Pharmaceutical Research And Preliminary Safety Evaluation Of Hayao Qufeng Paste

Ha Yao Qufeng paste is mainly composed of vinegar rhizome corydalis,peganalaum harmala,scutellaria,cork,rhubarb and other two flavors.It has the functions of removing wind and dispel cold,anti-inflammatory and analgesic,and It is used for neck,shoulder,waist and leg pain caused by injury or swelling of knee paralysis,lumbar paralysis,leaky shoulder wind,joints and other parts of the body.pharmaceutical research and safety evaluation are performed on the preparation.Research on the formulation molding process:The factors that affect the process are preferred.(I)With reference to the yield of the fine powder after pulverization and the pulverization characteristics as a reference,the two pulverization methods of single pulverization and mixed pulverization are investigated.The best process for pulverizing Liuwei Chinese medicinal materials,such as rhubarb,is preferred.(2)Taking the relative standard deviation of tetrahydrapalmatin at different time points and different mixing parts of the three-dimensional mixer as the index of investigation,the preferred mixing process:the mixing time of 20-25 min can be regarded as the mixing end point.(3)Investigate the honey refining time by using the stirring characteristics and coating characteristics of Hayao Qufeng paste.The results:The honey with a relative density of 1.410-1.420 g/cm3(25℃),a moisture content of 17.50%-18.50%(40℃),and a refining time of 15-20min was selected.(4)Taking the average content of fumaricin B and the relative standard deviations of tetrahydrapalmatin at different time points and in different mixing parts of the mixing vessel as evaluation indicators,using a single factor to investigate the optimal orthogonal experimental level,according to the L9(34)orthogonal test,Investigate the stirring time,stirring temperature and stirring speed to determine the best stirring process:stirring at 100℃ for 30 min at 250 r/min.(5)Taking the physical and chemical stability and coating characteristics of Hayao Qufeng Paste as indicators for evaluation,Sahaer’s drug form is preferred:Sahaer is mixed with six mixed powder and twice for refining in a solution form.(6)Three batches of pilot scale-up experiments were conducted,and the results showed that the transfer rate of tetrahydrapalmatin was more than 95%,indicating that the practical application of the process is stable and feasible.Study on quality standards of preparations and original medicinal materials:(1)Five thin-layer chromatography identification and thin-layer durability investigation of five medicinal materials in preparation,reference to the general provisions on ointments and pastes for pilot scaled samples The required inspections were carried out and the results were all acceptable.HPLC method was used to determine the content of tetrahydrapalmatin in the preparation,and the methodological investigation was completed.(2)Research on medicinal materials lacking the corresponding standards in the prescription,and improve the content determination method and thin-layer identification method of harmaline and harmine;take the total alkali content and yield as evaluation indicators,and follow the L9(34)orthogonal test Design the optimal preparation process of Yer:add 5 times the amount of y ash,extract twice,4min each time,and develop a method for measuring the total alkali content of Yer’s medicinal flavor,at last,Establish microbe identification and thin layer of Xroot.Identification methods,formulating standards for inspection items such as moisture of Xroot.Preparation stability study:Accelerated stability and long-term stability studies were performed on Hayao Qufeng Paste.Results:Stability can be maintained under accelerated experimental conditions for 6 months and long-term 12 months.Preparation Prelimilary Safety Evaluation:Acute toxicity,skin irritation and skin allergy research on Hayao Qufeng Paste.