| Acne is a chronic skin disease that occurs in the sebaceous glands of the hair follicle. At present western medicine for the treatment of acne is commonly used anti androgen drugs, antibiotics, vitamin A acid, benzoyl peroxide etc. But they are all easily to case a variety of adverse reactions, and drug resistance is easy to relapse; Traditional Chinese medicine(TCM) has the advantage of in the treatment of acne. It is safe and effective, but the application is usually lotion, it is inconvenient to use. At present, we need to develop new kinds of Chinese traditional medicine preparations to against Acne, which is effective, less side effects and convenient to use. This study on the basis of the research of traditional Chinese medicine in the treatment of acne medicine experience, Andrographis paniculata, Cortex Phellodendri, purslane, tea leaves, magnolia leaves prescription prepared acne cream, and relevant quality and in vitro drug release study, and provide experimental basis for its clinical application.In this prescription, andrographis and cortex phellodendri as monarch drug, contained andrographolide can deep within hair follicle, eliminate skin grease and dirt, kill acne propionic acid bacillus and other acne related bacteria. The Cork berberine in cationic state can be a long time remain in the skin layer to enhance the effectiveness of sterilization. Tea leaves and magnolia as minister drugs, the active ingredient in volatile oil, can promote the monarch drug through the stratum corneum, itself can also be dissolved cuticle, enhance the effect of sterilization and anti-inflammatory, control of local infection. Combined with purslane, contains the active components such as flavones, polysaccharide and so on, can clearing away heat and toxic materials, antioxidant, immune regulation and balanced ecological balance within the hair follicle, have elimination heat detoxification, anti-inflammatory anti-inflammatory effect, suitable for the treatment of acne.The main research contents and results are as follows:1. Extract effective partExtract of Andrographis paniculata:Andrographis paniculata prescriptions after crushing plus 10 times the amount of 75% ethanol, reflux extraction 1h, and 2 times at 85 ℃, combined extract, filtered, and the filtrate recycling ethanol to give the water content of 25% of liquid extract.The prescribed amount of cork, purslane, tea leaves, magnolia leaves after mixing pulverized plus 10 times the amount of water, extracted 1h and 2 times, combined extract, filtered, and the filtrate concentrated under reduced pressure to give the water content of 35% of liquid extract at 70 ℃2. Cream preparation:On the basis of the creams base commonly used, designed and compared four kinds of O/W base by their appearance, pH and centrifugal/heat/cold stability, and ultimately determine the acne cream matrix formulation.The proportion of each component:1% of stearic acid,10% white vaseline,8% cetyl alcohol, 4% glycerol monostearate,2% dodecyl sodium sulfate,13% glycerol,2% Andrographis liquid extract and 7% compound liquid extract. Place the oil and the water phases in 80℃ water, to make them completely melted and dissoluted, while put the oil phase into water phase. Emulsifying 2 minutes by homogenizer with 3000r/min, a brown and exquisite cream are prepared.3. Cream quality researchStudy on the quality of the cream from the appearance, particle size, pH, qualitative identification and content determination. The cream is moderate viscosity, smooth and delicate, easy to spread. By the dyeing experiments and conductance value determination, the cream can be determined as a O/W type cream. Measured by laser particle size analyzer, the average particle size of the dispersed phase is 120.3nm. Measured by precise acidimeter, the average pH of the cream is 6.52.In the selected medicinal herbs, Andrographolide and dehydroandrographolide are mainly active ingredients of Andrographis paniculata (Burm.f.) Nees. Andrographolide and dehydroandrographolide contents are high, and they are easily to be detected, so choose them as index components of the qualitative identification and content determination. Do qualitative identification by TLC, the cream and andrographolide, dehydroandrographolide show the same color fluorescence spots in the same position. Use high performance liquid chromatography to measure the content of Andrographis in the cream. And the determination shows that andrographolide content of the cream is 0.123%, dehydeoandrographolide is 0.057%.4. Transdermal drug delivery researchIn vitro transdermal experiment, study the distribution of andrographolide in different layers of skin. The experimental result shows that after a single dose, andrographolide content of the accept liquid increases linearly with time. By the calculation, Accumulated through the amount per unit area of linear fitting equation for Qn= 3.722 t-3.522 (R2= 0.997), Drug penetration rate (Js) is 3.722 μg/h/cm2, the delayed time is 0.95h, comply with the requirements of acne medication, drug retention in the skin layer, can give full play to the efficacy. |