【作者】 杨守娟；

【导师】 林桂涛；

【作者基本信息】 山东中医药大学 ， 中药学， 2008， 硕士

【摘要】 目的:研究治疗慢性鼻窦炎的中药制剂鼻窦净还原颗粒的研制方案。方法:采用正交实验设计,以挥发油提取率为指标,对川芎、细辛、辛夷、白芷、野菊花、当归、苍耳子七味药的水蒸汽蒸馏的最佳提取条件进行了筛选,同时确定了挥发油的β-环糊精包结的最适条件;以丹参酮ⅡA和正丁醇部位干浸膏为指标,优选败酱草、桔梗、丹参、皂角刺、薏苡仁药材的醇提工艺;以黄芩苷为指标,优选了黄芩、黄芪的水提取工艺;以其成型性、溶化性、颗粒口感为考察指标,筛选出制粒的最佳辅料及配比。本制剂质量标准的研究中,采用高效液相色谱法对黄芩苷进行了定量控制,并对黄芩、丹参、黄芪作了定性鉴别。同时进行了6个月的加速试验考察。结果:挥发油提取工艺为加8倍量水,浸泡2h,蒸馏提取6h,所提取的挥发油加入10倍量β-环糊精,40℃搅拌1h进行包合;醇提工艺采用8倍量90%乙醇回流提取1h,再用8倍量70%乙醇回流1h;水提取工艺为加水10倍,煎煮3次,每次1h。优选出糊精和微晶纤维素为最佳辅料,干浸膏:糊精:微晶纤维素=1:1:0.2,80%乙醇为润湿剂制粒。黄芩苷含量测定平均回收率为96.4%,RSB=1.66%。结论:工艺及质量控制方法简便可行,稳定可靠。更多还原

【Abstract】 Objective: A scientific researching proposal to develop a new traditional Chinese Medicine dosage form—Bi Doujing Reduced Granule, which is used to cure chronic nasoinusitis. Methods: Orthogonal Design is adopted to optimize the best conditions of the weater extraction from such materials as Ligusticum Chuanxiong Hort、Asarum sieboldii Miq、Magnolia biondii Pamp、Angelica dahurica Benth et Hook f、Chrysanthemum indicum L、Angelica sinensis(oliv)Diels、Xanthium sibiricum Patr in terms of the volatile oil extraction ratio, and at the same time the optimal parameter of including volatile oil with ?-cyclodextrin (?-CD) is determined.The technological process of the ethanol extraction from the materials such as P.villosa (Thunb.) Juss, Platycodongrandiflorum, Radix Puerariae, Salvia rniltiorrhiza Bge, Gleditsiasinensis Lam according to the content of Platycodon grandiflorum(Jacq )A.DC, Salvia miltiorrhiza BgeKetone-IIA and Dry extract.of n-BuOH content and the optimized weater extraction from Scutellaria baicalensis Georgi A.membranaceus(Fisch) Bge according to the content of baicalin are also obtained through the orthogonal design. The proper excipient and its ratio in the whole Granule are optimized in terms of its formation, solution and taste.The quality control of Baicalin and Salvia rnilti-orrhiza Bgeketone IIA in the Granule is carried out according to high efficiency liquid chromatography, and the ingredients of Scutellaria baicalensis Georgi Platycodongrandiflorum Ligusticum Chuanxiong Hort Salvia rnilti-orrhiza Bge are all TLC-appraised.Result: Tthe extract process parameters of volatile oil is with 8 times water, soaked for 2 hours and extracted for 6 hours in the steam, the optimal parameter of including volatile oil is with ?-cyclodextrin at the ratio of 10:1, mixed for one hour at 40℃; the ethanol extract technological process is carried out with eight times of 90% ethonol for one hour and with eight times of 70% ethanol for one hour; the weater extract process is boiled three times with 8 times of water and each time for one hour. The excipient is common cyclodextrin and minor fibrin at the ratio of 1:1:0.2, and 80% ethanol is taken as moisture. The average content retrieving ratio of Baicalin is 96.4 % , RSB=1.66%.Conclusion: The technological process and quality control are easy and practical. This granule is of highly reliable quality.更多还原