CN101129870A - 一种治疗前列腺增生症的药物及其制备方法 - Google Patents
一种治疗前列腺增生症的药物及其制备方法 Download PDFInfo
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- CN101129870A CN101129870A CNA2007100185258A CN200710018525A CN101129870A CN 101129870 A CN101129870 A CN 101129870A CN A2007100185258 A CNA2007100185258 A CN A2007100185258A CN 200710018525 A CN200710018525 A CN 200710018525A CN 101129870 A CN101129870 A CN 101129870A
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Abstract
本发明涉及一种治疗前列腺增生症的药物及该药物的制备方法。前列腺增生症是临床上的常见病、多发病,严重危害中老年人的健康,主要表现为尿频、尿急、排尿困难等。本发明由薏苡仁、浙贝母、川木通、栀子、金银花、旋覆花、泽兰、大黄、铜绿、甘草、黄芪共十一味药组成,方中薏苡仁为君药;以浙贝母、栀子、旋覆花为臣药;以金银花、黄芪为佐药;甘草为使药,以及其他辅药共十一味,用于治疗湿热蕴结,痰瘀交阻引起的前列腺疾病。本发明工艺简单、药效稳定、副作用小。
Description
技术领域
本发明涉及一种治疗前列腺增生症的药物,具体说是以中草药为原料制备的中成药,本发明还涉及该药物的制备方法。
技术背景
前列腺增生症是临床上的常见病、多发病,严重危害中老年人的健康,目前具体的发病原因还不清楚,这就造成了西药治疗疗效难以尽如人意,而手术治疗又有很大的局限性,这就使人们将眼光转向中医药。
目前,人们还无法防止前列腺增生的发生,西医治疗前列腺增生症的原则首当其冲应是尽快减轻、甚至解除梗阻,保护膀胱逼尿肌的功能,保护肾功能;药物治疗目前主要集中在α-受体阻断、5α-还原酶抑制、激素治疗(抗雄酮治疗为主)等几个方面,疗效均不够满意,可能与人们对前列腺增生症的发病原因了解不够有关。且许多药物价格高昂。对于手术治疗呢,一方面此类患者多年事已高,一部分患者可能有严重的合并症(如心、脑血管病变等),并且有一部分患者的前列腺增生到一定程度即不再发展,因此外科手术是治疗前列腺增生症的重要的、有效的一种方法,不是首选的、唯一的方法。因此寻找一种患者可耐受的、同时又是有效的方法至关重要。
发明内容
本发明的目的在于提供一种疗效显著且无毒副作用的治疗前列腺增生症的药物。
本发明的另一目的是提供一种工艺简单、药效稳定、副作用小的治疗前列腺增生症的制备方法。
为达到上述目的,本发明采用的技术方案为:
一种治疗前列腺增生症的药物,制成所述中药有效成分的原料组成及其重量配比为:
薏苡仁100-300份 浙贝母90-200份 川木通80-180份
栀子80-180份 金银花90-200份 旋覆花80-180份
泽兰80-180份 大黄20-50份 铜绿1-10份
甘草30-60份 黄芪100-220份。
上述的治疗前列腺增生症的药物,其中各原料的较佳的重量配比是:
薏苡仁150-200份 浙贝母100-170份 川木通90-150份
栀子90-150份 金银花100-170份 旋覆花90-180份
泽兰90-1 50份 大黄30-40份 铜绿5-8份
甘草40-50份 黄芪120-200份。
上述的治疗前列腺增生症的药物,其中各原料的最佳的重量配比是:
薏苡仁180份 浙贝母120份 川木通108份
栀子108份 金银花120份 旋覆花108份
泽兰108份 大黄36份 铜绿6份
甘草48份 黄芪144份。
上述的治疗前列腺增生症的药物及其制备方法,其特征在于:
所述的剂型为颗粒的制备方法的工艺步骤如下:
(1)、将各味药材按量称取,净制后备用;
(2)、将浙贝母、铜绿粉碎成细粉过100目筛,备用;
