桂皮醛牙周缓释制剂制备工艺研究

Study on Preparation Technology of Cinnamaldehyde Periodontal Sustained-release Preparation

目的 制备桂皮醛牙周缓释制剂并优化其处方与工艺。方法 采用正交试验考察聚丙烯酸树脂Ⅳ、羟丙基纤维素含量等因素对桂皮醛缓释制剂体外释放的影响,用高效液相色谱法(HPLC)测定制剂的累积释放率,根据体外释放情况优选最佳配方。结果 以累积释放率与缓释速率为考察指标,确定最优制备工艺参数为聚丙烯酸树脂Ⅳ、羟丙基纤维素、桂皮醛含量分别为18%,3%,3%,三醋酸甘油酯相:丙二醇相(m:m)为2:1。结论 该制剂制备工艺合理可行,释药速率平缓稳定,可为进一步临床研究提供理论依据和试验基础。

Objective To prepare cinnamaldehyde periodontal sustained-release preparation and optimize its formulation and technology. Methods The effects of mass fraction of polyacrylic acid resin Ⅳ and hydroxypropyl cellulose and other factors on the in vitro release of cinnamaldehyde periodontal sustained-release preparation were investigated by orthogonal test. The cumulative release of the sustained-release preparation was determined by HPLC, and the optimum formulation was selected according to the in vitro release. Results Using the cumulative release rate and sustained release rate as the investigation indexes, the optimal preparation parameters were determined as follows: the mass fraction of polyacrylic acid resin Ⅳ, hydroxypropyl cellulose and cinnamaldehyde were 18 %, 3 % and 3 %, respectively, and the mass ratio of glyceride triacetate phase to propylene glycol phase was 2:1. Conclusion The preparation process of the preparation is reasonable and feasible, and the drug release is smooth and stable. This research can provide theoretical foundation and experimental basis for further clinical research.