CN105343474A - 一种治疗男性更年期综合征的胶囊剂及制备方法 - Google Patents
一种治疗男性更年期综合征的胶囊剂及制备方法 Download PDFInfo
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Abstract
本发明提出了一种治疗男性更年期综合征的胶囊剂及其制备方法,先将以重量份数的生地150~450、牡丹皮150~450、枸杞子150~450、熟地150~450、补骨脂150~450、茯苓150~450、泽泻150~450、山茱萸150~450、炒淮山药150~450、党参150~450、五味子120~180、炒芡实150~450、黄柏120~180、巴戟天150~450、炒远志120~180、知母120~180、沙苑子120~180、肉桂60~140、当归120~180、炙甘草120~180、牡蛎150~450、葛根100~200、柴胡60~140混合经流通蒸汽灭菌、烘干、均匀混合、粉碎成100目以上的药粉、装入2号胶囊制成胶囊剂。本发明药效持续时间长,疗效显著,无副作用。
Description
技术领域
本发明涉及复方中药剂领域,特别是指一种治疗男性更年期综合征的胶囊剂及制备方法。
背景技术
男性更年期综合征是指男性在步入中老年期间,出现性腺功能由盛而衰的转变过程,并相应出现由此而引起的情绪、心理、志趣、精力、思维力、进取心、食欲、体力、和性欲等一系列临床症状的综合症。
中医认为男性更年期综合征多由于肾气衰,天葵竭、精少等生理变化,身体往往出现一种肾阴不足,阳失潜藏,或肾阳虚少,经脉失于温养的阴阳显著不平衡现象。在临床辩证常见有命门火衰型和肝郁脾虚型。命门火衰型伴有阳痿、早泄、小便清长、畏寒肢冷等;肝郁脾虚型伴有烦躁易怒、神疲乏力、纳减便溏等。总的治法以温肾壮阳,疏肝健脾为主,但专用于男性更年期疾病的防治中药制剂尚属少见。
发明内容
本发明提出一种治疗男性更年期综合征的胶囊剂及制备方法,提供一种疗效持续时间长、疗效显著、无副作用的胶囊剂。
提供该胶囊剂的制备方法是本发明的另一发明目的。
本发明的胶囊剂是由以下重量份数的中药为原料药制备获得的:
生地150~450牡丹皮150~450枸杞子150~450
熟地150~450补骨脂150~450茯苓150~450
泽泻150~450山茱萸150~450炒淮山药150~450
党参150~450五味子120~180炒芡实150~450
黄柏120~180巴戟天150~450炒远志120~180
知母120~180沙苑子120~180肉桂60~140
当归120~180炙甘草120~180牡蛎150~450
葛根100~200柴胡60~140。
所述各原料药的优选重量份数为:
生地300牡丹皮300枸杞子300
熟地300补骨脂300茯苓300
泽泻300山茱萸300炒淮山药300
党参300五味子150炒芡实300
黄柏150巴戟天300炒远志150
知母150沙苑子150肉桂100
当归150炙甘草150牡蛎300
葛根150柴胡100。
上述各组份的药物制成胶囊剂。
本发明药物具体的制备方法如下:将生地、牡丹皮、枸杞子、熟地、补骨脂、茯苓、泽泻、山茱萸、炒淮山药、党参、五味子、炒芡实、黄柏、巴戟天、炒远志、知母、沙苑子、肉桂、当归、炙甘草、牡蛎、葛根、柴胡按上述重量份数混合经流通蒸汽灭菌、烘干、均匀混合、粉碎成100目以上的药粉、装入2号胶囊制成胶囊剂。
本发明药物组方中,生地甘,寒;归心,肝,肾经;清热凉血、益阴生津;用于热入营血,阴虚发热,消渴,吐血,衄血,阴伤便秘;壮热神昏,口干舌绛。牡丹皮苦、辛,微寒;归心、肝、肾经;清热凉血,活血化瘀;主治热入营血,温毒发斑,吐血衄血,夜热早凉,无汗骨蒸,经闭痛经,跌扑伤痛,痈肿疮毒。枸杞子甘,平;归肝、肾经;滋补肝肾,益精明目;用于虚劳精亏、腰膝酸痛、眩晕耳鸣、内热消渴、血虚萎黄、目昏不明。熟地甘,微温;归肝、肾经;滋阴补血、补精益髓;主治阴虚血少,脑髓空虚所至的腰膝痿弱、劳嗽骨蒸,遗精,崩漏,月经不调,消渴,溲数,耳聋、目昏,心悸失眠、健忘,盗汗等。补骨脂苦、辛、温;归肾、脾经;补肾壮阳,固精缩尿,肾虚腰痛,小便频数,小儿遗尿,肾漏,温脾止泻,纳气平喘;用于治疗肾虚阳痿,腰膝酸软冷痛,肾虚遗精,遗尿,尿频等。茯苓味甘、淡,性平;归心、肺、脾、肾经;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。