壮药旱田草质量标准研究

发布时间：2018-06-08 04:52

本文选题：旱田草 + 质量标准　；参考：《广西中医药大学》2016年硕士论文

【摘要】：目的:依据壮药旱田草来源、性状、显微、常规检查、浸出物、含量测定和指纹图谱等系统的研究,初步建立旱田草质量标准。方法:通过基原鉴定、性状鉴定、显微鉴定与理化鉴定方法系统地对旱田草进行生药学定性研究;按《中华人民共和国药典》2015年版四部中规定的方法对旱田草药材进行限量检查,包括水分、总灰分、酸不溶性灰分、浸出物等;按照中药化学预实验方法对旱田草进行成分预试;以毛蕊花糖苷为对照品,采用高效液相色谱法对广西采集的各批次旱田草药材进行含量测定,确定了其中所含毛蕊花糖苷的限量;并标定毛蕊花糖苷为参照峰,运用《中药色谱指纹图谱相似度评价系统2012版》软件对旱田草进行初步指纹图谱研究。结果:1.原植物鉴定、性状鉴定、显微鉴定与薄层色谱鉴定均具显著性特征,可作为鉴别旱田草药材真伪的依据。2.旱田草药材水分含量范围为8.24%~11.76%,均在12.0%以下,故初步拟定其水分不多于13.0%;总灰分含量范围为11.62%~17.36%,大多数在16.0%以下,初步拟定总灰分不超过18.0%;酸不溶性灰分含量范围为1.55%~8.28%,大部分在7.0%以下,初步拟定酸不溶性灰分不得过9.0%;浸出物含量在17.27%~27.02%之间,均在17.0%以上,初步拟定醇溶性浸出物含量不得少于15.0%。3.预实验表明旱田草中含有酚类化合物、三萜化合物、甾体、内酯、多糖、氨基酸及挥发油等成分。4.旱田草最佳提取工艺确定为:取样量0.4 g,加入70%甲醇20 ml,超声处理2次,每次超声30分钟;毛蕊花糖苷进样量在0.0192~3.84μg之间与峰面积呈良好线性关系(r=0.99999);平均加样回收率为103.59%,RSD为2.88%;各批次旱田草药材中毛蕊花糖苷所测含量在0.23%~0.94%之间,以其中大多数在0.20%以上为依据,初步拟定其所含毛蕊花糖苷(C16H18O9)不得少于0.20%(2.00mg·g-1)。5.初步建立了旱田草HPLC指纹图谱提取方法及色谱条件,筛选出15个共有特征峰,其中以毛蕊花糖苷为参照峰,方法学考察达标,所采集的不同批次旱田草药材色谱图匹配度均大于0.96。结论:以上评价方法可为壮药旱田草药材质量标准的建立提供依据,可为其临床应用的安全、有效和质量控制奠定基础。
[Abstract]:Objective: to establish the quality standard of Rhizoma Artemisia on the basis of its origin, characters, microscopes, routine examination, extract, content determination and fingerprint. Methods: the pharmacognosy qualitative studies were carried out systematically by the methods of primordial identification, character identification, microscopical identification and physicochemical identification. According to the methods stipulated in the four parts of the 2015 edition of the Pharmacopoeia of the people's Republic of China, a limited amount of inspection was carried out on the medicinal materials of Artemisia sinensis, including moisture, total ash, acid insoluble ash, extracts, etc. In accordance with the method of chemical pre-experiment of traditional Chinese medicine, the composition of Rhizoma Rutheroside was pre-tested, and the content of each batch of Rhizoma Artemisia collected in Guangxi was determined by HPLC with Rulein as the reference substance. In this paper, the limit of the glucoside contained in Rulein was determined, and the reference peak was calibrated, and the preliminary fingerprint was studied by the software of similarity Evaluation system of chromatographic fingerprint of traditional Chinese Medicine (TCM) version 2012. The result is 1: 1. The original plant identification, character identification, microscopical identification and TLC identification all have significant characteristics, which can be used as the basis for the identification of the true and false medicinal materials. 2. The range of water content of Rhizoma Artemisia is 8.24% and 11.76%, all of which are below 12.0%, so it is preliminarily determined that the water content is not more than 13.0; the total ash content ranges from 11.62% to 17.36%, most of which are below 16.0%. The content of acid insoluble ash was 1.55% or 8.28%, most of which was less than 7.0%, and the content of acid insoluble ash should not exceed 9.0%, and the content of extract was between 17.27% and 27.02%, all of which were above 17.0%, and the total ash content was not more than 18.0%, and the total ash content was less than 18.0%, and the total ash content was 1.55% or 8.28%, most of which was below 7.0%. The content of alcohol-soluble extracts shall not be less than 15.0%. The results showed that there were phenolic compounds, triterpenoids, steroids, lactones, polysaccharides, amino acids and volatile oils. The optimum extraction technology was determined as follows: sampling quantity 0.4 g, adding 70% methanol 20 ml, ultrasonic treatment 2 times, each time ultrasonic 30 minutes; There was a good linear relationship between the sample quantity and peak area between 0.01922 渭 g and 3.84 渭 g, the average recovery rate was 103.59%, RSD was 2.88, and the content of mullein in each batch was between 0.23% and 0.94%, based on the fact that most of them were above 0.20%. It was preliminarily formulated that the content of C16H18O9 was not less than that of 0.20%(2.00mg g-1O. 5. the content of C16H18O9 was not less than that of C16H18O9. The HPLC fingerprint extraction method and chromatographic conditions were established, and 15 common characteristic peaks were screened out, in which Rulein was used as the reference peak, and the methodological investigation was up to standard. The matching degree of the chromatogram of different batches of Herba Artemisia was more than 0.96. Conclusion: the above evaluation methods can provide the basis for the establishment of the quality standard of Herba Artemisia, and lay the foundation for its clinical application safety, effectiveness and quality control.
【学位授予单位】：广西中医药大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R29

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