CN103919961A - 一种治疗中老年肾亏肾阳虚的中药制剂及其制备方法 - Google Patents
一种治疗中老年肾亏肾阳虚的中药制剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗中老年肾亏肾阳虚的中药制剂，它是由下述重量配比的原料制成：人参43-58，鹿茸35-45，山药85-96，补骨脂32-45，蛇床子40-50，淫羊藿90-99，海马22-35，山萸肉85-96，杜仲90-98，肉苁蓉92-99，熟地黄90-100，丹参92-99，川牛膝86-95，枸杞86-95，茯苓90-105，泽泻55-65，肉桂10-16。本发明制备方法，将所述十七味中药材于烘干,粉碎，过100-120目药筛，细粉与加蜂蜜混匀，制成小蜜丸。本发明配伍合理，临床也证实有明显的作用，它是集补气调经,补肾补血,活血通脉,通调机体为一体，它滋阴补肾，益精血,是补肾壮阳的良药。
Description
技术领域
本发明涉及中药制剂，具体涉及一种治疗中老年肾亏肾阳虚的中药制剂。
背景技术
中老年人常因肾精亏损导致早衰体弱、畏寒肢冷、神疲乏力、阳痿、健忘等，目前治疗和缓解中老年肾阳虚是一重大课题，中老年人的家庭幸福直接影响着家庭成员的和谐然而西药治标不治本，而中药能从根本上缓解这一病症。
发明内容
为了解决现有西药对中老年人肾亏肾阳虚治标不治本的问题，本发明提供了一种治疗中老年肾亏肾阳虚的中药制剂及其制备方法。
本发明的方案是：一种治疗中老年肾亏肾阳虚的中药制剂，它是由下述重量配比的中药原料制成的药剂：人参43-58，鹿茸35-45，山药85-96，补骨脂32-45，蛇床子40-50，淫羊藿90-99，海马22-35，山萸肉85-96，杜仲90-98，肉苁蓉92-99，熟地黄90-100，丹参92-99，川牛膝86-95，枸杞86-95，茯苓90-105，泽泻55-65，肉桂10-16。
所述的一种治疗中老年肾亏肾阳虚的中药制剂，它是由下述重量配比的中药原料制成的药剂：人参48-55，鹿茸38-42，山药90-93，补骨脂35-42，蛇床子45-48，淫羊藿95-98，海马25-30，山萸肉90-95，杜仲92-98，肉苁蓉95-98，熟地黄95-98，丹参95-98，川牛膝88-92，枸杞90-93，茯苓95-100，泽泻60-65，肉桂15-16。
所述的一种治疗中老年肾亏肾阳虚的中药制剂，它是由下述重量配比的中药原料制成的药剂：人参51，鹿茸39，山药90，补骨脂36，蛇床子45，淫羊藿98，海马30，山萸肉90，杜仲98，肉苁蓉98，熟地黄98，丹参98，川牛膝86-95，枸杞90，茯苓98，泽泻60，肉桂15。
上述的一种治疗中老年肾亏肾阳虚的中药制剂，其特征在于还包括蜂蜜适量。
本发明的另一目的在于提供一种治疗中老年肾亏肾阳虚的中药制剂制备方法，包括：将所述十七味中药材于60℃以下烘干,粉碎成细粉，过100-120目药筛，细粉与加蜂蜜混匀，制成小蜜丸，灭菌，检验，分装，即得。
上述的一种治疗中老年肾亏肾阳虚的中药制剂制备方法，所述每100克细粉用蜂蜜100～120克。
上述的一种治疗中老年肾亏肾阳虚的中药制剂制备方法，还包括在细粉和蜂蜜混合前还包括将蜂蜜加热至116～118℃，待冷却至60～80℃时再将药物细粉和蜂蜜混匀后应放置一定时间，使蜂蜜充分润湿药粉后再制丸。
上述的一种治疗中老年肾亏肾阳虚的中药制剂制备方法，在制蜜丸的过程中还应用有润滑剂，所述的润滑剂是蜂蜡与麻油的融合物，油蜡配比为7：3。