(3)、将川木通、薏苡仁、炒制过的栀子、金银花、旋覆花、泽兰、大黄、甘草、蜜炙过的黄芪九味药加10倍量水煎煮三次,每次1小时,合并煎液,滤过,滤液在-0.08Mpa,80℃的条件下减压浓缩,至在55℃下,相对密度为1.20~1.25的稠膏,喷雾干燥;
(4)、加入步骤(2)中的细粉、蔗糖和糊精,混匀,加适量乙醇润湿,制粒,即得。
本发明是根据前列腺增生因湿热蕴结,痰瘀交阻的病因病机而组方用药,经科学方法研制而成。组方中以薏苡仁为君药,取其健脾利湿,化痰软坚以助通利:以浙贝母、栀子、旋覆花为臣药,清热利湿、散结祛瘀;以金银花、黄芪为佐药,取其益气升提,以助气行水行;金银花性味甘寒,用之清热以解毒;甘草味甘性平,具中和之性,用之调和诸药为使药,以及其他辅药共十一味,用于治疗湿热蕴结,痰瘀交阻(即临床症状表现为:尿频、尿急、排尿困难等)引起的前列腺疾病。
具体实施方式
在祖国医学中,前列腺增生症属中医“癃闭”范畴,“癃闭”之病名首先见于《黄帝内经》,如《素问·宣明五气篇》说:“膀胱不和为癃,不约为遗溺。”《素问·标本病传论》说:“膀胱病,小便闭。”《灵枢·本输》篇也说:“三焦,……实则癃闭,虚则遗溺。”不仅首先提出其病名,还指出其病位在膀胱,并论述了其病因病机。汉代,张仲景在《伤寒杂病论》中因避讳称此为“淋病”及“小便不利”,并辨为气化不行(五苓散证)、水热互结(蒲灰散或滑石白鱼散证),脾肾两虚而挟热(茯苓戎盐汤证)。唐代,孙思邈在《千金要方》中不仅记载了用导尿术治疗小便不通,并还指出了本病的严重性:“……遂致天命,大不可轻之。”总之,中医认为,年老体衰、肾气亏虚是本病的发病基础,瘀血、痰浊、湿热、败精是基本的病理因素,劳力过度、情志刺激、外感六淫、饮食不节是常见的发病条件,本虚标实是本病的基本病机特点,临床上多辨为膀胱湿热、肺热壅盛、肝郁气滞、中气不足、肾元亏虚、下焦瘀阻六种基本证型来治疗。
现代临床研究进展综述:张氏[I]从疲辨治前列腺增生症52例,基本药用赤芍10g,桃仁10g、制大黄10g、石见穿10g、炮穿山甲(包煎)7g、海金砂(包煎)20g,琥珀(冲服)5g、生甘草5g,肾阳不足型加附子、肉桂、肉从蓉、川断,肾阴虚型加生地、枸杞子、知母、黄柏,湿热阻滞型加苍术、黄柏、薏苡仁、败酱草。每天1剂水煎服,20d为1个疗程,治愈35例,好转12例,无效5例,总有效率91%。许氏[2]辨证治疗20例,湿热蕴结型用八正散加味(滑石30g,车前子、篇蓄、瞿麦、栀子、荜薢、薏苡仁各10g,知母、生地各15g,甘草6g),肝郁气滞型用沉香散加味「沉香(后下6g),当归10g,王不留行10g,冬葵子10g,香附10g,郁金10g,石韦10g,滑石20g,柴胡、乌药、甘草、陈皮各6g」,疲血阻滞型用桃红四物汤加味(当归、桃仁、红花、大黄、赤芍、川芎、王不留行、炮山甲各10g,牛膝、生地各15g),中气不足型用补中益气汤加味(柴胡6g,党参15g,黄芪15g,升麻、白术、陈皮、当归、冬葵子、木通、篇蓄各11g,甘草6g),肾阴亏虚型用六味地黄丸加减(牛膝、生地、黄精、山茱萸各15g,山药、茯苓、泽泻、丹皮、瞿麦、车前子各10g),治疗20例,临床治愈7例,有效12例,无效1例。晃氏[3]分为4证,湿热证8例用八正散加味(篇蓄、瞿麦、山栀子、大黄、木通、甘草各9g,车前子、滑石各12g,灯心草2g),阴虚证7例用六味地黄汤加味(熟地、山茱萸、山药、泽泻、茯苓、丹皮、篇蓄、瞿麦、牛膝、木通、车前子),脾气两虚证54例用自拟老人瘾闭汤(党参24g,黄芪30g,茯苓12g,莲子18g,白果9g,荜薢12g,车前子15g,王不留行12g,吴茱萸5g,肉桂6g,甘草9g)加减,阳虚证6例用济生肾气汤加减治疗,临床治愈40例,好转12例,无效6例。华氏[4]辨证分3型,肾阴亏证6例用知柏地黄汤加山慈姑、夏枯草、海藻、海带、昆布之类,肾阳虚证75例用济生肾气丸去丹皮,酌加桑螵蛸、沉香、淫羊蕾、荔枝核、补骨脂、沙苑子、小茴香、枸杞子、生黄芪等,败精疲阻证49例用活血通精汤(当归、制首乌、鸡血藤、川牛膝、益母草、黄酒)随症加减,临床治愈76例,显效62例,有效9例,无效3例。叶氏[5]认为血疲成积,阻塞尿窍是本病的关键,气虚血疲、积阻尿窍证用前增汤(炙山甲、桃仁、当归、丹参各10g,酒大黄6g,琥珀3g冲服,黄芪10g,皂刺5g,肉桂2g冲服),积阻尿窍、浊气犯肺证用前增汤加桔梗、莱菔子各5g,苏子1og;积阻尿窍、中气不足证用前增汤加党参15g,柴胡5g、升麻3g,黄芪加至30g;积阻尿窍、膀胱湿热证用前增汤去黄芪、当归,加黄柏、知母、车前子各10g,石韦15g;积阻尿窍、肾阴亏证用前增汤去当归,加白芍、知母、黄柏各10g,鳖甲30g,肉桂减至1g;积阻尿窍、肾阳虚弱证用前增汤加仙茅、杜仲各10g,肉桂加至10g。
