Study On Preparation Process And Quality Standard Of Huangdi Cataplasm

Huangdi cataplasm is a Traditional Chinese Medicine, which consists of Astragali Radix, Sanguisorbae Radix and other six herbs. It has the function of clearing heat and removing toxicity, promoting blood circulation to remove blood stasis, relieving pain, convergence skin ulcer to promote tissue rege-neration, for the treatment of sore and ulcer, traumatic injury wound and etc. This subject is guided by Traditional Chinese Medicine theory, application of modern technology and methods for the preparation process and quality standards, to ensure scientific and rational preparation, pharmaceutical is safe and effective quality control.1. Study on preparation processThe extracting process of volatile oil:with volatile oil extraction volume as evaluation indexes, inspected the amount of water, extracting time on the effects of volatile oil extraction, the single-factor experimental method is used to extract technology conditions. The optimum extracting condit-ions are:with6times amount of water before complementing1.65times of water absorbing capacity soaking2hours and using steam distillation extraction8hours.The water extraction process of botanical:with the amount of Astragaloside IV and extraction rate as the evaluation indexes, inspected soaking time, the amount of water, extracti- on times on the effects of water extraction, the orthogonal design is used to water extraction process conditions. The optimum water extraction conditions are:with8times amount of water soaking0.5hours, extracting3times, each time1.5hours.The molding process of preparations:determining the kinds of matrixes and range of dosages on the base of preliminary experiments, with adhesive force and comprehensive scores of sensory evaluation as the evaluation indexes, the orthogonal design is used to optimize the compositions of matrixes. The optimum black proportions of matrixes are:PAAS:CMC-Na:White clay:Glycerin:Citric acid:Hydrated aluminium trichloride=1.25:0.2:0.5:9:0.18:0.27. Huangdi cataplasm is made of optimization of the black proportions of matrixes and drugs, its viscidities is preferably, physical properties stable, stick apply comfortable, good drug compatibility.2. Study the quality standardTLC qualitative research:the five tastes of traditional Chinese herbal medicine are identified by TLC, they are Astragali Radix, Angelicae Sinensis Radix, Chuanxiong Rhizoma, Rhei Radix Et Rhizoma, Resina Draconis. The test results show that the product chromatography, in contrast with control medicinal materials or reference substance chromatography corresponding position, all show the same color spots, and the negative control in the corresponding position without interference. And after repeated experiments, the reproduce-bility is good.Research content determination of Astragaloside Ⅳ: using HPLC for determination of the content determination of Astragaloside IV, with octadecyl silane bonded silica get as the filling agent; Mobile phase:acetonitrile-water (30:70); Velocity1.0mL·min-1;Column temperature30℃; Detector: SEDEX-DLSD75evaporative light-scattering detector; Nebulization temperature:40℃; Carrier gas:air; Pressure:3.5Bar. And the methodology test investigation, the results show that the method is rational, feasible, and reproducible, and can be used for the quality control of Huangdi cataplasm.The content of Astragaloside IV shall not be less than0.11mg in each piece.Research content determination of Aloureirin B:using HPLC for determination of the content determination of Aloureirin B, with octadecyl silane bonded silica get as the filling agent; Mobile phase:1%glacial acetic acid-acetonitrile (55:45); Velocity1.0mL·min-1; Column temperature30℃; Detected wave-length:277nm. And the methodology test investigation, the results show that the method is rational, feasible, and reproducible, and can be used for the quality control of Huangdi cataplasm.The content of Aloureirin B shall not be less than0.97mg in each piece.