本发明提及的17种天然中药材的性味、功能主治如下：
1.丹参
主要成分：含丹参酮类物质，还有原儿茶醛、原儿茶醛酸、VE等。
性味与归经：苦，微寒。归心、肝经。
功能与主治：祛瘀止痛，活血通经，清心除燥。
2.人参
主要成分：含人参皂甙Ro、Ra、Rb1、Rb2、Rc、Rp、Re、Ra1、Ra2、Ra3，三七皂甙R4，人参皂甙Rh3、Rf4，假人参皂甙F11、Rp1、Rt1等，人参皂甙元主要有人参二醇、人参三醇、果酸等。挥发油含人参烯、人参炔醇、人参炔三醇，人参多糖A、B、C、D、E、Q、R、S、T、U。，人参含38.7%水溶性多糖和8.7%-10.0%碱溶性多糖，其中80%为人参淀粉，20%为人参果酸。
性味与归经：微苦，甘，平。归脾、肺、心经。
功能与主治：大补元气，复脉固脱，补脾益肺，生津，安神。消积化滞。
3.山萸肉
主要成分：含山萸肉甙、熊果酸等成分。
性味与归经：涩，酸，温。归肝、肾经。
功能与主治：补益肝肾，涩精固脱。
4.山药
主要成分：根中含皂甙、黏液质、尿素囊、胆碱、精氨酸、淀粉酶、蛋白质、脂肪、淀粉及碘质等。
性味与归经：甘，平。归肺、脾、肾经。
功能与主治：补脾养胃，生津益肺，补肾涩精。
5.川牛膝
主要成分：川牛膝含昆虫变态激素，呈生物碱性反应。
性味与归经：甘、微苦、平。归肝、肾经。
功能与主治：逐瘀通经，通利关节，利尿通淋。
6.熟地黄
主要成分：含梓醇，此成分在加热烘干时大量产生，糖类是生地黄中的3倍多。性味与归经：甘、微温。归肝、肾经。
功能与主治：滋阴补血，益精填髓。
7.肉苁蓉
主要成分：含d-甘露醇、胡萝卜甙、丁二酸、三十烷醇、8-表马钱子酸葡糖甙、另含甜菜碱、咖啡酸糖脂和多糖类化合物，还含有多种氨基酸及睾丸酮和雌二醇等。
性味与归经：甘、咸、温。归大肠、肾经。
功能与主治：补肾阳，益精血，润肠通便。
8.柏子仁
主要成分：含脂肪油14%，还有少量挥发油和皂甙等。
性味与归经：甘、平。归心、肾、大肠经。
功能与主治：养心安神，止汗，润肠。
9.鹿茸
主要成分：含脑素、雌酮和19种氨基酸、骨质、骨胶、脂类等。
性味与归经：甘、咸、温。归肝、肾经。
功能与主治：壮肾阳，益精血，强筋骨，调冲任，托疮毒。
10.补骨脂
主要成分：果实含挥发油约20%、有机酸、一种甲基糖甙、碱溶性树脂、不挥发性萜类油、皂甙。种子含香豆精类补骨脂素和异补骨脂素共约1.1%、黄酮类补骨脂黄酮、甲基补骨脂黄酮、异补骨脂黄酮和查耳酮类补骨脂查耳酮、异补骨脂查耳酮、单萜烯酚衍生物补骨脂酚；尚含挥发油、树脂、脂肪油。花含脂肪油、挥发油、甾醇、生物碱等。本植物还含棉子糖。
性味与归经：辛，温。入肾经。
功能与主治：补肾助阳。治肾虚冷泻，遗尿，滑精，小便频数，阳痿，腰膝冷痛，虚寒喘嗽。外用治白癜风。
11.蛇床子
主要成分：果实含挥发油1.3%，主要成分为蒎烯、莰烯、异戊酸龙脑酯、异龙脑。又含甲氧基欧芹酚，蛇床明素，异虎耳草素，佛手柑内酯，二氢山芹醇及其当归酸酯、乙酸酯和异戊酸酯，蛇床定，异丁酰氧基二氢山芹醇乙酸酯。根含蛇床明素、异虎耳草素、别欧芹属素乙、花椒毒酚、欧芹属素乙。
性味与归经：辛苦。温。入肺、肾二经。
功能与主治：温肾助阳，祛风，燥湿，杀虫。治男子阳痿，阴囊湿痒，女子带下阴痒，子宫寒冷不孕，风湿痹痛，疥癣湿疮。
12.山萸肉即山茱萸
主要成分：含莫罗忍冬甙（morroniside）、7-0-甲基莫罗忍冬甙（7-0-methylmorroniside）、獐牙菜甙（sweroside）、番木鳖甙（Ioganin）、山茱萸鞣质1、2、3、（cornus-tannin1,2,3）等。
