| Quality control of Chinese patent medicines is the fundamental foundation to ensure the safety and effectiveness of medicines.Since the production of Chinese patent medicines is a complex system in which the flavors of prescriptions dissolve and interact with each other through different solvents,the development direction of quality control is multi-index and multi-way.Shuxin Jiangzhi Tablets are composed of 11 herbs.The original standard only controls the quality through simple color identification and routine tablet weight inspection.At present,the inspection technology and equipment are constantly changing,and the original control methods can not meet the needs of existing drug safety assurance.In this study,we established a thin-layer identification method for simultaneous detection of polydatin and puerarin in Shuxin Jiangzhi Tablets,established a thin-layer identification method for paeoniflorin and salvianolic acid B,established a HPLC method for simultaneous determination of three components in Shuxin Jiangzhi Tablets,and formulated a draft standard for Shuxin Jiangzhi Tablets;at the same time,we discussed the establishment of HPLC and TLC fingerprints of Shuxin Jiangzhi Tablets.The results show that:1 The four components in Shuxin Jiangzhi Tablets were identified by TLC technology.The identification method studied showed reasonable Rf value and good separation.In the TLC test sample chromatogram,the spots with the same color appeared at the corresponding position with the reference chromatogram,and the spots were clear,but there were no corresponding spots in the negative reference chromatogram.2 The three components in Shuxin Jiangzhi Tablets were simultaneously determined by HPLC using a C18 liquid chromatographic column(diameter 5 m)with gradient elutionof acetonitrile(A)-0.1% phosphoric acid aqueous solution(B)as mobile phase at a flow rate of 1.0 mL/min.The detection wavelength was 306 nm,the column temperature was30 ?,and the injection volume was 10 ?L.Puerarin ranged from 19.0 to 380.0 ug/mL,polydatin from 4.54 to 90.80 ug/mL,and salvianolic acid B from 60.58 to 1211.60 ug/mL had a good linear relationship.The average recovery of sample addition ranged from98.88% to 102.32%,and the RSD ranged from 0.807% to 0.926%(n=6).Through cluster analysis and principal component analysis on the peak area data of polydatin,puerarin and salvianolic acid B reference substances injected multiple times under the same condition,we can see that there are slight differences in samples among different injection times.The method has good separation effect,stability,convenient operation and can determine the content of Shuxin Jiangzhi Tablets stably.3 Through the determination of the content of active ingredients in different batches of Shuxin Jiangzhi Tablets,and then the similarity evaluation,the similarity of the marketed Shuxin Jiangzhi Tablets is higher than 0.9,indicating that the method of simultaneous determination of the three components of Shuxin Jiangzhi Tablets can establish an HPLC fingerprint model.Because there are fewer detection batches,it is necessary to further collect multi-batch atlas for comparison,and improve the fingerprint data.4 Through thin layer identification study of Shuxin Jiangzhi Tablets and one side multi-evaluation multi-component HPLC determination method,the original quality standard of Shuxin Jiangzhi Tablets was revised and a new draft quality standard was drafted.5 The establishment of TLC fingerprint model with different thin layer unfolding conditions was explored by Image J technology.Results TLC fingerprint model of components represented by polydatin and puerarin had good similarity and clear common peaks,which preliminarily indicated that TLC fingerprint model of components represented by polydatin and puerarin could be established under the current experimental conditions;due to fewer detection batches,more batches of atlases need to be collected for comparison,and fingerprint data should be improved. |
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