RESUMO
Objective To evaluate the security of big animals with a new bioartificial liver system .Methods Six Tibet pigs re-spectively received treatment of hybrid artificial liver and simple bioartificial liver ,observed and recorded the vital signs ,venous pressure ,transmembrane pressure and slurry pot pressure each hour ,and collected blood to make endotoxin and bacterial culture test in the zero hour ,fourth and eighth hour .Results Compared with the zero hour ,venous pressure ,transmembrane pressure ,slur-ry pot pressure were much higher in the fifth hour (P0 .05) .The mean arterial pressure and respiratory rate in all time point showed no significant changes (P>0 .05) .Com-pared with the zero hour ,the heart rate was much lower in the second hour (P<0 .01) .The values of blood endotoxin were less than 0 .5 EU/mL in the zero hour ,fourth and eighth hour from beginning ,and the bacterial culture test showed no growth of bacteria . Conclusion The experiment of big animals with a new bioartificial liver system was safe ,the efficacy in the treatment of hepatic failure could be assessed further .
RESUMO
OBJECTIVE:To improve the related standards in China Pharmacopoeia and to enhance its operation.METH_ ODS:Issues on“general rules on preparations”,“bacteria endotoxin test”,assaying of glucose injection in China Pharmacopoeia were analyzed and discussed.RESULTS&CONCLUSION:The dosage forms recorded are limited and some varieties of preparations are hard to be classified.How long exactly the gel formed by tachypleus amebocyte lysate and bacteria endotoxins remained cemented should be regarded as positive,which should be clearly defined.In determining the optical rotation by po?larimetry,ammonia test solution should be added to the semi-products to achieve balance but not in the finished products for differentiation.