發(fā)布時(shí)間：2018-01-18 16:18

  本文關(guān)鍵詞：銀杏葉、銀杏葉提取物口服制劑中黃酮苷類成分質(zhì)量分析研究　出處：《北京中醫(yī)藥大學(xué)》2017年碩士論文　論文類型：學(xué)位論文

  更多相關(guān)文章： 銀杏葉 銀杏葉提取物 銀杏葉口服制劑 指紋圖譜 黃酮苷類 定量方法 一測(cè)多評(píng)

【摘要】：銀杏葉為裸子植物銀杏Ginkgo biloba L.的干燥葉,以銀杏葉或銀杏葉提取物為原料的制劑是現(xiàn)代植物藥的重要產(chǎn)品,占據(jù)較大的市場(chǎng)份額,此類產(chǎn)品的質(zhì)量問題時(shí)有報(bào)道,解決問題的關(guān)鍵在于提高現(xiàn)行標(biāo)準(zhǔn)的質(zhì)量控制水平。本論文聚焦銀杏葉中主要有效成分之一的黃酮苷類化合物,通過采用指紋圖譜、一測(cè)多評(píng)以及對(duì)照提取物等技術(shù)手段,研究更加有效、簡(jiǎn)便和可行的質(zhì)控方法。由于其組成尚未完全闡明,加之對(duì)照物質(zhì)難以獲得,目前國內(nèi)外現(xiàn)行標(biāo)準(zhǔn)中,對(duì)于銀杏葉、銀杏葉提取物以及一系列制劑中銀杏黃酮苷類的質(zhì)量控制均采用酸水解這一間接方法,經(jīng)折算后計(jì)算出總黃酮苷的含量,該法雖可解決對(duì)照物質(zhì)缺乏的問題,但對(duì)質(zhì)量控制不準(zhǔn)確,并為人為添加黃酮苷元等造假行為提供了可能。本論文在前期研究的基礎(chǔ)上,對(duì)銀杏葉制劑中黃酮苷原型化合物,研究建立了銀杏葉片、膠囊、酊劑、滴劑、滴丸、軟膠囊等口服制劑的指紋圖譜,并采用相似度評(píng)價(jià)和特征黃酮苷峰面積比雙質(zhì)控指標(biāo)相結(jié)合的方式對(duì)樣品進(jìn)行定性分析研究,最終確定更加耐用和可行的判定標(biāo)準(zhǔn),即相似度0.90的同時(shí),特征黃酮苷與蘆丁的峰面積比((KRG+QRcG+KRcG)/Rutin)應(yīng)當(dāng)不低于1.60。為了解決銀杏葉黃酮苷對(duì)照品難獲得、成本高的問題,本論文在實(shí)驗(yàn)室前期研究的基礎(chǔ)上,建立了一測(cè)多評(píng)方法,針對(duì)銀杏葉中黃酮苷原型化合物,以蘆丁為內(nèi)參物,建立了蘆丁與其他5個(gè)黃酮苷的相對(duì)校正因子,實(shí)現(xiàn)了用"一測(cè)多評(píng)"法測(cè)定銀杏葉口服制劑中黃酮苷的含量。定向純化制備了銀杏黃酮苷對(duì)照提取物,優(yōu)化制備工藝,從銀杏葉提取物中分離制備出含有5個(gè)銀杏黃酮苷指標(biāo)性成分的對(duì)照提取物,并對(duì)黃酮苷含量進(jìn)行了標(biāo)定,通過量值轉(zhuǎn)化,可用于測(cè)定銀杏葉口服制劑中黃酮苷的含量。對(duì)中國食品藥品檢定研究院發(fā)放的銀杏葉對(duì)照提取物(供鑒別用)中6種黃酮苷含量進(jìn)行標(biāo)定,并通過量值轉(zhuǎn)移,用于測(cè)定銀杏葉口服制劑中黃酮苷的含量。這3種方法的測(cè)定結(jié)果與外標(biāo)法測(cè)定結(jié)果比較,統(tǒng)計(jì)分析結(jié)果顯示,方法間無明顯差異(P均0.05),說明均可用于銀杏葉多劑型口服制劑的定量分析。為了探究銀杏葉中黃酮苷類成分積累與季節(jié)變化的關(guān)系,2016年5月到10月底,對(duì)北京市3個(gè)不同地區(qū)、相同樹齡、不同性別的銀杏共162份銀杏葉樣品進(jìn)行生長(zhǎng)周期內(nèi)黃酮苷類成分含量的動(dòng)態(tài)監(jiān)測(cè),結(jié)果表明不同地區(qū)所測(cè)成分含量隨季節(jié)變化的趨勢(shì)基本一致,即三種黃酮苷蘆丁、山柰酚3-O-蕓香糖苷、異鼠李素3-O-蕓香糖苷含量都是在5月份變化不大,6、7月下降,8月開始回升,之后到10月雖有波動(dòng)但一直保持較高的水平;其他三種黃酮苷山柰酚3-O-鼠李糖-2-葡萄糖苷、槲皮素3-O-鼠李糖-2-O-(6-O-對(duì)羥基反式桂皮酰)-葡萄糖苷、山柰酚3-O-鼠李糖-2-O-(6-O-對(duì)羥基反式桂皮酰)-葡萄糖苷含量變化情況基本一致,在整個(gè)生長(zhǎng)周期內(nèi)各月雖有波動(dòng)變化,但整體變化不大,基本保持平穩(wěn)。雌、雄株中含量存在差異,雄株銀杏葉中6種黃酮苷含量高于雌株銀杏葉。三個(gè)地區(qū)雌、雄株銀杏葉中六種黃酮苷含量最大值出現(xiàn)的月份稍有不同,其中雌株分別出現(xiàn)在5月、8月、10月,雄株分別出現(xiàn)在5月和10月。上述研究和結(jié)果,為銀杏葉及其口服制劑的質(zhì)量控制提供了簡(jiǎn)便、耐用和可行的新方法,提高了銀杏葉及其口服制劑的質(zhì)量控制水平。
[Abstract]:Ginkgo biloba ginkgo Ginkgo biloba L. for gymnosperms, the dried leaf of Ginkgo biloba preparations or Ginkgo biloba extract as raw materials is an important product of modern plant medicine, occupy a larger market share, the quality problem of such products have been reported, the key to solve the problem is to improve the quality control level of the current standard. Flavonoids one of the main effective components of this paper focus in Ginkgo leaves, through the use of fingerprint QAMs and control extracts and other technical means to study more effective quality control method is simple and feasible. The group has not been fully elucidated, and the control of material is difficult to obtain, at home and abroad in the current standards, for Ginkgo biloba the quality control of Ginkgo biloba extract and a series of preparations of Ginkgo flavone glycosides are using this indirect method by acid hydrolysis, after conversion to calculate the content of total flavonoid glycosides, the Although the method can solve the control problem of lack of material, but the quality control is not accurate, and provides the possibility to artificially add flavonoid aglycones such as fraud. This paper based on the previous studies, the prototype of the flavonoids of Ginkgo biloba extract in the compound, study the establishment of Ginkgo Biloba Leaves Extract Tablets, capsule, tincture, pill drops, fingerprint atlas of soft capsule oral preparation, and the similarity evaluation and characteristics