本发明即是在以上理论指导下,结合研制者的临床经验,并参照现代药理成果而组方的。前列腺增生症相当于中医学的“癃闭”范畴。“癃”指小便不利,点滴而出,起病较缓慢;“闭”指小便闭塞,点滴不出,起病较急。从以上描述不难看出癃闭之表现与前列腺增生症颇有相似之处。从本病的病因病机看,比较公认的有以下几种:
(1)阴虚火旺房室过度,欲念放纵,以致肾阴亏耗,无阴则阳无以化,水液不得气化而下注膀胱,故产生癃闭。
(2)肾阳不足年老体弱或久病体虚,肾阳不足,命门火衰,无阳则阴无以生,膀胱气化无力,而致小便不出。
(3)湿热蕴结过食辛辣肥甘之品,中焦湿热不解,下注膀胱,或肾移热于膀胱,膀胱湿热壅滞,导致气化不利,小便不通,而成癃闭。
(4)脾气不升劳倦伤脾,饮食不节,或久病体弱,致脾虚而清气不能上升,则浊阴不能下降,小便因而不利。
(5)肝郁气滞七情内伤,引起肝气郁结,疏泄不及,从而影响三焦水液的运化及气化,致使水道通调受阻,形成癃闭。
(6)痰浊、瘀血、败精内停 痰浊、瘀血、败精内停,阻塞水道,气化不利而成癃闭。其中,最常见的是湿热蕴结(即西医所说的感染,包括细菌感染及非细菌感染,如尿路的刺激症状等)。湿热蕴结下焦,膀胱气化不利,故出现了尿频、尿急、尿通,甚至有尿有余沥,湿热蕴结日久入络,致局部气血不畅留而为瘀,津停为痰,痰瘀互结,故局部出现肿块,前列腺出现增生。
本发明是根据前列腺增生因湿热蕴结,痰瘀交阻的病因病机而组方用药,经科学方法研制而成。组方中以薏苡仁为君药,取其健脾利湿,化痰软坚以助通利:以浙贝母、栀子、旋覆花为臣药,清热利湿、散结祛瘀;以金银花、黄芪为佐药,取其益气升提,以助气行水行;金银花性味甘寒,用之清热以解毒;甘草味甘性平,具中和之性,用之调和诸药为使药,以及其他辅药共十一味,用于治疗湿热蕴结,痰瘀交阻(即临床症状表现为:尿频、尿急、排尿困难等)引起的前列腺疾病。
本发明由薏苡仁、浙贝母、川木通、栀子(炒)、金银花、旋覆花、泽兰、大黄、铜绿、甘草、黄芪(蜜炙)共十一味药组成。
1、薏苡仁:本品为禾本科植物薏苡Coix Lacryma-jobiL.var.ma-yuen(Roman)Stapf的干燥成熟种仁。秋季果实成熟时采割植株,晒干,打下果实,再晒干,除去外壳、黄褐色种皮及杂质,收集种仁。
本药材含有脂肪酸、氨基酸、糖类、甾醇类、生物碱酯与酯甙,还会有淀粉,维生素B,其中蛋白质含量为16~19%,主要作用是健脾渗湿,除痹止泻,清热排脓。用于水肿、小便不利。
本品应符合《中国药典》2000年版一部309页薏苡仁项下有关规定。
2、浙贝母:本品为百合科植物浙贝母Fritillaria thumbergri Miq.的干燥鳞茎。初夏植株枯萎时采挖,洗净。大小分开,大者除去芯芽,习称“大贝”;小者不去芯芽,习称“珠贝”。分别撞擦,除去外皮,拌以煅过的贝壳粉,吸去擦出的浆汁,干燥;或取鳞茎,大小分开,洗净,除去芯芽,趁鲜切成厚片,洗净,干燥,习称“浙贝片”。
本品主要含有生物碱类,浙贝母甲素(Peimine).浙贝母乙素(Peiminine).浙贝母甙(Peiminosde).异贝母甲素(isoverticine).贝母定,原贝母碱浙贝宁及β-谷甾醇、胡萝卜素等成分。药理研究表明贝母具有镇咳、镇静、镇痛作用。临床研究发现浙贝母的复方制剂治疗腮腺炎100多例,痊愈者占2/3,证明该药具有抗感染作用。
本品应符合《中国药典》2000年版一部240页浙贝母项下有关规定。
3、川木通:本品为毛茛科植物小木通Clematis armandii Franch或绣球藤Clematis montana Buch-Ham.的干燥藤茎。春、秋二季采收,除去粗皮,晒干,或趁鲜切薄片,晒干。
