用户名: 密码: 验证码:
肾衰葆片的药学及药效学研究
详细信息    本馆镜像全文|  推荐本文 |  |   获取CNKI官网全文
摘要
慢性肾功能衰竭是指肾脏功能逐渐丧失,不能将体内代谢废物及毒物排出体外,从而引起全身各脏器出现程度不同的病变。它具有极大的危害——危及全身各大系统,发病率、死亡率高,该病诊断困难,治疗费用高,周期长。
     虽然迄今尚无药物能逆转其病变,但合理的治疗和良好的医疗保健可阻止其恶化,推迟其进入肾脏替代疗法的时间。
     慢性肾功能衰竭从中医的角度来讲,属于中医肾劳范畴。脾肾衰败为本,浊邪壅塞三焦为标,这一正虚邪实的病机特点已成共识。目前许多治疗方法只能起到一定程度上的缓解作用,且费用较高,如肾移植等。而中医药在延缓肾衰的发生方面具有很好的疗效,并且有许多相关的报道,本课题正是基于上述考虑而展开的。
     本课题的主要研究内容包括:
     1、制剂工艺研究:淫羊藿、大黄采用醇提,以淫羊藿苷的提取率和收膏率作为综合评价指标,结果为淫羊藿、大黄加6倍量70%的乙醇,提取3次,每次1.5小时,能将淫羊藿中的主要有效成分淫羊藿苷提取较完全,且收膏率较接近。黄芪、茯苓、××水煎煮,以正丁醇浸出物量和干膏量为综合评价指标,结果为黄芪等三味药材加8倍量水煎煮2次,每次1.5小时,提取效果较好;水煎部分除杂时,将水煎液浓缩至相对密度约为1.02(80~85℃热测,此时煎煮液体积是生药:水=1:3),在80℃时加入Ⅱ型ZTC1+1天然澄清剂B8%,搅匀,保温5分钟,冷却至60℃时加入澄清剂组分A4%,搅匀,保温5分钟,静置24小时,滤过,澄清效果较好。制剂成型时,采用部分茯苓打粉做喷雾制粒的底料,结果能够减少片重,成型较好。
     2、质量标准研究:经各项检查,符合片剂的各项检查要求;确定了黄芪、大黄的薄层色谱鉴别方法;同时确定了淫羊藿苷为本品含量测定的特征性成分,高效液相色谱法测定表明,回收率合格,精密度、稳定性和重现性较好,说明了所制订质量标准的合理性和可行性。
     3、考察了本品的稳定性,结果表明本品稳定性较好。
     4、进行了相关的药效学实验。结果表明该制剂能加速肾脏排泄、防止损伤、促进组织代偿修复、改善肾功能,增强免疫、延缓慢性肾衰病程进展,为临床用药提供了药效学基础。
Chronic real failure, the kidney function gradually losing, which can't eject the discards and the poisonous things in the body to the outside, then cause the pathological changes of different degree in every organ of the body. Chronic real failure has great damages:it is bad to every system of the body,the causing and dying rate is very high, the clinic diagnosis is diffcult, the curing cost is high ,and the curing period is long.
    Though there are not any decent drugs which can reverse the illness changes up to now,we can use reasonable treatments and good medical protecting ways to prevent its' deterioration,which also can put off the time for kidney transplant.
    In the Traditional Chinese Medicine point of view,Chronic real failure belongs to the Chinese medicine kidney deficiency.Deficiency of the spleen and kindey is the real reason,and the stale-pathogen overtaking SanJiao is the exterior cause, the pathogenesis feature of which has become the common opinions .Now many curing methods can only alleviate a certain degree of the kindey function deficiency,and the expenses are high, such as the kidney transplant and so on.However the Chinese medicine and drugs have a better curative effect on the kindey deficiency,and there are many relative reports about them.This project is based on the above reasons.
