Wubai Lishi Granules Quality Standard Improvement And Pharmacodynamic Research

Eczema is the most common chronic inflammatory skin diseasea with clinical features of intense itching and inflammatory eczema-like lesions.Eczema imposes a heavy psychological and social burden on patients and increases the risk of food allergies,asthma,allergic rhinitis,and other immune-mediated inflammatory diseases.Currently,common eczema treatments include topical emollients,glucocorticoids,oral antihistamines,and calcineurin inhibitors.These treatments have good efficacy,but it is prone to cause adverse reactions under long-term use.Traditional Chinese medicine has unique advantages and characteristics for the treatment of eczema.As the in-hospital preparations,Wubailishi granules are used for clinical treatment of exudative eczema for more than 30 years.The curative effect is exact.No obvious adverse reactions have been observed,and there is a significant prospect of new dr?g conversion.Therefore,this topic is aimed at the pre-clinical research on the extraction process optimization,quality standard improvement and pharmacodynamics research of Wubailishi granules,in order to develop it into a new Chinese medicine with exact curative effect,controllable quality,convenient taking and good stability.In the first chapter,the thin-layer chromatography method was used to identify the medicinal herbs of Wubailishi granules,which all accord with the Pharmacopoeia regulations.Secondly,the orthogonal experimental design method is adopted.Using extraction yield,chlorogenic acid and luteolin as the evaluation index,factors such as the amount of solvent,soaking time and extraction time were investigated,and then the best extraction process is preferred.The number of extractions was investigated,and combined with cost of production,the best extraction process was established: the prescription medicines were decocted twice,12 times water and each boiling for 30 min.The second chapter raises the quality standard of Wubailishi granules and applies them to the quality control in the preparation process.First,HPLC method was used,using a YMC-Triart C18 column with 0.1% phosphoric acid aqueous solution as mobile phase A and acetonitrile as mobile phase B,and gradient elution as specified.Detection wavelength 0-100 min 327nm;100-120 min 210nm;Column temperature is 30?;injection volume 10ul;flow rate 1m L/min.Under this condition,a total of 15 peaks were displayed.By matching the raw materials,the 15 peaks are assigned and two peaks are identified.They were chlorogenic acid and luteolin,respectively,for methodological investigation.The results showed that the precision,stability,and reproducible RSD values were all less than 3%.The similarity between different batches of finished products is greater than 0.97,and the retention time RSD value is less than 1.6%.The HPLC fingerprint method of Wubailishi granules is simple,effective and reproducible,and can be applied to the quality control of intermediates in the preparation process.In addition,this chapter also established a thin layer identification based on Juhua and Baizhu.It is stipulated that the load difference of Wubailishi granules should be no more than 5% for every 10 bags,and no more than 10% for one bag.Particles passing through No.1 sieve and not passing through No.5 sieve should be greater than 85.0%,the bulk density should be between 0.39 and 0.47,the angle of repose should be less than 46,the solubility is good,and the water content is not more than 8%.In the process of accelerating the stability of Wubailishi granules,the traits were stable,load difference,particle size,moisture,microbial detection and content determination all met the requirements of the pharmacopoeia,which provided the basis for the formulation of the validity.In the third chapter,the model of guinea pig ear eczema induced by DNCB was established.The group was divided into 6 groups,including blank control group,model control group,positive control group,high,middle and low dose of Wubailishi extract.The dr?g was administered continuously for 12 days,and the ear tissue of the same position in both ears was taken,and the weight of the left and right ears was recorded to calculate the swelling degree.Next,the ear tissue was stained with HE for pathological section to observe its pathological changes.The results showed that the middle and high-dose groups of Wubailishi extract could alleviate the inflammatory symptoms such as skin swelling and scarring,reduce the swelling degree,and improve dermal edema and inflammatory cell infiltration(P<0.05).In addition,a histamine-induced itch threshold model of guinea pigs was established,which was divided into five groups: blank control group,positive group,high,medium and low Wubailishi extract.Measure the itching threshold after administration for 10 days.The high,medium and low dose groups can improve the itch threshold of guinea pigs and have anti-itch ability.By analyzing the anti-inflammatory and anti-itch effect of Wubailishi extract,it provides experimental basis for clinical treatment.In this study,the optimization of extraction process and quality standards of Wubailishi granules were carried out,and the pharmacodynamics was preliminary studied.Establish a quality standard that meets the intrinsic quality of the product and the development requirements of modern Chinese medicine,so as to provide a new Chinese medicine for the treatment of exudative eczema,and provide a reference for the conversion of hospital Chinese medicine preparations to new Chinese medicines.