性味与归经：酸、涩，微温。归肝、肾经。
功能与主治：补益肝肾，涩精固脱。用于眩晕耳鸣，腰膝酸痛，阳痿遗精，遗尿尿频，崩漏带下，大汗虚脱，内热消渴。
13.杜仲
主要成分：树皮含杜仲胶6～10%，根皮约含10～12%，为易溶于乙醇，难溶于水的硬性树胶。此外，还含糖甙0.142毫克%、生物碱0.066毫克%、果胶6.5毫克%、脂肪2.9毫克%、树脂1.76毫克%、有机酸0.25毫克%、酮糖(水解前2.15毫克%、水解后3.5毫克%)、维生素C20.7毫克%、醛糖、绿原酸。
性味与归经：甘微辛，温。入肝、肾经。
功能与主治：补肝肾，强筋骨，安胎。治腰脊酸疼，足膝痿弱，小便余沥，阴下湿痒，胎漏欲堕，胎动不安，高血压。
14.枸杞
主要成分：枸杞子中含胡萝卜素3.39毫克%，硫胺素0.23毫克%，核黄素0.33毫克%，菸酸1.7毫克%，抗坏血酸3毫克%。尚分离出β-谷甾醇、亚油酸。
性味与归经：甘，平。归肝、肾经。
功能与主治：滋肾，润肺，补肝，明目。治肝肾阴亏，腰膝酸软，头晕，目眩，目昏多泪，虚劳咳嗽，消渴，遗精。
15.茯苓
性味与归经：甘、淡，平。归心、肺、脾、肾经。
功能与主治：利水渗湿，健脾宁心。用于水肿尿少，痰饮眩悸，脾虚食少，便溏泄泻，心神不安，惊悸失眠。
16.泽泻
主要成分：块茎中分出五种三萜类化合物：泽泻醇A、泽泻醇B，乙酸泽泻醇A酯、乙酸泽泻醇B酯和表泽泻醇A；另含挥发油(内含糠醛)、小量生物碱、天门冬素、一种植物甾醇、一种植物甾醇甙、脂肪酸(棕榈酸、硬脂酸、油酸、亚油酸)；还含树脂、蛋白质和多量淀粉(23%)。性味与归经：甘，寒。入肾、膀胱经。
功能与主治：利水，渗湿，泄热。治小便不利，水肿胀满，呕吐，泻痢，痰饮，脚气，淋病，尿血。
17.肉桂
主要成分：皮含挥发油(称桂皮油)1～2%，主要成分为桂皮醛75～90%，并含少量乙酸桂皮酯、乙酸苯丙酯等。本品不含丁香油酚。尚含粘液、鞣质等。
性味与归经：辛甘，热。入肾、脾，膀胱经。
功能与主治：补元阳，暖脾胃，除积冷，通血脉。治命门火衰，肢冷脉微，亡阳虚脱，腹痛泄泻，寒疝奔豚，腰膝冷痛，经闭癥瘕，阴疽，流注，及虚阳浮越，上热下寒。
本发明以人参和鹿茸为主药应用，效果理想。人参主要含人参皂甙，功为大补元气，复脉固脱，补脾益肺，生津，安神，用于体虚欲脱，阳痿宫冷。资料显示人参能调整中枢神经系统的兴奋性，尤其使中枢神经系统的兴奋性增强明显，能提高大脑的记忆能力，延缓大脑的萎缩，增强机体的免疫力，抑制血小板的凝聚，降血脂及抗动脉粥样硬化，调节内分泌功能，抗衰老及增强机体抗应激能力，它是治疗心率失常、冠心病、高凝血症组方中的首选药，配以鹿茸（参茸为方中主药），鹿茸含脑素、雌酮、19种氨基酸和20多种元素，功为壮肾阳，益精血，强筋骨，调冲任，托疮毒，用于阳痿等症，它抗衰老、保护损伤、提高大脑的记忆能力，尤其对性功能的影响，鹿茸多肽能使雄性小鼠血浆中黄体生成素和睾丸酮含量均增加，以鹿茸为主药的神威丸，以3.0、1.5、0.75g/Kg的剂量灌胃，能促进雄性小鼠性腺和付性腺生长发育，还能使前列腺、精囊重量增加，有雄性激素样作用，鹿茸粉强筋壮骨，有增进食欲作用，抗失眠，临床上以人参和鹿茸为主药，配补骨脂、淫羊藿、海马、山萸肉、丹参、川牛膝及枸杞等组成，本发明效果较为理想。
中老年由于身体机能减退,阳气亏乏,肾精气日见匮乏,加之阴阳失衡导致精力低下,腰膝酸软,困倦,性功能低下,本病的主体为肾阳虚衰，经络调节失常所致阴阳两气上下运行阻滞,故应以补益肾气为主。
