The Biocompatibility Of A Sample Of An IUD For The Treatment Of IUAs

Objective To evaluate the biocompatibility of a sample of an IUD for the treatment of IUAs,as a new patent by animal embedding experiment and cytotoxicity in vitro.Methods According to GB/T16886 and ISO10993 as a standard of the animal embedding experiment and cytotoxicity in vitro were using a sample of an IUD for the treatment of IUAs.The animal of the embedding experiment:â‘ The sample of an IUD for the treatment of IUAs with silicone rubber and T-Cu IUD of polythene,they were make a uniform velvet cylinder for diameter 1.5mm and height 5mm.â‘¡Thirty healthy Sprague Dawley rats were selected and numbered randomly to placed silica and polythene module between the superficial fascia and muscle of both left and right leg, which served as a experimental group and control group. To dissect and suture the front legs, which serves as a blank group. For preventing of systematic error, the silicone rubber was implanted into the left leg of animals numbered in odd and the right leg of animals numbered in dual, and the polythene into the right leg of odd number of the animals and left leg of dual number of the animals. No.1-3, 4-6, and 7-9 SD rats were executed under anesthesia on days 7,30, and 90 after operation respectively. The modules and surrounding tissues were taken out from the animals for paraffin section, and HE staining. The reaction and changes of cell and surrounding tissues were observed under inverted microscope to compare their tissue-compatibility. The cytotoxicity experiment:L929 cells were cultured with different concentration to extracts the sample of an IUD for the treatment of IUAs (100%,50%,25%, V/V),the T-Cu IUD of polythene bracketed and RPMI-1640, which served as a experimental group,control group and blank group in vitro,and MTT assay was performed to evaluate the cell proliferation on days1,4,and 7.The morphologic changes of cells were observed by inverted microscope to evaluate the cytotoxicity.Results The animal embeding experiment:None of the SD rats was infected after operation and no antibiotics were used and no rejection were encountered.All of the SD rats's wound were healed.â‘ seven days after implantation, there were a great amount of infiltrated heterophilic granulocytg were accompanied by obvious congestion around the modules, but no cystwall formed.â‘¡Thirty days later, there were medium-amount of infiltrated heterophilic granulocytes and around two kinds of modules have loose cystwall formed. There were no capillary hemorrhage around the tissues.â‘¢Ninety days late, around two kinds of modules have pellucidly,compactly and sleazy cystwall formed, but the thickness were much thinner than after implantation, these two kinds of modules have no statistics discrepancy(P>0.5). The cytotoxicity experiment:MTT assay revealed to extracts of the sample of an IUD for the treatment of IUAs, enhanced the cell proliferation (P<0.01), but not a dose-dependent manner (P>0.05).In the experiment group, the cell proliferation and morphologic have no discrepancy compared with the control group and blank group. The cytotoxicity grade of the sample of an IUD for the treatment of IUAs was 0 or 1, suggesting that the material was almost free of cytotoxicity.Conclusion The sample of an IUD for the treatment of IUAs possesses ideal biocompatibility, free of cytotoxicity, according to the standard of clinical use, and has a great potential.