extraction time was 5 hours.Extraction,in which the particle size of the medicinal material is medium,13 times the amount of water,and the cooking time is 8 minutes;the O / W cream base is established as the ointment base of the experiment,and the oil phase component in the cream prescription is 3 g white petrolatum and 8 g liquid paraffin 5,5 g of lanolin,0.4 g of emulsifier diethanolamine,and emulsification temperature of 75 ° C,the appearance of the cream has excellent color and good stability;the appearance characteristics,particle size,p H value and microbial limit of Shufu cream are in line with “China Pharmacopoeia” 2015 version 0109 cream general requirements;microscopic identification,TCL identification and HPLC content determination have strong specificity,negative and no interference,the method is feasible;pharmacodynamic research results show high,medium and low(concentration 30 %,20%,10%)dose of Shufu cream can significantly improve the degree of eczema-like lesions and swelling in the ears of model mice compared with the model group.ELISA test results show that Shufu cream significantly reduces mouse cytokines IL-4 and TNF-? levels.Conclusion: The preparation method of traditional Chinese medicine compound Shufu cream is feasible,and quality can be controlled.It can treat eczema and improve skin symptoms by adjusting cytokine levels.