The Pre-clinical Studies Of The Compound Recipe Prunella Sustained-release Capsules

The compound Recipe Prunella (TCRP) is a clinical treatment prescription of hypertension with good clinical efficacy. Its effectiveness are improving liver function, Promoting blood circulation and lowering blood pressure and so on. The content of this thesis is a WuHan major technology project-----new drugs in preclinical studies of TCRP, which is received by Wuhan University of technology and HuQuan Pharmaceutical Company. Via the filtration assay to extract the active ingredient in TCRP, and the active substance is prepared nanocapsules, then research the preparation process and the physical and chemical properties of TCRP-nanocapsules(TCRP-NC). At the same time, the effects of antihypertensive activity of TCRP are studied. What is prepared for further study of TCRP.In this paper, the TLC identification of three herbs in TCRP is established. At the moment, by the mean of High Performance Liquid Chromatography(HPCL), the content of rhynchophylline(Rhy) is determinated in TCRP-NC. This mean could accurately Measure the content of Rhy in TCRP-NC and encapsulation efficiency of the nanocapsules.The orthogonal design of experiments is utilized to optimize the extraction of TCRP. The content of the Rhy in the Leachate as the quota, studying the affection on the extraction process by ethanol concentration, ethanol dosage, soak time and flow rate. The results show that the ethanol concentration is the most important factor. Verifying the optimal process, namely the concentration of ethanol80%and ethanol10times, soaking time of12h, velocity4ml/min, the Rhy is obtained2.734mg.Encapsulation rate as the index of the nanocapsules, the Preparation of TCRP-NC is to be orthogonal optimized. The three factors, which are the concentration of chitosan-acetic acid,concentration of the TPP and the amount of TCRP dry extract dosage, were mainly investigated. Ultimately the best preparation process was determined: the concentration of chitosan-acetic acid solution is2mg/ml, the concentration of TPP is0.8mg/ml, the amount of TCRP dry extract dosage is10mg. Proven tests showed that this preparation process is reasonably practicable, the encapsulation efficiency is69%.Malvern Zetasizer Nano ZS90nano-particle size analyzer was used to measure the size and distribution of TCRP-NC. The size distribution of TCRP-NC range is relatively narrow, and its average particle size is150nm, which is a normal distribution uniform. TCRP-NC was respectively put at room temperature (25℃) and refrigerator (4℃) for30days to research its encapsulation efficiency. At room temperature, on the condition of Light or dark, the encapsulation efficiency reduced obviously. These results showed that temperature and light could affect the encapsulation efficiency of TCRP-NC. Therefore, TCRP-NC should be stored under4℃in dark to maintain its stability.By the antihypertensive activity on SHR rats and normal cats, the antihypertensive effect of TCRP-NC,TCRP dry extract dosage and the control group are compared. The results showed that TCRP-NC and TCRP dry extract dosage have some antihypertensive effect, and TCRP-NC have a certain sustained release effect.