羚羊感冒制剂中连翘、荆芥挥发油的提

发布时间：2018-08-09 17:15

【摘要】：挥发油是解表类药物的一大类成分,是其主要功效的物质基础,但因其易挥发、易氧化、易分解,采用传统方法喷洒加入挥发油制得的制剂,无论是胶囊、片剂还是其他常见剂型,均存在有效成分损失严重等问题。河北省食品药品监督管理局在2014年12月25日召开的“2014年第四季度药品风险评估会议”上,提出了部分品种可能存在的质量风险和问题,其中就涉及到羚羊感冒胶囊剂、片剂。因此,采用新技术、新方法,提高中药挥发油的稳定性,保证其制剂的质量,是发展中药挥发油制剂的一项重要工作,也是目前中药生产中亟待解决的问题。本研究采用β-环糊精(β-CD)包合技术将连翘、荆芥的挥发油与薄荷素油一起混合后进行包合,提高其稳定性和溶解性,让液体药物变成粉末,改变其形态,减少挥发油损失,掩盖其不良气味,提高挥发油的生物利用度,进而保证其疗效,并进一步考察其制剂的稳定性。为提高中药制剂中挥发油的稳定性,开发含挥发油的中药制剂提供科学依据。目的:为使挥发油提取尽量完全,采用正交实验确定连翘、荆芥混合挥发油的最佳提取工艺;为保证挥发油成分含量稳定安全,本研究运用正交实验,优选羚羊感冒制剂中挥发油β-环糊精包合工艺条件及参数,考察包合物的热稳定性,为羚羊感冒组方制备现代制剂提供实验理论依据。方法:1连翘、荆芥混合挥发油的最优提取工艺:采用水蒸气蒸馏法提取连翘、荆芥挥发油,通过L9(34)正交实验,考察加水量(倍)、浸泡时间(h)、提取时间(h)、粒度4个因素对连翘、荆芥挥发油提取效果的影响,从而确定最佳工艺。2采用三种包合方法:选取饱和水溶液法、研磨法、超声法三种方法,通过L9(34)正交实验,采用综合评分的方法,以挥发油的利用率、包合物的收得率、包合物的含油率为评价指标,优选最佳包合工艺和方法。采用薄层层析法(TLC)、差示扫描量热法(DSC)、紫外分光光度法、显微镜法分别对包合物进行验证。3将挥发油的包合物与物理混合物在60℃中恒温保存七天,分别在1、3、5、7天数提取挥发油,然后使用紫外分光光度法测挥发油含量,比较其稳定性。结果:1用水蒸气蒸馏的方法提取连翘、荆芥混合挥发油的最佳工艺参数为:加入10倍量的水浸泡3小时,用水蒸气蒸馏的方法提取4小时,粒度为半瓣。2以β-CD为包合材料包合连翘、荆芥混合挥发油,薄荷素油,最佳的包合条件是:研磨法,挥发油与β-CD投料比为1:6,加水量为4倍,包合时间为45分钟。3高温稳定性实验中,包合物的挥发油比物理混合物更为稳定,包合技术能显著提高挥发油稳定性。结论:1连翘、荆芥挥发油的提取工艺条件采用正交实验优选,方法合理结果可靠,为羚羊感冒片中这两味药的挥发油提取条件提供依据。2本研究优选的包合方法工艺简单、可行,此工艺条件制备的环糊精包合物包合率高,稳定性好,为羚羊感冒制剂工业生产中挥发油的包合提供实验依据,为该方开发现代剂型提供理论依据。3包合后挥发油稳定性提高,包合技术可有效提高挥发油的稳定性,为应用于生产提供理论依据。
[Abstract]:Volatile oil is a major component of the solution, and it is the material basis of its main efficacy. But because of its volatile, easy oxidation and easy decomposition, the volatile oil is sprayed with the traditional method of spraying the volatile oil, whether it is capsule, tablet or other common dosage forms, there are some serious problems of serious loss, such as the supervision and management of food and drug in Hebei province. In December 25, 2014, the Bureau of drug risk assessment held in the fourth quarter of 2014, put forward the possible quality risks and problems of some varieties, involving the antelope's cold capsules and tablets. Therefore, the new technology, new method, the improvement of the stability of the volatile oil of Chinese medicine, the quality of its preparation, is the development of Chinese medicine. An important work of volatile oil preparation is an urgent problem to be solved in the production of Chinese medicine. This study uses beta cyclodextrin (beta -CD) inclusion technology to mix Forsythia forsythia, the volatile oil of Fructus forsythi and peppermint oil, so as to improve its stability and solubility, make liquid drugs turn into powder, change its morphology and reduce the loss of volatile oil. To cover up its bad smell, improve the bioavailability of volatile oil, and to ensure its curative effect, and to further investigate the stability of its preparation. In order to improve the stability of the volatile oil in Chinese medicine preparation, to provide scientific basis for the development of traditional Chinese medicine containing volatile oil. In order to ensure the stable and safe composition of volatile oil, the orthogonal experiment was used to optimize the conditions and parameters of the inclusion of volatile oil beta cyclodextrin in antelope's cold preparation, and to investigate the thermal stability of the inclusion compound, and provide