正交试验法优化玛咖石斛片处方

Formula optimization of Maca and Dendrobium officinale tablet by orthogonal experimental design

中文关键词:  玛咖  铁皮石斛  正交实验

英文关键词:Maca  Dendrobium officinale  orthogonal experimental design

中文摘要:

      目的 选用单因素分析和正交试验设计优化玛咖石斛片处方工艺。方法 采用湿法制粒, 经混合、制粒、干燥、压片等工序制备玛咖石斛片, 并以崩解时间、组织形态、硬度、色泽作为考察指标对处方中聚维酮(polyvinyl pyrrolidone, PVP) K-30用量、交联聚维酮(crosslinking polyvingypyrrolidone, PVPP)用量、羧甲基淀粉钠(carboxymethyl starch sodium, CMS-Na)和硬脂酸镁用量进行优化, 检测最优处方所制片剂的崩解时间、脆碎度和硬度。结果 得到的处方为70.11%(m:m)玛咖粉、14%(m:m)铁皮石斛粉、1%(m:m)PVP K-30、12%(m:m)PVPP、2.5%(m:m)CMS-Na、0.39%(m:m)硬脂酸镁。各因素对片剂质量的影响次序为: PVP K-30>硬脂酸镁>CMS-Na>PVPP, 其中PVP K-30和硬脂酸镁对片剂质量影响较大。结论 本研究优化所得处方工艺制备的玛咖石斛片表面光滑, 质量稳定。

英文摘要:

      Objective To optimize the prescription of Maca and Dendrobium officinale tablet by single factor analysis and the L9(34) orthogonal experimental design. Methods The wet granulation method was used to prepare Maca and Dendrobium officinale tablet through a series of processing including mixing, granulation, drying and tablet etc.. The disintegration time, texture, hardness and color were used to optimize the dosage of polyvinyl pyrrolidone (PVP) K-30, crosslinking polyvingypyrrolidone (PVPP), carboxymethyl starch sodium (CMS-Na) and magnesium stearate. Finally, the Maca and Dendrobium officinale tablet with the optimum formulation was prepared to test its disintegration time, friability and hardness. Results The optimal prescription was as follows: 70.11% (m:m) Maca powder, 14% (m:m) Dendrobium officinale powder, 1% (m:m) PVP K-30, 12% (m:m) PVPP, 2.5% (m:m) CMS-Na, 0.39% (m:m) magnesium stearate. The sequence of affecting quality was PVP K-30>magnesium stearate>CMS-Na>PVPP, while PVP K-30 and magnesium stearate had great effects on tablet quality. Conclusion Maca and Dendrobium officinale tablet, which is prepared according to the optimal prescription, has stable quality and smooth surface.