本发明中的人参大补元气、补脾益肺，鹿茸壮肾阳、益精血，二药为君药；补骨脂、蛇床子、淫羊藿、海马、肉苁蓉补肾壮阳，肉桂补火助阳、散寒止痛、温通经脉，山萸肉、杜仲补益肝肾，增强君药补肾阳的作用，共为臣药；熟地黄养血滋阴、补精益髓，枸杞滋补肝肾、明目、润肺，山药益气养阴、补脾肺肾，以上三药以补肾阴为主，根据阴阳互根原理，善补阳者，必以阴中求阳，则升化无穷，增强君药臣药补肾阳的作用，使肾阴肾阳并补，共为佐药；方中取丹参活血化瘀、养血安神,川牛膝活血祛瘀、补肝肾、强筋骨，引药下行，茯苓,泽泻利小便、健脾宁心，四药共为使药。
本发明产品的用法用量：口服：20丸/次，3次/日，饭后服用。每20丸相当于原药材2.8克。
下面结合临床试验数据对本发明效果进行详细说明：
方法:将100例自愿受试者随机分为治疗组50例和对照组50例。治疗组口服本发明制剂，每次6丸，每日2次；对照组口服金贵肾气丸(北京同仁堂)，每次1丸，每日3次。2组疗程均为2-4周。
结果:治疗组总有效率98%，明显优于对照组68%；统计学有显著差异；治疗组在改善性功能和缓解相应病症上、生活质量提高等方面均优于对照组。
结论:本发明制剂治疗和改善肾阳虚、肾亏及相应病症效果好。
资料与方法
临床病例
纳入标准：所有病例均符合肾阳虚、肾亏及其相应病症,符合中医诊断;主症:腰膝酸痛,畏寒肢冷,性欲减退,舌质胖大,苔白,脉沉;次症:精神不振,夜尿频多,下肢浮肿,气短而喘,大便溏,脱发。
剔除标准：(1)有明显兼夹证或合併证者。(2)18岁以下或者65岁以上,妊娠及哺乳期妇女,过敏体质(3)排除有心脏病、高血压、心肺功能严重障碍、重度心律失常,精神病患者(4)没安规定用药或无法判断疗效者。
病例来源：100例患者均为门诊病人。所有病例随机分为2组。治疗组50例，男40例，女10例，年龄36岁～50岁，平均43±7岁；病程2年～12年;对照组50例，男43例，女7例，年龄39岁～53岁，平均46±7岁；病程1年～13年，2组患者的年龄、性别、病程等资料均无显著性差异(P均值>0.05)，具有可比性。
治疗方法：治疗组口服本发明制剂，每次6粒，每日2次；对照组口服金贵肾气丸，每次1.丸，每日3次。2组疗程均为2-4周。2组患者治疗前均停服其它药1周以上；治疗期间禁服其它药物。
观察指标：
详细统计患者心慌、乏力、性功能、脉像、舌像、血压、肾功能及自身其它体症。
用药前后做心慌、乏力、性功能、脉像、舌苔、血压等统计及肾功能及等指标測试和记录。
疗效标准:
显效：肾阳虚的症状和体症等症壮显著改善,同等劳累程度不引起不适,房事过后不感觉劳累,房事时间明显延长,脉像、舌像好转,肝肾功能指标显著改善；
有效：肾阳虚的症状和体症等症有好转；
无效；肾阳虚的症状和体症等症无改善。
做肾功能指标用药前后统计。
统计学处理:计量资料用均数±标准差表示，采用方差分析；计数资料用X2检验，P<0.05为差异有显著性。
结果
症状改善情况
两组患者治疗后症状改善比较
表1两组患者治疗后症状改善比较
注：a:P<0.01治疗组vs对照组
两组患者治疗后的比较
表2两组患者治疗后二周疗效比较
注：a:P<0.01治疗组vs对照组
表3两组患者治疗后四周疗效比较
注：a:P<0.01治疗组vs对照组
两组患者治疗前后肾功能比较见表4,5。
表4两组患者治疗后二周肾功能比较
表5两组患者治疗后四周肾功能比较
该病属中医的肾阳虚衰及阴阳失蘅范畴，其病在于肾，主要病机为肾虚标实，标实责之于气滞、血瘀、身体机能调节失控，肾阳虚责之于气脉阴阳，经络阻滞,而主要病理仍为气滞,经络失调。本发明制剂具有滋阴补血,补肾壮阳，强筋健体,益精填髓,使肾阳虚得祛，气血调达，从而达到治疗中老年肾亏肾阳虚衰,通调机体的目地。
