褐藻酸硫酸酯凝胶剂的质量考察及安全性研究

目的 制备褐藻酸硫酸酯凝胶剂,并对其进行质量考察及安全性评价。方法 以褐藻酸硫酸酯为有效成分制备凝胶剂,从外观、装样量、酸碱度、粘度、有效成分含量及微生物限度方面对凝胶剂质量进行考察,并对其生物安全性进行评价,包括细胞毒性、刺激性及致敏性。结论 制备得到了性状良好、性质稳定的褐藻酸硫酸酯凝胶剂,并且具有较高的生物安全性,为后期褐藻酸硫酸酯药物或医用功能制品的开发奠定了基础。

Quality Investigation and Safety Evaluation of Alginic Acid Sulfate Gel

Objective To prepare alginic acid sulfate gel and inspect its quality and safety evaluation. Methods The gel was prepared with alginic acid sulfate as effective components. The quality of the gel was investigated in terms of appearance, loading amount, pH, viscosity, effective components content and microbial limit. Its biosafety was evaluated, including cytotoxicity, irritation and allergenicity. Conclusion The alginic acid sulfate gel with stable properties was prepared and it had good biosafety. It can provide basis for the development of alginic acid sulfate drug or medical functional products.