本药材含核糖、葡萄糖及甙,齐墩果酸,其水浸出物中所含无机成分以钾盐较多,约占原生药的0.2542%。川木通的各种提取物均具有比较确切的利尿作用。健康人口服水通煎剂3g(三次)有利尿作用,其尿量增加程度略高于淡竹叶。木通的水浸生物能促进K+排泄。木通皂甙对大鼠,小鼠均有利尿作用,并可使增加尿酸与电解质Na+、G-的排泄。木通水浸液和煎剂对多种致病菌有不同程度的抑制作用。
本品应符合《中国药典》2000年版一部27页川木通项下有关规定。
4、栀子:本品为茜草科植物栀子Gardenia jasminoides Ellis的干燥成熟果实。9~11月果实成熟呈红黄色时采收,除去果梗及杂质,蒸至上汽或置沸水中略烫,取出,干燥。
本品含有环烯醚萜甙类,氯原酸、奎宁酸、三萜类化合物藏红花素和藏红花,棕榈酸,丹皮酚、棕桐酸甲脂及鼠李糖,阿拉伯糖,另外还含有D-甘露醇,β-谷甾醇,胆碱、熊果酸。栀子对多种细菌真菌等有抑制作用。栀子水煎剂,体外实验表明,对多种真菌有不同程度的抑制作用。栀子可明显抑制巴豆油所致小鼠耳壳炎症和降低醋酸所致小鼠腹腔毛细血管通透性增加,其中以生栀子的抗炎作用最强。栀子甙对二甲苯致小鼠耳肿胀以及巴豆油致小鼠耳肿胀均有明显作用,抑制率分别为65.0%~77.3%。
本品应符合《中国药典》2000年版一部201页桅子项下有关规定。
5、金银花:本品为忍冬科植物忍冬Lonicera japonica Thunb、红腺忍冬Lonicera hypoglauca Miq、山银花Lonicera Confusa DC或毛花柱忍冬Lonicera.dasystyla.Rehd的干燥花蕾或带初开的花。夏初花开放前采收,干燥。
本品主要含挥发油,氯原酸、异氯原酸、黄酮类、三萜类及无机元素。实验研究表明,金银花对多种致病菌均有一定的抑制作用。体外实验表明金银花和其藤对多种致病毒如溶血性链球菌,大肠杆菌,痢疾杆菌霍乱弧菌,伤寒杆菌等均有一定抑制作用,对肺炎球菌、脑膜炎双球菌、绿脓杆菌结核杆菌亦有效,金银花加热后绿原酸含量有所下降,但其抑制作用却未见相应降低相反对痢疾杆菌和变形杆菌作用还有半强,表明绿原酸并非唯一的抑菌成分,实验证明金银花中的木犀草素也有较强的抗菌作用,金银花水浸剂在体外对铁锈色小芽孢癣菌星形奴卡氏菌等皮肤真菌有不同程度的抑制作用。金银花对多种病毒有抑制作用。
本品应符合《中国药典》2000年版一部177页金银花项下有关规定。
6、旋覆花:本品为菊科植物旋覆花Inula japonica Thunb或欧亚旋覆花Inula britannicaL.的干燥头状花序。夏、秋二季花开放时采收,除去杂质,阴干或晒干。
本品主要含有旋覆花素(inulicin).大花旋覆花宁(Britanin)等倍半萜内酯类及槲皮素(quercetin)。异槲皮素,咖啡酸、绿原酸、旋覆花甾醇B等成分。药理研究表明:本品所含黄酮类成分对组织胺引起的豚鼠与支气管痉挛有缓解作用,并有一定的利尿作用。
本品应符合《中国药典》2000年版一部260页旋覆花项下有关规定。
7、泽兰:本品为唇形科植物毛叶地瓜儿苗Lycopus lucidus Turcz.Var.hirtus Regel的干燥地上部分。夏、秋季茎叶茂盛时采割,晒干。
本品主要含有挥发油、葡萄糖甙、鞣质和树脂还有黄酮甙、酚类、氨基酸、有机酸、皂甙、糖类、熊果酸等。药理研究表明,泽兰(2g/kg)腹腔给药(家兔)能明显改善微循环障碍,4g/kg灌服给药对异常的血液流变学也有较好的改善作用,能降低血液粘度,抗血栓形成。
本品应符合《中国药典》2000年版一部183页泽兰项下有关规定。
8、大黄:本品为蓼科植物掌叶大黄Rheum palmatum L.、唐古特大黄Rheum tanguticum Maxim.ex Balf.或药用大黄Rheum officinale Baill.的干燥根及根茎。秋末茎叶枯萎或次春发芽前采挖,除去细根,刮去外皮,切瓣或段,绳穿成串干燥或直接干燥。
