羚羊感冒制劑中連翹、荊芥揮發(fā)油的提
發(fā)布時(shí)間：2018-08-09 17:15
【摘要】：揮發(fā)油是解表類藥物的一大類成分,是其主要功效的物質(zhì)基礎(chǔ),但因其易揮發(fā)、易氧化、易分解,采用傳統(tǒng)方法噴灑加入揮發(fā)油制得的制劑,無(wú)論是膠囊、片劑還是其他常見(jiàn)劑型,均存在有效成分損失嚴(yán)重等問(wèn)題。河北省食品藥品監(jiān)督管理局在2014年12月25日召開(kāi)的“2014年第四季度藥品風(fēng)險(xiǎn)評(píng)估會(huì)議”上,提出了部分品種可能存在的質(zhì)量風(fēng)險(xiǎn)和問(wèn)題,其中就涉及到羚羊感冒膠囊劑、片劑。因此,采用新技術(shù)、新方法,提高中藥揮發(fā)油的穩(wěn)定性,保證其制劑的質(zhì)量,是發(fā)展中藥揮發(fā)油制劑的一項(xiàng)重要工作,也是目前中藥生產(chǎn)中亟待解決的問(wèn)題。本研究采用β-環(huán)糊精(β-CD)包合技術(shù)將連翹、荊芥的揮發(fā)油與薄荷素油一起混合后進(jìn)行包合,提高其穩(wěn)定性和溶解性,讓液體藥物變成粉末,改變其形態(tài),減少揮發(fā)油損失,掩蓋其不良?xì)馕?提高揮發(fā)油的生物利用度,進(jìn)而保證其療效,并進(jìn)一步考察其制劑的穩(wěn)定性。為提高中藥制劑中揮發(fā)油的穩(wěn)定性,開(kāi)發(fā)含揮發(fā)油的中藥制劑提供科學(xué)依據(jù)。目的:為使揮發(fā)油提取盡量完全,采用正交實(shí)驗(yàn)確定連翹、荊芥混合揮發(fā)油的最佳提取工藝;為保證揮發(fā)油成分含量穩(wěn)定安全,本研究運(yùn)用正交實(shí)驗(yàn),優(yōu)選羚羊感冒制劑中揮發(fā)油β-環(huán)糊精包合工藝條件及參數(shù),考察包合物的熱穩(wěn)定性,為羚羊感冒組方制備現(xiàn)代制劑提供實(shí)驗(yàn)理論依據(jù)。方法:1連翹、荊芥混合揮發(fā)油的最優(yōu)提取工藝:采用水蒸氣蒸餾法提取連翹、荊芥揮發(fā)油,通過(guò)L9(34)正交實(shí)驗(yàn),考察加水量(倍)、浸泡時(shí)間(h)、提取時(shí)間(h)、粒度4個(gè)因素對(duì)連翹、荊芥揮發(fā)油提取效果的影響,從而確定最佳工藝。2采用三種包合方法:選取飽和水溶液法、研磨法、超聲法三種方法,通過(guò)L9(34)正交實(shí)驗(yàn),采用綜合評(píng)分的方法,以揮發(fā)油的利用率、包合物的收得率、包合物的含油率為評(píng)價(jià)指標(biāo),優(yōu)選最佳包合工藝和方法。采用薄層層析法(TLC)、差示掃描量熱法(DSC)、紫外分光光度法、顯微鏡法分別對(duì)包合物進(jìn)行驗(yàn)證。3將揮發(fā)油的包合物與物理混合物在60℃中恒溫保存七天,分別在1、3、5、7天數(shù)提取揮發(fā)油,然后使用紫外分光光度法測(cè)揮發(fā)油含量,比較其穩(wěn)定性。結(jié)果:1用水蒸氣蒸餾的方法提取連翹、荊芥混合揮發(fā)油的最佳工藝參數(shù)為:加入10倍量的水浸泡3小時(shí),用水蒸氣蒸餾的方法提取4小時(shí),粒度為半瓣。2以β-CD為包合材料包合連翹、荊芥混合揮發(fā)油,薄荷素油,最佳的包合條件是:研磨法,揮發(fā)油與β-CD投料比為1:6,加水量為4倍,包合時(shí)間為45分鐘。3高溫穩(wěn)定性實(shí)驗(yàn)中,包合物的揮發(fā)油比物理混合物更為穩(wěn)定,包合技術(shù)能顯著提高揮發(fā)油穩(wěn)定性。結(jié)論:1連翹、荊芥揮發(fā)油的提取工藝條件采用正交實(shí)驗(yàn)優(yōu)選,方法合理結(jié)果可靠,為羚羊感冒片中這兩味藥的揮發(fā)油提取條件提供依據(jù)。2本研究?jī)?yōu)選的包合方法工藝簡(jiǎn)單、可行,此工藝條件制備的環(huán)糊精包合物包合率高,穩(wěn)定性好,為羚羊感冒制劑工業(yè)生產(chǎn)中揮發(fā)油的包合提供實(shí)驗(yàn)依據(jù),為該方開(kāi)發(fā)現(xiàn)代劑型提供理論依據(jù)。3包合后揮發(fā)油穩(wěn)定性提高,包合技術(shù)可有效提高揮發(fā)油的穩(wěn)定性,為應(yīng)用于生產(chǎn)提供理論依據(jù)。
[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.