本发明配伍合理，临床也证实有明显的作用，它是集补气调经,补肾补血,活血通脉,通调机体为一体，它滋阴补肾，益精血,是目前补肾壮阳的良药。
本发明疗效优于对照组，治疗过程中未引起任何不良反应，认为此药是治疗肾虚衰肾亏较为理想的药物。
具体实施方式
实施例1
一种治疗中老年肾亏肾阳虚的中药制剂，它是由下述重量配比的中药原料制成的药剂：人参43-58，鹿茸35-45，山药85-96，补骨脂32-45，蛇床子40-50，淫羊藿90-99，海马22-35，山萸肉85-96，杜仲90-98，肉苁蓉92-99，熟地黄90-100，丹参92-99，川牛膝86-95，枸杞86-95，茯苓90-105，泽泻55-65，肉桂10-16。
本发明一种治疗中老年肾亏肾阳虚的中药制剂制备方法，包括：将所述十七味中药材于60℃以下烘干,粉碎成细粉，过100-120目药筛，细粉与加蜂蜜混匀，制成小蜜丸，灭菌，检验，分装，即得。所述每100克细粉用蜂蜜100～120克。在细粉和蜂蜜混合前还包括将蜂蜜加热至116～118℃，待冷却至60～80℃时再将药物细粉和蜂蜜混匀后应放置一定时间，使蜂蜜充分润湿药粉后再制丸。在制蜜丸的过程中还应用有润滑剂，所述的润滑剂是蜂蜡与麻油的融合物，油蜡配比为7：3。
实施例2
一种治疗中老年肾亏肾阳虚的中药制剂，它是由下述重量配比的中药原料制成的药剂：人参48-55，鹿茸38-42，山药90-93，补骨脂35-42，蛇床子45-48，淫羊藿95-98，海马25-30，山萸肉90-95，杜仲92-98，肉苁蓉95-98，熟地黄95-98，丹参95-98，川牛膝88-92，枸杞90-93，茯苓95-100，泽泻60-65，肉桂15-16。
制备方法同实施例1。
实施例3
一种治疗中老年肾亏肾阳虚的中药制剂，它是由下述重量配比的中药原料制成的药剂：人参51，鹿茸39，山药90，补骨脂36，蛇床子45，淫羊藿98，海马30，山萸肉90，杜仲98，肉苁蓉98，熟地黄98，丹参98，川牛膝86-95，枸杞90，茯苓98，泽泻60，肉桂15。
制备方法同实施例1。
实施例4
一种治疗中老年肾亏肾阳虚的中药制剂，它是由下述重量配比的中药原料制成的药剂：人参58，鹿茸45，山药96，补骨脂45，蛇床子50，淫羊藿99，海马35，山萸肉96，杜仲98，肉苁蓉99，熟地黄100，丹参99，川牛膝95，枸杞95，茯苓105，泽泻55-65，肉桂10-16。
制备方法同实施例1。
实施例5
一种治疗中老年肾亏肾阳虚的中药制剂，它是由下述重量配比的中药原料制成的药剂：人参43，鹿茸35，山药85，补骨脂32，蛇床子40，淫羊藿90，海马22，山萸肉85，杜仲90，肉苁蓉92，熟地黄90，丹参92，川牛膝86，枸杞86，茯苓90，泽泻55，肉桂10。
制备方法同实施例1。
实施例6
一种治疗中老年肾亏肾阳虚的中药制剂，它是由下述重量配比的中药原料制成的药剂：人参48，鹿茸38，山药90，补骨脂35，蛇床子45，淫羊藿95，海马25，山萸肉90，杜仲92，肉苁蓉95，熟地黄95，丹参95，川牛膝88，枸杞90，茯苓95，泽泻60，肉桂15。
制备方法同实施例1。
实施例7
一种治疗中老年肾亏肾阳虚的中药制剂，它是由下述重量配比的中药原料制成的药剂：人参55，鹿茸42，山药93，补骨脂42，蛇床子48，淫羊藿98，海马30，山萸肉95，杜仲98，肉苁蓉98，熟地黄98，丹参98，川牛膝92，枸杞93，茯苓100，泽泻65，肉桂16。
