Studies On The Preparation Technology And Stability Review Of Jiubiying Yixin Tablet

Cardiovascular and cerebrovascular disease is the first killer of human. In China, there are about 130 million people get sick,the number of which cause death accounted for nearly 50 percent.The survivors have varying degrees of loss of capacity of life and work. Cardiovascular and cerebrovascular disease has a great deal of harm to humanbeing when all countries in the world have attached great importance of cardiovascular and cerebrovascular diseases and put in a lot of labor force and material resources; it has been regarded as the most important health problems. With the continuous improvement of people's living standards, cardiovascular and cerebrovascular disease incidence increased year by year.In-depth study of prevention and treatment of angina pectoris and coronary heart disease is an importnet link to reduce the pain of patients and cut down the incidence of myocardial infarction and mortality, it also become one of the most important issues in the field of medicine in today's world.There are many kinds of which is used for coronary heart disease in current clinical, but because of long-term use of them may lead to serious side effects, patients often prefer to use traditional Chinese medicine due to their good pharmacodynamics and minor side effects. Searching for a new type of Chinese medicine preparations which is effective, safe, non-toxic and easy to take from traditional Chinese medicine has been the concern of the academic medicine at home and abroad. Therefore to seek and develop new type of traditional Chinese medicine treatments for cardiovascular and cerebrovascular diseases are completely essential.The material of product in this experiment, Jiubiying yixin tablet,was extracted from the effective parts of tranditional Chinese medcine Ilex rotunda Thunb. The total Jiubiying saponins is the effective site of Ilex rotunda Thunb which has therapeutic effect of cardiovascular disease. After extract and isolate from Ilex rotunda Thunb, combined with pharmacological screening, it is concerned that pedanculoside is the active ingredient of Ilex rotunda Thunb to cure cardiovascular diseases. After identification of the structure, it is confirmed that the chemical structure of pedanculoside is pentacyclic triterpenoid saponins, so that the total Jiubiying saponins is determined as the effective site of Ilex rotunda Thunb. Experiments confirmed that the effective part to cure coronary heart disease and other cardiovascular diseases will be the total Jiubiying saponins. It is refined by modern production technology into a tablet for angina pectoris with high technological content.Products have certain effective content, stable property and characteristics of obvious effect. The pharmacodynamic effects of Jiubiying yixin tablet against myocardial ischemia is significant, start with a fast onset, low toxicity. The effective part of the active ingredient in the chemical structure and its content are clear,having high content of active ingredients,controllable quality and good stability. It has the distinguishing feature of definited effect, fast onset, low toxicity, easy to take and low-cost, long-term medication for chronic disease and so on.This issue will be put out to study the preparation technology and quality control standards of Jiubiying yixin tablet.The pharmacy type of this medicine is tablet and conduct in-depth research in its preparation technology, quality standards, stability etc. Specific studies are as follows:(1) The extraction process of Chinese medicineThis project give research to the effective parts of Ilex rotunda Thunb.Taking the content of pedanculoside which is the active ingredients of Ilex rotunda Thunb as an index of selected research on the extraction process of Jiubiying yixin tablet prescriptions.Using orthogonal test method, the single factor of the solvent extraction and extraction method of the total Jiubiying saponins was given by the selection of choice. The extraction conditions were optimized to explore the relationship between water content,degree of enrichment of aqueous solution and sediment yield in the process of extraction and purification as well as the drying temperature on the impact of the total Jiubiying saponin content.Soak time, solvent volume, extraction number, extraction time factors for the study are carried out with four factors and three levels of the orthogonal test. At the same time ,in pre-production verification, optimized extraction of the total Jiubiying saponins get the best extraction technology ,the extraction process was stable and feasible.(2) Study on quality standardsWe use a thin-layer chromatography identification and quantitative study of high-performance liquid chromatography in the subject of Jiubiying yixin tablet. The utilization of high-performance liquid chromatography gave a method for the determination of the total Jiubiying saponins and Jiubiying yixin tablet; the use of thin layer chromatography developed the identification of the total Jiubiying saponins and Jiubiying yixin tablet; establishing a examination method for loss on drying and residue on ignition of the total Jiubiying saponins; working out a program for the inspection of weight differences and disintegration of the time limit of Jiubiying yixin tabletThe result of identification of TLC used in the preparation of pedanculoside show that the thin-layer chromatography spots were clear, with strong characteristic,good reproducibility and negative non-interference,and applicable to the qualitative identification of Jiubiying yixin tablet. HPLC method was used in the preparation of the content of pedanculoside. Established appropriate quality standards to provide for the content of pedanculoside in total saponins may not be less than 60%, total saponins content may not be less than 80%.Next, in order to optimized the tablet forming process, we aim to the factor which impact the shape of tablet with the disintegration of the time and the weight difference as an index to select the type and amount of material and humectant; using the disintegration of the time as a indicator to select the amount of starch material and magnesium stearate; using the water content and microbial limits as a indicator to select of the temperature and time of drying particle. All of these conditions were established to confirm the optimum process of shaping the Jiubiying yixin tablet and a small test and test were carried out.Through pilot production, the corresponding quality standard was established.In the quality standard, we used HPLC method for the determination of the active ingredients in the content of pedanculoside of Jiubiying yixin tablet and stipulate the content of pedanculoside per unit may not be less than 120mg, the total saponin content may not be less than 160 mg. Inspection by the methodology shows that the linear property, precision, reproducibility and recoveries of liquid chromatography were good, the quality standards were stable, accurate, reliable and easy to take.(3) Study on stabilityIn the stability of the agent, we utilize accelerated test and test at room temperature to respectively study the trait of the agent, differences in quantity, microbial limits, pH, relative density, qualitative identification, determination of content. Inspection were carried out after staying at room temperature for 6 months, accelerated test study for 6 months, the result shows no significant change, indicating that the stability of the product is good in the storage period. Preliminary experiments show that the stability of the total Jiubiying saponins and its preparation,Jiubiying yixin tablet, was very good.The characters, indexes, pedanculoside content and health examinations are qualified, not any change happens. It illustrates that the total Jlubiying saponins and its preparation Jiubiying yixin tablet are stable products .