【作者】 袁斌；

【导师】 欧阳臻；

【作者基本信息】 江苏大学 ， 生药学， 2006， 硕士

【摘要】 本论文系统地研究了肺气肿胶囊的制备工艺、质量标准及稳定性试验。主要研究内容和结果如下：1．对肺气肿胶囊的制备工艺进行研究。优选辅料及其用量，并以制粒的干燥条件、干燥时间、颗粒的吸湿性等因素作为指标进行了考察，研究了制剂的制备方法。选择微粉硅胶为辅料，辅料加入量的比例为10.7％，以5％聚丙烯酸乙醇溶液为润湿剂，采用湿法制粒，填充胶囊。所得胶囊美观，质量可控。中试结果表明该工艺合理可行，产品质量可控。2．对原料药材野马追的质量标准进行了研究。建立了野马追中槲皮素、山柰素定性定量分析方法。槲皮素、山柰素的TLC定性分析方法：以甲苯—乙酸乙酯—甲酸(9：3：1)为展开剂，硅胶G薄层板，显色剂为1％三氯化铝乙醇液。结果槲皮素R_f=0.54，山柰素R_f=0.62。HPLC定量分析方法：色谱柱为Kromasil-C18柱，流动相为甲醇-0.4％磷酸(60：40)，检测波长为370nm，柱温为30℃，流速为0.6ml／min，方法灵敏度高，重现性好，结果准确。3．研究建立了肺气肿胶囊质量标准。制剂中淫羊藿、牡荆油、丹参、补骨脂、黄芪采用薄层色谱法进行定性鉴别，方法灵敏度高，专属性强，重现性好。采用高效液相色谱法对主要成分淫羊藿苷及复方中化学药盐酸克伦特罗进行了定量分析。淫羊藿苷HPLC定量分析条件为：色谱柱为Kromasil-C18柱，流动相为甲醇-0.4％磷酸(55：45)，检测波长为270nm，柱温为35℃，流速为1.0ml／min，方法灵敏度高，专属性强，重现性好，结果准确。4．对肺气肿胶囊进行了稳定性试验研究。考察结果为本品性状、鉴别、检查、含量测定、卫生学检查均符合指标，说明本品质量稳定。更多还原

【Abstract】 A systematical study on the preparation techniques, quality standard, stability test of Feiqizhong capsules was carried out. The main contexts and conclusions were as following:1. To optimize the type and dosage of additive agents, the mono-factor design tests was used, and the factors of desiccation time, condition and grain’s moisture absorption were also examined, the preparation process was designed. The optimal conditions are as follow: the capsules were manufactured by wet granulation with 5% polypropylene acid ethanol solution was used to mix the micromeritics silicagel and drug powder in the partition of 10.7:1, and the outerside of capsules are polished and the quality is controllable. The results of middle scale experiment showed that the preparation is operationable reliablly and the quality of capsules is controllable.2. According to the relating references, the quality standards of herba Eupatorii was established. TLC was used to identify the main gradients of quercetin and kamepferol in herba Eupatorii:the silica gel thin layer plate and the developing agent consisting of a mixture of toluene-ethyl acetate-ethyl acid（9:3:1） were used, and the allunim trichloricide-ethanol solution was used to react to the gredients stains.The relative flow value of quercetin is 0.54, and the value of kaempferol is 0.62. HPLC was used to determinate the contents of quercetin and kamepferol, and the method was validated. A C18 column and the mobile phase consisting of a mixture of methanol-0.4%H₃PO₄（60:40）are used to determinate the contents with the wavelength of 370nm and the flow rate of 0.6ml/min at 30℃. The method is sensitive, reproducible and accurate.3. The quality standard of Feiqizhong capsules was established. TLC was used to identify the herba Epimedii, oleum Viticis negundo, radix Salviae miltiorrhizae, fructus Psoraleae, radix Astragali, and HPLC also was used to analysize the content of icariin and clenbruterol hydrochloride. The method are validated. A C18 column and the mobile phase consisting of a mixture of methanol-0.4%H₃PO₄（55:45）are used to determinate the content of icarrin with the wavelength of 270nm and the flow rate of1.0ml/minat35℃. 4. The stability of Feiqizhong capsules was studied for 3 months. The results indicated that the factors of characteristics, identificationtest, content determination and hygienics check remained unchanged. It showed that the quality of Feiqizhong capsules was stable.更多还原