Yangxin Particle Quality Standards And Pharmacodynamic Study

Yangxin particle is a new drug of compound which is consisted of Puerariae Radix, Schisandra chinensis(Turcz.) Baill, Salvia miltiorrhiz, Rhizoma Chuanxiong, red ginseng, Ophiopogon japonicus, Citri reticulatae Pericarpium,(honey-fried) Glycyrrhizae Radix et Rhizoma et al. Yang Xin particle plays an important role in replenishing qi and blood also ranquilizing by nourishing the heart. The purpose of this study is to establish the quality standards of Yangxin particles by thin layer chromatography(TLC), high performance liquid chromatography(HPLC) and pharmacodynamics studies. MethodsTo optimize the preparation process of Yangxin particles, the solvent volume, extraction time and extraction times were optimized using the content of six active ingredient substances in yangxin particle as indexes.By TLC, the main active compounds: Schisandrin A, Salvianolic Acid B, Tetrahydropalmatine, Emodin, Ginsenoside Rb1, Re, Rg1 are qualitative identified.To establish a new method of quality evaluation of Yangxin particles. The quality evaluation method was established and validated with puerarin was selected as markers of ingredients to establish HPLC fingerprint and internal reference standard to determine the contents of other components according to the relative correction factor.To provide experimental evidence for clinical practice, we observe the effect of the drug on the weight of heart-qi-deficient mice, resistant hypoxia, and load swimming. The changes in ECG and creatine kinase, lactate dehydrogenase, cardiac troponin T in serum were tested to study the cure role that Yangxin particles plays in mice who were deficient of Yin and Heart Qi, and isoproterenol-induced myocardial ischemia. Result and Evaluation:The optimum preparation process was selected as follows: extracted twice with 8 times the amount of water for 1h each time. The conclusion is that the optimized extraction process is effective, and the assessment indicator is stable and controllable.The results of TLC show that, on the corresponding position of the reference substance, the same color spots or fluorescent spots of the 5 tested Chinese Medicine and Yangxin particles can be found. Due to that no interference can be found in negative sample, the sample are in line with regulations.Establish a new method of quality evaluation of Yangxin particles by fingerprint and quantitative analysis of multi-components by single marker method(QAMS).The accuracy and feasibility of QAMS was evaluated by comparison of the results between external standard method and QAMS. 17 common peaks were identified in the HPLC characteristic chromatograms of ten batches six components were verified good similarities with correlation coefficients higher than 0.99 were found in fingerprints. There was no significant difference between the quantitative results of 6 ingredients of external standard method and QAMS in 10 batches. The method of fingerprint combined with QAMS has been verified in Yangxin particles, it could be used as a reference for the quality control of multiple components determination and fingerprint chromatography for Yangxin particles in futureHigh and medium dose of Yang Xin particles can significantly improve the their fur color, mice activity and their body weight, also increase their thymus and spleen weight, effectively extend the hypoxia tolerance time, which indicated that the particles of the Yin Yang Xin virtual mouse has a better therapeutic effect. By controlling mice food, load swimming and fed mice Propranolol in a high dose, we built a heart qi deficiency model uccessfully. Yangxin particles can significantly improve symptoms in mice, enhancing their body weight, effectively extend their hypoxia tolerance time and swimming time. Each dose group of Yangxin particles could significantly inhibit the increasing of J point after injecting isoproterenol, especially the medium dose group had the best effect. In addition. Each dose group of Yangxin particles can dramatically reduce the content of creatine kinase, lactate dehydrogenase and cardiac troponin T in serum, which showed that Yang Xin particles had protective effect on myocardial ischemia(cell), and reduced enzymes leakage.