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1、最新资料推荐妇炎康复片制备工艺及质量标准的研究摘要目的 妇炎康复片是由黄芩、赤芍、陈皮等7味中药组成,临床用于治疗慢性盆腔炎、宫颈炎、阴道炎等妇科疾病。为更好更好的确保药品质量,本课题是对妇炎康复片的制备工艺及质量标准进行相关研究,为今后提高妇炎康复片药品的质量奠定了相应的基础。方法 本课题对妇炎康复片制备工艺及质量标准进行研究。制备工艺研究方法 黄芩、赤芍、陈皮3味主药分别提取,试验中运用正交试验法,其中黄芩采用水提法从加入水量、水提取时间、水提取次数几个影响因素进行考察,赤芍及陈皮采用醇提法,从加入乙醇量、乙醇倍数、乙醇提取时间、乙醇提取次数几个影响因素进行考察,确定了最优提取工艺。质量标
2、准研究方法 按照中国药典2010版中的相关规定,对妇炎康复片各主要成分的质量标准进行研究。结果 制备工艺研究结果 通过正交试验法,分别确定了黄芩、赤芍、陈皮的提取工艺,黄芩为加8倍水、提取3次、每次1h,赤芍为70%乙醇提取,8倍量,提取3次,每次1.5h,陈皮为95%乙醇提取,8倍量,提取2次,每次4h。质量研究结果 建立了以HPLC法测定妇炎康复片中芍药苷、橙皮苷、黄芩苷含量的分析方法:以十八烷基键合硅胶为填充剂;乙腈一磷酸二氢钾水溶液(O.05 molL,磷酸调节pH值为3.5)为流动相;流速:0.9 mLmin;梯度洗脱:0 min,15:85;10min,15:85;15min,20
3、:80;30min,25:75;45min,30:70;柱温:4O ;进样量:10ul;检测波长:231nm。方法简单可行。同时,按照中国药典2010版中药物制剂稳定性试验的相关规定,对按照本课题中制备工艺的生产的妇炎康复片成品进行长期及加速试验考察,结果良好,表明该制备工艺下的成品质量稳定。结论 通过本课题中的相关研究,确定了妇炎康复片的最佳制备工艺,建立了控制产品质量的分析方法,产品质量稳定性良好。关键词 妇炎康复片;制备工艺;分析方法学;稳定性考察AbstractObjective Fuyankangfu piece by skullcap, peony, orange peel, se
4、ven Chinese herbal medicines, for the treatment of chronic pelvic inflammatory disease, cervicitis, vaginitis and other gynecological diseases. In order to better ensure a better quality of medicines, the subject is a preparation process and quality standards Fuyankangfu pieces related research laid
5、 the foundation for the future accordingly to improve the quality Fuyankangfu piece drugs.Meyhods The topic of the preparation process and quality standards Fuyankangfu pieces research.Preparation Process study Skullcap, peony, orange peel flavor three main drugs were extracted, experiments using or
6、thogonal test method, which uses water extraction from Scutellaria adding water, water extraction time, water extraction times to inspect several factors, red peony and orange peel uses ethanol extraction, from the amount of ethanol added, multiple ethanol, ethanol extraction time, ethanol extractio
7、n times to inspect several factors to determine the optimal extraction process.Quality Standards study Refer to Chinese Pharmacopoeia the relevant provisions of the 2010 edition of Fuyankangfu sheet quality standards for research.Results Preparation Process study By orthogonal experiment were determ
8、ined skullcap, peony, orange peel extraction process, skullcap for 8 times in water, extracted three times, each time 1h, TPG is 70% ethanol, eight times the amount extracted three times, every 1.5h, 95% ethanol extract of dried tangerine peel, eight times the amount of extracted 2 times 4h.Quality
9、Standards study The establishment of a HPLC method for the determination of paeoniflorin Fuyankangfu tablets, hesperidin, analysis of baicalin. Octadecyl bonded silica as a filler; acetonitrile an aqueous solution of potassium dihydrogen phosphate (O.05 mol / L, phosphoric acid adjusted to pH 3.5) a
10、s the mobile phase; flow rate: 0.9 mL / min; gradient: 0 min, 15: 85; 10min, 15: 85; 15min, 20: 80; 30min, 25: 75; 45min, 30: 70; column temperature: 4O ; injection volume: 10ul; detection wavelength: 231nm. The method is simple and feasible.At the same time, in accordance with the relevant provisio
11、ns of Chinese Pharmacopoeia 2010 version of the drug formulation stability tests on Fuyankangfu sheet preparation process of the production of finished products in accordance with this issue in the long-term and accelerated testing study, with good results, showing that the preparation process stabl
12、e product quality.Conclusion Through this project the relevant studies to determine the best preparation Fuyankangfu sheet established analytical methods to control product quality, product quality and good stability.Key words Fuyankangfu piece; Preparation crafts; Analysis methodology; Stability st
13、udy英文缩写词(Abbreviation)英文缩写 英文全称 中文全称HPLC High Performance Liquid Chromatography 高效液相色谱法HPV Human papilloma virus 人乳头状瘤病毒GH Growth Hormone 生长激素AUB Abnormal uterine bleeding 子宫异常出血MHC Major histocompatibility complex 主要组织相容性复合体 序言伴随着现代生活与工作节奏越来越快,导致工作压力逐渐增大,现代女性不仅要面临来自生活和工作双重压力,还要遭受到各类妇科疾病。目前,随着社会的进步,
14、女性受教育程度越来越高,女性在社会当中的责任越来越大,导致广大女性没有更多的精力去顾及自身的健康。更多的女人因为感觉自己正值年轻力强,从而忽视了对自身对疾病的防范。疲劳症、抑郁症、更年期提前等慢性疾病和心理疾病正在一步一步侵蚀女性的身体健康,有些疾病甚至已经严重影响到女性正常的生命安全。据世界卫生组织(WHO)的统计显示:百分之九十以上的妇女患有不同程度的妇科疾病,更有超过百分之四十的女性,遭受妇科疾病反复发作的痛苦。妇科疾病主要分为阴道炎、宫颈炎和盆腔炎三大类。我国相关妇科炎症疾病的发病率相当高。随着我国社会当中女性所承担的责任越来越重,有关女性疾病的研究报道越来越多,有关研究显示,我国患有妇科疾病的已婚或未婚妇女比例为46.10%,其中,患病率处在第一位的为慢性宫颈炎(39.30%);患病率处在第二位的为阴道炎(15.90%);患病率处在第二位的为慢性盆腔炎(10.27%) 1。本课题中的妇炎康复片对上述症状疗效确切,在临床上应用多年,本课题在临床以及药理学研究的基础之上,对妇炎康复片的制备工艺及质量标准进行了相关研究。最新精品资料整理推荐,更新于二二一年一月二十日2021年1月20日星期三20:05:43目 录第一章 引言1一、选题目的和依据 2 二、国内外研究情况概述 2三、文献综述 2第二章 妇炎康复片的处方分析及临床应用 27一、妇炎康复片处方中主要药材研究情况