    Main research contents on this lesson including:
    1.Research into technology of preparation. The technology of preparation is as follows: the optimum processing conditions of Epimedium and Rheum.palmatam.L were studied by orthogonal design with the extraction rate of iccariine and dry cream as detective markers.The result was adding 6 times 70% ethanol to extract for three times, l.Shours each time,which obtains the satisfactory result with repeated examination.The extraction and purifing process of Radix Astragali.and Poria cocos(Schw.)Wolf was studied by orthogonal design with the extraction yield of n-Bunatol lixiviated materials and the weight of dry cream as detective markers;using the yield of n-Bunatol lixiviated materials and dry cream as the detective index while purifying the water-extraction solution with the tape II of NATURAL CLEARING,the best processing condition is adding 8 times amount of water to the drugs,then decoting two times,!.5 hours each time,The optimum purifying condition is condensing the water-extraction solution to the degree, t
    he volume of which is as three times as the material, at 80℃ adding 8%B, after mixing,keeping warm for five minutes,and cooling to 60℃,adding 4%A, after mixing,keeping warm for five minutes,and laying
    
    
    aside 24 hours,filtering,which is superior to the traditional purifying methods.The optimum extraction and purifying conditions obtain the satisfactory result with repeated examination,which can also shorten producing time.
    2.Research into criteria of quality. All the results of check show that Shenshuaibao Tablets accord with the demands of tablet;after checking by TLC,we determined the way to check Rheum.palmatam.L, Radix Astragali by TLC; Poria cocos(Schw.)Wolf was not recorded because of the inference by blank contarary;Epimedium,without interference's proved to be the characterized ingridents in determining its content.The HPLC shows that the rate of recovery is up to standard and its precisonn,stability and reappearance are good.All the above indicates that the criteria of quality laid down are reasonable and feasible.
    3.Research on the stability of the Pharmaceuticals. Stability of the Pharmaceuticals was good within the time.
    4.Research on the Pharmacodynamical experiment.The Pharmacodynamical experiment shows the preparation can promote kidney's ejecting function,prevent the damage to it, can improve the reverse progress of the issue and the function of kidney,also can intensify immune function, prevent its deterioration and put off the progress of Chronic real failure ,which offer a base to clinical use.
引文
[1] 柴逸峰,李修禄.用反相高效液相色谱法测定淫羊藿及其制剂中淫羊藿甙的含量研究[J].药物分析杂志.91,11(3):207-209.
    [2] 梁建英,陈钧,段更利.反相高效液相色谱法测定淫羊藿叶和浸膏中淫羊藿甙的含量[J].上海医科大学学报.2000,27(3):185-186.
    [3] 李苑,张敏.中草药中黄酮类化合物提取工艺的研究概况[J].广东药学.99,9(2):4-5.
    [4] 中药制药技术及工艺汇编[M].国家药品监督管理局.(2000年1月版):202.
    [5] 中华人民共和国药典[S].2000年版(一部):18.
    [6] 中华本草[M].上海科学技术出社,1999年9月第1版.
    [7] 汪显阳,孙作民.从黄中提取大黄素的研究[J].中国现代应用药学.97,14(4):16-18.
    [8] 中国药典[S].2000年版(一部):249.
    [9] 潘飞,冯毓秀,张颖.黄芪研究的概况[J].国外医药.植物药分册.95,10(3):110-115.
    [10] 余灏,杨胜华.黄芪皂苷分析方法研究近况[J].华西药学杂志.1993,8(3):163-166.
    [11] 万日义,刘锡钧.黄芪及其制剂中有效成分鉴别盒含量测定研究概述[J].海峡药学.1998,10(4):7-12.
    [12] 南京药学院中药学编写组。中草药学[M].中册.江苏:江苏人民出版社.1976:15.
    [13] 中华人民共和国药典[S].(2000年版)一部:附录63.
    [14] 余灏,杨胜华.黄芪皂苷分析方法研究进展[J].华西药学杂志.1993,8(3):163-166.
    [15] 江永南,姚彩霞,黄趣碧.淫羊藿黄芪口服液的工艺研究[J].广东药学.2000,10(4):27-29.
    [16] 史同生,郭俊,林彤慧,等.影响一步制粒机制粒因素探讨[J].世界科学技术-中药现代化.2003,4(1):50.
    [17] 罗明生.药剂辅料大全[M].成都:四川科学技术出版社,1995年1月第一次印刷:664.
    [18] 罗明生.药剂辅料大全[M].成都:四川科学技术出版社,1995年1月第一次印刷:742.
