Studies On The Preparation Process,Quality Standard And Preliminary Pharmacodynamics Of ShenHua Compund Liniment

Objective The aim of this study is to provide a experimental evidence for the preparation of traditional chinese medicine in hospital and for further better clinical application in the light of optimization the extraction process, establishment the quantitive standard of Shenhua compound liniment and confirmation its bacteriostasis activities in vitro.Methods According to the main effective component of matrine in the radix sophorae flavescentis, L9(34) orthogonal experimental was performed to optimize the technology for extracting matrine with the content of matrine and the yield of extract serving as the criteria. The influence factors such as the volume of water to material, the concentration and volume of ethanol, extraction times and extraction hour were evaluated with each factor had three levels.Five ingredients in the liniment including radix sophorae flavescentis, honeysuckle, cortex Phellodendri, cortex dictamni, Fructus Cnidii, were identified by the thin-layer chromatography (TLC) method. The content of matrine in the Shenhua liniment was determined by HPLC. Also the stability experiments were performed by influencing factor test, acceleration test and storaged at room temperature to verify its stability in vitro. The bacteriostasis activities of this liniment on Staphylococcus aureus, proteusbacillus vulgaris, escherichia coli and pseudomonas aeruginosa were also studied through the K-B disk diffusion method in comparison with primal Shenhua liniment. At last the clinical therapeutical effects on the patients surffered from eczema were also observed.Results The optimal preparation process was established as follows:the amounts of water reach to eight times to material, extracting2hours for2times.A specific, sensitive and reliable TLC method was eatablished for identification radix sophorae flavescentis, honeysuckle, cortex Phellodendri, cortex dictamni, Fructus Cnidii.The content of matrine in the Shenhua liniment was determined by HPLC. An Econobase Cis analytical column was used with the mobile phase of acetonitrile and0.1%(v/v) aqueous phosphoric acid (20:80) at the detection wavelength of210nm. The results of HPLC determination revealed that the linear range of Matrine was at1.038-20.76mg·L-1, the average recovery were99.5%with a RSD of1.95%(n=9). The repetitive test proved good stability of the approved method.The preparation of Shenhua lotion showed well stability and retained its identity, property and quality throughout temperature (60±2℃), humidity (90%±5%) and light exposure (4500±500lx) for six months during the influencing factor test, acceleration test and storaged at room temperature. The concentration of matrine in the lotion was not significantly changed in the long term stability test.The results of antimicrobial test showed that this liniment had distinctly inhibited the four bacteria and the antimicrobial effect was increased significantly when compared with primal Shenhua liniment. The clinical cases of Shenhua liniment got96.4%total efficiency, the reoccurrence rate is only22.7%. In comparison with primal Shenhua liniment, the effective rate of Shenhua compound liniment was improved by10%and the reoccurrence rate reduced by20%.Conclusion The present extraction procedure was stable and feasible, which can be used in the clinical practice. And the established standard can be used to control the quality of Shenhua lotion. The treatment effect of eczema was clear.