摘要
目的:筛选痔特佳栓剂的最佳制备工艺,并制备其复方栓剂和制定质量控制标准。方法:用4因素3水平正交设计法确定最佳制备工艺,以外观、硬度及融变时限的综合分评价栓剂质量;采用薄层色谱对该制剂中的槐角、枳壳、当归、黄芩进行鉴别。结果:流浸膏密度是影响痔特佳栓剂质量的主要因素;所制栓剂符合药典栓剂的规定;薄层鉴别斑点清晰,重复性好,专属性强。结论:该制剂制备工艺可行,性质稳定,质量可控。
Objective: To screen of the best preparation of suppository, prepare the compotmd suppository from Zhitejia and establish the quality control standards. Methods: To determine the optimum preparation process by Orthogonal design method; Huaijiao Zbiqiao Danggui and Baicalin were identified by TLC. Result: Density of liquid extract are the main factors; What be made a suppository according with pharmacopoeia suppository is in connection with suppository regulation; The TLC spots were Clear and the repeatable. Conclusion: The suppository can be prepared feasibly, the nature is stable and the quality is controllabie.
出处
《中国医药导刊》
2009年第6期978-980,共3页
Chinese Journal of Medicinal Guide