Study On Preparation Process And Quality Standard Of The Yangxintongmai Mixture

Objective The prescription of the Yangxintongmai mixture was a proved effective recipe that has been used for many years in the treatment of coronary heart disease by the famous doctor of Traditional Chinese Medicine in hospital.It is composed of Astragali radix praeparata cum melle,Codonopsis pilosula,Salvia miltiorrhiza,Ophitopogin japonicum,steamed fructus schisandrae with vinegar and Glycyrrhizae radix et rhizome,and the effect is exact.The purpose of this study is to explore the preparation process and quality standard of the Yangxintongmai mixture,to evaluate the pharmacodynamics of extraction process and provide reference for mass production in the future.Methods This study is based on the relevant provisions of the 2015 edition of the Chinese pharmacopoeia.The whole Preparation process using orthogonal test method for the water extraction of Astragaloside IV by four factors,soaking time,volume of water,boiling time and boiling times.The preparation process of the mixture is obtained by means of data analysis.In the quality standard,TLC is used for qualitative identification of Astragali radix and Salvia miltiorrhiza and HPLC-ELSD provided the content determination of Astragaloside IV.The packing quantity,pH value and relative density of Yangxintongmai mixture were checked and the initial stability test was carried out.Throughthe establishment of coronary heart disease in mice model of Qi deficiencybl ood stasis syndrome,observe different extraction technology on hemorheology indexes in mice,the influence of the serum levels of NO,ET-1.Results The preparation process of the Yangxintongmai mixture was combined the traditional chinese medicinal materials in the prescription in proportion and soaked 1hour,with 8 times the amount of water,extracted 3 times,0.5 hours each time,immediate filtered.Then merged the filtrate,stay overnight,filtered.The filtrate was concentrated to proper amount,and then sodium benzoate and ethylparaben was added and mixed.Then the filtrate was boiled for 15 minutes,mixed,filtered,subpackaged to 500 ml each bottle,110 ? autoclave for 30 minutes.The TLC method of Astragali radix and Salvia miltiorrhiza was determined as qualitative identification method,and the method was feasible and reproducible.HPLC-ELSD determination of Astragaloside IV,linear regression equation was y=1.5311x+3.7183,exhibiting a good linear relationship within the rang of 0.0499~0.9998mg/ml,r = 0.9998,recovery rate was 96.47%~102.59%,RSD=2.39%(n=6).The established method is stability,feasible and reproducible.It is stipulated that the content of Astragaloside IV should not be lower than 0.0284mg/ml.The test results of packing quantity,pH value and relative density are also met.The results showed that the stability of Yangxintongmai mixture was good within 3 months.Pharmacodynamics experiment results confirmed that the optimization of extraction process for the best preparation process.Conculsion The results showed that the preparation process of the Yangxintongmai mixture was reasonable and feasible.The quality standard is controlled and the finished product has good initial stability.It provides a basis for controlling the quality of its products.