of flavonoid glycosides in peak area than the double quality control index of combination of qualitative analysis and Study on the sample, and ultimately determine the more durable and feasible criteria, namely 0.90 similarity and peak area characteristics of flavonol glycoside and rutin ratio ((KRG+QRcG+KRcG) /Rutin) it should be no less than 1.60. in order to solve the ginkgo flavone glycoside reference is difficult to obtain, the problem of high cost, this paper based on previous studies, the establishment of the QAMs method for Ginkgo biloba leaves The prototype of flavonoid glycosides compounds, with rutin as a reference substance, a relative correction factor of rutin and other 5 flavonoid glycosides, implementation of the "content of a QAMs method for the determination of flavonoid glycosides in Ginkgo biloba oral preparation. The preparation and purification of Ginkgo flavone glycosides extract directional control, optimizing the preparation process, preparation a control extract of Ginkgo flavone glycosides 5 index components isolated from the extract of Ginkgo biloba leaves, and the contents of flavonoids were calibrated, value transformation through, can be used for the determination of Ginkgo biloba in the oral preparations of Huang Tonggan. The Chinese Institute for food and drug control release Ginkgo biloba extract (for identification) in 6 kinds of flavone glycosides were calibrated, and through value transfer, for the determination of flavonoid glycosides in Ginkgo biloba oral preparation. The determination results of the 3 methods external standard method and the results were compared, the results of statistical analysis show that. No significant difference between the method (P 0.05), that can be used for quantitative analysis of Ginkgo biloba multi dosage oral preparation. In order to explore the relationship between flavonoid glycosides accumulation and seasonal variation in Ginkgo biloba leaves, May 2016 to the end of October, the same in Beijing city in 3 different areas, different age, sex and a total of 162 Ginkgo biloba leaf samples were dynamic monitoring during the growth cycle of flavonoid glycosides content, the results show that the different area measured by the composition of seasonal changes in the content of trend is basically the same, namely three kinds of flavonoids rutin, kaempferol rutinoside 3-O-, isorhamnetin 3-O- rutinoside content is little change in May, 6,7 month decline since August again, after October despite fluctuations but has maintained a high level; the other three flavonoid glycosides of kaempferol 3-O- rhamnose glucose -2- glycosides, quercetin 3-O- rhamnose -2-O- (6-O- hydroxy trans cinnamoyl) - glucosidase. Kaempferol, 3-O- rhamnosus -2-O- (6-O- hydroxy trans cinnamoyl) - glucoside content changes are basically the same, in the whole growth period of each month despite fluctuations, but the overall change is not big, remained stable. The female, there are differences in male plants, the content of 6 kinds of male ginkgo flavone glycosides in the leaves of Ginkgo biloba were higher than female. Three in female, the content of six kinds of flavonoid glycosides in Ginkgo biloba leaves male strain maximum month is slightly different, the female plants respectively in May, August, October, male plants respectively in May and October. The above research and results for the quality control of ginkgo leaf and the oral formulation provides a simple and feasible method, new durable, improve the level of quality control of Ginkgo biloba and its oral preparation.

【學(xué)位授予單位】：北京中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R286.0

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