Wood Herb Granule Preparation Process And Pharmacodynamics Screening Process Research

Objective:Radix bupleuri and Agastache rugosus decoction, which is a hospital clinical experiential prescription, has been clinically studied and has definite effect. And our research based on the decoction, was to explore its preparation process to make it better suit for hospital use and finally make it a hospital agent of practical use. We are aiming to make itconvinient in taking orally, having deifinite effect and more acceptable taste for children, which would be more suitable for clinical use.Methods:1.Extraction technology:Considering the decoction effect, this study remained the effective parts as more as possible during reasearch.And the concrete steps was as follow:to extract the effective part of decoction with water, and with method of single factor to study relative factors, such as water absorption rate,extraction time of volatile oil.And the trasfer rate of baicalin as indicator,the relative factors during water extraction,such as times of water extraction,water amount,and whole extraction time,have been explored by L9(34).2.The research on refining process:in the process of refining,the alcohol precipitation has been used; with the trasfer rate of baicalin as indicator,and use the method of L9(34) to find out the most suitable conditions of relative factors of this refining process,such as liquor concentration,concentation of alcohol,time of alcohol precipitation process.3. The study on inclusion process of volatile oil:in this process,the volatile oil β-CD(g), the time of inclusion process of volatile oil,and the temperature during the process were the main relative factors has been explored.The indicators for it were inclusion rate of volatile oil and yield of inclusion compound.4. The drying process:this process include the spray drying and depression dry.In the spray drying process,we used the L9(34) and the rate of powder output as indicator, the concentration of water extaction (A),speed of spray and outlet temperature,which were the main relative factors,have been explored to find out the most suitable conditions. With single factor test during process of depression drying, the ideal press and temperature also have been detected with the trasfer rate of baicalin as indicator.5.Formation technology:we used the L9(34) to investigate three main relative factors including Powdered sugar and accessories proportion,proportion of powdered sugar and dextrin,and adhesive(alcohol)concentration. Weselected the most suitable formation parameter with rate of finished product and mobility as indicators.6.Pharmacodynamics screening:technology of water extraction and technology of refined alcohol precipitation have been compared with each other in pharmacodynamics and safety to ensure the efficacy of refined water extraction keep stable.And antivirus test in vitro, antipyretic experiment and acute toxicity test have been used to test the efficacy and controllability of preparation.Conclusion:1. The more sutible process of water extraction of Radix bupleuri and Agastache rugosus particle:The time of medicine materials soak was1h, volatile oil of extraction was3h from single factor test. L9(34) has indicated magnitude of extraction water was8times as much as medicine materials volume extracted three times(lh per time).2. The refining process of Radix bupleuri and Agastache rugosus particle:liquid concentration was0.8g/ml crude materials,concentration of alcohol precipitation was 60%,and alcohol precipitation time was24h.3. The inclusion process of volatile oil:the proportion of volatile oil and β-CD was1:10,inclusion temperature was40℃and inclusion time was60min.4. The drying process:the most suitable technological parameter were crude materials content (0.8g/ml),spray speed (2ml/min) and outlet temperature (80℃);The optimum technological parameter of depression drying include press(0.06MPa)and temperature(75℃).5. Formation technology:the optimized technology include Powdered sugar and accessories proportion(1:1.5), proportion of powdered sugar and dextrin(1:5), and adhesive(alcohol)concentration(70%).6. Pharmacodynamics screening:technology of water extraction was more ideal compared with alcohol precipitation, and acute toxicity tests of this two showed no significant difference, therefor, based on above, water extraction has been the selected one.Conclusion:Radix bupleuri and Agastache rugosus particle made in this research had features as follow:definite efficacy,safety and controllable nature, simple preparation technology,controllable quality,stable reliable reproducible and exclusive ration way.All of these features could providexperimental basis for Radix bupleuri and Agastache rugosus particle, which was applying for six types of Chinese new medicine before it used in clinic.