| Dropping pill is a sort of solid dispersion, which has many good characters such as quick result and high efficiency. It can be easily prepared, exactly quantifiable and easily controlled. Nowadays, it is more and more widely used in the area of medicine, particularly in the traditional Chinese medical preparation. But what cannot match up to such development is the fundamental research in dropping pill, especially the study on the auxiliary material. Today most of the bases of pill are PEG in the market. They all have some toxicity and cannot suit for the pill's long-term development. With the continuously improvement of science& technology and people's higher and higher request in health, especially for the wider and wider application in Chinese medical preparation research, it is necessary to develop a new base with better quality and better security.On the basis of eutectic mixture principle, it is the first time to screen new base from natural plant. We exploit compound danshen dropping pill for the second time. Compound danshen dropping pill is the main medicine in such therapy as coronary heart disease, cardiac angina and so on. And the study on the new base compound danshen dropping pill will have great significance in further improving its quality and increasing its domestic and foreign marketing share. Obviously, this research will guide other natural green preparation in theory.We took compound danshen extract as medical model, in the basis of screening single medical accessories, then screened double of them, finally defined Xylitol as the main, Starch as the supplement to be the new base of compound danshen pill.Melt technique is used to prepared compound danshen dropping pill with Xylitol as the base. In the basis of screening single medical accessories, we used orthogonal design and selected 8 factors to observe them on how to affect the pill's preparation and shaping. The factors are the proportion between drug and its base, dropping and condensation temperature, adding mode, the sort of condensation, diameters of dropper, dropping rate and heating time. The result proved that the optimum technique is that the ratio between drug and base is 1:5.5, the temperature of drug solution is 85-95 C,the dropping rate is 35-45dropmin'',the distance between dropper and condensation is 5-10cm,and selecting heavy liquid petrolatum as condensation, dropping temperature was -2-4 C.Using that technique can prepare good quality pills with better appearance, hardness and condensate.By observing the trait of new base dropping pill and contrasting with originalcompound danshen pill, we knew that the new pill can disintegrate faster and take effect faster. It also can avoid desiccation effectively. X-ray powder diffraction patterns and DifferentialScanning Calorimetry (DSC) were used to prove that the drug had changed its crystal pattern inside the pill and perhaps scattered in the carrier as molecular or minor crystalline and the drug and base existed as eutectic mixture.The result of stability test showed that under the condition of room temperature and 40C,the dropping pill had better stability in such marker as trait, dissolution test, content of danshensu, solubility. Under 60 C other markers were all stable except the pill's color were changed compared with original.HPLC method was established for determining compound danshen dropping pill.The method is simple, rapid, accurate and achieves the request. For the study invitro ,the linear relationship was good within 10-160 u g/ml, the mini limitation is 0.1u g/ml.For the study in vivo, the linear relationship was good within 1.25~160 u g/ml,the mini limitation is 0.3 u g/ml.Pharmacokinetics on the comparison between new and original pill were evaluated in rabbits by oral taken. The results demonstrated Cmax and Ka were significantly different(p<0.05).Compared with the original pill, it showed that the new base compound danshen dropping pill increased as well as contained the good trait of quick result and high efficiency.The result indicated...
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