Study On Preparation Technology And Quality Standard Of Rumo Bawei Jiegu Pill

The Rumo Bawei Jiegu Pill is composed of Olibanum,Myrrha,Carthami flos,Angelicae sinensis radix and Psoraleae fructus et.al.and the original prescription has been widely used in powder in Jiugang Hospital for many years.It has effect of stasis-dissolving,blood-activating,swelling-subsiding granulation-promoting and bone-reunion.It is mainly used for bruises,broken tendons fracture,stasis swelling,pain treatment and its positive effect in clinic has been observed for many years.Because the powder is not suitable for mass production has poor stability,and is not convenient to carry,so we have changed the dosage form to pills and apply for the pill as a new preparation in medical institution.The research was based on the theory of Traditional Chinese Medicine and the modern scientific technology,the method was also adopted to investigate the process of preparation,stability and the quality standard of Rumo Bawei Jiegu Pill.The main research content was as follows:Firstly,research of the preparation technology.According to the clinical needs of the actual medication and function of prescription,water pill was selected as its dosage forms.High temperature damp heat sterilization and ethanol sterilization were used to sterilize the raw materials.By orthogonal experiment methods,the preparation process was as follows: mixing the above Traditional Chinese Medicines and then crushing into fine powder;sieving No.6 screen;homogeneous mixing,then mix pills with water.The diameter of pills must be controlled in the range of 4.5-5.0mm and then make desiccation and packaging.Three batches of pill samples were found to be stable.Secondly,research of quality standard.Carthami flos and Angelicae sinensis radix were respectively identified by thin layer chromatography.The plots showed good separation and the chromatogram was clear.Negative control without interference and the method was feasible.The contents of psoralen and isopsoralen in the pill were determined by high performance liquid chromatography.Through the methodology study,it showed that this method was reasonable,feasible and reproducible.The quality standard(draft)of Rumo Bawei Jiegu Pill according to the results was established.The established analytical methods for the quality control of the pill was accurate,reliable,simple and easy to operate and can be used to effectively control the quality of Rumo Bawei Jiegu Pill.Thirdly,research of stability.High humidity storage test,hygroscopicity test,affecting factor trials involving high temperature and strong radiation,accelerated test and long-term test were conducted.The results indicated that the pill had directly good compatibility with packaging materials in contact of 6 months.In accordance with the relevant requirements of the State Administration of Food and Drug Administration and the Measures for the Administration of the Registration of Medical Agency Formulations(Order No.20).The preparation has been successfully passed the approval of medical institutions(approval number: Ganzi Z20140065).The preparation has been started to use and has achieved good social and economic benefits.