制备方法同实施例1。
实施例8
一种治疗中老年肾亏肾阳虚的中药制剂，它是由下述重量配比的中药原料制成的药剂：人参5.1g，鹿茸3.6g，怀山药9.0g，补骨脂3.6g，蛇床子9.0g，淫羊藿9.8g，海马6.0g，山萸肉9.0g，杜仲9.8g，肉苁蓉9.8g，熟地黄9.8g，丹参9.8g，川牛膝9.0g，枸杞9.0g，茯苓9.8g，泽泻6.0g，肉桂15.0g，蜂蜜适量，共制成1000丸。
制备方法同实施例1。
下面对本发明的初步稳定性实验进行详细描述
一.实验方法：正常室温留样观察法。
1.实验用仪器：岛津LC－10A高效液相色谱仪、岛津CS-930型薄层扫描仪、显微镜、水浴锅、烘箱、分析天平、层析缸、培养箱等。
2.试剂试药：十八烷基硅烷键合硅胶、乙醇、乙酸乙脂、正己烷、甲醇、甲苯、氢氧化钠、乙酸、三氯化铝乙醇试液等。
3.硅胶G（薄层分析用）。
4.丹参酮ⅡA对照品。
二.正常室温留样观察室条件
留样室面积20平方米，室内通风、防潮、照明设施良好，室内最高温度35℃，最低温度15℃左右，相对湿度45～65％。
三.检测方法：根据卫生部药品卫生标准，对本发明样品的不同贮存期进行检验。1.取本品10g，放于干燥恒重扁形称瓶中，精密称重后，打开瓶盖置于干燥箱中（100℃-105℃）5h，盖上瓶盖取出，冷却30分钟，精密称重，重复干燥一次，称重，两次连续称重差异未超过5mg以上。根据减失的重量和挥发药品的重量来计算供试品中含有水份的百分比，本品水分含量未超过15%。
2.取本品10份(标示总重100丸/瓶)，每份称重，与标示重量比较,重量差异均在±10%的范围之内。
3.取本品1瓶，加水50-100ml，1小时内全部溶解，有极少量软化无硬心者。
4.微生物检测均符合规定。
六、结论与讨论
经对三个批次的本发明样品为期0个月至一年的质量考察，考察结果表明，本发明制剂质量比较稳定，各项指标均符合质量标准及药品卫生标准项下有关各项规定。
提示：本品初步稳定性良好。见表6、表7、表8。
表6稳定性实验表第一期样品
表7稳定性实验表第二期样品
表8稳定性实验表第三批样品
下面结合动物试验对本发明进行详细说明：
实验材料动物：SD系雄性大鼠，体重151±12g，试剂：腺嘌呤。放免试剂盒。0.5%腺嘌呤饲料，腺嘌呤占大鼠基础饲料的5%。本发明制剂，用蒸馏水配成50%浓度备用。杞菊地黄丸，长沙九之堂集团有限公司，批号20040405。
实验方法50只大鼠购入后先用市售固体饲料喂养5d，然后将动物随机分为造模组（本发明制剂高、低剂量组，杞菊地黄丸组，模型对照组），空白对照组。造模组用0.5%腺嘌呤饲料喂养30d。30d中，模型对照组、空白对照组灌胃给水（2ml/100g·），其他组用相应浓度的药物（2ml/100g·）灌胃给药。空白对照组正常饲养。每7d称重1次，测1次尿量，根据体重调整给药量，并观察动物的神态、体毛、活动。30d后处死动物，颈动脉取血放免测定其T、E2、LH、T3、T4、F，并测定血尿素氮和肌酐，解剖动物称取肾重并作肾小体数检查。
数肾小体数方法：常规切片，HE染色，在×20光学显微镜下，每张切片任选3个视野，数肾小体数目（肾小球清晰完整，全在视野内为选取条件）。
结果
一般情况模型组：大鼠随着进食含0.5%腺嘌呤饲料日数的增加而日益消瘦，生长发育远不如正常组，出现多尿、体毛干枯不齐、稀疏、脱落现象，畏赛，缩拱背，精神萎顿，反应迟纯，尾部苍白等现象。空白对照组：大鼠活动、饮食正常，毛色光亮。杞菊地黄丸及本发明组：大鼠随着日数的增加而日益消瘦，生长发育不如正常组，出现多尿、体毛干枯不齐、稀疏、脱落现象，畏寒、缩拱背，精神萎顿，尾部苍白等现象，与模型对照组相比较轻。
