山茶油及其复方软胶囊的质量研究

发布时间：2018-05-12 16:14

本文选题：山茶油 + 软胶囊　；参考：《福建中医药大学》2017年硕士论文

【摘要】：山茶油是从山茶科植物油茶(Camelliaoleifera Abel)籽中经压榨或浸出法制取,福建是我国山茶油主产地之一。现代药理研究表明,山茶油具有调节免疫功能、改善血液循环、抗疲劳、抗氧化、降血脂、降血糖、抗辐射、抗菌消炎、预防肥胖、抗肿瘤等功能,山茶油的营养保健功能产品开发日益受到重视。本研究拟对不同制备工艺、不同产地山茶油进行质量研究与比较,并对山茶油复方软胶囊进行质量标准研究与稳定性考察,以期为山茶油及相关医药产品的质量控制提供实验依据。一、山茶油质量研究本研究依据国标对不同制备工艺的山茶油进行折光指数、相对密度、皂化值、碘值、不皂化物含量、酸值等理化指标测定分析;建立了山茶油中主要功能性成分角鲨烯含量的HPLC测定方法,并比较了不同制备工艺山茶油中角鲨烯含量;采用GC法随行26种对照品,比较了不同制备工艺山茶油中脂肪酸成分的组成和含量;建立了不同产地来源山茶油HPLC指纹图谱。研究结果表明:1.不同制备工艺山茶油的酸值和过氧化值有显著差异,酸值和过氧化值从高依次为浸出山茶油冷榨山茶油热榨山茶油。2.采用HPLC法测定山茶油中角鲨烯含量,角鲨烯在1.0～200.0mg/L浓度范围内线性关系良好,精密度、重复性、稳定性RSD均小于2%,平均回收率为98.12%,不同制备工艺山茶油中角鲨烯含量波动范围为0.0139%～0.0045%,有极显著差异,热榨山茶油中角鲨烯含量最低,仅为浸出山茶油的约30%。3.GC测定结果显示浸出山茶油和冷榨山茶油主要脂肪酸成分均为油酸、棕榈酸、亚油酸、硬脂酸、花生一烯酸,从浸出山茶油中可检出γ-亚麻酸和亚麻酸,而冷榨山茶油中未检出。4.10批不同产地山茶油HPLC指纹图谱呈现9个共有特征峰,来自福建地区的5批山茶油指纹图谱特征基本一致,整体相似度高于90%,提示福建产山茶油成分较为接近。二、山茶油复方软胶囊质量研究山茶油复方软胶囊是课题组前期采用山茶油与灵芝孢子油按一定比例复配研制的抗疲劳功能性食品。本研究测定4批山茶油复方软胶囊的折光指数、相对密度、皂化值、碘值、不皂化物含量和酸值等理化性质;建立了山茶油复方软胶囊中主要功能性成分角鲨烯含量的HPLC测定方法,并测定4批山茶油复方软胶囊中角鲨烯含量;连续3个月考察山茶油复方软胶囊的制剂稳定性。研究结果表明:1.4批山茶油复方软胶囊的平均酸值、过氧化值、皂化值、碘值和不皂化物分别为2.11mg/g、5.31mol/kg、173mg/g、70g/100g和20g/kg。2.采用HPLC法测定山茶油复方软胶囊中角鲨烯含量,角鲨烯在1.0～200.0mg/L浓度范围内线性关系良好,精密度、重复性、稳定性RSD均小于2%,平均回收率为93.86%,4批山茶油复方软胶囊中角鲨烯含量为0.0067%～0.0071%。3.在此基础上初步拟定了山茶油复方软胶囊的质量标准草案。4.山茶油复方软胶囊室温条件下放置连续考察3个月,其外观性状、理化性质、角鲨烯含量等指标均无明显改变,软胶囊稳定性良好。三、山茶油复方软胶囊抗氧化功能初探山茶油复方软胶囊是作为抗疲劳功能性食品研发的,文献报道山茶油和灵芝孢子油还具有抗氧化等作用。为此木研究对山茶油复方软胶囊的DPPH自由基清除能力进行了初步试验,结果表明山茶油复方软胶囊具有较好的抗氧化功能,清除DPPH自由基的半抑制浓度IC50为33.2mg/ml,相当于0.03mg/ml VC的清除DPPH自由基能力;且随着浓度增加,山茶油复方软胶囊对DPPH自由基清除效果逐渐增加。初步试验结果为后续进一步拓展山茶油复方软胶囊抗氧化新功能提供依据。四、结论1.目前山茶油标准缺乏活性成分定量指标,同样符合标准的不同制备方法山茶油,其活性成分含量差异较大,山茶油质量标准应增加定量检测项目。2.本研究建立的山茶油中角鲨烯含量HPLC测定方法,快速、简便、准确,可为山茶油及相关医药产品的质量控制提供检测手段,也为提高完善山茶油质量标准提供依据。3.山茶油制备工艺对角鲨烯、γ-亚麻酸、亚麻酸等活性成分有显著影响,浸出山茶油含有的活性成分较压榨法山茶油更丰富,研发山茶油医药产品应首选浸出山茶油。4.福建产山茶油液相色谱指纹图谱基本一致,有较高相似度,其所含化学成分总体概貌接近,为福建山茶油资源开发利用及产业链的延伸提供科学依据。5.山茶油复方软胶囊质量稳定、可控,贮藏稳定性良好。6.初步试验表明山茶油复方软胶囊对DPPH自由基有较好的清除作用,为后续拓展山茶油复方软胶囊新功能提供实验依据。
[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.

【学位授予单位】：福建中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R284.1

【参考文献】