本品含有大黄酚、大黄素、大黄素甲醚、芦荟大黄素、大黄酚、配糖型蒽醌、二蒽酮二苯乙烯甙类、萘酚甙类、苯丁酮类、挥发性成分、根茎中含有钾、钙、镁、铝等无机元素。实验表明大黄中多种蒽醌衍生物都有不同程度的抗菌作用,其中以大黄酸、大黄素及芦荟大黄素三者的抗菌作用较强,大黄素的抗菌作用是和它对细胞呼吸的影响密切联系的,它可能首先阻断细菌呼吸链,使细菌生长所需能量来源断绝。大黄酸大黄素均有利尿作用,口服大黄尿中钠、钾明显增加、尿PH逐渐上升。实验结果:大黄素和大黄酸对家兔排尿,排Na+和排K+有明显促进作用。致使Na+的重吸水减少,尿中排Na+增多,因而达到利尿作用。
本品应符合《中国药典》2000年版一部18页大黄项下有关规定。
9、铜绿:本品为铜器表面经二氧化碳或醋酸作用后,生成的绿色锈衣。全年均可制取,主含碱式碳酸铜(CuCO3·Cu(OH)2)。将铜器久置潮湿处,或将醋喷涂抹于铜器上,待铜器表面产生青绿色的锈衣时刮取,干燥。
本品主含碱式碳酸铜(CuCO3·Cu(OH)2),药理研究表明,本品具有祛腐、敛疮、杀虫等功效。用于疽痔恶疮、顽癣等症。
本品应符合《山东省中药材标准》1995年版176页铜绿项下有关规定。
10、甘草:本品为豆科植物甘草Glycyrrhiza uralensis Fisch.胀果甘草Glycyrrhiza inflata Bat.或光果甘草Glycynhiza glabra L.的干燥根及根茎。春、秋二季采挖,除去须根,晒干。
本品含有三萜皂甙甘草酸,其钾、钙盐为甘草甜素,黄酮类、生物碱类、多糖类、香豆素。甘草有效成分的抗炎作用。甘草中的主要成分甘草甜素和甘草次酸具有类骨醇的骨架结构,又有多种激素样作用,从这两点出发很多人研究了甘草浸膏多组份的抗炎作用,甘草次酸对大鼠的棉球肉芽肿,甲醛性脚肿皮下肉芽肿性炎症等均有抑制作用,其抗炎效价约为可的松或氢化可的松的1/10,甘草甜素和甘草次酸,对炎症反应1、2、3期都有抑制作用。关于甘草及其有效成分的抗炎机理,研究表明与甘草的肾七腺皮质激素样作用有关。
本品应符合《中国药典》2000年版一部65页甘草项下有关规定。
11、黄芪:本品为豆科植物蒙古黄芪Astragalus membranaceus(Fisch.)Bge.var.mongholicus(Bge.)Hsia或膜荚黄芪Astragalus membranaceus(Fisch.)Bge.的干燥根。春、秋二季采挖,除去须根及根头,晒干。
本品含有三萜皂甙,黄酮类,氨基酸,无机元素及微量元素。现代药理研究表明:煎剂给兔口服,可增加尿量17.5%,醇浸剂给兔腹腔注射,可增加尿量36%。
黄芪0.5g/kg给麻醉犬静注,于给药15分钟左右排尿暂受抑制,1~1.5小时后尿量显著增加。黄芪具有免疫增强作用,对小鼠巨噬细胞和中性粘细胞及人淋巴细胞有直接活化作用。
黄芪(蜜炙),取黄芪片,照蜜炙法(附录IID)炒至不粘手。
本品应符合《中国药典》2000年版一部250页炙黄芪项下有关规定。
(一)本发明制剂工艺优选
本制剂对其中的具体工艺参数进行细化优选。
本发明的制备工艺如下:以上十一味,浙贝母、铜绿粉碎成细粉过100目筛,备用。其余川木通等九味加10倍量水煎煮三次,每次1小时,合并煎液,滤过,滤液减压浓缩(一0.08Mpa,80℃)至相对密度为1.20~1.25(55℃,热测)的稠膏,喷雾干燥(进风温度160℃~180℃,出风温度70~75℃),加入上述细粉、蔗糖和糊精(蔗糖∶糊精=3∶1),混匀,加适量乙醇润湿,制粒,即得。
1、粉碎工艺研究
(1)铜绿粉碎条件考察
①铜绿为金属药,质地坚硬、脆,易于粉碎,故直接粉碎,过100目筛,即得。
②铜绿出粉率考察:取铜绿1.2kg,分成三份,每份0.4kg,直接粉碎,过100目筛,得细粉,称重,计算出粉率,结果见表1。
表1铜绿出粉率
试验次数 | 1 | 2 | 3 | 平均值 |
药材重(kg)细粉重(kg)出粉率(%) | 0.40.37493.42 | 0.40.37694.05 | 0.40.37794.21 | 0.40.37693.89 |
结果表明:铜绿出粉率不低于93%。
(2)浙贝母粉碎条件考察
①浙贝母为根茎类药物,质硬而脆,易于粉碎,故直接粉碎,过100目筛,得细粉,称重,计算出粉率,结果见表2。
②浙贝母出粉率考察:称取浙贝母6.0kg,分成三份,每份2.0kg,直接粉碎,过100目筛,得细粉,称重,计算出粉率,结果见表2。
