Studies On Preparation Technology,Quality Control And Preliminary Pharmacodynamics Of Zengye Tang Decoction Agent

Objective: To study the preparation technology,quality control and preliminary pharmacodynamics of Zengye tang decoction agent,at the same time to formulate quality standard draft,in order to lay the foundation for subsequent research and development and application of Zengye tang decoction agent.Methods: 1.Preparation technology research:(1)With the yield rate of paste and Harpagoside extraction rate selected as investigational indexes,single factor experiment design and orthogonal design were adopted to investigate effects of solvent multiple,decocting time,decocting times on extraction technology by using the method of boiling water extraction,in order to optimize the best extraction conditions.(2)Concentration technology research: With the yield rate of paste and Harpagoside extraction rate used as investigational indexes,stress concentration and atmospheric concentration were compared to optimize the appropriate concentration technology of Zengye tang decoction agent.(3)The yield rate of paste and Harpagoside extraction rate were selected as investigational indexes to verify forming process.(4)The sterilization of Zengye tang decoction agent was investigated by comparing three moist heat sterilizations,such as live steam sterilization,normal autoclaving and boiling method.2.Quality control research: TLC was used to establish identification items about gentleman medicine radix scrophulariae in preparation.HPLC was adopted to determine the content of Harpagoside which was active ingredient of gentleman medicine radix scrophulariae in preparation,establishing the methodology at the same time.The quality standards were set up.3.Preliminary pharmacodynamics research: The influence of Zengye tang decoction agent on the movements of small intestine about normal mice and constipation mice was studies by determining the telecarbon propulsion rate of small intestine about normal mice and constipation mice.Results: 1.In the study of Zengye tang decoction agent Preparation technology research: Optimal extraction technology was extracted 3 times with10 times the amount of water for 2 hour per time.Optimal concentration technology was concentrated under the pressure of 0.095 MPa and 80℃,the range of relative density was set from 1.32 to 1.35 in the concentration technology research at the same time.The extractum was made into the final product without any other auxiliary materials.The sterilization of Zengye tang decoction agent was investigated by comparing three moist heat sterilizations,such as live steam sterilization,normal autoclaving and boiling method.Because moist heat sterilizations had no influence on The quality of preparation,appropriate moist heat sterilizations could be adopted to sterilize the preparation.2.In the study of quality control research: The character and check of preparation conformed to the requirements of the pharmacopoeia.The TLC relevant spots without negative interferenc were distinct and specific strong compared with their control.On the methodology established by HPLC for determining the content of Harpagoside,the result of methodology study showed that the precision,stability,repeatability,and accuracy conformed to the requirements and the method was accurate and feasible.3.In the study of preliminary pharmacodynamics research: Each dose group of Zengye tang decoction agent could improve the telecarbon propulsion rate of small intestine about normal mice and constipation mice,obviously promoting the peristalsis of small intestine.Conclusion: This experiment preparation technology which is reasonable and reliable is suitable for mass production.Reasonable and effective quality control lay a foundation for confirming the quality standard finally.The runchang purge role is preliminary confirmed by the preliminary pharmacodynamics research.This study provides reliable basis for its development and application.