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目的制备具有止血、止痛、抗感染,减少瘢痕形成及色素沉着的创伤止血海绵。方法以胶原蛋白为载体,附加中药等制成止血海绵,并对其进行质量检测、皮肤急性毒性试验、皮肤刺激试验、皮肤过敏试验等。结果创伤止血海绵质量达到《中华人民共和国药典》中吸收性明胶海绵和冻干制剂标准。动物实验:其经皮毒性属低毒;皮肤刺激强度评分<5分值;无致敏性;临床观察对溃疡创面治疗的有效率100%,4周愈合率为97.0%。结论研制的创伤止血海绵安全、稳定,具有临床使用价值。
Objective To prepare wound hemostasis sponges for hemostasis, analgesia, anti-infection, and reduction of scar formation and pigmentation. Methods Hemostatic sponge was made from collagen as a carrier and added with traditional Chinese medicine, and its quality was tested, skin acute toxicity test, skin irritation test, skin allergy test and so on. [Results] The quality of traumatic hemostatic sponge reached the standard of absorbent gelatin sponge and freeze-dried preparation in “The People’s Republic of China Pharmacopoeia”. Animal experiments: The transdermal toxicity is low toxicity; skin irritation intensity score <5 points; no sensitization; clinical observation of the efficiency of the treatment of ulcer wounds 100%, 4 weeks healing rate of 97.0%. Conclusion The traumatic hemostatic sponge developed is safe and stable, and has clinical value.