Study On Quality Control Analysis And Preliminary Pharmacodynamics Of Shenling Sedative Granules

Shenling Sedative Granules is composed of 9 herbal medicines,such as Radix Rehmanniae,Spina Date Seed,Poria,Radix Scrophulariae.It has the function of nourishing yin to clear away heat and enriching blood to anchor the mind.In clinic,mainly used for the prevention and treatment of insomnia caused by yin-blood deficiency,etc.This topic by the theory of TCM as a guide,application modern scientific methods,on the basis of original Decoction according to 6.1class new drugs of Chinese traditional medicine registration requirements for secondary improvement of dosage form.The quality analysis,fingerprinting and preliminary pharmacological investigation study on the multi batches preparation were carried out,to ensure Shenling Sedative Granules is effective and safe,stable and controllable.1 Quality Analysis ResearchInspection study:According to the 2015 edition of Chinese Pharmacopoeia(four general principles 0104),the characteristics,moisture,particle size and solubility of the products were examined,which indicated that the process parameters and operation of the preparation were reasonable and feasible.TLC identification : Established the TLC method of Radix Rehmanniae and other six herbs contained in the preparation.The experimental results show that in the chromatography of the test product,the same spot is displayed in the corresponding position of the control product or the control medicinal material.Through the specificity test.After many tests,to reproduce well.Determination of content:Determination of the preparation Mullein glucoside and tanshinone II a two index component content,and the linear relationship,precision,stability,repeatability and recovery rate of system methodology investigation by HPLC.The results show that this method is simple,reproducible,high recovery rate,and can be used for the quality control of this product.Through the determination of 10 batches of samples,the product to each bag of particles(10g / bag)with verbascoside meter,temporarily not less than 0.147 mg.In terms of tanshinone IIA,temporarily not less than 0.103 mg.Determination of extract:Determination of the method of extraction(2015 edition < Chinese Pharmacopoeia > four general rules 2201) under the hot dipping method.The water soluble extract of this product should not be less than 27.1%,the alcohol soluble extract is not less than 3.4%.2 Fingerprint ResearchEstablished the fingerprint method using HPLC-DAD gradient elution,in order to control the main components of Shenling Sedative Granules.According to the fingerprints of 10 batches of samples,28 common peaks were established,and the similarity was above0.95;This product and the main chemical components were calibrated,determine the fingerprint in the No.15 peak was spinosin,No.16 peak was verbascoside,No.17 peak was(-)-syringaresinol-4-O-?-Dglucopyranoside,No.21 peak was Salvianolic acid B,No.22 peak was harpagoside,No.28 peak was tanshinone IIA;At the same time carryed on the herbal tracing investigation on fingerprint of each chromatographic peak.The results show No.7,8,9,10,16 peak were originated from Radix Rehmanniae,No.11?19?20?21?25?26?27?28 peak were originated from Salvia miltiorrhiza,No.3?4?12 peak were originated from Radix Codonopsis,No.13 peak were originated from Poria,No.14 ? 15 peak were originated from Semen Ziziphi Spinosae,No.17 peak were originated from Cortex Albiziae,No.22 peak were originated from Radix Scrophulariae,No.23 peak were originated from Acorus tatarinowii Schott,No.6 peak may be rehmannia root,dangshen and poria cocos common components,The rest of the1,2,5,18,24 peak could be the herbal extracting reaction products together.The intermediate and the preparation also have the good similarity,the research shows that the fingerprint provides an effective basis for the quality control of Shenling Sedative Granules.3 Preliminary Pharmacodynamic ResearchMultiple factors model were established with Yin-blood deficiency induced by cyclophosphamide and hydrocortisonum,and sleep deprivation on 48 h induced by using water platform method.The content levels of amino acid neurotransmitters Glu,Gly,Tau and GABA in the brain of insomnia rats were explored from the point of view of neurotoxicity.The results show that after the group of granules intervention of Glu,Tau and GABA were decreased to varying degrees,simultaneously the ratio of Glu/(Tau+ GABA)was descent,In the middle and high dose group,the reduction is more significant.It was suggested that the effect of granule on promoting sleep may be related to reducing the toxic effect of excitatory amino acids in the brain and reducing the delayed neuronal damage induced by Glu and GABA.