复方三七注射液质量标准及药效学研究

【作者】 李海燕；

【导师】 王玥琦；

【作者基本信息】 北京中医药大学 ， 中药学， 2003， 硕士

【摘要】 心脑血管疾病已经成为人类主要杀手之一，为适应临床需要，在中医药理论指导下，我们拟开发复方三七注射液，该方以三七为主药，佐以葛根，功能主治为活血散瘀、解毒通络。用于营卫失和，毒损脑络所致脑血栓及后遗症，如神昏闭厥、半身不遂等。制成静脉注射液，药效迅速，作用可靠，更适用于抢救危重病症。 我们检索查阅了近十年来有关三七及其制剂研究文献，就其化学成分、质量分析方法、药理作用及临床应用等研究进展进行了较为全面的综述。 本课题试验研究分两部分。一、复方三七注射液质量标准及指纹图谱检测标准的建立。二、复方三七注射液主要药效学研究。 在第一部分实验中，参照国家药品监督管理局国家标准（试行）WS3-B-3590-2001（Z）三七总皂苷项下有关规定，首先建立了原料药三七总皂苷的质量检验标准，控制其主要有效成分三七皂苷R₁、人参皂苷Rg₁、人参皂苷Rb₁含量。随后，在此基础上，拟订复方三七注射液的质量标准，鉴别项采用TLC方法，三七参照中国药典2000年版一部10页三七项下有关规定；葛根参照第273页葛根项下有关规定，均取得良好效果。制剂的含量测定项，制定三种皂苷含量最低线，保证了制剂的有效性。制剂中三七指纹图谱检测标准的建立，采用HPLC方法，分别建立了复方三七注射液、原料药三七总皂苷及实验用三七药材的检测标准，并进行了方法学考察，结果稳定、可行。 在第二部分试验中，针对该制剂具有凉血解毒、化瘀通络之功效，通过阻抑脑中风的缺血级联反应，改善脑微灌流，达到抗神经元损害的治疗目的。具体采用三氯化铁致大鼠大脑中动脉血栓形成的脑缺血损伤模型，研究了复方三七注射液对此模型的大鼠神经症状、脑含水量、血瘀大鼠血液流变学的影响，结果显示能降低大鼠手术侧脑含水量、明显改善神经症状和明显降低血瘀症大鼠全血粘度和血浆粘度，使红细胞变形性增强，聚集性下降。为进一步证明其药理作用，在所做药效学项目中均与阳性药血栓通注射液比较，结果显示在疗效不减的情况下，用药剂量有所降低，从而达到了减毒增效目的。更多还原

【Abstract】 Heart cerebrovascular disease is one of chief enemies of beings. To fit clinic,we plan to develop "Fufang sanqi injection" according to traditional Chinese medicine theory. The prescription is made up of radix notogiseng and kudzuvine root. Us effect is promoting blood circulation and detoxicating. It is used in brain theombiis and sequelae by YingWeiQi disorder or torin injuring center colluterals,with arthragia and unconciousness. The vein injection effects quikly to whole body and is the best to enmmergency.We search a qutity of documents about radix notogiseng and its preparption of lately ten years and summarize its reseaeching evolution about chemical ingredient qualitative analysis methods* pharmacology and clinical usage.The problem has two parts, including drawing up of the quality standard and examination standard of fingerprint and major oharmacodynamics of "Fufangsanqi injecting".The first of the test,we draft the quality standard of radix total saponin, and control their contents with radix notogiseng saponin RI, ginseng saponin Rgb ginseng saponin Rbi according to standard of nation WS3-B-3590-2001 (Z) .Subsequently we draw up the quality standard of "Fufangsanqi injection". The item of distinguishing has a good effect with TLC method according to pharmacopoeia of People’s Republic of China (1st section of 2000 version,10). In the determining content,we plan to limitate three saponins’ content to ensure its effectiveness .The sencond of the test,we peotect neuron through repress cerebral paralysis ischemia cascade reaction and improve brain subtle flow aiming cool blood and detoxicat and invigoratchannels whth a cerebeal chemia pattern of big mouses middle cerebral artery thrombosed by FeCl3. And we demonstrare that "Fufangsanqi injection" improve obviously these symptom in psychoneurosis, brain containing liquid and hemorrheology. To prove gharmacodynamics effect, we compare with positive drug "Xueshuantong injection". "Fufangsanqi injection" is used with smaller dose while the same effect than "Xueshuantong injection". We achieve to purpose of attenuation and increasing curative effect ,更多还原