RESUMO
OBJECTIVE:To screen the optimal micronization technology of Alitretinoin crude drug. METHODS:Using characteristic value of particle size distribution [d(0.9)] and the content of impurity A of crude drug after crushed as indexes, crushing method(universal pulverizer,ball crusher,airslide disintegrating mill),crushing gas source(compressed air,high pressure nitrogen)and crushing pressure(0.2,0.4,0.6 MPa)of Alitretinoin crude drug were screened,and validation test was also conducted. RESULTS:The optimal technology was as follows as airslide disintegrating mill,high pressure nitrogen as gas source,at 0.4 MPa.In validation test,particle sizes for 3 batches of crude drug after crushed were 8.57,8.55,8.54 μm(<10 μm, RSD=0.15%,n=3). The content of impurity A was not increased compared with before crushed(0.07%). CONCLUSIONS:Screened micronization technology of Alitretinoin crude drug is feasible and stable in quality.
RESUMO
The isolation and culturation of SSCs of different stage of Wuzhishan Mini Porcine (WZSP) with different way of enzymatic digestion and culturation were deaded in this study. The results of the experiment described are as the following: The proper time of isolation and culturation of SSCs of WZSP is 1-20 old days. Different old of piglets with different method. Using DMEM medium as a fundmental culture medium add different gradient at 34 degrees C in a water-saturated atmosphere of 95% air, 5% CO2. The mulberry-shaped SSCs clusters appeared as original generation in 7-8 days culture. The SSCs clusters developed half-suspendedly in the culture medium. SSCs alkaline phosphatase (AKP) staining expressed positively. Mouse embryonic fibroblast was used as feeder layer for the SSCs passage cultured, The SSCs show good attached attributes, but the number of SSCs decreased quickly after 4 days culture. By seminiferous cord fragment culturation can also appear SSCs clusters in 5 days, The SSCs clusters developed half-suspendedly in the culture medium. In addition, the testes placed in cold (4 degrees C) PBS banlanced salt solution for 24 h also can be used as a good matierials for preparation of SSCs. These results indicate that the method of solation and culturation of SSCs are very correct and efficient, all these can be utilized as a good reference for future studies.