【作者】 苏玉春；

【导师】 王全凯； 高继山；

【作者基本信息】 吉林农业大学 ， 中药学， 2002， 硕士

【摘要】 本文对小檗科Berberidaceeae淫羊藿属Epimedium L.植物进行了植物资源、质量评价、化学、药理等方面的调查研究。结果表明：淫羊藿资源分布广泛，产量高，化学成分以黄酮类为主要有效成分，国内外学者己对该属13种植物进行了化学研究，分得各类成分100多种，其药理作用也是多方面的，药理实验与临床研究表明，淫羊藿能增加冠脉血流量、但进体液免疫和细胞免疫、促进DNA合成率、影响核酸代谢、抗衰老、对组织胺及乙酰胆碱所致咳喘，有镇咳平喘作用。本文利用淫羊藿的丰富资源，开发其又一新的制剂，并对其制剂进行了质量标准的研究。 本文首次对淫羊藿的平喘作用开发研制出新的注射液，通过对制剂提取工艺的研究，制定出最佳提取方案，运用传统制药工艺和现代化手段，采用了水提醇沉法，过聚酰胺柱，水洗除去杂质，收集其醇洗脱部分。既符合中医的指导原则，同时也减少了工序，提出了有效成分。 本文首次对淫羊藿注射液的药效、一般药理学进行了全面深入的研究，通过对该注射液的药效学研究表明，喘康注射液对氨水引咳法引起的小鼠咳嗽，有明显的镇咳作用，对喘息动物有平喘作用；对气管平滑肌有明显的松驰作用。该注射液还具有抗过敏作用；对慢性气管炎模型动物有明显的增强机制的体液免疫与细胞免疫的功能；在抗炎及抑菌试验中，该药表现出一定的抗炎与抑菌作用。该药能增强抗体的应激能力。毒理学研究表明，给小鼠皮下注射喘康注射液的LD₅₀很难求出，毒性相当低。 本文首次对淫羊藿注射液的质量标准进行了研究，为中药注射液的开发研制提供了科学依据。喘康注射液为治疗慢性支气管炎及哮喘的中药注射剂，处方由淫羊藿等组成，淫羊藿活性成分明确，所以本品的质量标准研究，主要是围绕着淫羊藿黄酮类成分及部分糖进行。文中对淫羊藿总黄酮的含量测定和淫羊藿苷成分及总糖的测定分别采用了紫外分光光度法和高效液相色谱法及分光光度法。含量测定为本品总黄酮为8.373mg／ml；淫羊藿苷为0.48mg／ml；总糖为0.3mg／ml。为制剂的质量控制提供了依据。 另一方面，根据新药审评中中药注射剂研制指导原则，使该注射剂达到安全、有效、可控、稳定，对此注射剂的质量提供了保证，也为注射剂的指纹图谱打下基础。更多还原

【Abstract】 This paper studied the plant resource, quality evaluation, chemistry, pharmacology andect. al of Berberidaceae Epimedium L. The result indicate that it is a large distribution ofEpimedium, large amout of yield, and flavonolignan is the mainly effective chemical substance. The researcher of home and abroad had studied 13 varieties of this genus, got over 100 kinds of components, and had versatile pharmacologic effect. Pharmacologic experiment and clinical study indicate that Epimedium may increase blood stream of coronary vein, increase humoral immunity and cellular immunity, increase DNA synthesis rate, effect nucleic acid metabolism, antisenescence, may cure mouse’ cough and gasping that caused by augmented and acetylcholine. The paper use the abundant resource of Epimedium, developed a new preparation, and studied the quality standard.The paper is the first one that invented a injection according to the calm-gasping effect of Epimedium, studied the extract process of preparation, developed an optimal process of extraction with traditional medicated process and modern technique, the method is water extraction and ethanol precipitation, water washing-out supernumerary substance in polyamide column, collect ethanol elution. It is obey the rule of Chinese Medical, extract the effective component and simplify the process at the same timeThe paper studied the effect and general pharmacology of Epimedium injection comprehensively and deeply. The effect research indicate the Chuankang injection had distinct effect on calm cough of mouse that caused by ammonium hydroxide; may calm down the gasping; also it can release the air tube smooth muscle distinctly. The injection had antianaphylaxis activity. Increase humoral immunity and cellar immunity action of chronic trachitis model animal distinctly, it also has some tense of anti-inflammatory action and bacteriostasis action. It can increase stress ability of sensitizer.Toxicology experiment result indicate that LDso of hypodemic injection mouse is difficult to detect, has fairly low of toxicity. Long-time toxicology experiment showed that the injection have no distinct effect on animals physiogmonic activity, blood, urine, blood serum, heart beating rate, blood pressure and kidney function, no distinct toxic and side effectThe paper studied the quality standard of Epimedium injection firstly, present the scientific method for develop Chinese Medicine injection. Quankang injection is a kind of Chinese Medical injection for cure chronic bronchitis and asthema, it composed of Epimedium et al. herbs. The active substance of Epimediumis distinctly, so the study of this quality standard mainly to test the flavonoid and some glucose of Epimedium. This paper use ultraviolet spectroscopy, HPLC and spectrophotometric method to determine the content of total flavonoid, glucose and icariin. Content determination of this injection is that total flavonoid 1.28mg/ml, icariin o.48mg/ml, total glucose 0.3mg/ml. Present the evidence to quality control of the preparation.On the other hand , according to the guide rules of Chinese medical injection in new medicine evaluation, to make sure this injection is safety, effective and stability, assurance the quality of the injection, and found the base of injection’s fingerprint.更多还原