蝉蛇膏的制备及其质量研究

【作者】 袁建；

【导师】 胡荣；

【作者基本信息】 扬州大学 ， 中药学， 2013， 硕士

【摘要】 湿疹是在皮肤发生的一种迟发型变态反应,本病常发生于具有过敏体质的个体,其发病机制是由多种因素相互作用所致。通过对古今湿疹外治处方进行分析,统计每味药物使用频率,找出用药频次较高者进行分析,发现其用药倾向性,以找到核心药物,从而有利于发现其用药规律。经过筛选,决定选取蛇床子,蝉蜕,苦参,白鲜皮,金银花这五种药物作为处方药物,提取挥发油,制备成软膏并对其进行质量考察,在体透皮实验。主要内容如下：目的：制备蝉蛇膏并对其质量进行考察；测定蝉蛇膏在皮肤内的滞留时间和透皮速率常数。方法：蒸馏水加热回流法提取药物中的挥发油；通过均质机乳化制备乳膏；薄层色谱法对蛇床子素进行定性鉴别；反相高效液相法测定蛇床子素的含量：(色谱柱：SinoChrom ODS-AP5μm,柱长：250mm,柱径：4.6pm,检测波长：322nm,流动相：甲醇-水(80：20),压力：10MPa,流速1ml/min);通过离心、高温、低温试验考察乳膏的稳定性；以荧光分析法作为定量手段,通过荧光倒置显微镜的观察以及荧光分光光度计的测定(扫描方式：EM扫描,EX波长：365nm,EM波长：410nnm,速度：高速,灵敏度：2,EX缝宽：10nnm,EM缝宽：10nm),来确定蝉蛇膏在皮肤内的滞留时间和透皮速率常数。结果：处方为：蛇床子240g,蝉蜕40g,苦参40g,白鲜皮40g,金银花40g。所制得的乳膏外观性质良好,颜色为乳白色,细腻光滑,易涂展。经薄层色谱鉴别,供试品色谱与对照品色谱在相应的位置上,显示相同颜色的荧光斑点,证实含蛇床子素。经反相高效液相测定,乳膏中蛇床子素的含量大于0.4%。经稳定性试验,乳膏离心后无分层、破乳等现象,耐寒耐热试验亦表明其性质稳定。自制中药复方湿疹乳膏各方面性质稳定,可作为新的湿疹治疗制剂开发使用,本实验可以作为今后该制剂生产应用的依据。蝉蛇膏的透皮速率常数较小,这可能与蝉蛇膏中蛇床子素的含量较低有关。8小时左右,真皮层药物量达到最高,并能维持4-5个小时。其未被吸收的药物量加上累计透过量,角质层剩余量,去角质层剩余量等于给药量,说明药物利用度高,没有因为挥发等原因造成药物损失。制剂的滞后时间比较大,可能是因为皮肤的角质层是药物透皮吸收的主要屏障,而皮肤表层的角质层中脂溶性物质比较容易穿过,有效物质只有穿过角质层后才能进入真皮层发挥药效。因此,为使蝉蛇膏中有效组分更快速地渗透皮肤进入真皮层发挥药效,需要进一步地考察促渗剂对透皮吸收的影响,既能提高药物的速率常数,又能降低滞后时间,更好地发挥药效。更多还原

【Abstract】 Objective:Cicada snake cream preparation and quality study; determination of residence time within the cicada snake cream on the skin and skin penetration rate constant.Methods:Water extraction of volatile oil in drug; By homogeneous emulsion preparation cream; Thin-layer chromatography of osthol on qualitative identification; Reversed-phase high performance liquid chromatography determination of osthole content(Chromatographic column:SinoChrom ODS-AP5μm, long column:250mm, column diameter:4.6μm, detection wavelength:322nm, mobile phase:methanol-water (80:20), pressure lOMPa, velocity lml/min); centrifugal, high temperature, low temperature experimental investigation on emulsion stability.Fluorimetric method as a quantitative tool, through inverted fluorescence micros cope observation and determination of fluorescenc spectrophoto(Scanning mode:EM scan EX wavelength:365nm,EM wavelength:410nm, speed:high speed, sensitivity:2,EX crack width:10nm,EM crack width:10nm), to determine the residence time of cicadas snake cream on the skin and penetration rate constants.Results:Cream produced by nature good appearance, the color is creamy white, fine and smooth, easy painting exhibition. By thin-layer chromatography, test control pink pinkco spectrum and spectrum in the appropriate position, displaying the same colors of fluorescent spots, had been found to contain osthole. By reversed-phase high perfor-mance liquid chromatography determination of osthol content in cream is greater than0.4%. Stability testing, cream no layering, centrifugal rupture phenomena such as milk, cold heat resistance test also demonstrated its stability. All aspects of traditional Chinese medicine compound eczema cream stable nature, could serve as a new develo-pment of eczema treatment preparations, this experiment can be used as a basis for the future application of the preparation. Cicada skin of snake cream rate constant is smaller, according to Ficks the first law, the steady flow of drugs is proportional to the concentration of drug in the skin, this may be related to cicadas of osthol content in lower Snake cream. Greater lag time of preparation, may be because the stratum corneum of the skin is the main barrier of the transdermal absorption of drugs and in the stratum corneum of the skin surface lipid soluble substances are easier to cross, activity of active substance can be entered only after through the stratum corneum skin then is absorbed.更多还原