表2浙贝母出粉率考察
试验次数 | 1 | 2 | 3 | 平均值 |
药材重(kg)药材细粉重(kg)出粉率 | 2.01.9497.00 | 2.01.9396.50 | 2.01.9195.50 | 2.01.9396.50 |
结果表明:浙贝母出粉率不低于95%。
2、水提工艺研究
①加水量的选择:提取次数、提取时间保持原标准不变(3次、1小时),对加水量进行优选,根据处方中药材的性质及试验,选择加水量为8倍、10倍、12倍,以方中金银花含有的已知有效成分绿原酸和出膏率为考察指标,做平行实验,进行加水量的选择。
②样品制备:按处方比例,准确称取1600g药材,共三份,分别加水煎煮三次,每次1小时,加水量根据设计试验条件进行试验,最后得3份提取液定容于500ml量瓶中,备用。
③出膏率的测定:将3份提取液分别浓缩后定容于500ml量瓶中,摇匀,分别精密量取50ml,置于已于105℃条件下干燥恒重的蒸发皿中,烘干至恒重,计算出膏率,结果见表3。
④绿原酸的含量测定:照高效液相色谱法(《中国药典》2000年版一部附录VID)测定。色谱条件与系统适用性试验:德国诺尔高效液相色谱仪,欧洲色谱工作站。K-501泵,K-2501检测器,Uitrosphere ODS C18(4.6×250mm,5μm)色谱柱,流动相为乙腈-0.4%磷酸溶液(13∶87),柱温为室温,检测波长327nm,流速1.0ml/min。
对照品溶液的制备:精密称取绿原酸对照品4.1mg置棕色量瓶中,加50%甲醇制成每1ml含41μg的溶液,即得。
供试品溶液的制备:精密量取上述定容于500ml量瓶中的提取液2ml,置具塞锥形瓶中,精密加50%甲醇50ml,称定重量,超声处理30分钟,放冷,再称定重量,用50%甲醇补足减失的重量,摇匀,滤过,精密量取续滤液5ml,置25ml棕色量瓶中,加50%甲醇至刻度,摇匀,即得。
测定法:分别精密吸取对照品溶液与供试品溶液各20μl,注入液相色谱仪测定,结果见表3。
表3加水量的选择结果
加水量 | 出膏率 | 绿原酸含量(μg/ml) |
81012 | 11.1612.1912.29 | 22.8724.9024.91 |
由表3结果表明,加水量对出膏率影响较大,加8倍量的水与加10、12倍量的水出膏率相差较大,加10倍量的水出膏率与12倍量相差不大;加水量对绿原酸含量影响不大,加8倍量、10倍量与12倍量,绿原酸含量几乎相等,并结合生产实际,故选择加水量为10倍量水。
3、水煎液浓缩工艺研究
本发明采用减压浓缩(-0.08Mpa,80℃),减压浓缩较常压浓缩温度低,效率高,有效成分不易破坏,且减压浓缩设备为药厂常用设备之一,易于实现,水煎液减压浓缩至相对密度为1.20~1.25(55℃热测)的清膏。
4、干燥条件的选择
为了保证能够有效地控制成品的总量,使每批成品含量一致,对清膏进行干燥,根据文献报道及生产经验,对于常温干燥、真空干燥、喷雾干燥三种干燥方法,喷雾干燥较前两种干燥方法具有受热时间短,成品疏松色泽浅,含水量低等特点,所以在制备本品时选择喷雾干燥。经过试验,对于进风温度控制在150℃~170℃,可使喷塔温度在75℃~80℃,出风温度70℃~75℃,在此条件下含水量,收率为考察指标对清膏相对密度进行考察。
5、清膏相对密度的考察
按处方比例取处方量2倍的药材,称取3份,按上述考察确立的工艺条件进行提取、精制,按表4设计的相对密度水平进行考察,转速固定为2.5万转/分钟,考察结果见表4。
表4喷雾前清膏相对密度的考察
序号 | 相对密度 | 含水量(%) | 收率(%) |
123 | 1.15-1.201.20-1.251.25-1.30 | 4.33.53.0 | 97.395.291.5 |
注:喷粉收率按不含水分理论计算。
从表4试验结果表明。相对密度越高,含水量越低,但收率亦随之降低,在试验中观察到相对密度越高,粘附到器壁上的清膏越多,且较难以喷出,结合生产实际情况,清膏浓缩至相对密度为1.20~1.25(55℃)最为适宜。
6、转速的选择