【學(xué)位授予單位】：河北醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R283.6
本文編號(hào)：2174767
[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.
【學(xué)位授予單位】：河北醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R283.6
【參考文獻(xiàn)】
相關(guān)期刊論文 前10條
1 張靜宜;張華潭;魏艷婷;白瑞丹;李春花;;多指標(biāo)綜合評(píng)價(jià)優(yōu)選葶藶生脈方中桂枝、白術(shù)提取工藝[J];中國(guó)現(xiàn)代中藥;2016年08期
2 施曉光;;復(fù)方魚(yú)腥草顆粒中連翹揮發(fā)油β-環(huán)糊精包合工藝優(yōu)化研究[J];中國(guó)藥業(yè);2016年06期
3 張艷軍;王永香;孟瑾;朱明巖;吳云;蕭偉;;連翹、薄荷混合揮發(fā)油β-環(huán)糊精包合物的制備工藝研究[J];世界科學(xué)技術(shù)-中醫(yī)藥現(xiàn)代化;2016年03期
4 張林;李元波;朱麗萍;張愛(ài)軍;;多指標(biāo)優(yōu)選香芍顆粒揮發(fā)油中β-環(huán)糊精的包合工藝[J];中成藥;2016年02期
5 石婷婷;陳翠微;吳鑫;曹崗;蔡寶昌;;桂枝和肉桂混合揮發(fā)油的包合工藝研究[J];中華中醫(yī)藥雜志;2016年02期
6 楊瓊;李亮;陳蓓;馬李夏子;趙越平;石小鵬;文愛(ài)東;成源;;紫蘇揮發(fā)油羥丙基-β-環(huán)糊精包合工藝研究[J];山西醫(yī)藥雜志;2016年02期
7 朱慶英;張永輝;朱瓊;丁樂(lè);;丁香酚-β-環(huán)糊精包合物的制備與表征[J];中國(guó)藥房;2016年01期
8 李進(jìn)霞;于肯明;張慧芝;閆燕艷;孫樹(shù)茂;;芹菜素-環(huán)糊精包合物在溶液中的制備、表征及抗氧化性[J];山西大同大學(xué)學(xué)報(bào)(自然科學(xué)版);2015年06期
9 王杰;史德勝;劉冰;周軍;邵建強(qiáng);唐素芳;閆東;;含揮發(fā)性成分中藥牡丹皮和肉桂配方顆粒不同制備工藝的比較研究[J];中草藥;2015年24期
10 張雷;尹蓮;;正交試驗(yàn)優(yōu)選定痛寧顆粒中揮發(fā)油的提取和包合工藝[J];湖北民族學(xué)院學(xué)報(bào)(醫(yī)學(xué)版);2015年04期
相關(guān)碩士學(xué)位論文 前1條
1 楊文婧;連翹—荊芥揮發(fā)油不同活性部位的抗炎作用及其納米乳的制備[D];西北大學(xué);2010年
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