本文選題：山茶油 + 軟膠囊��； 參考：《福建中醫(yī)藥大學(xué)》2017年碩士論文

【摘要】：山茶油是從山茶科植物油茶(Camelliaoleifera Abel)籽中經(jīng)壓榨或浸出法制取,福建是我國山茶油主產(chǎn)地之一�，F(xiàn)代藥理研究表明,山茶油具有調(diào)節(jié)免疫功能、改善血液循環(huán)、抗疲勞、抗氧化、降血脂、降血糖、抗輻射、抗菌消炎、預(yù)防肥胖、抗腫瘤等功能,山茶油的營養(yǎng)保健功能產(chǎn)品開發(fā)日益受到重視。本研究擬對不同制備工藝、不同產(chǎn)地山茶油進行質(zhì)量研究與比較,并對山茶油復(fù)方軟膠囊進行質(zhì)量標(biāo)準(zhǔn)研究與穩(wěn)定性考察,以期為山茶油及相關(guān)醫(yī)藥產(chǎn)品的質(zhì)量控制提供實驗依據(jù)。一、山茶油質(zhì)量研究本研究依據(jù)國標(biāo)對不同制備工藝的山茶油進行折光指數(shù)、相對密度、皂化值、碘值、不皂化物含量、酸值等理化指標(biāo)測定分析;建立了山茶油中主要功能性成分角鯊烯含量的HPLC測定方法,并比較了不同制備工藝山茶油中角鯊烯含量;采用GC法隨行26種對照品,比較了不同制備工藝山茶油中脂肪酸成分的組成和含量;建立了不同產(chǎn)地來源山茶油HPLC指紋圖譜。研究結(jié)果表明:1.不同制備工藝山茶油的酸值和過氧化值有顯著差異,酸值和過氧化值從高依次為浸出山茶油冷榨山茶油熱榨山茶油。2.采用HPLC法測定山茶油中角鯊烯含量,角鯊烯在1.0～200.0mg/L濃度范圍內(nèi)線性關(guān)系良好,精密度、重復(fù)性、穩(wěn)定性RSD均小于2%,平均回收率為98.12%,不同制備工藝山茶油中角鯊烯含量波動范圍為0.0139%～0.0045%,有極顯著差異,熱榨山茶油中角鯊烯含量最低,僅為浸出山茶油的約30%。3.GC測定結(jié)果顯示浸出山茶油和冷榨山茶油主要脂肪酸成分均為油酸、棕櫚酸、亞油酸、硬脂酸、花生一烯酸,從浸出山茶油中可檢出γ-亞麻酸和亞麻酸,而冷榨山茶油中未檢出。4.10批不同產(chǎn)地山茶油HPLC指紋圖譜呈現(xiàn)9個共有特征峰,來自福建地區(qū)的5批山茶油指紋圖譜特征基本一致,整體相似度高于90%,提示福建產(chǎn)山茶油成分較為接近。二、山茶油復(fù)方軟膠囊質(zhì)量研究山茶油復(fù)方軟膠囊是課題組前期采用山茶油與靈芝孢子油按一定比例復(fù)配研制的抗疲勞功能性食品。本研究測定4批山茶油復(fù)方軟膠囊的折光指數(shù)、相對密度、皂化值、碘值、不皂化物含量和酸值等理化性質(zhì);建立了山茶油復(fù)方軟膠囊中主要功能性成分角鯊烯含量的HPLC測定方法,并測定4批山茶油復(fù)方軟膠囊中角鯊烯含量;連續(xù)3個月考察山茶油復(fù)方軟膠囊的制劑穩(wěn)定性。研究結(jié)果表明:1.4批山茶油復(fù)方軟膠囊的平均酸值、過氧化值、皂化值、碘值和不皂化物分別為2.11mg/g、5.31mol/kg、173mg/g、70g/100g和20g/kg。2.采用HPLC法測定山茶油復(fù)方軟膠囊中角鯊烯含量,角鯊烯在1.0～200.0mg/L濃度范圍內(nèi)線性關(guān)系良好,精密度、重復(fù)性、穩(wěn)定性RSD均小于2%,平均回收率為93.86%,4批山茶油復(fù)方軟膠囊中角鯊烯含量為0.0067%～0.0071%。3.在此基礎(chǔ)上初步擬定了山茶油復(fù)方軟膠囊的質(zhì)量標(biāo)準(zhǔn)草案。4.山茶油復(fù)方軟膠囊室溫條件下放置連續(xù)考察3個月,其外觀性狀、理化性質(zhì)、角鯊烯含量等指標(biāo)均無明顯改變,軟膠囊穩(wěn)定性良好。三、山茶油復(fù)方軟膠囊抗氧化功能初探山茶油復(fù)方軟膠囊是作為抗疲勞功能性食品研發(fā)的,文獻報道山茶油和靈芝孢子油還具有抗氧化等作用。為此木研究對山茶油復(fù)方軟膠囊的DPPH自由基清除能力進行了初步試驗,結(jié)果表明山茶油復(fù)方軟膠囊具有較好的抗氧化功能,清除DPPH自由基的半抑制濃度IC50為33.2mg/ml,相當(dāng)于0.03mg/ml VC的清除DPPH自由基能力;且隨著濃度增加,山茶油復(fù)方軟膠囊對DPPH自由基清除效果逐漸增加。初步試驗結(jié)果為后續(xù)進一步拓展山茶油復(fù)方軟膠囊抗氧化新功能提供依據(jù)。四、結(jié)論1.目前山茶油標(biāo)準(zhǔn)缺乏活性成分定量指標(biāo),同樣符合標(biāo)準(zhǔn)的不同制備方法山茶油,其活性成分含量差異較大,山茶油質(zhì)量標(biāo)準(zhǔn)應(yīng)增加定量檢測項目。2.本研究建立的山茶油中角鯊烯含量HPLC測定方法,快速、簡便、準(zhǔn)確,可為山茶油及相關(guān)醫(yī)藥產(chǎn)品的質(zhì)量控制提供檢測手段,也為提高完善山茶油質(zhì)量標(biāo)準(zhǔn)提供依據(jù)。3.山茶油制備工藝對角鯊烯、γ-亞麻酸、亞麻酸等活性成分有顯著影響,浸出山茶油含有的活性成分較壓榨法山茶油更豐富,研發(fā)山茶油醫(yī)藥產(chǎn)品應(yīng)首選浸出山茶油。4.福建產(chǎn)山茶油液相色譜指紋圖譜基本一致,有較高相似度,其所含化學(xué)成分總體概貌接近,為福建山茶油資源開發(fā)利用及產(chǎn)業(yè)鏈的延伸提供科學(xué)依據(jù)。5.山茶油復(fù)方軟膠囊質(zhì)量穩(wěn)定、可控,貯藏穩(wěn)定性良好。6.初步試驗表明山茶油復(fù)方軟膠囊對DPPH自由基有較好的清除作用,為后續(xù)拓展山茶油復(fù)方軟膠囊新功能提供實驗依據(jù)。
[Abstract]:Camellia oil is extracted from Camellia oleifera (Camelliaoleifera Abel) seed by press or leaching method. Fujian is one of the main origin of Chinese camellia oil. Modern pharmacological research shows that camellia oil has the function of regulating immune function, improving blood circulation, anti fatigue, antioxidation, blood fat, blood sugar, radiation resistance, anti-inflammatory and anti-inflammatory, prevention of obesity, anti-tumor and so on. The quality of camellia oil has been paid more and more attention to. This study intends to study and compare the quality of camellia oil from different producing processes and different habitats, and to study the quality standards