按处方比例取处方量2倍的药材,称取3份,按上述考察确立的工艺条件进行提取、精制,浓缩至相对密度为1.20~1.25(55℃)的清膏,按表5设计的转速进行考察,结果见表5。
表5转速考察结果
序号 | 转速(万转/分钟) | 含水量(%) | 收率(%) |
123 | 1.82.02.5 | 3.03.13.2 | 95.695.895.2 |
从表5试验结果表明,转速对含水量,对收率几乎无影响,结合生产实际情况,在保证含水量符合要求的情况下,为提高生产效率,其设定转速选择2.5万转/分钟较为适宜。
(二)、制剂成型工艺研究
1、颗粒辅料的选择
本品为中药制剂,为了矫味,便于患者服用,本发明选用目前最常用的蔗糖做稀释剂,但因蔗糖含糖量高且易于吸潮,制得的颗粒不宜长期贮存,参考资料,分别选择加入适量的淀粉、糊精、乳糖等常用辅料,测其成型性及吸湿性,结果因乳糖吸潮后易于液化,使颗粒颜色加深、粘连,而淀粉易吸潮,使颗粒变软、结块,糊精成型性好,且不易吸潮,故选择蔗糖、糊精作稀释剂。
2、辅料配比的选择
根据试验的结果,设计表6的辅料与干浸膏的配比,取按表6规定的干浸膏与药材细粉、蔗糖、糊精混合,加70%乙醇制软材,用14目尼龙网制粒,干燥。测定成型率和24h吸湿率,结果见表7。
表6混合辅料与浸膏的配比
物料 | 1 | 2 | 3 | 4 | 5 | 6 |
干浸膏(g)药材细粉(g)糊精(g)蔗糖(g) | 12122056 | 12121957 | 12122155 | 12122254 | 12122353 | 12122452 |
表7混合辅料不同配比试验结果
处方号 | 1 | 2 | 3 | 4 | 5 | 6 |
成型率吸湿率综合 | 80.246.3086.54 | 90.346.5096.84 | 85.386.8592.23 | 82.366.8389.19 | 82.547.2089.74 | 78.727.0585.77 |
从表7可以看出2号样品制得的颗粒成型性高,吸湿率低,符合颗粒剂的质量要求,故确定糊精∶蔗糖=1∶3的混合辅料作为颗粒剂的辅料。
为验证其具体疗效,将近年来,河北省泊头市医院应用本发明治疗非细菌性前列腺炎100例的情况总结如下:
1资料与方法
1.1诊断标准选择会阴痛,睾丸痛,阴茎痛,腰痛,下腹部或腹股沟区胀痛不适,尿道灼热,尿频,尿不尽感,性功能不良等症状中至少有2个以上症状的门诊患者,但前列腺液常规检查白细胞<20%,细菌培养阴性,排除细菌性前列腺炎,尿常规检查正常,细菌培养阴性,排除尿路感染。
1.2一般资料本组100例,年龄17~45岁,平均32岁;病程1~5个月36例,1~4年64例。均经抗生素治疗但疗效不佳,近15日未使用抗生素。
1.3治疗方法本发明5g,每日2次,口服,连用30日。
1.4疗效标准[1]治愈:症状完全消失,前列腺液常规检查白细胞数降低呈正常水平;显效:症状评分减少80%;有效:症状部分消失或减轻,白细胞数有所降低,症状评分减少50%;无效:症状无改善,白细胞数有所降低或上升,症状评分无变化。
2结果
2.1临床疗效本组100例,治愈60例,显效16例,有效3例,无效21例,总有效率79%。直肠指诊有前列腺压痛或不适14例,复查前列腺压痛或不适消失10例,B超检查治疗前后前列腺大小无明显变化。
2.2毒副作用患者服药后均无不良反应,血常规、尿常规、肝功能、血糖、电解质、血压、心电图检查均无明显变化。
贵阳中医学院附属医院应用本发明治疗慢性前列腺增生38例,现综述如下:
1.1病例选择
38例病人,年龄19~67岁,平均29.6岁;未婚8例;病程1~6个月21例,7~12个月6例,13个月以上11例。
1.2诊断标准
1.2.1临床表现:尿频,排尿不尽,尿道外口有粘液,腹股沟区不适或睾丸隐痛,小腹坠胀,腰骶部不适,失眠,健忘,头晕或阳痿,早泄,遗精,射精痛,性功能障碍。
1.2.2肛门指诊前列腺体积正常或增大,压痛,质地变硬或不均匀。
1.2.3前列腺液实验室检查卵磷脂小体减少或消失,白细胞大于10个或脓细胞“+”以上/每高倍镜视野。38例中有35例做VBI及EPS细菌培养,其中17例有细菌生长,且与VBI细菌不同,余18例无细菌生长。
