Study On Quality Standard And Stability Of Filifolium Sibiricum Flavonoids Dropping Pills

Objective:In order to better control the quality of the Filifolium sibiricum flavonoids dropping pills and ensure the safety,effectiveness and stability of the drug,this paper was based on the characteristics of the Filifolium sibiricum flavonoids dropping pills,combined with the requirements of the 2015 edition of the Chinese Pharmacopoeia Pills.The quality standard and its stability of the Filifolium sibiricum flavonoid dropping pills were studied,which provided a scientific basis for the production and clinical application of the dropping pills.Methods:(1)Check whether the traits of the Filifolium sibiricum flavonoids dropping pills were in compliance with the requirements;the TLC was used to qualitatively identify the Filifolium sibiricum flavonoids dropping pills,and the durability of the identification method was investigated;check the weight diffierence and the dissolution limit time of the Filifolium sibiricum flavonoids dropping pills to meet the requirements.(2)The content of isoquercitrin,eriodictin,quercetin,apigenin and isorhamnetin in the Filifolium sibiricum flavonoids dropping pills was determined by HPLC,and the durability was investigated;using the"quantitative analysis of multi-components by single-marker",quercetin was used as an internal reference substance to establish a relative correction factor(RCF)with isoquercitrin,eriodictin,apigenin and isorhamnetin,and investigate the durability of relative correction factors.Finally,a comparison between the quantitative analysis of multi-components by single-marker(QAMS)and the external standard method(ESM)was used to determine whether there were significant differences in the contents of the five components in the Filifolium sibiricum flavonoids dropping pills.(3)The traits,contents,related substances and dissolution limit time were used as the stability investigation items,and the influencing factors,accelerated tests and long-term tests were carried out on the Filifolium sibiricum flavonoids dropping pills.Results:(1)It is determined that the Filifolium sibiricum flavonoids dropping pills are brown to brown pills,which are fragrant and slightly odorous;in the TLC identification study,the three batches of pills were chromatographed at the positions corresponding to the chromatograms of quercetin,apigenin and isorhamnetin,and the R_f was moderate,the negative sample had no corresponding spots,and the durability of the thin-layer,temperature and humidity were investigated.The weight difference and the dissolution time limit of the three batches of pills were in compliance with the requirement.(2)Established a method for simultaneous determination of five components of isoquercitrin,eriodictin,quercetin,apigenin and isorhamnetin in the Filifolium sibiricum flavonoids dropping pills,and discussed the"quantitative analysis of multi-components by single-marker"The relative correction factors for isoquercitrin,eriodictin,apigenin and isorhamnetin with quercetin as internal reference materials were 0.8655,0.5215,0.3810 and 0.5404,respectively,for different instruments and columns,the small changes in column temperature and flow rate were investigated for durability.It was found that there was almost no influence on the relative correction factor.The relative error method was used to compare the results of the quantitative analysis of multi-components by single-marker method with the external standard method.It was found that there was no significant difference between the two methods.(3)The influencing factors test results show that the Filifolium sibiricum flavonoids dropping pills are stable under high temperature and strong light conditions,and the stability is poor under high humidity conditions,and the dropping pills are easy soften and adhere;the accelerated test and the long-term test have good stability of the drop pills,and the shelf life can be tentatively set at 9 months,The long-term test is still under investigation.Conclusion:This paper has carried out a comprehensive quality standard study and stability study on the Filifolium sibiricum flavonoids dropping pills.The method is simple,accurate,specific and strong,and the stability of the dropping pills is good.It has laid a foundation for the production,application and further research of the Filifolium sibiricum flavonoids dropping pills.