and stability of the soft capsule of camellia oil compound in order to provide experimental basis for the quality control of camellia oil and related pharmaceutical products. First, the study on the quality of camellia oil in this study was based on the index of refractive index, relative density, saponification value, iodine value, non saponified substance content, acid value and other physical and chemical indexes of camellia oil, based on the national standard. A HPLC method for determining the content of the main functional squalene in camellia oil was established, and the different preparation techniques of camellia oil were compared. The content of medium squalene; the composition and content of fatty acids in camellia oil from different preparation processes were compared with 26 control products by GC. The HPLC fingerprint of camellia oil from different sources was established. The results showed that there were significant differences in acid value and peroxide value of camellia oil from 1. different preparation processes, and the acid value and peroxide value were in the order of higher order. .2. was used to determine the content of squalene in Camellia Oil by HPLC method for extracting camellia oil from camellia oil. The linear relationship of squalene in the range of 1 ~ 200.0mg/L was good, precision, reproducibility, and stability RSD were less than 2%, the average recovery rate was 98.12%. The range of squalene content fluctuated from 0.0139% to 0 in the different preparation of industrial mountain tea oil. .0045%, there are very significant differences. The content of squalene in hot camellia oil is the lowest. Only 30%.3.GC determination of the extraction of camellia oil shows that the main fatty acids in the leached camellia oil and cold squeezed camellia oil are oleic acid, palmitic acid, linoleic acid, stearic acid, arachidic acid and cold pressed linolenic acid and linolenic acid from the soaked camellia oil, and cold pressed mountain. The HPLC fingerprint of camellia oil in the tea oil was not detected in.4.10 batch. The fingerprint of the 5 batches of camellia oil from Fujian was basically the same, the whole similarity was higher than 90%, suggesting that the composition of the tea oil in Fujian was close. Two, the quality of the camellia oil compound capsule was the subject group. This study determined the refractive index, relative density, saponification value, iodine value, non saponified substance content and acid value of the 4 batches of camellia oil compound soft capsules, and established the main functional squalene content in the camellia oil compound soft capsule. The content of squalene in 4 batches of camellia oil compound soft capsules was measured by HPLC method and the stability of the preparation of the soft capsule of camellia oil compound was investigated for 3 months. The results showed that the average acid value, the peroxide value, the saponification value, the iodine value and the non soap of the 1.4 batches of Camellia oleum soft capsules were 2.11mg/g, 5.31mol/kg, 173mg/g, 70g/100g and 20g/, respectively. Kg.2. was used to determine the content of squalene in camellia oil compound soft capsules by HPLC