Through a large number of clinical trials over the past 3 years, researchers from the CAS Shanghai Institute of Materia Medica (SIMM) have developed a new cardiovascular drug with a definite effective component extracted from Dan Shen (Saliva miltiorrhiza), a medicinal herb widely used in China.
It is confirmed to be safe and effective. On May 25, a New Drug Application (NDA) of depsides salts from Salvia miltiorrhiza and its preparation for the potential treatment of chronic angina obtained State Food and Drug Administration (SFDA) approval.
Dan Shen (or Chinese Salvia) is a renowned Asian traditional herb, used for centuries to support cardiovascular health. Based on its extract, many pharmaceuticals have been developed in China. For instance, more than three billion such injections are used annually as an alternative approach to treat cardiovascular patients. But until recently, due to a lack of understanding of its efficient components, it is difficult to control the quality of the medicine.
With the support of CAS, Ministry of Science and Technology, and Shanghai Municipal Government, SIMM researchers began their studies on Dan Shen systematically in 1992. Chemical characterization and compositional analysis of the herbal medicine provide the necessary scientific basis for the discovery and development of a new drug of natural origin. They identified that its most effective component is depsides salts from Salvia miltiorrhiza with magnesium lithospermate B as its primary active compound. Based on the discovery, the scientists invented a new extraction process technology with magnesium lithospermate B as the criteria for quality control. The new approach could fully guarantee the drug's efficacy and thus both the drug itself and its preparations have their quality to be subject to an all-round control.
The new drug has a definite effective component, featuring about 80% of magnesium lithospermate B. The fingerprint technology is used for the overall quality control of the medical herbs, raw materials and drug products.
The results in preclinical pharmacological studies of depsides salts from Salvia miltiorrhiza indicated that the drug remarkably reduced myocardial infarct size and attenuated ischemic myocardial injury, lowered the oxygen consumption of the myocardium in models in vitro and in vivo, and had inhibitory effects on ADP-induced platelet aggregation and thrombosis formation. Especially, it has great promise as a drug that it had little effect on hemadynamics within the recommendable dosage.