复方紫草油制备工艺及质量标准探究.doc

复方紫草油制备工艺及质量标准探究[摘要] 目的：验证复方紫草油的制备工艺，提高质量标准控制水平。方法：以左旋紫草素的含量为指标，考察制备工艺的合理性。采用薄层色谱法对白芷、忍冬藤、冰片进行鉴别，用高效液相色谱法测定左旋紫草素的含量。结果：制备工艺过程中左旋紫草素稳定，原制备工艺合理；白芷、忍冬藤、冰片的鉴别斑点清晰，阴性无干扰；左旋紫草素测定方法经方法学验证，结果可行。结论：结果表明，制备工艺合理，新建立的质量标准可行。 [关键词] 复方紫草油；制备工艺；质量研究；左旋紫草素 [中图分类号]R917 [文献标识码]A [文章编号]1673-7210（2008）07（b）-041-03 Study on preparation technology and quality standard of Compound Radix Arnebiae Oil CHEN Pei-wen, LIU Xiang-rong, ZHANG Ying (Jiangxi People’s Hospital, Nanchang 330006,China) [Abstract] Objective: To study the preparation technology of Compound Radix Arnebiae Oil and its feasibility, and to improve the quality standard level. Methods: The preparation technology was studied by determining the stability of L-shikonin during the time of preparation. Angelica dahurica, Honeysuckle stem, Borneol in Compound Radix Arnebiae Oil were identified by TLC. The content of L-shikonin was determined by HPLC. Results: L-shikonin was stable during the time of preparation. The preparation technology was feasible. The dots of TLC were clear, separation degree was good, and specific attribute was strong. The negative control showed no interference.The HPLC method was able to determine the content of L-shikonin. Conclusion: Preparation technology is feasible, and the quality of Compound Radix Arnebiae Oil can be controlled. [Key words] Compound Radix Arnebiae Oil;Preparation technology;Quality standard; L-shikonin 复方紫草油（烧伤油）系我院自制制剂，由紫草、忍冬藤、冰片、白芷、石蜡、香油等药材煎制而成，临床应用20多年，本品对各种烧伤疗效果确切。虽然目前有关紫草油的制备工艺和质量研究有很多报道，但本院处方与文献报道又有较大不同[1,2]，而且文献报道的质量研究不全面[3,4]。为确保制剂质量，有必要对本院制剂的制备工艺进行验证，对质量标准进行系统全面研究。现报道如下： 1 仪器与试药 1.1 仪器 岛津系列高效液相色谱仪（包括LC-2010AHT，Solution工作站）；Sartorius BP 211D电子天平（十万分之一）。 1.2 试药 白芷（中检所，120945-200406），忍冬藤（中检所，121069-200502），冰片（中检所，110743-200504 ），左旋紫草素（中检所，110769-200506，鉴别用，经标化含量为99.7%）。其余试剂为分析纯。 2 制备工艺验证 2.1 制备工艺 先取香油，用文火加热至130℃，加入白芷、紫草、忍冬藤，加热到150℃维持0.5 h，待白芷炸成焦黄色为度，趁热用多层纱布过滤，加入切片石蜡搅溶，冷却到50℃，加入冰片搅匀即可分装备用。 2.2 考察指标选择 紫草含色素成分萘醌类化合物。紫草根含紫草素、乙酰紫