Pharmaceutical Research Of Tribulus Terrestris L. Sustained-release Tablet

The coronary heart disease has been one of the highest morbidity and mortality of diseases in middle-aged and elderly population, seeking an effective drug for treatment of the coronary heart disease has been on the research hotspots. The auxiliary traditional Chinese medicine of cardiovascular and cerebrovascular disease has hugely market demands, it will be included in the planning of large varieties of traditional Chinese medicine. Therefore, it needs to deeply develop the variety of Traditional Chinese Medicine with clinical curative effect for treating cardiovascular and cerebrovascular disease.With the guidance of the theory of Traditional Chinese Medicine, in combination with modern pharmacological research results, Tribulus terrestris L. Sustained-release Tablets is prepared the extract of Tribulus terrestris L. by adopting the modern pharmacy technology. It has the effect of promoting blood circulation and removing blood stasis for the treatment of angina pectoris of coronary heart disease.Based on the physical and chemical properties of effective components of Tribulus terrestris L., the optimum extraction process of Tribulus terrestris L. is selected by adopting single factor tests, orthogonal test and multi-index(furostanol saponins and total flavonoids)comprehensive evaluation. The results are that herb is to be extracted with 10 times the amount of water for 3times,1.5 hours for each time. In order to enrich and purify the effective components of Tribulus terrestris L. purification process is optimized with furostanol saponins amount and total flavonoids amount as evaluation index by alcohol precipitation techniques and D101macroporous resin purification techniques.The optimized process of purification of Tribulus terrestris L. is that the extract liquid is concentrated by normal pressure condense and the concentration is 1 g/mL. Filtrating the extract liquid and reclaiming alcohol, then regulating the liquid to the concentration 0.4g/mL after alcohol precipitation techniques. That is to get sample solution. The sample solution passed through D101macroporous resin column which the ratio of diameter to height is 1:8. It was eluted by 4BVwater at 3BV/h, then it was eluted by 5BV 50% ethanol and 70% ethanol at 2BV/h respectively.Filtrating the eluted liquid and reclaiming alcohol.The products contain furostanol saponins of Tribulus Terrestris more than 50 percent by optimum purification technology.According to the physical and chemical properties of extraction and the clinical medication needs, extraction of Tribulus terrestris L. is made to Sustained-release Tablet. Take the dissolution of furostanol saponins of Tribulus Terrestris as the evaluation index, the type and amount of the excipient is selected. Based on the results of Single factor, the prescription is optimized by Central composite design-Response surface methodology.According to the requirement in the appendix of the Chinese Pharmacopoeia 2010 version 1, the quality analysis of the preparation is carried on. Then the drug release model in vitro is established, release mechanism is discussed preliminarily.The research results show that the preparation process of Tribulus terrestris L. Sustained-release Tablet is scientific, reasonable and controllable.