Chinese Medicine Water Gel Pediatric Fever Micro-enema Preparation Process And Quality Standards

The micro enema is a dosage form developed in a recent few years. Because its dosage is commonly less than 5mL, the micro enema is convenient in use, and takes effect very quickly. Its curative effect can completely compare with injection. It is especially suitable for curing acute and inadvisable oral administration diseases and clinical application of Pediatric diseases. So it is worth research and development of a new formulation. And Micro enema of hydrogel type of Chinese herbal medicine in this thesis is studied firstly in international. In this article, we settled standstill of fluid of extracting Chinese herbal medicine in rectum. At the same time, we solved a problem of hydrogel molding destroyed by concentrated solution of extracting Chinese drugs. This paper made an academic base for preparation process of the new dosage form. In the thesis, we mostly study three sides as follows:(1) xiao'er Allaying a Fever hydrogel type Micro Enema made up of several traditional Chinese drugs of bupleurum root, gardenia, Anemarrhena Asphodeloides, radix glycyrrhizae, forsythia suspense , can be used in treating having a fever. It has the function of dispelling wind-heat and clearing heat and detoxicatior. In prescription, efficiency ingredient of Chinese traditional medicine is volatilizable and water soluble. To essential oil, extracting processing adopts steam distillation. And using orthogonal design involving the extracting rate of the essential oil optimizes distilling factors of crush grade of drug and marinates time etc. To water soluble component, they are extracted by water decoction. The optimum process was determined by L₉(3⁴) orthogonal test with extraction rate of geniposide as determination markers.(2) xiao'er Allaying a Fever hydrogel type micro enema is made for clinical use. Substratum of Gel and molding technics and permeation enhancer, are optimized by simulating penetrating experiment on excised pig rectum mucous membrane. The accumulated permeation amount of geniposide as determination markers, finally, the optimum Substratum of gel was crylic acid colopony. Optimum permeation enhancer is menthol. For molding technics, the optimum process was determined by a L₉(3⁴) orthogonal testing with the accumulated permeation amount of geniposide.(3) In the experiment of quality standards, we determined the active composition content by HPLC. The limited content of geniposide in xiao'er Allaying a Fever hydrogel type micro enema were fixed by analyzing the different samples. In addition, we identified the four drugs by TLC, which are bupleurum root, gardenia, Anemarrhena Asphodeloides, essential oil from the forsythia suspensa (thunb.) vahl. Moreover, we study the principium stability of xiao'er Allaying a Fever hydrogel type micro enema.