Study On Preparation Process And Quality Standard Of Chimonanthus Nitens Tablets

Chimonanthus nitens belongs to the genus Chimonanthus of the family Chimonanthus,and its dried leaves are medicinal parts.The leaves of Chimonanthus nitens are slightly bitter and cool,and the main chemical components are flavonoids,coumarins,alkaloids,volatile oil,etc.,which have the main pharmacological effects of promoting digestion,lowering blood pressure and lipids,bacteriostasis and anti-inflammation,antipyretic and analgesic,anti tussive and expectorant,cooling and relieving summer heat,relieving diarrhea and so on.In this paper,the preparation technology and quality standard of Chimonanthus nitens leaf tablets were studied.The main research contents are as follows.(1)study on the extraction technology of Chimonanthus nitens leaves.A method for the determination of Rutin by high-performance liquid chromatography was established.On the basis of single-factor experiment,the extraction process of Chimonanthus nitens leaves was optimized by orthogonal experiment,and the optimum extraction process was determined as follows:50%ethanol,the ratio of material to liquid 1:15(g/mL),extraction time 2.5 h,extraction times 1 time.(2)study on the purification technology of Chimonanthus nitens leaves.A UV-visible spectrophotometric method for the determination of total flavonoids in Chimonanthus nitens leaves was established.The static adsorption and resolution ability of 11 types of macroporous resin to total flavonoids in Chimonanthus nitens leaves were compared,and the purification process of total flavonoids in Chimonanthus nitens leaves was optimized.Finally,LS-300B macroporous resin was selected,and the best purification process was as follows:the mass concentration of sample solution was 520.97 μg/mL,pH was 4.0,and the eluent was 70%ethanol and 1 mL·min-1.(3)study on the preparation technology of Chimonanthus nitens leaf tablets.Taking the degree of brittleness and disintegration time as the investigation index,the best preparation process was determined as follows:powder direct pressing method,filler anhydrous lactose,anhydrous lactose:dry extract=1:1,lubricant 1.5%talc powder and 1.0%magnesium stearate.(4)study on the quality standard of Chimonanthus nitens leaf tablets.Rutin,Kaempferol-3-O-β-D-rutinside,Scopoletin,Scoparone and Isofraxidin in Chimonanthus nitens leaves were qualitatively identified by TLC.HPLC method was established for the simultaneous determination of Rutin,Scopoletin,Isofraxidin,Kaempferol-3-O-β-D-rutinside and Scoparone in the leaves of Chimonanthus nitens.In TLC,the spots of tablets and five components are clear and well separated.The linear ranges of Rutin,Scopoletin,Isofraxidin,Kaempferol-3-O-β-D-rutinside and Scoparone were 9～174.4 μg/mL,0.33～3.32μg/mL,1.23～12.26 μg/mL,108～1080 μg/mL and 0.86～8.57 μg/mL respectively(R2≥0.9991).The contents of Rutin,Scopoletin,Isofraxidin,Kaempferol-3-O-β-D-rutinside,and Scoparone were 4.77 mg/g,0.102 mg/g,0.371 mg/g,6.496 mg/g,0.075 mg/g.The method is accurate and reproducible and can provide reference for the quality evaluation of Chimonanthus nitens leaf tablets.In this paper,the extraction process and purification process of Chimonanthus nitens leaves were studied by means of modern instrumental analysis,the molding process of Chimonanthus nitens leaves tablets was optimized,and the quality standard of the tablets was established to provide reference for the further development and utilization of the medicinal materials.