Huoge Capsule Preparation Technology And Quality Control Research

Object: Using the Traditional Chinese herbal compound prescription, as research object,which is made of Herb Pogostemonis, Radix Puerariae, Herb Andrographis, FructusForsythiae, Fructus Trichosanthis, combining with modern pharmacological study andconducting primary research of extraction, separation and purification，drying，formation andquality standard, synthesize a Huoge capsule for cold caught in summer and upper respiratorytract infection. In addition, established its quality standard. The compound prescription hasunderlying value and will benefit many patients.Methods:1. According to the physicochemical property of the main ingredients, such asHerb ageratum, Root of Kudzu, Herb andrographis, Fructus forsythiae and FructusTrichosanthes, I optimized the extraction process by orthogonal test and taking the content ofvolatile oil, the yield of dry extract and the primary components in each herb as evaluationindex.2.According to orthogonal design of β-cyclodextrin inclusion levels of the volatile oilfrom Herb Pogostemonis and Fructus Forsythiae to optimize the inclusion process.3According to the content of andrographis lactone and puerarin to optimize the concentrationand drying process.4. According to the properties of the auxiliary material and hygroscopicity,I investigated the optimum volume of the auxiliary materials by single factor, the criticalrelative humidity of particles by different saline solution, and the liquidity of particles byangle of repose.5.According to the proposed preparation prescription, Huoge capsule weremanufactured in granulation and tabletting.6. According to the packing volume,disintegration time limit, and liquidity indicators to evaluate its preparation process.Results:1. Confirmed the optimum extraction process of orthogonal method: addingwater6times and conducting reflux extraction3times. the essential oils were extracted bysteam distillation, volatile oil and water extract another device to collect; Liquid and radixpuerariae， fructus water decoction twice, the first time with10times the amount of water,decoction for1hour, filtration, collecting filtrate; For the second time with eight times morewater, decoction for1hour, filtration, abandon to liquid; Combination of above the filtrateand the aqueous solution, decompression to concentrate relative density is1.1-1.2g/mL (30℃), cool to room temperature, adding ethanol alcohol content was70%, and the place for the night, filtration. The filtrate recovery ethanol; And concentrated to the relative density of1.25-1.30(80℃), decompression drying, crushing.2. β-cyclodextrin inclusion process is: thevolatile oil in β-cyclodextrin inclusion (1:6),50℃dry.3.Concentration, optimum process fordrying: andrographolide with70%ethanol diacolation,10times the amount collecteddiacolation liquid; Leachate recycling at low temperature and ethanol concentration to clearcream of relative density of1.28(80℃), relief pressin low temperature(55℃) drying,crushed into fine powder.4. The preparation process is that the fine powder blending, addright amount of starch, sugar and ethanol made from soft material, granulating, drying,granulation, encapsulating.Conclusion: The extraction process of ever herb are reasonable and datas are reliable; theformation technology meets the requirements; Using HPLC methods to test the content ofPuerarin, which is a convenient, accuracy and steady method, and will be helpful forestimation of quality and the quality control.