the theoretical basis for the preparation of modern preparations of the antelope cold group. Method: 1 Forsythia forsythia, and the thorcp. The optimum extraction process of mixed volatile oil is: using steam distillation to extract Forsythia forsythia and essential oil of chincen chinensis. Through the orthogonal experiment of L9 (34), the effect of 4 factors on the extraction effect of Forsythia forsythia and the volatile oil of Forsythia forsythia and chinensis is determined by the effect of 4 factors on the extraction effect of Forsythia forsythia, and the extraction time (H), and the grain size. The optimum process is to select the saturated water. Three methods of solution, grinding and ultrasonic method were used. Through the orthogonal experiment of L9 (34), the comprehensive scoring method was used to evaluate the utilization rate of the volatile oil, the yield of the inclusion compound, the oil content of the inclusion compound as the evaluation index, and the optimum inclusion process and method. The thin layer chromatography (TLC), differential scanning calorimetry (DSC), ultraviolet spectrophotometry and microscope were used. The inclusion compound was verified by.3, and the volatile oil was preserved at 60 degrees at constant temperature for seven days, and the volatile oil was extracted at 1,3,5,7 days respectively. Then the volatile oil content was measured by UV spectrophotometry, and its stability was compared. Results: the best work of Forsythia forsythia and the mixed volatile oil of Forsythia forsythi was extracted by steam distillation. The art parameters are: soaking 10 times water for 3 hours and distilling water steam for 4 hours. The granularity is half petal.2 with beta -CD as the inclusion of Forsythia forsythia, mixed volatile oil and peppermint oil, the best inclusion conditions are: grinding, the ratio of the volatile oil to beta -CD is 1:6, the amount of water is 4 times, and the inclusion time is 45 minutes.3 high temperature stability. In sex experiments, the volatile oil of the inclusion compound is more stable than the physical mixture, and the inclusion technology can significantly improve the stability of the volatile oil. Conclusion: the extraction process conditions of the volatile oil of 1 Forsythia forsythia, the optimum result of the method are reliable, which provides the basis for the extraction conditions of the volatile oil of the two flavors of the antelope's cold tablets by.2. The technique is simple and feasible. The inclusion compound of cyclodextrin inclusion compound prepared by this process is high in inclusion rate and good in stability. It provides experimental basis for the inclusion of volatile oil in the industrial production of antelope's cold preparation. It provides a theoretical basis for the development of modern dosage forms for this prescription, and the stability of volatile oil after.3 inclusion is improved, and the inclusion technology can effectively improve the stability of volatile oil. It provides a theoretical basis for the application of the production.
【学位授予单位】：河北医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R283.6

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