    [19] 罗明生.药剂辅料大全[M].成都:四川科学技术出版社,1995年1月第一次印刷:627.
    [20] 罗明生.药剂辅料大全[M].成都:四川科学技术出版社,1995年1月第一次印刷:629.
    [21] 李文魁,林新,罗崇念,等.近年来国内外淫羊藿甙的研究概述[J].西北药学杂志.1995,10(3):138-140.
    [22] 陈明,刘燕.反相高效液相法测定舒压片中淫羊藿甙的含量[J].中药新药与临床药理.1995,6(2):39-40.
    [23] 国家药品监督管理局.中药新药研究的技术要求[M].1999年11月
    [24] 范碧亭.中药药剂学[M].(普通高等教育中医药类规划教材).上海:上海科学技术出版社,1997年12月第1版:552.
    [25] Yokzawa PidOnSZhenS, Owa H. Animal mode Of adenine-induced chronic renal failure in rats Nepheron, 44: 230.
    [26] 王雷,王绵之.中医药治疗慢性肾衰的动物实验研究概况[J].中国中西医结合杂志,1990,16(1):58.
    [27] 李仪奎,王饮茂.中药药理实验方法学[M].上海科技出版社.1991.6.
    [28] 卫生部药政局.新药(中药)临床前研究指导原则汇编[M].(药学药理学毒理学)1993.9
    [29] 侯连兵,石兴华.廖锡麟等.三种慢性肾衰动物模型的制备及意义[J].华西药学杂志,1994,9(3):169~171.
    [30] 王北婴,李仪奎.中药新药研制开发技术与方法[M].上海科技出版杜,2001,12:565.
    [31] 徐叔云等.药理学实验方法[M].人民卫生山版社,2002,7.
    [32] 陈琦.中药药理研究方法学[M].人民卫生出版社.2001,9.
    [33] 叶任高主编.内科学[M].人民卫生出版社.2002年第5版第35次印刷:567-579.
    
    
    [34] 邢儒伶,王秀英,吕仁和指导.吕仁和治疗慢性肾功能衰竭验案[J].山东中医杂志2002,21(6):364-366.
    [35] 陆晓东.郑平东治疗慢性肾功能不全的经验[J].辽宁中医学院学报.2001,3(1):62-63.
    [36] 莫凤金,武鸣.慢性肾功能衰竭的中药保留灌肠治疗及护理[J].广西中医学院学报.2000,17(4):98-100.
    [37] 张大宁.实用中医肾病学[M].第1版.北京:中国医药科技出版社.1990,488—535.
    [38] 吕天恒,邢书然,尹荣举.中西医结合治疗慢性肾功能衰竭21例[J].实用中西医结合杂志.1997,10(21):72-73.
    [39] 刘靖芳,吴佩云.中西医结合治疗慢性肾衰40例临床观察[J].实用中西医结合杂志.1997,10(7):688-689.
    [40] 黎磊石,刘志红.张景红,等.大黄廷缓慢性肾衰的临床和实验研究[J].中西医结合杂志.1991,11(7):392-396.
    [41] 杨俊伟,黎磊石.大黄对实验性糖尿病大鼠肾脏肥大及高滤过作用的影响[J].中国中西医结合杂志.1993,13(5):286-288.
    [42] 邱阳,杨玉秀,任青,等.大黄素对慢性肾功能衰竭患者肿瘤坏死因子产生的抑制作用[J].中华肾脏病杂志.1998,14(3):188-189.
    [43] 杨焕荣,马景春,王秀华,等.黄芪对慢性肾功能衰竭患者免疫功能的影响[J].中西医结合实用临床急救.1997,4(9):404-405.
    [44] 刘志一.黄芪药理作用的研究进展[J].中西医结合杂志.1991,11(5):312-313.
    [45] 田劲,陈香美,黎磊石.冬虫夏草、大黄及肾大部切除大鼠血清对肾小管上皮细胞生长的影响[J].中西医结合杂志.1991,11(9):547-549.
    [46] 郑丰,田劲,黎磊石.冬虫夏草对肾毒性急性肾功能衰竭的疗效及机制探讨[J].中国中西医结合杂志.1992,12(5):288-291.
