Subtractive Analysis of Size Exclusion Chromatography and Fingerprint for Radix Salviae Miltiorrhizae Injection
- VernacularTitle:注射用丹参分子排阻色谱及指纹图谱差减分析
- Author:
Yuhong LAI
;
Huizhen TONG
;
Xiaoqun ZHANG
;
Yankang XIE
;
Fei LONG
;
Jinfei LI
- Publication Type:Journal Article
- Keywords:
Radix Salviae Mihiorrhizae;
Injection;
Adverse drug reaction;
Fingerprint;
Size exclusion chromatogra-phy;
Chromatographic toxicities;
Safety evaluation
- From:
Traditional Chinese Drug Research & Clinical Pharmacology
2009;20(4):376-379
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the the analytical method for the quality difference of Radix Salviae Mihiorrhizae (RSM) injection. Methods Parallel intercomparison experiment was carried out in different batches of RSM injection samples which had different degrees of adverse drug reaction. The samples were analyzed by gel size exclusion chromatog-zraphy and C18 HPLC fingerprint. Subtractive analysis was used to reveal the information of the non-low molecular weight phenolic acids. Results There were obvious differences between the results of size exclusion chromatography. The amount of the non-low molecular weight phenolic acids from different batches of the samples was also different, which was correlated with the degrees of acute toxicity in guinea pigs. Conclusion The amount of the non-low molecular weight phenolic acids varies with different batches of Radix Salviae Mihiorrhizae injection. It is suggested that non-low molecular weight phenolic acids can be used for the quality control of Radix Salviae Mihiorrhizae injection. For the first time, the perspective that the corresponding relationship between the fingerprint and their toxicities of Traditional Chinese medicine injection may be one of the most important fields is put forward.
