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目的制备猫爪草提取物离子敏感型原位凝胶,并对其灭菌工艺、溶蚀率、粘度、最佳Ca2+浓度、体外释药行为进行考察。方法以海藻酸钠作为辅料,猫爪草提取物(10%乙醇作为溶剂),在室温下磁力搅拌使其充分溶胀,采用智能溶出试验仪、粘度仪和流变仪等分别对灭菌工艺、溶蚀率、粘度、最佳Ca2+浓度、体外释药行为等原位凝胶的性质进行表征。结果 1%海藻酸钠离子敏感型原位凝胶采用先制备凝胶再高压灭菌的工艺对溶蚀率和小毛茛内酯含量影响最小[溶蚀率为(52.13±4.17)mg/(cm2·h)、小毛茛内酯含量为(1.23±0.18)%],此方法制备的原位凝胶粘度为1.49±0.18(Pa·s)、最佳Ca2+浓度为1ml原位凝胶:10-5mol Ca Cl2,采用Franz扩散池测定体外释放速率可知12h小毛茛内酯的累积释放率为91.46%,分别用不同的数学模型对各时间点累积释放量进行处理可知其释药规律符合Weibull方程,拟合方程为ln[-1/(1-Q)]=-0.3618lnt-1.7174(r=0.9931)。结论采用海藻酸钠作为猫爪草提取物离子敏感型原位凝胶的载体,其凝胶性质良好,体外释药缓慢,可为中药治疗肺结核提供一种新型的缓释制剂。
OBJECTIVE To prepare the ion sensitive in situ gel of cat’s claw extract and investigate its sterilization process, dissolution rate, viscosity, optimal Ca2 + concentration and in vitro release behavior. Methods Alginate as an adjuvant, cat’s claw extract (10% ethanol as a solvent), magnetic stirring at room temperature to make it fully swollen, the use of intelligent dissolution tester, viscometer and rheometer, respectively, sterilization process, Dissolution rate, viscosity, the best Ca2 + concentration, in vitro release behavior of in situ gel characterization. Results 1% sodium alginate ion-sensitive in-situ gel with the first preparation of gel re-autoclaving process on the dissolution rate and Ranunculus lactone content minimum [dissolution rate (52.13 ± 4.17) mg / (cm2 · h (1.23 ± 0.18)%], the in-situ gel viscosity prepared by this method was 1.49 ± 0.18 (Pa · s), the optimal Ca2 + concentration was 1ml in situ gel: 10-5mol Ca Cl2, Franz diffusion cell measured in vitro release rate was 12h small ranolactone cumulative release rate of 91.46%, respectively, using different mathematical models for the cumulative release at each time point processing shows that the release of its law consistent with the Weibull equation fitting The equation is ln [-1 / (1-Q)] = -0.3618lnt- 1.7174 (r = 0.9931). Conclusion Sodium alginate is an ion-sensitive in situ gel carrier of cat’s claw extract, which has good gel properties and slow release in vitro. It can provide a new sustained-release preparation for Chinese medicine treatment of pulmonary tuberculosis.