NWIPB OpenIR
BN胶囊的药学研究
其他题名Pharmaceutical Studies on BN Capsules
马明英
学位类型硕士
导师张晓峰
2007-06-09
学位授予单位中国科学院西北高原生物研究所
学位授予地点西北高原生物研究所
关键词Bn胶囊 制备工艺 质量标准 初步稳定性
摘要BN胶囊由黄芪、当归、延胡索、白花蛇舌草、铁棒锤、甘草等药组成,具有清热解毒,镇惊、解痉止痛的功效,用于外伤疼痛、术后疼痛、各种内脏痉挛性疼痛以及中晚期癌痛。本课题以传统藏医药理论和中医药理论为指导原则,采用现代制药技术制成新型止痛药物。 处方相较于西药止痛药副作用小,无成瘾性,对于减轻患者的疼痛,使用安全有效的止痛药,显得尤其重要。本课题对制备工艺、质量标准、稳定性进行了研究。 根据处方的功能主治及药物所含成分的理化性质,采用正交试验方法以多指标综合评分筛选出最佳工艺为:取全部药材用70%乙醇做溶剂提取两次,第一次加8倍量,提取2小时;第二次加6倍量,提取1.5小时。同时考察了浓缩工艺、干燥工艺、成型工艺;对BN胶囊进行了质量标准研究:采用TLC法鉴别了方中黄芪、当归、延胡索、白花蛇舌草,各方法专属性强,检出斑点清晰。对铁棒锤进行了薄层色谱限量检查,方法稳定,符合规定。采用HPLC法测定方中主药黄芪所含黄芪甲苷的含量,回收率为99.77%,表明方法准确可靠,拟规定BN胶囊每粒含黄芪甲苷不得少于0.05mg;此外,在质量标准可控的基础上对该制剂进行了初步稳定性研究,结果各项指标均符合要求。 以上试验结果表明:BN胶囊制备工艺合理可行,质量标准可控,成品质量基本稳定。 关键词:BN胶囊 制备工艺 质量标准 初步稳定性
其他摘要Pharmaceutical Studies on BN Capsules Ma Ming-ying (Phytochemistry) Directed by:Prof. Zhang Xiaofeng Northwest Plateau institute of Biology, Chinese Academy of Sciences ABSTRACT The BN Capsules was compounded by traditional Chinese-Tibetan medicine prescriptions,which consists of Astragalus membranaceus (Fisch.) Bge. var. mongholicus Hsiao.,Angelica sinensis (Oliv.) Diels,Corydalis yanhusuo W. T. Wang,Oldenlandia diffusa (Willd.)Roxd., Aconitum. pendulum Busch.,Glycyrrhiza glabra L.,it has the efficiency of analygesia, Clearing Heat Antitoxicant,relieving spasm and pain. It was mainly used to relieve traumatic pain, postoperative pain, various visceral convulsion pain and later period cancer pain.With the guidance of the theories of Tibetan Medicine and Traditional Chinese Medicine, Compound BN capsules was studied as new type analgesic drugs on pre-clinical pharmacy with modern pharmaceutical technology. Compared to Western medicine, this prescription has less side-effect and no drug addiction. It’s important to alleviate the pains of patients by using this analgesic, which is secure and efficient. This subject mainly deals with the technique of preparation, quality standard and preliminary stability. On the basis of the function and treatment as well as the characters of the component of the herbs, the optimum extract conditions about alcohol-extract was selected by using orthogonal design which use quite a few assessing norms to evaluate them comprehensively; After that the quality standard of the drug was finished.To identify Astragalus membranaceus (Fisch.) Bge. var. Mongholicus Bge.,Angelica sinensis (Oliv.) Diels,Corydalis yanhusuo W. T. Wang,and Hedyotis diffusa Willdv by using TLC.the limitative quantity of aconitine was controlled by TLC. Determine the content of Astragaloside Ⅳ in the preparation by HPLC (ELSD), the average recovery was 99.77, The results show that the contents in every capsules of Astragaloside Ⅳ shouldn’t be less than 0.05mg. These methods were distinct highly specific and the result was accuracy; Then the preliminary stability was fulfilled, the results show that all indexes didn’t change apparently. All results indicated that the technique of preparation was reasonable and practical, the standard was controllable and the qualities of the samples were steady as well. Key words:BN Capsules,technique of preparation,quality standard,preliminary stability
页数55
语种中文
文献类型学位论文
条目标识符http://210.75.249.4/handle/363003/3122
专题中国科学院西北高原生物研究所
推荐引用方式
GB/T 7714
马明英. BN胶囊的药学研究[D]. 西北高原生物研究所. 中国科学院西北高原生物研究所,2007.
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