肺痿颗粒的制备工艺研究及医院中药临床药学服务模式探讨

发布时间：2018-05-04 21:15

本文选题：肺痿 + 高效液相色谱指纹图谱　；参考：《北京中医药大学》2017年硕士论文

【摘要】：专业学位是培养特定职业高层次创新应用型专门人才的重要途径,近年来成为我国研究生教育的重要形式。而中医中药作为我国独特的医药学体系和国学文化的延伸,已经受到国家的高度重视,国家对中医药学科专业应用型人才的需求日益增加。因此,国务院学位委员会决定设置中药学硕士专业学位,并于2011年起我国首次招收中药学专业学位研究生。目的是培养具有实践能力和创新应用能力的高层次复合人才,以适应我国中药行业现代化,多元化的发展模式。中药学硕士专业学位是一种有别于学术型硕士的高级人才培养模式。专业学位采用"校企合作"、"政、校、行、企"合作的"双导师制"的培养模式,理论课程以学校为主,实践环节到校外单位完成,一种全新的培养模式。本论文结合临床中药学专业学位研究生培养要求,分为实验研究和药学实践两部分。第一部分,实验研究部分。首先是文献综述,该部分阐述了特发性肺间质纤维化的病因病机、中医药治疗现状,以及特发性肺间质纤维化目前治疗过程中存在在的问题并提出合理的建议;综述了肺痿颗粒中主要药味的化学成分和药理作用研究进展。其次是肺痿颗粒的制备工艺研究,结合工艺路线建立肺痿颗粒中各药味以及水提和醇提的HPLC指纹图谱,并将其运用到工艺优化环节,与传统以单指标为指标的工艺优化研究方法进行对比分析,优选出最佳提取工艺,干燥工艺,结合正交设计优选肺痿颗粒的成型制备工艺。实验研究内容及结果如下:目的和意义特发性肺间质纤维化是一种病因不明,发病机制不清,缺乏治疗手段,以弥漫性肺泡炎和肺泡结构紊乱的慢性纤维化性间质性肺疾病。平均生存期仅2年,5年生存率不足50%。目前西医学对尚缺乏特异性的治疗手段,寻找新的更为安全有效的治疗药物具有重要的现实意义。为了方便患者临床应用,将其制成颗粒剂。肺痿颗粒由人参、三七、紫菀、五味子、山萸肉等药味中药组成,具有补益肺肾,益气活血之功效。本文在中医药理论指导下,结合处方中各药的理化性质及药理活性,从处方饮片的指纹图谱、提取工艺及成型工艺方面进行系统性研究,从而为临床治疗提供安全、有效、服用方便的肺痿颗粒。方法1建立肺痿颗粒主要药材饮片的HPLC指纹图谱:根据药材理化性质和药理活性确定处方的工艺路线,再依据工艺路线,分别建立饮片、醇提液和水提液的HPLC指纹图谱,对比饮片和醇提液、水提液的HPLC指纹图谱,指出各味药的专属峰和共有峰。2提取工艺研究:采用正交试验设计,以峰面积,指标成分,得稿率为考察指标,进行多指标综合评价优选出最佳提取工艺,并与单指标定量方法优选出的最佳工艺作对比,确定肺痿颗粒的最佳醇提工艺、水提醇沉工艺和干燥工艺,并对该优化工艺进行验证。3成型工艺研究:设计正交试验,以颗粒成型率、吸湿率、溶化性作为考察指标进行指标综合评价,筛选最佳制剂处方;采用挤出制粒法制粒。对制得的颗粒进行水分、粒度、吸湿性等项目考察。结果1人参和三七醇提,山萸肉、五味子、紫菀、麦冬、白果等味药水提醇沉,从醇提液HPLC的指纹图谱中选取了 24个峰,水提液的HPLC的指纹图谱中指认出13个峰。2最佳醇提工艺条件为10倍量60%乙醇,提取3次,每次1h;水提醇沉的最佳工艺条件为8倍量水,提取2次,每次2小时;水提液浓缩至密度至1.11～1.15(室温测),加入95%的乙醇使含醇量达到60%,放置18h。将醇提液和水提液合并浓缩至稠膏,在80℃条件下减压干燥至干浸膏。证明了多指标成分定量法较单指标定量法更加准确和全面。3最佳成型制备工艺为:将干浸膏粉碎,加入1:0.5的辅料,混合均匀,在搅拌下加入8%的干浸膏量的90%乙醇(喷淋的方式加入),制软才,将制得的软材用14目筛制粒,80℃下干燥3小时,14目筛整粒。水分、粒度、流动性均符合药典规定。结论本研究确定的肺痿颗粒提取工艺、干燥工艺、制剂成型工艺合理、稳定、简单可行。实践研究内容及结果如下:本文通过药学实践部分旨在通过对中日友好医院临床中药学服务现状研究,改善临床中药学服务模式,提高服务质量,保障患者的合埋用药。作者通过在卫计委中日友好医院2年多的实践,对该院已开展的中药临床药学服务项目内容、服务方法、服务水平和服务质量等相关资料进行综合概括、分析,研究该院中药临床学服务工作开展情况。对比分析临床药学和中药临床药学服务模式,并为中药临床药学服务提出以下几点建议:1完善相关法律法规及行业规范体系;2加强对药学服务的政策支持;3改变药房调剂模式,发挥药师专业作用;4加强药师人才培养;5提高药学科研水平。
[Abstract]:Professional degree is an important way to train special professionals of high level and innovative application type. In recent years, it has become an important form of graduate education in China. As a unique medical system and the extension of Chinese culture, traditional Chinese medicine has been highly valued by the state. As a result, the degree committee of the State Council decides to set up a master's degree in Chinese pharmacy and is the first to recruit a graduate student of professional degree in Chinese pharmacy in 2011. The aim is to cultivate high level compound talents with practical ability and innovative application ability in order to adapt to the modernization of Chinese medicine industry and the diversified development model. Master degree is a kind of advanced talent training model which is different from academic master. Professional degree adopts "school enterprise cooperation", "dual tutor system" mode of "school enterprise, school, business, enterprise". The theory course is based on school, practice link to out of school units, a new training mode. This paper combines with clinical pharmacy major. The training requirements of graduate students are divided into two parts: experimental research and pharmaceutical practice. The first part, the experimental research part. First, the literature review. This part expounds the etiology and pathogenesis of idiopathic pulmonary fibrosis, the status of traditional Chinese medicine treatment, and the problems in the treatment process of idiopathic pulmonary fibrosis. The research progress on the chemical composition and pharmacological action of the main medicinal herbs in the lung flaccid granules was summarized. Secondly, the preparation technology of the lung flaccid granules was studied. The HPLC fingerprint of the drugs in the lung granule and the water extraction and alcohol extraction were established by combining the process route. The optimum extraction process, drying process, and orthogonal design were selected to optimize the preparation process of lung flaccid granules. The contents and results were as follows: objective and significance idiopathic pulmonary fibrosis is a kind of unknown etiology, unclear pathogenesis, lack of treatment, diffuse alveolitis and alveoli. Chronic fibrotic interstitial lung disease with structural disorder. The average survival time is only 2 years, and the 5 year survival rate is less than 50%.. At present, western medicine is of great practical significance for the lack of specific treatment and finding new and more safe and effective treatment drugs. 