Study On The Preparation And Preliminary Pharmacodynamics Of Shanhe Lipid-lowering Powder

Objective:Shanhe lipid-lowering powder is an experience-based medicine.It is mainly composed of four herbal and food herbs,such as hawthorn,lotus leaf,radish seed,and kelp.It has the effects of removing qi and dissipating blood stasis,reducing phlegm and lowering lipid,which is mainly used in the prevention and treatment of hyperlipidemia.In this study,the preparation process of the powder was determined,the quality control method was established,and the preliminary pharmacodynamics evaluation was carried out,so as to provide scientific basis for the production of the enterprise.Method:1.The optimum extraction techniques of Nelumbo nucifera and Semen Raphani were determined by single factor experiment and orthogonal test,with the content of total flavonoids and raymond salt precipitation and the rate of dry paste were used as the indexes of evaluation.The repeatability test was carried out to verify the feasibility of the process.The physicochemical properties and production feasibility of other medicinal materials in the prescription were combined to determine the final preparation process.2.The qualitative identification of Hawthorn,lotus leaf and Lycium barbarum L.in the Shanhe lipid-lowering powder was carried out by TLC.3.According to the relevant regulations in the Pharmacopoeia powder,check the Shanhe lipid-lowering powder.4.UV spectrophotometry was used to determine the content of total flavonoids in Shanhe lipid-lowering powder.5.HPLC method was used to determine the content of phytoplankton in Shanhe lipid-lowering powder.6.To establish a“multi-evaluation”quality control method for determining the contents of sinapine thiocyanate,hyperin,and kaempferol in the Shanhe lipid-lowering powder simultaneously by only determining the content of quercetin with relative correction factors.7.To carry out a preliminary pharmacodynamics study and evaluation of the functional properties of the Shanhe lipid-lowering powder by establishing an acute hyperlipidemia mouse model.Result:1.The final preparation process was as follows:Hawthorn medicinal materials were crushed over 80 mesh sieve,set aside.Lotus leaves were refluxed and extracted at 80?with 60 times amount of 80%ethanol solution for 2 times,2.5 hours each time,and then concentrated at 60°C for dehydration.After drying at a vacuum of-0.09 MPa and a temperature of 60°C for 12 hours under reduced pressure,crushed over 80 mesh sieve,set aside.Semen Raphani was 10 times water extraction for 3 times,1.5 hours for each time,and then concentrated at 60°C for dehydration.After drying at a vacuum of-0.09 MPa and a temperature of 60°C for 12 hours under reduced pressure,crushed over 80 mesh sieve,set aside.Kelp was dried at 80?for 20 minutes,crushed over 80 mesh sieve,set aside.Lecithin powder was dried at 40?for 1 hour,crushed over 80 mesh sieve,set aside.The powder above were mixed according to the formulation mass ratio,and the packaging was obtained.2.The TLC method for identification of Hawthorn,lotus leaf and semen Raphani was established.The target spots were clear and round,the separation degree was good and R_f value was moderate,no interference was found in the negative,and the method was simple and feasible.3.The appearance uniformity,moisture content,volume difference and microbial limit of the powder were all in accordance with the regulations of pharmacopoeia.4.The established violet spectrophotometric method for the determination of total flavonoids is accurate,reliable,and repeatable.The rutin showed good linear relationship at the range of0.0192~0.1152 mg/m L(r=0.9996).The average recovery was 100.53%with RSD was1.45%(n=6).The content of total flavonoids in three batches of Shanhe lipid-lowering powder was 6.18%~6.42%.5.The established HPLC method for the determination of nuciferine is accurate,reliable,and repeatable.The nuciferine showed good linear relationship at the range of 1.5~24.0?g/m L(r=0.9999).The average recovery was 100.16%with RSD was 1.17%(n=6).The content of nuciferine in three batches of the powder was 1.58~1.66 mg/g.6.The established QAMS quantitative method is accurate and feasible.The RCF values of sinapine thiocyanate,hyperoside and kaempferol were 1.5452,1.6346,0.8947,respectively.The reproducibility and durability were good.There was no significant difference between the calculated values of four components in three batches of the powder by QAMS method and external standard method.7.Compared with the model group,serum TC and TG in each dose group of Shanhe lipid-lowering powder decreased significantly;The HDL-C of high dose group increased significantly,the HDL-C of medium and low dose group increased significantly;The LDL-C of high dose group decreased significantly,but there was no significant difference between middle and low dose group.Conclusion:The extraction and preparation process of the powder was reasonable and feasible,the quality standard was stable and controllable,and it has a certain regulatory effect on exogenous lipid disorders,which can lay a foundation for the further research of the production of the powder.