本发明制剂对腺嘌呤诱发大鼠肾虚模形的影响
本发明制剂对大鼠体重的影响见表9
表9各组大鼠体重变化的比较
与空白组比较△P＜0.01；与模型组比较*P＜0.05，**P＜0.01
本发明制剂对大鼠尿量的影响见表10
表10各组大鼠尿量变化的比较
与空白组比较△P＜0.05；与模型组比较*P＜0.05，**P＜0.01
本发明制剂对大鼠肾重、肾小体数的影响见表11
表11各组大鼠肾重、肾小体数的影响
本发明制剂对大鼠肌酐、尿素氮的影响见表4
表12各组大鼠组肌酐、尿素氮的比较
本发明制剂大鼠F、T、E2、LH的影响见表5
表13各组大鼠血F、T、E2、LH的比较
本发明制剂对T3、T4的影响
表14各组大鼠血F、T、E2、LH的变化
| 组别 | T3 | T4 |
| 空白对照组 | 45.2±8.1 | 7.5±1.1 |
| 模型对照组 | 36.8±8.1△ | 5.2±0.9△ |
| 杞菊地黄丸（1.6g/kg） | 52.0±11.0* | 8.6±1.8* |
| 本发明制剂(4.4g/kg) | 42.0±5.6* | 7.4±0.9* |
| 本发明制剂(13.2g/kg) | 46.5±9.8* | 8.8±1.4* |
该病属中医的肾阳虚衰及阴阳失蘅范畴，其病在于肾，主要病机为肾虚标实，标实责之于气滞、血瘀、身体机能调节失控，肾阳虚责之于气脉阴阳，经络阻滞,而主要病理仍为气滞,经络失调。本发明制剂具有滋阴补血,补肾壮阳，强筋健体,益精填髓,使肾阳虚得祛，气血调达，从而达到治疗中老年肾亏肾阳虚衰,通调机体的目地。
本发明配伍合理，临床也证实有明显的作用，它是集补气调经,补肾补血,活血通脉,通调机体为一体，它滋阴补肾，益精血,是目前补肾壮阳的良药。
下面结合动物试验对本发明原药粉急性毒性进行说明
实验动物
种属：清洁级昆明种小白鼠
体重：实验开始时18-22克。
动物数：共72只，预实验32只，正式实验40只，每组20只。
性别：雌雄各半。
动物标识方法：苦味酸体表标记结合笼牌标记。
动物适应期：2天。
饲养条件：灭菌全价营养颗粒饲料喂食，自由饮水。雌雄分笼饲养，每笼10只。室温24±2°C，相对湿度45～60%，每天光照12h。给药前适应性饲养一天。
实验动物选择理由
在安全性评价研究中昆明种小鼠具有丰富的历史背景数据，是ICH及SFDA的急性毒性研究指导原则中推荐使用动物。此外，前期研究表明啮齿类动物（包括小鼠、大鼠）对该供试品有敏感的生物活性。故选择昆明种小鼠进行急毒试验。
给药途径灌胃给药
实验方法
预实验参照霍恩（Horn）氏方法，取小鼠32只，雌雄各半，随机分成4组，每组8只，分别灌胃给予不同剂量的本发明制剂原药粉0.1ml·10g-1，0.2ml·10g-1，0.3ml·10g-1，0.4ml·10g-1，连续观察72h，未见毒性反应。提示灌胃给药难以测出其LD50。故进行最大耐受量实验。
剂量设置及依据本发明原药粉的临床拟用量为3-5g/次，2次/天，即6-10g/天，按60kg成人计，为0.1g·kg-1。根据预实验结果，以最大浓度48%，最大灌胃体积0.4ml·10g一日内分两次灌胃给药（间隔6-8h）；同时以蒸馏水作为对照。
最大耐受实验：小鼠40只，雌雄各半，随机分成2组，每组20只，分别灌胃给予本发明原药粉和蒸馏水，连续观察14天。
给药体积按0.4ml·10g-1给药。
