Study On Digitized Fingerprints Of Compound Salvia Miltrorrhiza Tablets

Compound salvia miltrorrhiza tablet is a classical Traditional Chinese Medicine (TCM) compound preparation, which is widely applied in the treatment of cardiovascular and cerebrovascular diseases. It has the efficacy of promoting blood circulation and removing blood stasis as well as regulating vital energy and relieving pain. Used for chest impediment, caused by qi stagnation and blood stasis, with symptoms as chest stuffiness and precordial stabbing pain; and coronary heart disease angina pectoris with same syndrome above. In this paper, HPLC fingerprints and HPCE fingerprints were developed and used to control the quality of compound salvia miltrorrhiza tablet, meanwhile the RP-HPLC method was also developed for the study on dissolution behavior of this preparation in 3 different dissolution media.1. The HPLC fingerprints of compound salvia miltrorrhiza tablets under 290 nm was established while the index of chromatographic fingerprints (F) was used as an indicator to select the best experimental conditions. All of 40 co-possessing peaks were defined while the salvianolic acid B peak was chosen as the referential peak. The fingerprints were evaluated by the software of "Digitized Evaluation System for Super-information Characteristics of the Traditional Chinese Medicine Fingerprints 3.0", and it was found that the chemical composition proportion and content of compound salvia miltrorrhiza tablet from different batches has great differences, which affects their quality levels.2. Used F as the index to optimally select determining conditions, the HPLC fingerprints of compound salvia miltrorrhiza tablets under 203 nm was established and 24 co-possessing peaks were defined while the ginsenoside Rg1 peak was chosen as the referential peak. The fingerprints were comprehensively evaluated by 42 digitized criterion parameters as well as dual qualitative similarity parameters and dual quantitative similarity parameters. The results showed great differences exist on the chemical composition proportion and content of compound salvia miltrorrhiza tablet from different batches, and this causing their different quality levels.3. The HPCE fingerprints of compound salvia miltrorrhiza tablets was established after optimized selecting of experimental conditions such as background electrolyte (BGE), pH and addition agent and so on. And total 13 co-possessing peaks were defined, taking the rosmarinc acid peak as the referential peak. The similarities between sample fingerprints and referential fingerprint were evaluated on the aspects of proportion and content of each chemical composition by "Digitized Evaluation System for Super-information Characteristics of the Traditional Chinese Medicine Fingerprints 3.0". Meanwhile their quality levels were divided according to systematic quantified fingerprint method.4. Preliminary study of accumulative dissolution fingerprints of compound salvia miltrorrhiza tablets was carried out, and the dissolution rates and degrees of this preparation in 3 different dissolution media were compared. This provided important reference for comprehensive quality control to this preparation.