| Pain and inflammation are associated with concomitant symptom of many diseases, which bother countless patients in the world every year. At present, there are two major categories of analgesic widely used in clinic. One is nervous analgesic, which easily leads to addiction after a long-term continuous application. The other is a antalgic, antipyretic, and anti-inflammatory non-steroidal drug. Long-term use of this analgesic could easily causes adverse reactions to digestive and cardiovascular systems. Therefore, if we can develop a curative effect, less toxic side effects of analgesic drug for the treatment of pain will have a profound impact.To take full advantage of our precious traditional Chinese medicine resources, in the premise of assurancing Chinese medical scientific theories and characteristics, features and advantages of clinical application, we should inherit and carry forward. In this paper, based on summary of the previous theoretical and experimental researches, and by using the advanced modern pharmaceutical science and technology, the extraction process of Armadillidiam Vulgare and Paniculate Swallowwort root, pharmacodynamics and preparation process were studied.Choose water as the extraction solvent with the mouse acetic acid writhing test. According to the central composite experimental design theory, response surface method on Armadillidiam Vulgare and Paniculate Swallowwort root dose were optimized to determine the optimal analgesic effect. Under these conditions, analgesia rate of extracts was 52.6 percent. The model is very nicety.Using response surface analysis Armadillidiam Vulgare and Paniculate Swallowwort root extraction of active ingredients conditions were optimized. Set three single factors:extraction temperature, extraction time and ratio of water to sample. with the mouse acetic acid writhing test the analgesic effect of the extract. According to single factor test results. According to Box-Benhnken the central composite experimental design theory, response surface method in the three factors and three levels on Armadillidiam Vulgare and Paniculate Swallowwort root extraction conditions were optimized to determine the optimal extraction conditions: extraction temperature 100℃, extraction time 45min, ratio of water to sample (g/ml) 10:1. Under these conditions, analgesia rate of extracts was 55.1 percent.Filler and adhesive were screened with tablet appearance, tablet weight variation, hardness and disintegration time are evaluated. Ultimately determine the prescription. Every 3000 tablets, Armadillidiam Vulgare 7000g, Paniculate Swallowwort root 5400g, starch 1240g, magnesium stearate 2.5g, talcum powder 2.5g, adhesive 80% ethanol. Each of the tablets is 0.5g.The establishments of quality standards were established, including tablet character, tablet weight variation, hardness and disintegration time. Using colorimetric and HPLC to obtained the total sterol and paeonolum content of the tablets. The methodological study was also investigated, including method linearity, precision, reproducibility, and recovery. The results showed that this method is accurate, effective, and can be applied to the preparation of quality control.Pharmacodynamics and toxicity of the tablets were studied. The result of pharmacodynamics showed that the analgesia effect of the tablets is very good. In acetic acid writhing in mice, mouse hot plate and thermal stimulation in mice flick method, the analgesia effect of the tablets is better than yuanhu analgesia tablets in high and middle dose. In maximum amount toxicity test and long-term toxicity test, the animals didn't show any toxic reaction or abnormal, indicating the toxicity of the analgesia tablets is small, and safe to use.Useing room temperature test, accelerated test and influencing factor test to study items of character, weight difference, hardness, disintegration time, content and microbial limit. The result showed the tablets had good stability. |
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