痛风宁丸制备及临床疗效观察.doc

痛风宁丸制备及临床疗效观察摘要：目的研究中药制剂痛风宁丸工艺制备及观察其治疗痛风性关节炎的临床疗效。方法按规定剂量取薏苡仁等15种中药水乏制成痛风宁丸，选择符合诊断标准的患者98例进行临床治疗观察。结果制剂理化性质稳定， 临床观察治疗总有效率86.8%，对照组总有效率46.7%。结论痛风宁丸制备工艺技术成熟，临床治疗痛风性关节炎疗效肯定。 关键词：痛风宁丸；制备；质量控制；临床疗效 中图分类号：R282.71文献标识码：A文章编号：1672-979X(2007)02-0023-02 Preparation and Clinical Efficacy of Tongfengning Pill LIANG Su-dong，SHI Ding-yi (Weihai Hospital of Traditional Chinese Medicine, Weihai 264200,China) Abstract：Objective To study the preparation technology and observe clinical efficacy of Tongfengning Pill, a Chinese drugs preparation, in the treatment of gouty arthritis. Methods Coix seed and other fifteen Chinese medicinal materials were chosen according to the regulated dosages and solved with water for the preparation of Tongfengning Pill. According to the diagnostic criteria, Tongfengning Pill was used to treat 98 patients with gouty arthritis and its clinical efficacy was observed. Results The physico-chemical property of the preparation was stable, and the total effective rate was 86.8% for the treatment group, compared to 46.7% for the control group. Conclusion The preparation technology of Tongfengning Pill is mature and the clinical efficacy is significant in the treatment of gouty arthritis. Key words：Tongfengning Pill; preparation; quality control; clinical efficacy 痛风宁丸是威海市中医院研制开发的中药制剂，主要用于治疗痛风急性关节炎发作、痛风石性慢性关节炎和关节畸形，及由此引起的慢性间质性肾炎和尿酸肾结石。发病期给于患者口服痛风宁丸，3次/d，6 g/次。取得较好疗效。 1处方与制备 1.1处方 苍术6 g，薏苡仁252 g，萆懈126 g，黄柏63 g，虎杖60 g，泽泻60 g，土茯苓126 g，元胡63 g，知母63 g，山慈菇84 g，秦皮63 g，秦艽126 g，益母草126 g，防己63 g，徐长卿126 g。 1.2制备 取薏苡仁、萆懈、泽泻、虎杖和黄柏加水煎煮2次，每次1 h，合并煎液滤过，滤液浓缩成干浸膏。与苍术等10味药粉碎，过120目筛，用水乏丸，制成1 kg。 2质量鉴别 2.1性状 本品为浅黄褐色浓缩丸，气微，味苦。 2.2鉴别 2.2.1取本品置显微镜下观察草酸钙结晶成束或散在或细小，石细胞呈淡黄色，类圆型或长圆形，直径约60 mm，壁较厚，纹孔细密。木栓细胞被分割成2～3个子细胞。纤维及石细胞单个散在或成群。纤维及晶鞘纤维呈鲜黄色，石细胞呈鲜黄色。草酸钙针晶束存在于黏液细胞中或散在。 2.2.2取本品8 g研碎，乙醚30 mL超声处理15 min，滤过，滤渣备用。滤液低温挥去乙醚，残渣加醋酸乙脂1 mL溶解，作为供试品溶液，另取苍术对照药材0.5 g，同法制成对照药材溶液。按中国药典2005年版附录VIB薄层色谱法[1]试验，量取上述2种溶液5～10 mL，分别点于同一硅胶G薄层板上，以石油醚为展开剂，展开取出，晾干，