| Xianfang Huoming Yin(XHY)is a classical formula prescribed for treating skin and external variolar carbuncle in practice.Based on the clinical application of XHY in the treatment of acne,this paper provides experimental basis for the development and application of the simplified XHY(SXHY)gel.This work intends to simplify XHY for gel preparation,optimize the preparation technology,develop analytical method for quality control and investigate the biological effect of the gel.The main contributions of the thesis are as follows:1.Simplification of XHY prescription.According to the effect of the herbs,XHY formula was divided into three simplified prescription groups.The anti-acne effect of XHY formula and each group was investigated by acne mouse model.The results revealed that the effect of Jiedu coupled with Xiaoyong group had no significant difference compared with XHY.The herbs of Jiedu coupled with Xiaoyong were believed to be the components of simplified XHY(SXHY)for exerting anti-acne effect.2.Optimization of preparation technology for SXHY gel.The acne mouse model was used to optimize the extraction process for the herbs of SXHY.And orthogonal design was applied to screen the best extracting condition.Box-Behnken central composite design was adopted to optimize the gel preparation formula.The results showed the most favorable condition for preparation of the gel was extracted twice for 1 h with 12 times of 80% ethanol,the gel matrix was collected as 1.5% of kapom-940,15% of glycerin and 1.5% of triethanolamine in mass concentration.3.Establishment of qualification method of the SXHY gel.We used thin layer chromatography to qualify the herbs used in the prescription and high performance liquid chromatography to quantify the main compounds of the herbs such as chlorogenic acid,glycyrrhizic acid and imperatorin.The results depicted that all the herbs satisfied the requirements of the authentic crude drug.And the content of the above mentioned bioactive compounds were determined as 1.318,0.757 and 0.038 mg/g with the RSD values of 1.45%,1.85% and 1.52%,respectively.4.Pharmacodynamic evaluation of the SXHY gel.The apparent effect and the histopathology of the rabbit acne were applied for the evaluation of the gel.The results reminded us that the gel can significantly improve the thickness,hardness,roughness and the histopathology of the acne rabbit,relive the pathological changes of hair follicle lipid embolism and sebaceous duct epithelial hyperplasia significantly.The expression of p38 MAPK and TNF-alpha in the ear tissue of rabbits in the treatment group was significantly lower than that in the control group,suggesting that p38 MAPK signaling pathway may play a role in the therapeutic effect. |
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