Study Of The Preparation Process Of Sophora Flavescens Dispensing Granules And Its Quality Control

Objective:Through studying on the best of cutting process of Sophora flavescens, and water extraction method and semi-bionic extraction of the optimal extraction process, as well as the comparison, combined pharmacodynamic comparison, to optimize the the best preparation process of Sophora flavescens dispensing granules, at the same time through studying on the fingerprint of the medical materials and its dispensing granules and their efficacy, studying of heavy metals and pesticide residues in Sophora flavescens dispensing granules, in order to ensure the industrialization of its dispensing granules large-scale production, and to ensure that its clinical safety and efficacy of drug use provide a scientific basis.Methods:A high performance liquid chromatographic method was developed to study the alkaloid content of Sophora flavescens, optimization of the best of cutting process of Sophora flavescens, and water extraction method and semi-bionic extraction of the optimal extraction process, as well as the comparison; compared the pharmacodynamic with the different extraction, and between Sophora flavescens and its dispensing granules; seted up the fingerprint of Sophora flavescens and its dispensing granules, at the same time, the contents of Cu, Pb and Cd in Sophora flavescens were determined by atomic absorption spectrometry, the contents of As and Hg were determined by atomic fluorescence spectrometry, the contents of BHC and DDT were determined by capillary gas chromatograph, to get a systematic study of kushen dispensing granules.Results:1.To determine the best of cutting process of extraction, which was that: With 0.7 times the amount of water soaking herbs 3h and infiltration 9h, Pieces of cutting thickness of 2mm.2. To determine the best of water extracting method of kushen dispensing granules were as follows:Sophora pieces with 10 times the amount of water soaking and a half an hour later, reflux extracted three times, each 2 hours.3.To determine the optimum semi-bionic extract condition of Sophora flavescens dispensing granules were as follows:three fried water pH were as follows:2.0,7.5,9.0; boiling time,followed by 2h, 1h,0.5h, and it was better than the water extracting method.4. By pharmacodynamic studies to determine that there were apparent efficacy between the water extraction and semi-bionic extraction of Sophora flavescens, and there were no difference in efficacy between the water extraction and its dispensing granules.5. The fingerprint of Sophora flavescens and its dispensing granules were set.6. The contents of heavy metal and pesticide residues in Sophora flavescens comformed to the standard, and they were different in Sophora flavescens from different habitats.Conclusion:Through the combination of determination of the content of index component and the comparion of pharmacodynamics, got a integrated optimizated preparation process of Sophora flavescens dispensing granules; the same time, through the development of fingerprint particles of Sophora flavescens and its granules, and detecting the content of the various heavy metals and pesticide residues in Sophora flavescens, to provide evaluation basis for safety assessment of Sophora flavescens dispensing granules.