Study On The Preparation And The Quality Control Method Of Yixin Xuezhikang Capsules

Objective: Yixin Xuezhikang capsules,estracted from Astragalus,Panax notoginseng,Rhizoma chuanxiong,developed as a new patent Chinese drug,Which has the effect of supplementing qi,activating blood circulation,activating microcirculation and removing stasis,ect.Yixin Xuezhikang capsules can be used to treat coronary heart disease and angina caused by qi deficiency and blood stasis.The paper studied on the preparation and the quality control method of Yixin Xuezhikang Capsules.Methods: 1.On the basis of the literature data of various ingredients,properties of effective parts and pharmacological effects,in combination with clinical application form of the original formula which would ensure a considerable clinical curative effect of Yixin Xuezhikang Capsules with its Decoction,it can be determined that the extraction solvent of the herbs in Yixin Xuezhikang Capsules.2.Volatile oil of Rhizoma chuanxiong was collected by steam distillation.Then on the basis of the literature data and the preliminary results in our laboratory,considering the extraction times with the indexes of the amount of oil,the best steam distillation extraction process can be got.3.Using extraction time,extraction times and water volume as three main influencing factors,which has three levels,orthogonal experimental can be designed with the indexes of the content of astragaloside IV,calycosin-7-?-?-D-glucoside and ferulic acid,to select the optimum water extraction craft and perform a process validation.4.The TLC be used to identify Astragalus,Panax notoginseng and Rhizoma chuanxiong.5.With suitable chromatographic conditions,using HPLC-UV to determinate calycosin-7-?-?-D-glucoside and ferulic acid simultaneously.6.Withsuitable chromatographic conditions,using HPLC-ELSD to determinate ginsenosides Rg1,Rb1,Rd and astragaloside IV simultaneously.Results: 1.Volatile oil of Rhizoma chuanxiong was collected by steam distillation,then using water as the extraction solvent to extract Rhizoma chuanxiong that the volatile oil has been collected and Astragalus simultaneously.2.The optimal extraction process of volatile oil in Rhizoma chuanxiong was determined based on the early test results in our laboratory.Rhizoma chuanxiong was soaked for 3 hours with 10 times water,and distillated for 5 hours.Reference preliminary result of laboratory experiments to determine the optimum extraction process of volatile oil is: adding 10 times water,soaked for 3hours and distillated for 5 hours.3.The optimal extraction process of Rhizoma chuanxiong and Astragalus that optimized by orthogonal experimentsis adding 6 times water,extracted 2 times,andhalf hour for eath time.Validation tests showed that this extract process had good repeatability.4.The TLC identification methods were distinct and highly specific.It is suitable for the quality identify of Yixin Xuezhikang capsules.5.The HPLC-UV for simultaneous determination of calycosin-7-?-?-D-glucoside and ferulic acid is simple,accurate,good reproducibility and stability.A good linearity of calycosin-7-?-?-D-glucoside was showed in the range of 0.084~1.688 ?g(r =0.999 8),and that of ferulic acid was in the range of 0.043~0.868 ?g(r =0.999 7).The average recovery rates(n=6)were 99.96%(RSD=2.65%)and 99.66%(RSD=2.28%)respectively.6.The HPLC-ELSD for simultaneous determination of ginsenosides Rg1,Rb1,Rd and astragaloside IV is accurate,excellent chromatographic separation,good reproducibility and stability.Thefour active compounds(ginsenosides Rg1,Rb1,Rd,and astragaloside IV)have good linearity(r?0.999 1).The average recovery rates were 99.56%(RSD 2.01%),100.63%(RSD=2.45%),99.97%(RSD=1.86%)and 98.99%(RSD=2.53%).Conclusion: The research results showed that the preparation of Yixin Xuezhikang capsules was reasonable and practicable;A qualitative identification method for Yixin Xuezhikang capsuleswas established;The HPLC-UV method for simultaneous determination of calycosin-7-?-?-D-glucoside and ferulic acid in Yixin Xuezhikang Capsule and the HPLC-ELSD method for simultaneous determination of ginsenosides Rg1,Rb1,Rd and astragaloside IV in Yixin Xuezhikang capsules were established.The two method is simple,accurate,good reproducibility and stability.It is suitable for the quality control of Yixin Xuezhikang capsules.