CAJ | 학술논문

采用淀粉为主要原料经乳化交联制备一种具有微孔结构的新型可降解止血材料。并根据GB/T16886医疗器械生物学评价标准规定的皮内反应试验、致敏试验、全身急性毒性试验和植入试验方法评价可吸收多糖微球的生物相容性，同时与进口微球作对比，以验证其安全性。试验结果显示无皮内反应、无致敏、无全身急性毒性、肌肉植入2周后未见固形物，无明显组织反应。可吸收多糖微球具有良好的生物相容性，符合临床使用要求。
채용정분위주요원료경유화교련제비일충구유미공결구적신형가강해지혈재료。병근거GB/T16886의료기계생물학평개표준규정적피내반응시험、치민시험、전신급성독성시험화식입시험방법평개가흡수다당미구적생물상용성，동시여진구미구작대비，이험증기안전성。시험결과현시무피내반응、무치민、무전신급성독성、기육식입2주후미견고형물，무명현조직반응。가흡수다당미구구유량호적생물상용성，부합림상사용요구。
The absorbable polysaccharide microspheres is made of potato starch by emulsion and cross-linking,which is a kind of novel biodegradable hemostatic materials with microporous structure.The absorbable polysaccharide microspheres was studied by using the subcutaneous reactivity,sensitization,acute systemic toxicity,intramuscular implantation tests described in GB/T16886.The ex-perimental results showed that the microporous polysaccharide microspheres had no subcutaneous reactivity,no sensitization,no acute systemic reaction,no solids and obvious tissue reaction observed after 2 weeks implantation.It is concluded that the absorbable poly-saccharide microspheres has excellent biocompatibility and meets the requirement for clinical application.