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Purpose: To prepare No.1 pellets preparations low back pain. The experiment was conducted to classify the extraction of water-soluble and fat-soluble components in the drug compound, and extract the active ingredients as the raw material pellets to prepare traditional Chinese medicine preparations.Method: Extract the water-soluble components of drug compound by decoction,and the fat-soluble components with ethanol, water-soluble and fat-soluble components are combined as a group of drug active ingredients, pharmacodynamic indices as a reference, optimize the structure and dose of prescription by uniform design, prescription drugs optimized is proven safe and effective through the pharmacodynamics and acute toxicity test.Extract drug active ingredients group according to the optimized prescription to prepare Chinese medicine pellets.Result: The prescription form of the optimal screening, the group of active ingredients of drugs are composed by the Antlers, Rehmannia, Astragalus, Angelica, Coix Seed, Millettia water-soluble drugs and the alcohol-soluble components of Tianma, Earthworm, Achyranthes, Corydalis and so on. The mixed group as the delivery systems, biological indicators as the basis, using the scientific method of uniform design to obtain optimum formulation composition.Terms of pharmacodynamics, extract active ingredients of drugs according to the optimized prescription, and observe the writhing of white mouse caused by acetic acid, their blood clotting time and blood rheology changes. The results show that the drugs have significant analgesic effect on the pain caused by acetic acid, prolong clotting time of mice, and reduce blood viscosity. Acute toxicity test confirmed that all mice at the maximum dose tested have no adverse conditions and mortality, body weight changes before and after administration have no significant differences ,so drug safety is good.In terms of pharmaceutical technology, prepare the pellets preparation by extrusion-spheronization using excipients as microcrystalline cellulose, a certain percentage of alcohol as binder. Determine the ratio of microcrystalline cellulose and drug in the pellets preparation, the proportion of ethanol, and the added amount of chitosan, and ultimately by the orthogonal test method, establish the optimal prescription of No1. pellets low back pain: the ratio of drug powder and excipients 1:2,in which chitosan is 5%, and 25% ethanol as adhesive.Quality controling aspect,determine the content of Naring in the pellets preparation,the results show that naringin content is stable,the content of naringin in the No1. pellets low back pain is 0.176752mg per gram.Conclusion: Using the active ingredient group as the raw material to prepare No1. pellets low back pain is feasible,compound of traditional Chinese medicine can extract following the classification of the nature of extraction,and it can be prepared into Chinese Medicine pellets.
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