吲达帕胺滴丸的制备与质量控制摘 要目的：高血压是最常见的心血管疾病，是全球范围内重大的公共卫生问题。吲达帕胺是目前临床治疗中度高血压常用药物，对于慢性肾衰及血液透析病人同样有效而且并不增加肾脏负担；同时由于其低毒性，广泛用于临床。本试验制备吲达帕胺滴丸，旨在增加其生物利用度，达到高效的目的。方法：选择PEG 6000为基质，以液体石蜡为冷凝剂，采用自制滴丸器滴制成丸。通过三因素三水平的正交实验，以圆整度合格率为评价指标，综合考察滴距、滴速、冷凝柱长对滴丸的影响，确定滴丸的优化制备工艺。采用紫外-可见分光光度法测定滴丸中吲达帕胺的含量。结果：对正交试验进行极差与方差分析，确定吲达帕胺滴丸的最佳制备工艺为滴速65滴/分，滴距8厘米，冷凝柱高80厘米。吲达帕胺滴丸的重量差异、崩解时限、溶出度和含量均匀度均符合规定。结论：本品制备工艺可行，所建立的质量控制方法准确可靠。关键词：吲达帕胺；滴丸；制备工艺；质量标准 Preparation and Studies on Indapamide Dropping PillsABSTRACTObjectives: Hypertension, a worldwide common disease of cardiovascular system is also a public health problem in global. Indapamide has been shown to be effective antihypertensive agents in patients with chronic renal failure. It was used most frequently for the treatment of hypertension. In the present experiments, we prepared Indapamide dropping pills to increase its bioavailability and absorption. Methods: The matrix was PEG6000, the coolant was liquid paraffin and the instrument to make up dropping pills was artificial. Then through the orthogonal experiment of three influencing factors and three levels, taking spherical degree as index, we analyzed the effects of dropping distance, dropping rate and the freeze-pillar height to select the optimal technology. In this experiment we determine the content of Indapamide by UV-VIS Spectrophotometry. Results: The optimal formulation determined by range analysis and analysis of variance was just as following: the dropping dist...
