Further Study On The Quality Standard And The Stability Of Fanggan Spray

Object:To give further establishment of the Fanggan spray quality standards on the basis of the previous research, discusses the stability of the preparation and to provide theoretical basis for the development of the new drug.Methods:Thin layer chromatography (TLC) was used to identify the ten medicines of the preparation, for example, Fructus Forsythiae, Flos Lonicerae Japonicae, Fructus Arctii, and Rhizoma Belamcandae. High performance liquid chromatography (HPLC) was used to determine the main effective component forsythin in Fructus Forsythiae and the other main effective component irisflorentin in Rhizoma Belamcandae. Quality standards draft was drawn up and accelerated test and long term stability experiment had been done according to quality standards draft.Result:①Fructus Forsythiae, Rhizoma Belamcandae, Radix Saposhnikoviae and Radix et Rhizoma Glycyrrhizae in preparation were indentified by TLC. All spots were separated in a clear map. Repeatability was good and negative control could be done without interference.②High-performance liquid chromatography (HPLC) method for the determination of forsythin in primary drug Fructus Forsythiae was established. The separation was performed on Agilent XDB-C18column(250mm×4.6mm,5μm), using with Acetonitrile-water(24:76) as mobile phase, the flow rate was1.0ml/min, the column temperature was30℃, the detection wave length was277nm. High-performance liquid chromatography (HPLC) method for the determination of irisflorentin in another drug Rhizoma Belamcandae was established. The separation was performed on Agilent XDB-C18column(250mm×4.6mm,5μm), using with Methanol-0.2%H3PO4(60:40) as mobile phase, the flow rate was1.0ml/min, the column temperature was30℃, the detection wave length was266nm. The results showed that there was a good linear relationship between peak area and amount when the content of forsythin was0.472～2.832ug. Regression equation was A=687910C-64810(r=0.9999), The average recovery was99.95%and RSD was2.04%. There was also a good linear relationship between peak area and amount when the content of irisflorentin was0.302～3.755μg. Regression equation was A=4823.9C+125.83(r=0.9997), The average recovery was99.38%and RSD was1.12%.The above quantitative method is simple, accurate, and has good repeatability. It also can be used for the determination of corresponding components in preparation.③We had investigated properties, pH, relative density, ejection disparity, the content of uniformity and microbial limit test with the methods in Pharmacopoeia. The results showed:Preparation pH in the range of4.5～6.5, relative density in1.10～1.15and the weight per injection of a bottle should be in weight of0.120～0.140g, microbial limit test to meet the requirements.④In order to inspect stability of Fanggan spray, an accelerated test and a room-temperature test have been taken for six months. The results show that every index mark was normal in the experiment period except for the slightly decrease of the content of irisflorentin. This phenomenon implies that some anti-oxidant should be addded to prevent oxidation of the active components.Conclusion:The method is simple, accurate and highly reproducible. It could be used for the quality control of Fanggan Spray and could provide an experimental basis for this medicine in the process of applying Chinese liquid sprays new medicine standard.