山楂菊花颗粒的制备和质量标准研究-中国中医药信息杂志.PDF

·38· Chinese Journal of Information on TCM Aug.2005 Vol.12 No.8 山楂菊花颗粒的制备和质量标准研究 李 琴,周 海,陈 献,蒋瑞进 (广西玉林制药有限责任公司,广西 玉林 537001) 摘要：目的 研究山楂菊花颗粒的制剂工艺及其质量控制标准。方法 山楂采用水提法,菊花采用醇提法,喷 雾制粒工艺制备山楂菊花颗粒。采用薄层色谱法建立了处方中山楂、菊花的鉴别项；用高效液相色谱法测定了菊 花中木犀草素的含量。结果 定性定量方法简便、准确、专属性强、重现性好。结论 本制备工艺合理,质量控制 方法准确,可用于本品的质量控制。 关键词：山楂菊花颗粒；喷雾制粒；薄层色谱法；高效液相色谱法；木犀草素 中图分类号：R284.1 文献标识码：A 文章编号：1005-5304(2005)08-0038-02 Studies on Preparation Technique and Quality Standards of Shanzhajuhua Granules LI Qin, ZHOU Hai, CHEN Xian, et al (Guangxi Yulin Pharmaceutical Co., Ltd., Yulin 537001, China) Abstract ：Objective To study the technique of Shanzhajuhua Granules and its quality control standard. Methods Adopting extraction technology in which water used as solvent for Fructus Crataegi, adopting extraction technology in which alcohol used as solvent for Flos Chrysanthemi and the technique of spray-granulated. Radix Fructus Crataegi and Flos Chrysanthemi were identified by TLC. The content of luteolin was determined by HPLC. Results The identification and content determination methods are simple, convenient, accurate, high exclusive and good reproducibility. Conclusion The preparation technique of this product is reasonable. And its method of quality control is accurate. They can be used in the quality control of this product. Key words：Shanzhajuhua Granules；spray-granulated；TLC ；HPLC；luteolin 山楂菊花颗粒具有消食化滞、清肝明目之功,用于饮食积 3.1.1 山楂 取本品 5 g,研细,加甲醇 20 mL,超声处理 30 滞和肝阳上亢引起的头痛、目赤、眼花等。为提高该产品的 min,滤过,滤液蒸干,残渣加甲醇 2 mL 使溶解,作为供试品溶 技术含量,我们对其生产工艺和质量标准进行了研究。 液。另取山楂对照药材2 g,加水50 mL,煎煮2次,每次30 min, 1 设备、仪器与试药 合并煎液,放冷,滤过,滤液蒸干,残渣