| Coronary atherosclerotic heart disease is a kind of disease which is caused by blood vessel stenosis or occlusion cavity due to coronary atherosclerosis or (and) by myocardial ischemia, hypoxia or necrosis due to coronary artery functional changes (cramps). Angina are a group of clinical syndromes which are caused by temporary myocardial ischemia, hypoxia and whose main performance is paroxysmal chest pain. In the modern society, alongside the changes of the influencing factors such as lifestyle, cardiovascular and cerebrovascular diseases have ranked among the major diseases that threaten people's life, health and quality of life. Moreover, the disease is becoming more and more harmful because of the gradually increasing incidence, especially the cardiovascular disease in China with the highest incidence rate among all diseases. Angina pectoris is one of the diseases. Along with the improvement of people's standard of living and the development of the aging of the population in China, its incidence and mortality rates are showing an upward trend year after year, and it has become the number one killer that endangers the life and health of our people. Although drug treatments keep emerging, results of the prevention of coronary heart disease are still far from satisfactory. Nowadays the pharmaceutical market is in urgent need of new drugs for the treatment of coronary heart disease with high efficiency and low toxicity. This paper systematically studies the drug for cardiovascular disease, a unilateral injection of Chinese medicine taking the American ginseng leaf saponins diol as raw material developed according to Chinese medicine treatment of chest pain as a fifth-class new drug.Araliaceae Panax ginseng is a Panax quinquefolim L. It originates in the United States and Canada, was introduced into China in the early 1980s, and is one of the rare special medicinal herbs in Changbai Mountain district , Jilin Province. But the application of American ginseng in traditional Chinese medicine is only limited to roots, while the renewable resources, the stems and leaves, are discarded which is really a great pity. This paper develops the new drug, IPQDS, turning American ginseng stems and leaves from waste into treasure. The product is safe and reliable with a distinct composition, stabile technology, controllable quality and definite efficacy. And compared with previous formulations made from stems and leaves of Panax quinquefolium saponins, it has its own breakthrough in term of form, therefore can better meet coronary heart disease and angina pectoris patients'need of urgent rescue treatment whose disease may come on rapidly. The project has won the support of the State high-tech research and development (863) plans (2004AA2Z3681). This study not only meets the market demand, but also re-uses"waste"to reduce costs, applies advanced science and technology. It will bring good socialeffects and economic returns and benefit humankind on the whole.This paper effectively separates the original ginseng saponins from the total saponins of American ginseng stems and leaves with the patented technology (have gained patent, patent No.: ZL98100069.X). Since it can dissolve in water without hemolysis, conventional methods can be used to make it directly dissolve in water and then make it into injections, without any auxiliary materials or additives. In clinical application, the drug can be given through intravenous administration to achieve a faster, to meet the aim of quick effect. This method is simple, safe, stable, and suitable to industrial production. In order to improve the quality controllability of the product, this paper makes content analysis of its five major components (ginsenoside Rb1, ginsenoside Rb2, ginsenoside Rb3, ginsenoside Rc, ginsenoside Rd) and calculates their total quantity on the basis of meeting quality standards. According to the requirements of the appendix XⅧof the Chinese Pharmacopoeia 2005 edition, a linear relationship, precision, stability, reproducibility and recovery tests and the determination of three batches of samples are respectively carried out in accordance with the law. The results showed that: Ginsenoside Rb1 and Ginsenoside Rc are within the range of 0.10112 ~ 3.16μg with a good linear relationship of peak area; ginsenoside Rb2 within the range of 0.784 ~ 4.704μg with a good linear relationship of peak area; ginsenoside Rb3 within the range of 1.632 ~ 9.792μg with a good linear relationship of peak area; ginsenoside Rd within the range of 0.96 ~ 5.76μg with a good linear relationship of peak area. In precision, stability, reproducibility and recovery test, RSD values are all less than 3%. In three batches of samples, the total quantity of ginsenoside Rb1, ginsenoside Rb2, ginsenoside Rb3, ginsenoside Rc, ginsenoside Rd are all more than 80%. This indicates that the method is stable, accurate, reasonable, and can realize a better product quality control.The paper used the acute myocardial infarct(AMI) model formed by ligating the rat's left anterior descending coronary artery(LAD). After 24 hours of AMI, MIS was calculated, activities of serum creatine hosphokinase(CK), lactate Dehydrogenase(LDH), aspartate aminotransferase (AST), superoxide dismutase(SOD), GSH-Px, contents of Nitric Oxide(NO) and malondialdehyde(MDA), changes of blood low, middle and high viscosity, and platelet aggeration rate and platelet adherence rate were measured. The protective effect of IPQDS on experimental myocardial infarction in rats and its mechanism analysis were reported in this paper to provide a scientific basis for its development and utilization.Acute myocardial infarct(AMI)model was established as follows: after anesthetised with ether, rats were fixed on the operating table on their backs.The chest was opened between the left third and fourth rib and the heart was exposed. Then the left anterior descending coronary artery was found, and a nylon suture attached to a fine needle was placed under the left anterior descending coronary artery to ligate coronary artery immediately. After the heart was returned into the chest, the air in the chest was squeezed out and the chest was closed swiftly. The opening time of the chest was no more than 30 seconds. Sham surgical group placed the suture withnot ligating. After coronary artery was ligated for 24 hours, rats were anesthetized with 30% barbital sodium(30mg/kg, ip). The hearts were taken out and perfused with NS through aorta. Atrium tissue and fat were removed, and myocardium of left ventricle was crosscut into four or five slices, then immersed into the N-BT phosphate buffer in water bath at 37℃, and taken out after completely dyed. Normal tissues were dyed while ischemic tissues not. Ischemic myocardium was sliced and weighed. MIS was expressed as the ratio of ischemic myocardium weight to left ventricle wet weight. Blood was collected from the abdominal main artery of half of the rats from each group, to measure activities of serum CK, LDH with COBAS-FARA, and to measure activities of AST and SOD and contents of NO and MDA. The blood of the other half of the rats was collected to determine low shearing specific viscosity, middle shearing specific viscosity, high shearing specific viscosity, and platelet aggregation rate and platelet adherenc rate. The results showed that: in rats treated with IPQDS (in a dosage of 25 and 50mg/kg.dip×3d ), the MIS was significantly reduced, and the activities of serum CK, AST and LDH were lowered. In addition, blood viscosity, platelet aggregation rate and platelet adherence rate could be reduced by decreasing the content of serum MDA, and increasing activities of SOD,GSH-Px and the content of NO. What we observed suggests that IPQDS has a protective effect on myocardial ischemia by improving free radicals and myocardial metabolism etc.From the above experimental data, we can conclude that: IPQDS has a reasonable technology, clear composition, quality controllability, and it is a very good drug to fight against myocardial ischemia and infarction. Moreover China is rich in American ginseng; American ginseng stems and leaves are renewable resources whose costs are low. The development of this product will bring good social and economic benefits.
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