Preliminary Study On Quality Standard And Effectiveness Of Lian-wei Anacyclus Granules

Objective:Preliminary establish the quality standard of Lian-wei Anacyclus granules and further to research its effevtiveness.Methods:1)The qualitative and quantitative composition of Lian-wei Anacyclus granules were preliminary determinated by the relevant provisions of 2015 edition of "Chinese Pharmacopoeia";2)The content of rutin and polysaccharide in Lian-wei Anacyclus granules were determined by HPLC and UV spectrophotometry respectively;3)Based on the determination of polysaccharide and useing UV visible spectrophotometry method to determine the dissolution of Lian-wei Anacyclus granules in vitro;4)Quality standards of Lian-wei Anacyclus granules were established by using the methods of qualitative and quantitative analysis and on the basis of controllable quality;5)The study of anti-inflammatory and analgesic effects of Lian-wei anacyclus granules were observed by the mice ear swelling test,acetic acid writhing test and hot plate test;6)Using RCT method to observe the clinical effect as anti-inflammatory and analgesic of Lian-wei Anacyclus granules.Results:1)The qualitative identification showed that Lian-wei Anacyclus granules prescription medicines are containing flavonoids and polysaccharides;2)Each gram Lian-wei Anacyclus granules with an average 0.338 mg of rutin were measured by HPLC,the average recovery rate was 97.6%,RSD was 0.95%,rutin was linear in the range of 1~20?g/mL(0.9993);UV spectrophotometry measured per gram of Lian-wei Anacyclus granules content polysaccharide 24.6mg;3)The dissolution rate of Lian-wei Anacyclus granules in artificial gastric juice is in accordance with the provitions of the Chp,simple operation and effective control of drug quality;4)Lian-wei anacyclus granules could inhibite ear swelling caused by Xylene in mice markedly and there was significant difference between the control group and the blank control group(P<0.05).The high and medium doses of Lian-wei anacyclus granules could increase pain threshold significantly and there was significant difference between the control group and the blank control group(P<0.05);5)The investigation of clinical effect of Lian-wei Anacyclus granules showed that it has significant anti-inflammatory and analgesic effect.Clinical total effective rate was 87.09% and there was significant difference between the effect of Lian-wei Anacyclus granules and control group(P<0.05).Lian-wei Anacyclus granules is safe and effective and no obvious adverse reaction.Conclution:1)HPLC and UV spectrophotometry method with good reproducibility and rutin quality in controllable to be used for quality control of Lian-wei Anacyclus granules;2)In vitro dissolution of Lian-wei Anacyclus granules in water and artificial gastric juice medium have consistent dissolution behavior,which can provide reference for the quality control of the drug;3)Lian-wei Anacyclus granules remarkably has anti-inflammatory and analgesic effect and without any obvious adverse reactions.