Preparation Of Sanhuang Removing Acne Gel And Evaluation Of Its Safety And Efficacy

Object: "Sanhuang Xiexin decoction" is the classic Chinese herbal compound from the "Golden Chamber" written by Zhang Zhongjing.It has the efficacy of clearing heart fire,and it usually used to heal liver fire exuberance in internal medicine and heal ulcers in surgery.In this paper,the acne removing effect of Sanhuang Xiexin decoction was investigated,and its antibacterial active ingredients were studied basing on the pathogenesis of inflammatory acne.The effective amount was determined using the microbiological method.A Sanhuang removing acne gel was prepared.The results can provide ideas for the development of Chinese cosmetic,as well as its safety and efficacye valuation.For the problem of stratification and deterioration caused by the addition of Chinese herbal extracts to cosmetics,?-cyclodextrin was used to encapsulate the extract of Sanhuang Xiexin Decoction.The research methods and results are as follows:1)The inhibition ratio of the main acne bacteria,Propionibacterium acnes and Staphylococcus aureus,were measured with the microbiological methods.The inhibition ratio of different Chinese herbalformula and extractive solvents were studied.The results showed that alcohol was better than water as the extractive solvent,and the best formula of Sanhuang Xiexin decoction was Coptis: rhubarb: scutellariae as 1: 1: 1.2)The Sanhuang Xiexin Decoction was extracted using ultrasonic extraction method with ethanol solution of different concentrations,and its extraction process was optimized.berberine,1,8-dihydroxyanthraquinone and baicalin were characterized and their contents were determined by UV spectrophotometry.The effect of ethanol mass concentration,solid-liquid ratio,temperature,ultrasonic power and ultrasonic time on the extraction rate were inspected.The data analysis results showed that the ethanol concentration and extraction temperature had the greatest influence on the extraction rate.The best extraction process was 95% ethanol solution,solid-liquid ratio of 1:15,and the ultrasonic power of 150 W.The extraction was carried out at a constant temperature of 40 °C for 30 min twice.3)An acne gel was prepared with the addition of Sanhuang Xiexin decoction extraction.The thickening property and ion resisting of the polyacrylic acid thickeners were analyzed.The minimum inhibitory concentration(MIC)was measured which can determine the effective amount of the extraction.The formula of Sanhuang removing acne gel was obtained after determining the amount of glycerol,propylene glycoland 1,3-butanediol.The results showed that Carbomer 940 had the best thickening property and Zen was the best ion-resistance thicker.0.3 %Carbomer 940 and 0.5 % Zen were selected as the matrix of Sanhuang removing acne gel.The effective dosage of the Sanhuang Xiexin decoction extraction was 1.25 %.The mass contents of glycerin,propylene glycol,1,3-butanediol and Sanhuang Xiexin decoction extraction were 3 %,3 %,3 % and 1.5 % respectively.And the Sanhuang removing acne gel was shiny and stable.4)After preparated Sanhuang removing acne gel,the safety of product was evaluated.First,the safety of the product is evaluated by measuring the rate of hemolysis of the RBC at the cellular level.Then,takes dermal irritation / corrosivity test on rabbits at the animal level.Finally,the human skin patch tests were carried out on the human skin at the human level.The safety of Sanhuang removing acne gel was evaluated from cells to animals to the human.The results show that the product is safe and non-stimulating.The cell-animal-human safety assessment method as the axis is feasible.5)The Kligman method was used to make the model of rabbits,which was used to investigate the treatment efficacy.The treatment efficacy of Sanhuang Xiexin decoction extraction,Sanhuang removing acne gel was investigated and compared with erythromycin ointment.The results showed that the Sanhuang Xiexin decoction extraction and its gelcan treat the acne ear model,and their efficacy had no difference compared with erythromycin ointment.But the Sanhuang Xiexin decoction extraction had pigmentation residues,Sanhuang removing acne gel not only can treat the acne model but can repair the skin lesions.6)Sanhuang Xiexin decoction extraction was included with ?-cyclodextrin using saturated aqueous solution method.The inclusion complex was identified by UV spectrophotometry and microscopic imaging.The inclusion process was optimized as 95 % ethanol,mass ratio of extraction and ?-cyclodextrin was 1: 1,the experiment was performed at 60 ? for 2 h and the inclusion rate is 92.36 % under this process.Sanhuang Xiexin extract ?-cyclodextrin inclusion compound were detected and was successfully included.