Dermal Toxicology And Clinical Study Of Compound Diandao Pulvis Drug Facial Mask

Purpose:1.To investigate technological process Compound Diandao Pulvis Drug Facial Mask.2.To estimate the quantity of Compound Diandao Pulvis Drug Facial Mask.3.To estimate the safety of Compound Diandao Pulvis Drug Facial Mask applied on skins.4.To estimate the clinical efficacy of Compound Diandao Pulvis Drug Facial Mask applied on skins.Method:1.According to the single factor and just hand over the experiment to design excellent the prescription,taking Mono-and-Di-Glycerrides,Cetostearyl alcohol and Liquid paraffin as oil purification,taking EDTA-2Na and Pure water as water purification,taking Stearin to alcohol ether-2 and stearin ether -21 as a non-ionic surfactants,taking Glycerol and Propylene Glycol as a moisturizing agent,taking Xanthan Gum as the glue,taking Titanium Dioxide as a sunscreen,we used the method of Cream at a high temperature and solidification at a low temperature to prepare Compound Diandao Pulvis Drug Facial Mask.2.Use our own coating,eye and under a microscope to evaluate the mask and the appearance of fine;respectively temperature incubator,refrigerators,centrifuges and stored at room temperature to investigate the stability of the mask;Determination of use of reverse PH casual drug mask the PH value.3.Select Fmmu 150 guinea pigs,rabbits New Zealand 8.①from 70 guinea pigs,according to the random number table is divided into seven groups,namely integrity of the skin high-dose group,complete skin dose group,complete low-dose group and skin damaged skin high-dose group,damaged skin dose group, low-damaged skin dose group and the normal control group,n=10,acute skin toxicity test.The experimental method:administration before guinea pigs symmetry shed,shed area of approximately 4cm×5cm.Damaged skin group used scalpels tablets in the region to shed the skin # scratches,bleeding for the degree.Respectively from 2.5 g(high dose),2 g(dose),1.5 g(low dose) uniformly applied to shed area. And double again in cellophane packets tested gauze area.After 24 hours of cleaning subjects,we should observe body weight,food intake,breathing,posture,eyes, central nervous system,limbs,feces characters and deaths of the guinea pigs everyday for 14 d,.②40 from guinea pigs,according to the random number table divided into four groups,namely high,medium and low dose group and the normal control group.N=10,a long-term skin toxicity test.The experimental method: guinea pigs will be back before the administration shed on both sides,shed area of 4 cm×5cm.Respectively from 2.5g(high dose),2g(dose),1.5g(low dose) uniformly applied to shed area.Then double-covered gauze and cellophane,and then no irritation tape closed,fixed,four hours after the cleaning of subjects.We should consecutively give guinea pigs the delivery and observe guinea pig body weight, food intake,breathing,posture,eyes,central nervous system,limbs,feces characters and deaths everyday for 60d.The administration at the end of 24 hours after 10%of the guinea pigs CH anesthesia(8 ml/kg),then abdominal aortic blood from 3 to 4 mil for hematology and blood chemistry examination,and tested organs and skin tissue District a pathological examination.Inspection organs:liver,kidneys,lungs, heart,spleen,stomach,pancreas,thyroid,brain and genitals.③compound reversed Powder 2g topical,compared with the control area,regardless of integrity rabbit skin or damaged skin There were no significant differences,neither formation of erythema, edema nor there.Test results show that the compound casual drug reversed the integrity of the film on the skin and rabbit skin damaged no irritation.④score by allergy skin sensitization rate and classification standards to judge,casual drug compound reversed mask group and the control group of guinea pig skin shed District 6～72 hours there was no obvious erythema,edema,and other symptoms,no asthma, shock and other serious systemic anaphylaxis.Positive control group after the administration have different levels of skin erythema,edema formation,in accordance with the standard score of 2.9 points,to allergic rate was 100%,still 24,48,72 hours after skin erythema,edema there.Test results show that compound reversed scattered on the surface and the matrix of the skin were not sensitized.4.we randomly divided 81 patients into experimental group(41 cases) and the control group(40 cases),giving the patients of the test group Diandao Pulvis Drug Facial Mask,giving the patients of the control group Peacekeeping Amine Ester of vitamin E cream.And the patients should use drug everyday and wash away the drug after one hour.We estimated the treatment effect after four weeks.5.Statistics and analysis:Statistic software SPSS13.0 was used for statistic analysis.Measurement data were expressed with(?)±S.T test was used for significant test with two groups.One-way Annova analysis was used for significant test with 3 groups or more than 3 groups.Two different points in time before and after the use of repeated measurements comparison analysis of variance,Differences were significant if P＜0.05.Result:1.Preparation of CDPDFM turned casual drug for the short yellow mask, uniform texture,appearance and delicate sense of a rich luster O/W(oil-in-water type) forms.2.Preparation of CDPDFM turned casual drug film,the heat and cold,room temperature storage and centrifuge testing,free from the oil phase and phase separation in the water,no deeper,no color change,no precipitation and Drug precipitation;PH measured surface Paste the membrane PH value of 5.83±0.12.3.150 experimental guinea pigs,rabbits eight,and entered the final analysis. Compound reversed casual drug mask skin toxicology studies show that:in the effective time of observation①subjects were given a single after two weeks of the guinea pigs with one case of death.High,medium and low dose group compared with the control group and a complete skin and skin damage compared to the skin and mucous membrane,and no change in diet,the system no abnormal changes.②consecutive subjects were given 60 days,the groups are not guinea pigs died. Compared with the control group,high-dose group,in the dose group and low dose group guinea pig weight,mental,restaurants,as well as skin and mucous found no abnormal performance of the system and limbs,no abnormal activities.At the end of 24 hours after administration of the hematology and blood chemistry test results(see table 3) in each group showed no significant difference(P＞0.05).Histopathologic examination of the organ Results:Organ smooth surface,organizational structure are orderly,and the size of normal cells,the cytoplasm,the nucleus no abnormal coloring. Histological examination of skin Results:epidermis,the dermis and subcutaneous tissue structural integrity,without degeneration and necrosis,and no neutrophil infiltration and vascular endothelial cell injury.③compound reversed Powder 2g topical,compared with the control area,regardless of integrity rabbit skin or damaged skin There were no significant differences,neither formation of erythema,edema nor there.Test results show that the compound casual drug reversed the integrity of the film on the skin and rabbit skin damaged no irritation.④score by allergy skin sensitization rate and classification standards to judge,casual drug compound reversed mask group and the control group of guinea pig skin shed District 6～72 hours there was no obvious erythema,edema,and other symptoms,no asthma,shock and other serious systemic anaphylaxis.Positive control group after the administration have different levels of skin erythema,edema formation,in accordance with the standard score of 2.9 points,to allergic rate was 100%,still 24,48,72 hours after skin erythema,edema there.Test results show that compound reversed scattered on the surface and the matrix of the skin were not sensitized.4.The Mask of ache,papules and the pustules lesions improve performance better than the control group(Victoria amine ester of vitamin E group),in patients with acne on the overall response rate was 86.5 percent,and fewer adverse reactions, its effects are gifted In the control group,so the mask for acne patients with good results,especially suitable for patients with mild to moderate acne treatment.And fewer adverse reactionsConclusion:1.CDPDFM has the craft in brief,the quantity is more ideal.2.This experimental study showed that in the effective time and observe certain dose range,casual drug compound reversed mask on experimental animals showed no toxicity absorption system,no skin sensitization,a uniform texture,delicate appearance,easy coating,the drug Percutaneous Absorption good advantage.3.CDPDFM with better clinical efficacy for the treatment of patients with mild to moderate.