Studies On Quality Standard And Fingerprint Of Kangnaoshuai Capsule

This paper aimed at resolving the lack of quality standerd system on safety,efficacy, controllability and stability of Kangnaoshuai capsule, and meeting therequirements of industrialization, modernization and internationization of Chineseherbal medicine. We established the HPLC methods for paeoniflorin, puerarin andbaicalin determination and the TLC method for Radix Ophiopogonis to improve thequality standerds of Kangnaoshuai capsule.The optimized extraction condition was 80% methanol, return flow time for60min after the orthogonal test for extraction method, solvent concentration andextraction time of Kangnaoshuai capsule.According to Chniese Codex (2000) and relationship references, Chromato-graphic conditions of Kangnaoshuai capsule were studied. HPLC condition forKangnaoshuai capsule is ODSC18 column, mobile phase A methanol, B 0.6% AceticAcid, linear gradient elution, eluting time 60min, flow rate 0.9mL/min, detectingwavelength 280nm and filling volume 20μL.Chromatographic parameters were studied, and HPLC fingerprint map ofKangnaoshuai capsule was achieved. At 280nm, total of shared 28 peaks weredetermined as characters of the map.The relationship of the shared peaks betweenKangnaoshuai capsule and medicinal herbs confirmed the absorptive peaks specificfor paeoniflorin, puerarin and baicalin. The methodological studies indicated that thisHPLC fingerprint is of high precision, strong repeatability and good stability,conforming to the establishment principle of Chinese Medicine (TCM) fingerprint.The fingerprint can be used for controlling the final quality of Kangnaoshuai capsule.The similarity evaluation system for chromatographic fingerprint of TCM(Version 2004A) was used to ten batch samples. The results of evaluation were thatseven batch similarity was over 0.9, conforming to the requirements of TCMpreparation.