内蒙古鄂托克前旗苦豆子总碱及苦参碱制剂稳定性研究
发布时间:2018-03-29 08:01
本文选题:苦豆子总碱和苦参碱制剂 切入点:UV法 出处:《内蒙古农业大学》2015年硕士论文
【摘要】:苦豆子总碱和苦参碱制剂具有清热解毒,消肿止痛和杀虫等广泛药理活性和药用价值,临床应用于抗病毒、抗肿瘤、抗寄生虫试验的研究,调结体内免疫系统、心血管系统、中枢神经系统。本试验中苦豆子总碱和苦参碱来自鄂托克前旗,采摘的苦豆子经内蒙古农业科学院兽医研究所研制苦豆子总碱和苦参碱制剂。通过UV法和HPLC法对苦豆子总碱和苦参碱制剂进行影响因素试验进行稳定性试验,恒温加速试验测定药物保质期。为苦豆子的开发应用及保存有重要意义。本研究得出的结论如下:(1)成功用UV法和HPLC法构建了苦豆子总碱和苦参碱制剂的测定方法,两种方法测定的结果差异显著,得到较为理想的结果,然后并用两种方法对两种药物的初始浓度进行稳定性试验、精密度测定、重复性测定、加样回收试验,比较两种方法的RSD值。HPLC法测定的RSD值都在0.1-0.2之间,而UV法测定的RSD值在0.8-5.04之间,说明HPLC法测定结果要精确,HPLC法比UV法测定方法重现性好,灵敏度好,精密度高。(2)文章第二部分以起始浓度为基准。在不同光照和温度下,用UV法和HPLC法对苦豆子总碱和苦参碱浓度进行测定,并观察颜色变化,测定两种药物的PH值。应用SAS9.0的GLM过程进行方差分析,不同温度下,4℃时浓度降低最慢,45℃浓度降低的最快。在不同光照下,冷荧光灯中30001x浓度最慢,紫外光下浓度降低的最快。两种方法测定的药物浓度均有差异。(3)本研究成功用两种方法测定苦豆子总碱和苦参碱恒温加速实验,HPLC法测定苦豆子总碱保质期为1年,UV法测定苦豆子总碱保质期为1.9.HPLC方法测得苦参碱保质期为2.7年。UV.法测定苦参碱保质期为2.1年。
[Abstract]:The preparation of total alkaloids and matrine has a wide range of pharmacological activities and medicinal value, such as clearing heat and detoxification, reducing swelling and relieving pain and killing insects. It has been used in the study of antiviral, anti-tumor and anti-parasitic tests, in regulating the immune system in vivo and in cardiovascular system. Central nervous system. In this experiment, total alkaloids and matrine came from the former flag of Otok. The total alkaloids and matrine preparations were prepared by the Veterinary Research Institute of Inner Mongolia Academy of Agricultural Sciences. The stability tests of total alkaloids and matrine preparations were carried out by UV and HPLC methods. It is of great significance for the development, application and preservation of Sophora alopecuroides to determine the shelf life of the drug. The conclusions of this study are as follows: 1) the method for the determination of total alkaloids and matrine preparations has been successfully constructed by UV and HPLC methods. The difference between the two methods was significant and the results were satisfactory. Then the initial concentration of the two drugs was tested for stability, precision measurement, reproducibility test, sample recovery test, and then two methods were used to test the initial concentration of the two drugs. The RSD value of the two methods was 0.1-0.2, and the RSD value of UV method was 0.8-5.04, which indicated that the results of HPLC method were more reproducible and sensitive than that of UV method. The second part of the paper is based on the initial concentration. Under different light and temperature, the total alkaloids and matrine concentrations were determined by UV and HPLC methods, and the color changes were observed. The pH value of the two drugs was measured. The analysis of variance using the GLM process of SAS9.0 showed that the slowest decrease of concentration at 4 鈩,
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