method. The linear relationship of squalene in the range of 1 ~ 200.0mg/L was good, precision, repeatability, stability RSD were less than 2%, the average recovery rate was 93.86%. The content of squalene in 4 batches of camellia oil compound soft capsules was 0.0067% to 0.0071%.3. and the mountain was preliminarily drawn up on the basis of this The quality standard draft of tea oil compound soft capsule.4. the soft capsule of camellia oil compound was placed under room temperature for 3 months. The appearance, physicochemical properties, squalene content and other indexes were not obviously changed, and the stability of the soft capsules was good. Three, the antioxidant function of the camellia oil compound soft capsule was used as the antifatigue of the camellia oil compound soft capsule. It was reported that camellia oil and ganoderma spore oil were also antioxidation. The DPPH free radical scavenging ability of camellia oil compound soft capsules was preliminarily tested. The results showed that the soft capsule of camellia oil compound had good antioxidant function and the semi inhibitory concentration of DPPH free radical was 33.2. 33.2 Mg/ml, equivalent to the ability of 0.03mg/ml VC to scavenge DPPH free radicals, and with the increase of concentration, the effect of camellia oil compound soft capsule on DPPH radical scavenging gradually increased. The preliminary test results provided a basis for further expanding the antioxidant function of camellia oil compound soft capsule. Four, conclusion 1. the lack of active ingredients in camellia oil standard at present The content of camellia oil is very different. The quality standard of camellia oil quality should increase the method of determining the content of squalene in Camellia Oil by quantitative detection project.2., which is fast, simple and accurate. It can provide testing means for quality control of camellia oil and related pharmaceutical products. In order to improve the quality standard of camellia oil,.3. camellia oil preparation technology has a significant influence on the active ingredients such as squalene, gamma linolenic acid, linolenic acid and other active ingredients. The active ingredients in the leached camellia oil are more abundant than the pressed camellia oil. The first choice for the research and development of camellia oil pharmaceutical products should be the leached camellia oil.4. Fujian tea oil liquid chromatographic fingerprint The spectrum is basically the same, with high similarity, and the general general outline of chemical composition is close. It provides scientific basis for the development and utilization of Fujian camellia oil resources and the extension of industrial chain. The quality of.5. camellia oil compound soft capsule is stable and controllable and the stability of storage is good.6. preliminary test shows that the soft capsule of camellia oil compound can clear the free radical of DPPH better. This study will provide experimental basis for further developing the new function of camellia oil compound soft capsule.

【學(xué)位授予單位】：福建中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R284.1

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