1.3治疗方法口服本发明5g,2次/d,4周为一疗程。每周复查前列腺液1次,如未愈再进入第2个疗程,最长治疗4个疗程。
2疗效观察
2.1疗效评定标准
治愈:症状全部消失,前列腺液常规检查结果正常;显效:上述两项,一项正常,一项好转;有效:两项均好转或其中一项好转;无效:两项均无变化或加重。
结果见下表:
治疗前后临床症状对比
症状 | 疗前例数 | 疗后消失例数 | 有效率(%) |
小腹坠涨尿频尿痛排尿不尽尿道口有粘液腹股沟及睾丸痛腰骶发酸功能性阳痿遗精早泄情绪低落、顾虑重重 | 2824238231753117 | 262012620142285 | 92.983.352.275.087.082.440.066.772.771.4 |
疗效与病程关系
病程 | n | 治愈 | 显效 | 有效 | 无效 | 有效率(%) |
1~6个月7~12个月13个月以上 | 21611 | 1644 | 201 | 211 | 115 | 95.2483.3354.55 |
具体实施例1:
按下述配比称取原料:
薏苡仁180g 浙贝母120g 川木通108g
栀子108g 金银花120g 旋覆花108g
泽兰108g 大黄36g 铜绿6g
甘草48g 黄芪144g
其颗粒的制备方法的工艺步骤如下:
所述的剂型为颗粒的制备方法的工艺步骤如下:
(1)、将各味药材按量称取,净制后备用;
(2)、将浙贝母、铜绿粉碎成细粉过100目筛,备用;
(3)、将川木通、薏苡仁、炒制过的栀子、金银花、旋覆花、泽兰、大黄、甘草、蜜炙过的黄芪九味药加10倍量水煎煮三次,每次1小时,合并煎液,滤过,滤液在-0.08Mpa,80℃的条件下减压浓缩,至在55℃下,相对密度为1.20~1.25的稠膏,喷雾干燥;
(4)、加入步骤(2)中的细粉、蔗糖和糊精,混匀,加适量乙醇润湿,制粒,即得。
具体实施例2:按下述配比称取原料:
薏苡仁100g 浙贝母90g 川木通80g
栀子80g 金银花90g 旋覆花80g
泽兰80g 大黄20g 铜绿1g
甘草30g 黄芪100g
其颗粒的制备方法的工艺步骤如实施例1。
具体实施例3:
按下述配比称取原料:
薏苡仁300g 浙贝母200g 川木通180g
栀子180g 金银花200g 旋覆花180g
泽兰180g 大黄50g 铜绿10g
甘草60g 黄芪220g
其颗粒的制备方法的工艺步骤如实施例1。
Claims (4)
1.一种治疗前列腺增生症的药物,其特征在于制成所述中药有效成分的原料组成及其重量配比为:
薏苡仁100-300份 浙贝母90-200份 川木通80-180份
栀子80-180份 金银花90-200份 旋覆花80-180份
泽兰80-180份 大黄20-50份 铜绿1-10份
甘草30-60份 黄芪100-220份。
2.根据权利要求1所述的治疗前列腺增生症的药物,其特征在于:其中各原料的较佳的重量配比是:
薏苡仁150-200份 浙贝母100-170份 川木通90-150份
栀子90-150份 金银花100-170份 旋覆花90-180份
泽兰90-150份 大黄30-40份 铜绿5-8份
甘草40-50份 黄芪120-200份。
3.根据权利要求1所述的治疗前列腺增生症的药物,其特征在于:其中各原料的最佳的重量配比是:
薏苡仁180份 浙贝母120份 川木通108份
栀子108份 金银花120份 旋覆花108份
泽兰108份 大黄36份 铜绿6份
甘草48份 黄芪144份。
4.根据权利要求1或2或3所述的治疗前列腺增生症的药物及其制备方法,其特征在于:
所述的剂型为颗粒的制备方法的工艺步骤如下:
(1)、将各味药材按量称取,净制后备用;
(2)、将浙贝母、铜绿粉碎成细粉过100目筛,备用;
(3)、将川木通、薏苡仁、炒制过的栀子、金银花、旋覆花、泽兰、大黄、甘草、蜜炙过的黄芪九味药加10倍量水煎煮三次,每次1小时,合并煎液,滤过,滤液在-0.08Mpa,80℃的条件下减压浓缩,至在55℃下,相对密度为1.20~1.25的稠膏,喷雾干燥;
(4)、加入步骤(2)中的细粉、蔗糖和糊精,混匀,加适量乙醇润湿,制粒,即得。
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