Improve Study Quality Control And Pharmacodynamics Of Kangshuailing Gao

KANGSHUAILING GAO is a commonly used traditional Chinese medicine preparation,and its pharmacological effect has been verified.It consists of Polygoni multiflori Radix,Mume Fructus,Astragali Radix,Lycii Fructus,Salviae miltiorrhizae Radix et Rhizoma,Glycyrrhizae Radix et Rhizoma and other 26 kinds of rare Chinese herbal medicines.It is capable of invigorating spleen,tonifying kidney,nourishing blood,relieving body fatigue,moistening intestine and bowel movement,improving sleep,inhibiting prostatic hyperplasia and delaying senility.In order to control the quality of KANGSHUAILING GAO,to ensure the effectiveness and safety of clinical medication and the accuracy of the production batch,guided by the interdisciplinary principles and methods,this study employs literature analysis,case observation,test design,the establishment of pathological model,routine examination,HPLC content determination and other methods,and takes a closer look into pharmacodynamics and quality evaluation of KANGSHUAILING GAO,so as to provide references for rational application of KANGSHUAILING GAO.Five steps will be carried out accordingly.1.According to the description of the Twelfth volumes of traditional Chinese medicine prescription for drug standards published by the Ministry of Health,the shape,color and odor of KANGSHUAILING GAO will be recorded and evaluated.2.According to the Chinese Pharmacopoeia TLC 2015 edition,six components like Polygoni multiflori Radix,Mume Fructus,Astragali Radix,Lycii Fructus,Salviae miltiorrhizae Radix et Rhizoma,Glycyrrhizae Radix et Rhizoma in KANGSHUAILING GAO will be identified.3.According to the Chinese Pharmacopoeia 2015 edition the relative density,insoluble substance,quantity,microbial limit and other items will be checked.4.According to the Chinese Pharmacopoeia method 2015 edition,six Chinese herbs in KANGSHUAILING GAO will be determined with the help of HPLC method,and the method of content by HPLC with ammonium glycyrrhizinate and salvianolic acid B as index components will be established.5.According to the characteristics of pharmacodynamics of KANGSHUAILING GAO,different pathological models will be established and tested separately so as to prove that it is effective in invigorating spleen,tonifying kidney,nourishing blood,relieve fatigue,laxative,improve sleep,inhibit prostatic hyperplasia and delaying senility effects.As the results show,it is accurate,precise and easy to apply TLC mehtod to identifying Polygoni multiflori Radix,Mume Fructus,Astragali Radix,Lycii Fructus,Salviae miltiorrhizae Radix et Rhizoma,Glycyrrhizae Radix et Rhizoma.All the other examinations meet the requirements of the relevant provisions of decoction agent of the Chinese Pharmacopoeia(Edition 2015,Vol.?).Besides,we have established a quantitative method for the determination of ammonium glycyrrhizinate and salvianolic acid B,which is simple,reproducible and of strong specificity.Thanks to the improvement,the quality control method of KANGSHUAILING GAO has been proved to be simple,strong and reproducible,and can effectively control the quality of the drug.In addition,pharmacological studies showed KANGSHUAILING GAO was helpful for spleen strengthening,kidney nourishing,blood nourishing,relieving body fatigue,Runchang catharsis,improving sleep,inhibiting hyperplasia of prostate and delaying senility effects.