基于白及多糖的用于宫颈糜烂创伤出血的可降解止血海绵剂的制备

Preparation of Biodegradable Sponge Based on Bletilla Striata Polysaccharide for the Wound Bleeding of Cervical Erosion

目的:以白及多糖为骨架材料包载积雪草总苷,制备用于宫颈糜烂术后创伤出血的可降解止血海绵剂,考察其药剂学性质及初步药效学评价。方法:以止血海绵剂的外观饱满度、柔软舒适度、孔径均匀度、弹性回复率为评价指标,通过单因素试验筛选最佳处方及工艺,并对其外观形态、吸水率、透气性等相关药剂学性质进行考察;以传统纱布止血为对照考察海绵剂的止血效果并对其安全性进行初步评价。结果:当白及多糖浓度为0.05 g·ml~(-1),甘油用量3%,乙二胺:环氧氯丙烷(3∶1)用量4%,匀质时间60 s,经交联60 min时,可制得外观呈淡黄色、疏松饱满、质地柔软、孔径均一的止血海绵剂;扫描电镜下观察呈三维网状结构,载药空间大,吸水率1421%,透气率81.12%;初步药效学试验显示其止血效果较传统纱布具有明显优势,且对阴道黏膜细胞无明显毒性。结论:以白及多糖为骨架材料的载药止血海绵剂可为宫颈糜烂术后创伤出血患者提供一种依从性高、疗效可靠的生物可降解制剂,具有较大的实用价值及开发前景。

Objective:To prepare the biodegradable sponge by using Bletilla striata polysaccharide(BSP)as the matrix loaded with Centella asiatica total glucosides(CTG)for the wound bleeding of cervical erosion,and evaluate its pharmaceutical properties and preliminary pharmacodynamics.Methods:The appearance plumpness,softness,aperture uniformity and elastic recovery rate of hemostatic sponge were used as the evaluation indexes,and the optimal formulation and preparation technology were selected by single factor test.The appearance shape,water absorption and air permeability of hemostatic sponge were investigated.The hemostatic effect of sponge was studied and its safety was preliminarily evaluated with traditional gauze as comparison.Results:When the concentration of BSP was 0.05 g·ml^(-1),glycero dosage was 3%,ethylenediamine∶epichlorohydrin(3∶1)was 4%,the homogenizing time was 60 s and the cross-linking time was 60 min,the hemostatic sponge showed light yellow appearance,soft texture and uniform aperture.It showed a three-dimensional network structure with large drug loading space under a scanning electron microscope(SEM).The water absorption rate was 1421%,and the air permeability was 81.12%.The preliminary pharmacodynamics test revealed that the hemostatic effect of sponge was superior to traditional gauze,and it had no obvious toxicity to the vaginal mucosa cells.Conclusion:Drug-loaded hemostatic sponge with BSP as the skeleton material can provide a biodegradable preparation with high compliance and reliable efficacy for patients with traumatic bleeding after cervical erosion operation,which has great practical value and development prospect.