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目的:制备银杏叶提取物胃漂浮滞留缓释片,考察其体外释放度。方法:以漂浮时间、起漂时间为指标,采用单因素试验考察缓释骨架材料、起漂剂、十八醇用量及HMPC用量;以累积释放率、起漂时间及漂浮时间的综合评分为指标,选取HPMC K4M,PVPP,泡腾剂、十八醇的用量为考察因素,采用正交试验优选银杏叶提取物胃漂浮滞留缓释片的处方与制备工艺,并考察其体外释药机制。结果:最佳处方为HPMC K4M,PVPP,银杏叶提取物、十八醇及泡腾剂的质量分数分别为30%,2%,20%,48%,4%;MCC为稀释剂以补足质量。银杏叶提取物胃漂浮滞留缓释片的释药动力学模型符合Higuchi方程。结论:制备的胃滞留漂浮片外观及可压性良好,具有良好的缓释性能,释药机制为扩散和溶蚀的双重作用。
Objective: To prepare ginkgo biloba extract sustained-release gastric floating tablets to investigate its in vitro release. Methods: Floating time and bleaching time were taken as indexes. The single factor experiment was used to investigate the effect of sustained-release matrix material, bleaching agent, octadecyl alcohol dosage and HMPC dosage. The cumulative release rate, bleaching time and floating time were taken as indexes , The dosage of HPMC K4M, PVPP, effervescent and octadecanol were selected as the investigation factors. The prescription and preparation process of Ginkgo biloba leaf extract in gastric floating sustained-release tablets was optimized by orthogonal test, and the in vitro drug release mechanism was investigated. Results: The best prescriptions were 30%, 2%, 20%, 48% and 4% of HPMC K4M, PVPP, ginkgo biloba extract, stearyl alcohol and effervescent agent respectively. MCC was a diluent to make up the mass . The release kinetics model of Ginkgo biloba extract gastric floating sustained-release tablets conformed to the Higuchi equation. CONCLUSION: The prepared gastric retention floating tablets have good appearance and compressibility and good sustained-release properties. The mechanism of drug release is dual action of diffusion and dissolution.