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目的:确定粗叶悬钩子总生物碱缓释片的制备工艺,并进行其释放特性的研究。方法:以羟丙甲基纤维素为骨架材料,采用湿法制粒压片制备缓释片,用紫外分光光度法测定主药的含量。通过测定其体外释放度,进行释放机制及影响因素的研究。结果:所制备的粗叶悬钩子总生物碱缓释片质量稳定,体外释放性能好,持续释药达12h,符合设计要求,体外释放符合Higuchi方程。结论:方法简便,结果可靠,可作为粗叶悬钩子总生物碱缓释制剂生产过程的质量控制依据。
OBJECTIVE: To determine the preparation technology of total alkaloid sustained release tablets of Rubus pruinis and to study its release characteristics. Methods: The hydroxypropyl methylcellulose was used as the matrix material, and the tablets were prepared by wet granulation. The content of the main drug was determined by UV spectrophotometry. By measuring its in vitro release, the release mechanism and the influencing factors were studied. Results: The prepared total alkaloid tablets were stable in quality and release in vitro was satisfactory. The sustained release rate reached 12h, which met the design requirements. The in vitro release was consistent with Higuchi equation. Conclusion: The method is simple and reliable. It can be used as the quality control basis for the production process of total alkaloid sustained-release preparation of Rubus.