| Objective:This topic was aimed to research the optimum technological conditions, establish quality control standards, and the effects of therapeutic effect on rats, through the preparation process, quality control and initial pharmacodynamics test of Taohong Siwu Granules. It was use to provide basis and reference in future development and clinical application of Taohong Siwu Granules.Methods:1. With yield of total flavonoids and extract as indexes, orthogonal test was adopted to optimize the ethanol extraction technology by taking the concentration of ethanol,the amount of solvent, extraction time and extraction times as factors.2. With yield of Peoniflorin and extract as indexes, orthogonal test was adopted to optimize the water extraction technology by taking the amount of water, extraction time and extraction times as factors.3. The ethanol extract was concentrated with decompression and evaluated with the content of total flavonoids in the different temperature in order to select conditions of concentration. Concentration conditions of the water extract was evaluated with the content of paeoniflorin in the different methods.4. Concentrated liquid was dried by spray drying. The single factor experiment was conducted on the relative density of the liquid, air temperature and volume of sample in order to choose best conditions of spray drying.5. The forming process of Taohong Siwu Granules was experimented by adding different materials and evaluated with rates of forming and moisture. The type and amount of wetting agent was also investigated.6. Honghua, Danggui, Chuanxiong, Baishao in Taohong Siwu Granules were determined by TLC.7. Hydroxysafflor yellow A and Paeoniflorin in Taohong Siwu Granules were determined by HPLC.8. Particle size, moisture, melting, heavy metals and arsenic salt of Taohong Siwu Granules were all checked.9. Using the model of acute blood stasis rats, blood rheology, ET-1 and NO were investigated to observe the effect of Taohong Siwu Granules in promoting blood circulation and removing blood stasis.Results:1. The optimal process of the ethanol extraction technologies were as follows: add3 times with 6 times amount of 80% ethanol, and 1.5h for each time.2. The optimal process of the water extraction technologies were as follows: add 3times with 12 times amount of water, and 1.5h for each time.3. The best concentration conditions of Taohong Siwu Granules were as follows:extraction respectively concentrated in 70 ℃ with decompression to which relative density was 1.15.4. The optimal drying conditions of Taohong Siwu Granules were as follows: mix concentrated solutions and add 3% dextrin, the inlet air temperature is 180℃, and the sample volume was 30%.5. Powder and dextrin were mixed in the ratio of 1:1 and ground into fine, sprayed into about 19% of the 90% ethanol to granulate, and dried at 60℃.6. The results which Honghua, Danggui, Chuanxiong, Baishao in Taohong Siwu Granules were determined by TLC were that spots were clear and negative interference.7. HPLC methods for Hydroxysafflor yellow A and Paeoniflorin in Taohong Siwu Granules were easy and reproducible.8. The results of particle size, moisture, melting, heavy metals and arsenic salt of Taohong Siwu Granules were in accordance with the regulations..9. Taohong Siwu Granules significantly induced the value of blood viscosity and plasma viscosity, promoted the concentration of NO and induce the expression of ET-1in rats. The results indicated that Taohong Siwu Granules could promot blood circulation and remove blood stasis. The possible potential mechanism might beassociated with endothelial function.Conclusion:The preparation process of Taohong Siwu Granules was stable, controllable and reasonable, which could provide basis and reference for the future industrial production.The quality control method of Taohong Siwu Granules was simple and had strong specificity. Taohong Siwu Granules could promot blood circulation and remove blood stasis on the acute blood stasis rat model. |
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