Study On Chemical Component Transfer And Quality Correlation Of Huoxue Xiaoying Tablets

Objective:Through the study of the chemical components and the determination of the quality markers of each medicinal material in the prescription corresponding to the function and main treatment of the new Chinese medicine Huoxue Xiaoying tablet.Based on the quality markers of each medicinal material,the fingerprint determination method of five medicinal materials was established to improve the quality control standard of each medicinal material.The quality control standard of the extract was established by studying the standard decoction of Huoxue Xiaoying tablet.Through the research on the key quality control indexes of extracts,preparation intermediates and finished products,the quality control standards of extracts,preparationintermediates and finished products areestablished,the contentdetermination and fingerprint based on the components of quality markers are constructed,and the quality control of the whole process is carried out from medicinal materials-extract-particles-finished products.Methods:Through the literature search and analysis of the corresponding pharmacodynamic components in the various herbs of Huoxue Xiaoying tablet,the chemical components closely related to the function and main treatment of Huoxue Xiaoying tablet were identified.Combined with HPLC-MS technology,the chemical composition of Huoxue Xiaoying tablet was analyzed,and the chemical composition of Huoxue Xiaoying tablet was determined,which can be used as a quality marker for the study of medicinal materials,intermediates and finished products.Based on the identified key quality marker components,HPLC was used to establish the fingerprint method of each kinds of plant medicinal materials and to verify the methodology,and the fingerprint of at least 10 batches of each kind of medicinal materials was determined.To establish and verify the method of content determination and fingerprint of standard decoction of Huoxue Xiaoying tablet,and to study the standard decoction of no less than 15 batches with different sources and batches of different herbs,and to establish the quality standard of standard decoction.A HPLC method was established for the determination of flavonoid glycoside and amygdalin in extracts,granules and finished products of Huoxue Xiaoying tablets.Results:13 chemical components in Huoxue Xiaoying tablet were identified by searching and analyzing the chemical components closely related to the function and main treatment of Huoxue Xiaoying tablet and LC-MS analysis.It can be divided into the following components:erythrinaine,flavonoid glycoside,cyclopeptide a,amygdalin,kaempferoside andrapeseed sterol in the peachkernel,xanthogen ketoacid,6'-o-acetyl-saikosaponin a,saikosaponin B1 in the bupleurum,curcumone,epoxone and isocurcumenol in the zedoary,stearic acid in the claw grass.Through the above mentioned chemical components,the fingerprint of 5 kinds of herbal medicines was established and verified.The method is stable and reliable,and can be used as the quality control index of e-ach kind of herbal medicine.Through the study of 15 batches of standard decoction of Huoxue Xiaoying tablet,the quality standard of standard decoction was established with pH,total solid,paste rate,content determination and fingerprint as the control index,which provided the basis for the formulation of the standard of extraction solution in the industrialized production of Huoxue Xiaoying tablet.To determine the content of Amygdalin inpeach kernel and flavonoid glycoside in Bupleurum,the extract,granule and finished product of Huoxue Xiaoying tablet were determined.The method is stable and reliable.The fingerprint peaks of curcumin,curcumin,amygdalin,flavonoid glycoside,erythrinaine,saikosaponin B and saikosaponin a were determined.Conclusion:The chemical components of the herbs in Huoxue Xiaoying tablet were confirmed.The traceability and correlation of the chemical components from the five herbal medicines to the extracts solution,extracts,granules and finished products were established,which provided the basisfor the quality control of the herbs,the extract,the granule and the finished product in the industrialization research of Huoxue Xiaoying tablet.