坤怡宁颗粒的制备工艺研究.PDF

坤怡宁颗粒的制备工艺研究 王溶溶，陈丹菲，汤建成，潘建明(浙江省中药研究所，杭州 310023) 摘要：目的 研究坤怡宁颗粒的制备工艺。方法 以出膏率和芍药苷总量为指标，正交试验法优选水提条件；以颗粒吸 湿性、流动性和成型性为指标，筛选颗粒最佳辅料与配比。结果 最佳提取工艺为药材加 10 倍量水，煎煮 2 次，每次 1.5 h；制备坤怡宁颗粒的最优处方组成为：1 份浸膏与 1 份辅料(乳糖 ∶蔗糖粉 ∶糊精=3 ∶1 ∶1)混合制粒。结论 该制备 工艺合理、简便、实用，质量稳定。 关键词：坤怡宁颗粒；正交试验；工艺研究 中图分类号：R943.4 ；R944.27 文献标志码：B 文章编号：1007-7693(2011)09-0850-04 Study on the Preparation Technology of Kunyining Granule WANG Rongrong, CHEN Danfei, TANG Jiancheng, PAN Jianming(Zhejiang Institute of Chinese Materia Medica, Hangzhou 310023, China) ABSTRACT: OBJECTIVE To optimize the preparation process of Kunyining granule. METHODS With the paste-forming rate and total content of paeoniflorin as the indexes, the optimal water-extraction condition was screened by orthogonal design. With hydroscopicity, fluidity and formability as the indexes, the appropriate ratio of the excipient and the formula were selected. RESULTS The optimum water-extraction condition was as follows: 10-fold water, decoction for 2 times and 1.5 hour for each time. The optimal ratio of the excipient and the formula for preparation of Kunyining granules were one proportions of the extract and one proportion of the excipient which consisted of lactose, sucrose powder and dextrin(3 ∶1 ∶1). CONCLUSION The technology is effective, scientific, reasonable, and practical. KEY WORDS: Kunyining granule; orthogonal design; process research 围绝经期综合症是女性常见病，其发病机制 1 仪器及试药 复杂，中医认为本病是年龄增长肾气渐衰、精血 101-A 型数显式电热恒温烘箱(上海阳光仪器 不足、冲任亏虚、阴阳失衡所致，将其归属于“经 有限公司) ；FL-5 沸腾制粒器(上海华韦制药器械有 断前后诸证”、“脏躁”、“郁证”等病的范畴。临 限公司) ；高速管式离心机(上海市离心机械研究 床主要表现为潮热、盗汗、失眠、精神压抑、神 所) ；JA2OO3X 型电子分析天平(上海精密科学仪器 经质、烦躁不安、感觉异常、肌肉痛、头痛、关 有限公司) ；PE Series 200 高效液相色谱仪(美国 节痛、皮肤干燥等症状。