    [47] 管益君,胡昭,侯明,等.冬虫夏草对慢性肾功能衰竭T细胞亚群的影响[J].中国中西医结合杂志.1992,12(6):338-339.
    [48] 刘强,侯积寿,马济民,等.虫草影响慢性肾功能衰竭进展的实验研究[J].中华肾脏病杂志.1995,11(2):81.
    [49] 金和筠,王爱民,王玉坤.丹参对实验性急性肾功能衰竭的防治作用[J].中国中药杂志.1997,22(4):236-238.
    [50] 徐再春,李学铭,凌雅芬,等.丹参对腹膜透析效能的影响[J].中国中西医结合杂志.1993,13(2):74-76.
    [51] 胡列卫,马永江,郑家富,等.川芎对急性肾功能衰竭家兔血浆TX82、6ketoPGF1 α含量影响[J].中国中西医结合杂志.1993,13(9):549-550.
    [52] 刘云海,顾青兰,刘英华,等.川芎嗪对慢性肾衰患者肾血流量和肌酐清除率的影响[J].中国中西医结合杂志.1993,13(2):107.
    [53] 李文魁,林新,罗崇念,等.近年来国内外淫羊藿甙的研究概述[J].西北药学杂志.1995,10(3):138-140.
    [54] 刘江虹,沈连生.淫羊藿的研究进展[J].北京中医学院学报.1993,16(1):29-32.
    [55] 石纪才,夏晓红,薛玉凤,等.水蛭防治初发期急性肾功能衰竭的实验研究[J].中国中西医结合杂志.1992,12(5):295-296.
    [56] 张盛光,熊国良,阳晓,等.益气补肾冲剂治疗慢性肾功能不全的初步临床及实验研究[J].中国中西医结合杂志.1992,12(6):335-337.
    [57] 朱辟疆,周逊,韦先进.保元强肾Ⅱ号对慢性肾功能衰竭血浆及尿SOD、MDA的影响[J].中国中西医结合杂志.1997,17(11):649-652.
    
    
    [58] 李雪巧.谢天忠治疗慢性肾功能衰竭经验[J] .辽宁中医杂志.2001,28(6):8-9.
    [59] 江志勤.郑平东治疗慢性肾功能衰竭经验[J].安徽中医临床杂志.2001,13(6):854-855.
    [60] 张秋霞,于海燕.中药灌肠治疗慢性肾功衰竭的护理[J].甘肃中医.1999,12(5):53-54.
    [61] 覃玉芳.中药保留灌肠治疗慢性肾功能衰竭的护理[J].广西中医药.2000,23(5):46.
    [62] 赵松梅,戴强发,谢长和.药浴疗法治疗慢性肾功能衰竭22例[J].江苏中医.1999,20(1):52-53.
    [63] 韩家强,王金萍,李仁善.中西医结合治疗老年慢性肾功能衰竭的体会[J].中西医结合实用临床急救.1996,3(12):547-548.
    [64] 龙子江,吕小英,彭代银,等.虫类药物对慢性肾功能不全大鼠的实验研究[J].中国实验方剂学.2000,6(3):32-33.
    [65] 郭秀丽,经建波,靖新文,等.肾毒清冲剂治疗慢性肾功能不全的实验研究[J].中成药.2001,23(7):506-508.
    [66] 王元勋,张敏华,吴雪影,等.人工虫草及其复方对大鼠慢性肾功能不全治疗的实验研究[J].甘肃中医学院学报.1994,11(4):37-39.
    [67] 程庆乐,于力方,师锁柱,等.冬虫夏草对5/6肾切除大鼠肾脏病理改变的影响[J].军医进修学院学报.1994,15(1):39-41.
    [68] 唐抗,陈嘉.六味地黄丸对慢性肾功能不全大鼠的实验研究[J].中医药学刊.2003,2l(2):258-259

© 2004-2018 中国地质图书馆版权所有 京ICP备05064691号 京公网安备11010802017129号

地址:北京市海淀区学院路29号 邮编:100083

电话:办公室:(+86 10)66554848;文献借阅、咨询服务、科技查新:66554700