观察指标给药后立即观察动物活动情况包括（小鼠的呼吸、运动、反射、眼检指征、唾液分泌、竖毛、肌张力、大便、尿液、皮肤反应等）及死亡情况。每天再观察上述指标，并记录体重变化以及死亡情况。
实验结果
本发明原药粉灌胃给药后，小鼠无明显中毒反应，呼吸正常，自主活动与行为活动无改变，未见流泪、眼球突出现象，大便、尿液无异常。观察期间，实验动物摄食正常，体重增加，一般情况良好。实验结束，处死动物进行解剖肉眼观察，心、肝、脾、肺、肾、睾丸、子宫等脏器未见明显病理改变。
实验结论
本实验测得本发明原药粉的最大耐受量为38.4g·kg-1，相当于临床人（60kg）拟用量0.1g·kg-1的384倍。
急性毒性试验动物分组与体重纪录表（首页）
急性毒性试验动物分组与体重纪录表（续页）
急性毒性试验动物分组与体重纪录表（续页）
以上显示和描述了本发明的基本原理和主要特征和本发明的优点。本行业的技术人员应该了解，本发明不受上述实施例的限制，上述实施例和说明书中描述的只是说明本发明的原理，在不脱离本发明精神和范围的前提下，本发明还会有各种变化和改进，这些变化和改进都落入要求保护的本发明范围内。本发明要求保护范围由所附的权利要求书及其等效物界定。
Claims (8)
1.一种治疗中老年肾亏肾阳虚的中药制剂，其特征在于它是由下述重量配比的中药原料制成的药剂：
人参43-58，鹿茸35-45，山药85-96，补骨脂32-45，蛇床子40-50，淫羊藿90-99，海马22-35，山萸肉85-96，杜仲90-98，肉苁蓉92-99，熟地黄90-100，丹参92-99，川牛膝86-95，枸杞86-95，茯苓90-105，泽泻55-65，肉桂10-16。
2.根据权利要求1所述的一种治疗中老年肾亏肾阳虚的中药制剂，其特征在于它是由下述重量配比的中药原料制成的药剂：
人参48-55，鹿茸38-42，山药90-93，补骨脂35-42，蛇床子45-48，淫羊藿95-98，海马25-30，山萸肉90-95，杜仲92-98，肉苁蓉95-98，熟地黄95-98，丹参95-98，川牛膝88-92，枸杞90-93，茯苓95-100，泽泻60-65，肉桂15-16。
3.根据权利要求1所述的一种治疗中老年肾亏肾阳虚的中药制剂，其特征在于它是由下述重量配比的中药原料制成的药剂：
人参51，鹿茸39，山药90，补骨脂36，蛇床子45，淫羊藿98，海马30，山萸肉90，杜仲98，肉苁蓉98，熟地黄98，丹参98，川牛膝86-95，枸杞90，茯苓98，泽泻60，肉桂15。
4.根据权利要求1-3任一项所述的一种治疗中老年肾亏肾阳虚的中药制剂，其特征在于还包括蜂蜜适量。
5.一种如权利要求1所述的一种治疗中老年肾亏肾阳虚的中药制剂制备方法，其特征在于包括：将所述十七味中药材于60℃以下烘干,粉碎成细粉，过100-120目药筛，细粉与加蜂蜜混匀，制成小蜜丸，灭菌，检验，分装，即得。
6.根据权利要求5所述的一种治疗中老年肾亏肾阳虚的中药制剂制备方法，其特征在于所述每100克细粉用蜂蜜100～120克。
7.根据权利要求5所述的一种治疗中老年肾亏肾阳虚的中药制剂制备方法，其特征在于在细粉和蜂蜜混合前还包括将蜂蜜加热至116～118℃，待冷却至60～80℃时再将药物细粉和蜂蜜混匀后应放置一定时间，使蜂蜜充分润湿药粉后再制丸。
8.根据权利要求5所述的一种治疗中老年肾亏肾阳虚的中药制剂制备方法，其特征在于在制蜜丸的过程中还应用有润滑剂，所述的润滑剂是蜂蜡与麻油的融合物，油蜡配比为7：3。
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