| Objective: To establish the preparation of Apocynum venetum extract and the preparation technology of Apocynum venetum tablet,study the pharmacodynamics of Apocynum venetum extract,establish the quality standard of Apocynum venetum extract,and investigate its stability.Methods:(1)Extraction technology: The extraction technology of Apocynum venetum was studied by orthogonal test,and the parameters were optimized by taking water content,yield,total flavonoids and Hyperoside content as the indexes.(2)Preparation technology:According to the physical and chemical properties of Apocynum venetum extract and the safety of excipients and the technology of Apocynum venetum To determine the dosage form and specifications;(3)Efficacy component methodology: Referring to the 2015 Pharmacopoeia of Apocynum venetum in the determination of hyperoside,specific,linear,quantitative limit,stability of the test products,sample recovery test,and three batches of verification,determine Hyperoside determination method;Referring to health food Technical Specification for Product Inspection and Evaluation(2003 Edition)Determination of Total Flavonoids in Health Food,Wavelength Selection,Specificity,Linear Relationship,Stability,Repeatability,Sampling Recovery,and Three Batch Validation to Determine the Determination Method of Total Flavonoids;(4)Efficacy Study: Using Conifer Bean Protein A pair To investigate the protective effect of Apocynum venetum extract on acute liver injury in mice;(5)Quality standard and stability study: to establish the quality standard of Apocynum venetum extract and preparation,referring to the notice of the General Office of Food and Drug Administration on the guidelines for the stability test of health food issued by the Food and Drug Administration The stability of tablet was studied by letter 2013 [500].Result:(1)The extraction process of Apocynum venetum was determined as water decoction process.The method was: taking Apocynum venetum leaves,washing,adding 10 times water,decocting three times,1 hour each time,combined with filtrate,filtered,filtrate concentrated to about 2 times the volume.Add ethanol to 60% ethanol concentration to precipitate,filter,concentrate and dry extract.(2)The preparation process is as follows:Apocynum venetum extract and microcrystalline cellulose are added to the wet mixing granulator respectively,mixing at low speed for 5 minutes,adding ethanol,granulating,16 mesh shaking granulator,drying below 50 C,moisture control at 3-5%,whole granule,adding magnesium stearate,mixing evenly(3)Establishment of a method for the determination of functional components: hyperin methodologies are exclusive and free of interference from impurity peaks.The concentration of hyperin in the sample ranges from 0.036 mg/ml to 0.216mg/ml has good linearity,r = 0.9999,the sample solution is stable within 12 hours,and the recovery test results are good.At the same time,three batches of validation are carried out to determine the determination method of hyperin.The total flavonoids of Apocynum venetum L.were determined by three batches of validation.(4)Efficacy study: Apocynum venetum was extracted from Apocynum venetum.It has protective effect on acute liver injury induced by concanavalin A.The extract has auxiliary protective effect on chemical liver injury.(5)Quality standard: The quality standard of the preparation was established by sensory index,physicochemical index,efficacy component index and microbial index.(6)Stability study:accelerated for 3 months,compared with 0 months,there was no significant change in the indexes of the samples.Conclusion: Apocynum venetum Tablet is stable and feasible in production process,and has strong specificity and protective effect on concanavalin an induced acute liver injury. |
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