37, the medicinal herbs of aster, Schisandra chinensis and Cornus officinalis have the effect of tonifying lung and kidney, promoting qi and promoting blood circulation. This article, under the guidance of traditional Chinese medicine theory, combines the physical and chemical properties and pharmacological activities of each prescription in the prescription, and systematically studies the fingerprint of prescription pieces, the extraction technology and the molding technology, thus providing a safety for clinical treatment. All, effective, take the convenient lung flaccid granules. Method 1 the HPLC fingerprint of the main medicinal herbs of Fei Wei granule was established. According to the physicochemical and pharmacological activity of the medicinal materials, the HPLC fingerprints of the decoction pieces, alcohol extract and water extract were established according to the technological route, and the HPLC fingerprints of the water extract and the water extract were compared. The special peak of each flavour and the extraction process of the common peak.2 were studied. The optimum extraction process was selected by orthogonal experiment design with the peak area, the index component and the draft rate as the inspection index, and the optimum extraction technology was selected by multi index comprehensive evaluation, and the optimum extraction technology of the lung flaccid granules was determined by comparison with the best process selected by the single index quantitative method. Water extraction and alcohol precipitation process and drying technology, and the optimization of the process to verify the.3 molding process: design orthogonal test, taking the particle molding rate, hygroscopic rate and solubility as an index to evaluate the index synthetically, screening the best preparation prescription, using the extrusion granulating particle. Results 1 ginseng and 37 alcohol extraction, the flavour of Cornus, Schisandra, aster, Ophiopogon, and white fruit were extracted and alcohols, and 24 peaks were selected from the HPLC fingerprint of the alcohol extract. The fingerprint of the HPLC of the water extract was identified as the optimum alcohol extraction process of 13 peaks, 10 times 60% ethanol, 3 times, each 1H, and the best process bar for water extraction and alcohol precipitation. 8 times the amount of water, 2 times, 2 hours each time; the water extract is concentrated to 1.11 ~ 1.15 (Shi Wen test) and 95% ethanol is added to the alcohol content to 60%. The alcohol extract and water extract are concentrated to the thickening paste by 18h., and then dried to dry extract at 80 C. It is proved that the quantitative method is more accurate than the single index quantitative method. The optimum preparation process of the comprehensive.3 molding is to crush the dry extract, add the auxiliary material of 1:0.5, mix evenly, add 8% dry extract of 90% ethanol (spray method) under stirring, make soft material, make the soft wood with 14 mesh screens, dry 3 hours at 80 degrees C, and screen the whole grain. Water, grain size and fluidity all conform to the stipulations of the Pharmacopoeia. To study the extraction process of lung flaccid particles, the drying process, the preparation process is reasonable, stable, simple and feasible. The contents and results of the practice are as follows: This article aims to improve the service mode of clinical traditional Chinese medicine through the research on the clinical pharmacy service in China-Japan Friendship Hospital, improve the quality of service and guarantee the patient Through more than 2 years' practice in China-Japan Friendship Hospital of Wei Planning Commission, the author comprehensively summarized and analyzed the contents, service methods, service level and service quality of TCM clinical pharmacy service projects that had been carried out in the hospital, analyzed the development of clinical service work of Chinese medicine in the hospital, compared and analyzed clinical pharmacy and Chinese medicine. Bed pharmacy service model, and to provide the following suggestions for the clinical pharmacy service of Chinese medicine: 1 improve relevant laws and regulations and industry standard system; 2 strengthen the policy support for pharmaceutical services; 3 change the mode of pharmacy dispensing, play the professional role of pharmacists; 4 strengthen the training of pharmacists; 5 improve the level of pharmaceutical research.

【学位授予单位】：北京中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R283.6;R288

【参考文献】