苦豆子灌注剂制备工艺及质量标准研究

发布时间：2018-03-23 00:30

本文选题：苦豆子总碱　切入点：苦豆子灌注剂　出处：《甘肃农业大学》2015年硕士论文　论文类型：学位论文

【摘要】：本文以苦豆子总碱为研究对象,将其制成水溶性灌注剂,并建立该制剂的质量标准。选用单因素试验及正交试验并结合酸性染料比色法测定苦豆子总碱含量确立酸水提取法的最佳工艺路线。以苦豆子总碱对小鼠的急性试验、苦豆子总碱对奶牛子宫内膜炎5种致病菌的抑菌试验为制剂含药量提供依据;分别采用高效液相色谱法(HPLC)和薄层色谱法(TLC)对苦豆子总碱灌注剂进行定量测定、定性鉴别,建立该制剂的质量标准。通过L9(34)正交试验设计,最终确立最佳提取工艺条件为:中药粉与酸水的体积比为1:20,浸泡时间为24h,0.6%的酸水,提取2次;通过酸性染料比色法测得总生物碱含量为7.08%。通过苦豆子总碱对小鼠的急性毒性试验和苦豆子总碱对5种致病菌的抑菌效果,最终确定苦豆子总碱灌注剂有效药量为120 mg/mL。通过TCL定性鉴别了处方中的槐定碱并用HPLC测定了处方中槐定碱的含量。苦豆子总碱的水溶液理化性质稳定并具有良好的扩散能力,注入子宫后,既避免了局部药物浓度过高引起的粘膜刺激,又起到清洗子宫内膜的效果。苦豆子总碱灌注剂制备工艺简单、释药平缓、性质稳定,且水制剂使用方便。苦豆子总碱是天然产物,不会产生耐药性和药物残留,并且它具有良好的抑菌和抗炎效果;在抗生素滥用严重的社会现状下,为苦豆子总碱灌注剂的研发提供了广阔的研究潜力和应用前景。
[Abstract]:In this paper, the total alkaloids of Sophora alopecuroides were used as water soluble perfusers. To establish the quality standard of this preparation, single factor test and orthogonal test, combined with acid dye colorimetry to determine the content of total alkaloids of Sophora charantia L. the best technological route of acid water extraction method was established. The acute experiment of total alkaloids of Sophora alopecuroides on mice was carried out. The bacteriostatic test of total alkaloids of Sophora alopecuroides against 5 kinds of pathogenic bacteria in dairy cow endometritis provided the basis for the drug content of the preparation, the HPLC and TLC were used to determine the total alkaloid perfusion agent of Sophora alopecuroides quantitatively and qualitatively, respectively, and identified qualitatively. The quality standard of the preparation was established. The optimum extraction conditions were determined by orthogonal design: the volume ratio of traditional Chinese medicine powder to acid water was 1: 20, the soaking time was 24 hours, 0.6% acid water, 2 times extraction; The content of total alkaloids was 7.08 by acid dye colorimetry. The acute toxicity of total alkaloids of Sophora flavescens to mice and the bacteriostatic effect of total alkaloids of Sophora flavescens to 5 kinds of pathogenic bacteria were tested. Finally, the effective dosage of total alkaloid perfusion was determined to be 120mg / mL. Sophorine was identified qualitatively by TCL and the content of Sophorine was determined by HPLC. The physicochemical properties of the aqueous solution of total alkaloid were stable and had good diffusion ability. After injected into uterus, the mucosal irritation caused by local drug concentration was avoided and the endometrium was cleaned. The preparation process of total alkaloid perfusion agent of Sophora alopecuroides was simple, the drug release was smooth, and the nature was stable. Water preparation is convenient to use. Total alkaloids of Sophora alopecuroides are natural products, do not produce drug resistance and drug residues, and it has good bacteriostasis and anti-inflammatory effect. It provides broad research potential and application prospect for the research and development of total alkaloid perfusion agent of Sophora alopecuroides.
【学位授予单位】：甘肃农业大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：S853.73

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