Objective Due to the limited resource and the large demand,many kinds of Bovis Calculus(BC) including artificial Bovis Calculus(ABC),in vivo cultured Bovis Calculus(in vivo CBC),and in vitro cultured Bovis Calculus(in...Objective Due to the limited resource and the large demand,many kinds of Bovis Calculus(BC) including artificial Bovis Calculus(ABC),in vivo cultured Bovis Calculus(in vivo CBC),and in vitro cultured Bovis Calculus(in vitro CBC)were used in Chinese patent medicines(CPMs).Previous studies have shown that the chemical constituents of ABC and their properties were different from other BC.The two types of CBC with much higher price than ABC were approximately equivalent with natural Bovis Calculus in quality and clinical effect.The aim of the study is to establish a rapid and effective method for the identification of BC in CPMs.Methods An HPLC method with the higher specificity for analyzing bilirubin was established to distinguish ABC from other three kinds of BC by comparing the change of bilirubin content with the addition of EDTA-2Na as the extraction solvent and stabilizer.Results The bilirubin content in CPMs containing ABC was basically unchanged,while that in CPMs containing other kinds of BC showed significant difference.The proposed method was employed to analyze a variety of CPMs containing Bovis Calculus(CPMBCs) and proven to be universal.Conclusion An effective analytical method is established for the quality control of CPMBCs and further ensures the safety and efficacy of these drugs in clinical practice.展开更多
文摘Objective Due to the limited resource and the large demand,many kinds of Bovis Calculus(BC) including artificial Bovis Calculus(ABC),in vivo cultured Bovis Calculus(in vivo CBC),and in vitro cultured Bovis Calculus(in vitro CBC)were used in Chinese patent medicines(CPMs).Previous studies have shown that the chemical constituents of ABC and their properties were different from other BC.The two types of CBC with much higher price than ABC were approximately equivalent with natural Bovis Calculus in quality and clinical effect.The aim of the study is to establish a rapid and effective method for the identification of BC in CPMs.Methods An HPLC method with the higher specificity for analyzing bilirubin was established to distinguish ABC from other three kinds of BC by comparing the change of bilirubin content with the addition of EDTA-2Na as the extraction solvent and stabilizer.Results The bilirubin content in CPMs containing ABC was basically unchanged,while that in CPMs containing other kinds of BC showed significant difference.The proposed method was employed to analyze a variety of CPMs containing Bovis Calculus(CPMBCs) and proven to be universal.Conclusion An effective analytical method is established for the quality control of CPMBCs and further ensures the safety and efficacy of these drugs in clinical practice.