Study On The Quality Standard Of Guaiixin Qiwei Tablets

Objective The current quality standard of Guanxin Qiwei Tablets is lack of inspection items in Mongolian medicine volume of drug standard of the Ministry of health.The purpose of this project is to study the components and main components of Guanxin Qiwei Tablets qualitatively and quantitatively,establish and improve the inspection standard.Methods sandalwood,Dalbergia,Kaempferia and Nutmeg were directly used as medicine by fine powder.The microscopic identification items of the medicine were established by determining the typical microscopic characteristics of the four herbs;A TLC method was established for the identification of Salvia miltiorrhiza,sandalwood,Dalbergia,Kaempferia,Nutmeg,Guangzao and Hippophae rhamnoides;A method for the determination of water-soluble and liposoluble components in Salvia miltiorrhiza was developed by using quantitative analysis of multi—components by single marke;Because there are many kinds of herbs containing volatile components in the prescription,the quality of volatile components should be controlled by establishing characteristic map.Results(1)To establish the micro identification characteristics of Guanxin Qiwei Tablets,calcium oxalate crystals and crystal fibers of Salvia miltiorrhiza and dalbergia,starch grains of Kaempferia and Nutmeg were used.(2)To establish a TLC identification method for comparison of Salvia miltiorrhiza and its control,and to compare Salvia miltiorrhiza and tanshinoneⅡ_AComparison of sandalwood and sandalwood oil by TLC.To establish a TLC method for the comparison of Dalbergia odorifera and its control herbs.To establish a TLC method for the comparison of Dalbergia odorifera and its control herbs.Comparison of nutmeg and control herbs by TLC.Comparison of Guangzao and gallic acid by TLC.Comparison of seabuckthorn and control herbs by TLC.(3)Determination of water-soluble components of Salvia Miltiorrhiza in Guanxin Qiwei tablets with salvianolic acid B as reference substance,and the relative correction factors of salvianolic acid B,Sodium Danshensu and protocatechuic Aldehyde were 2.294 and 0.313 respectively.Salvianolic acid B showed a good linear relationship in the range of 0.7876-7.8760μg,and the linear regression equation was y=1201.2014x+10557.4237(R=0.9999).Danshensu Sodium showed a good linear relationship in the range of 0.0787-0.7872μg,and the linear regression equation was y=510.1021x+942.5214(R=0.9999).Protocatechualdehyde showed a good linear relationship in the rangeof 0.0031-0.031μg,and the linear regression equation was y=4007.3x-619.42(R=0.9999).(4)Therelativecorrectionfactorsof cryptotanshinone,dihydrotanshinone I,tanshinone I and tanshinone II_Awere 3.647,1.557 and1.013 respectively.Cryptotanshinone showed a good linear relationship in the range of0.1752-1.7528μg,and the linear regression equation was y=57.9791x+0.09564(R=0.9999).Dihydrotanshinone I showed a good linear relationship in the range of 0.1148-1.1483μg,and the linear regression equation was y=16.6522x+0.0117(R=0.9999).Tanshinone I showed a good linear relationship in the range of 0.0655-0.6654μg,and the linear regression equation was y=40.9047x+0.0185(R=0.9999).TanshinoneⅡ_Ashowed a good linear relationship in the range of 0.1523-1.5232μg,and the linear regression equation was y=54.6984x+0.0446(R=0.9999).(5)Thevolatilecomponentsof sandalwood,Dalbergia,Hippophae rhamnoides and Nutmeg in Guanxin Qiwei Tablets were analyzed by gas chromatography,a total of 11 characteristic peaks were identified.Conclusion The methods of microscopic identification,thin layer identification,content determination and characteristic map of Guanxin Qiwei Tablet established by the experiment are accurate,reliable and specific,which can provide reliable basis for the establishment of its quality standard.