泽泻味甘、淡,性寒;归肾、膀胱经;利水渗湿,泄热,化浊降脂;用于小便不利,水肿胀满,泄泻尿少,痰饮眩晕,热淋涩痛,高脂血症。山茱萸味酸、涩,性微温;归肝、肾经;补益肝肾,收涩固脱;用于眩晕耳呜,腰膝酸痛,阳痿遗精,遗尿尿频,崩漏带下,大汗虚脱,内热消渴。炒淮山药甘,平,无毒;归脾、肺、肾经;补脾养胃,生津益肺,补肾涩精,清热解毒;主治脾虚食少、久泻不止、肺虚喘咳、肾虚遗精、带下、尿频、虚热消渴。党参甘,平,无毒。归脾、肺经;主补中,益气,生津;治脾胃虚弱,气血两亏,体倦无力,食少,口渴,久泻,脱肛。五味子味酸,甘,性温,归肺,心,肾经,收敛固涩,益气生津,补肾宁心,用于久嗽虚喘,梦遗滑精,遗尿尿频,久泻不止,自汗盗汗,津伤口渴,内热消渴,心悸失眠。炒芡实味甘、涩,性平;归脾、肾经;益肾固精,补脾止泻,除湿止带;用于遗精滑精,遗尿尿频,脾虚久泻,白浊,带下。黄柏味苦,性寒;归肾、膀胱、大肠经;主清热;燥湿,泻火,解毒;治热痢,泄泻,消渴,黄疸,痿躄,梦遗,淋浊,痔疮,便血,赤白带下,骨蒸劳热,目赤肿痛,口舌生疮,疮疡肿毒。巴戟天味辛甘,性微温;归肾经;补肾阳,强筋骨,祛风湿;用于阳痿遗精,宫冷不孕,月经不调,少腹冷痛,风湿痹痛,筋骨痿软。炒远志苦、辛、温;归心、肾、肺经;安神益智,解郁;主治惊悸,健忘,梦遗,失眠,咳嗽多痰,痈疽疮肿。知母苦,寒;归肺、胃、肾经;清热泻火,滋阴润燥;主治热病烦渴,肺热燥咳,骨蒸潮热,内热消渴,肠燥便秘。沙苑子味甘,性温;归肝、肾经;补肾固精、养肝明目;主治腰膝酸痛、遗精早泄、遗尿、尿频、白带、神经衰弱及视力减退、糖尿病等症。肉桂味辛、甘,性大热;归肾、脾、心、肝经;有补火助阳,引火归元,散寒止痛,温通经脉的功效;用于阳痿宫冷,腰膝冷痛,肾虚作喘,虚阳上浮,眩晕目赤,心腹冷痛,虚寒吐泻,寒疝腹痛,痛经经闭。当归甘、辛、温。归肝、心、脾经;补血活血,调经止痛,润肠通便,用于血虚萎黄、眩晕心悸、月经不调、经闭痛经、虚寒腹痛、肠燥便秘、风湿痹痛、跌扑损伤、痈疽疮疡。炙甘草性平味甘;归心、肺、脾、胃经;补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。牡蛎味咸,性微寒;归肝,肾经;平肝潜阳,重镇安神,软坚散结,收敛固涩;主治眩晕耳鸣,惊悸失眠,瘰疬瘿瘤,症瘕痞块,自汗盗汗,遗精,崩漏,带下。葛根味甘、辛,性凉;归肺、胃经;解肌退热,透疹,生津止渴,升阳止泻;用于表证发热,项背强痛,麻疹不透,热病口渴,阴虚消渴,热泻热痢,脾虚泄泻。柴胡味辛、苦,性微寒;归肝、胆、肺经。和解表里,疏肝解郁,升阳举陷,退热截疟;用于感冒发热,寒热往来,胸胁胀痛,月经不调,子宫脱垂,脱肛。
本发明采用多种药材组合协同,主要用于温肾壮阳、疏肝健脾为主,治疗男性更年期综合症效果显著。本发明将上述药物制成复方中药胶囊既保护了药物药性不被破坏,也保护了消化器官和呼吸道等。
为进一步考察本发明胶囊剂治疗男性更年期综合症的临床疗效,选择150例更年期综合症患者进行了临床疗效观察。
选择门诊男性病人150例,年龄45~55岁,病程最短1年,最长4年,随机分为三组,每组50例,每组一般资料如年龄、病程及治疗前各指标等经统计学处理,差异无显著性意义(P>0.05),具有可比性。中医诊断标准依据广州中医药大学《中医诊断治疗全书》中有关男性更年期综合征的疗效评定标准确诊。
诊断标准
1、精神与神经症状:如神经过敏,情绪不稳,易激动,易躁,易发脾气,倦怠,常有压抑感,记忆力、思维力和集中力减退,皮肤及肢端感觉异常、有麻木、刺痛感,常不安,有恐怖感、孤独感,缺乏自信心,易纠缠琐事。
2、血管调节性失常:如烦热不安,头痛,心悸,眩晕,高血压,与情绪改变密切相关,有时会有自我暗示。
3、性功能减退:大部分病人性欲减低,可有阳痿、早泄、梦遗、滑精等。
检查事项
血浆睾丸酮、雄激素生物活性、垂体促性腺激素水平显著低于正常值,精子数减少稀少I,畸形或缺凹,精液清稀,尿促绒毛膜性腺激素明显升高。
治疗方法
口服本发明胶囊剂,一日2-----—3次,一次5—6粒,在服药期间忌辛辣食物。
疗效标准
治愈:临床症状消失,精神状态恢复正常;
有效:临床症状部分消失,精神状态基本正常;
无效:临床症状以及精神状态无改善。
治疗结果
150例患者的治疗后疗效比较统计结果入下表所示:
组别 | 实施例1 | 实施例2 | 实施例3 |
例数 | 50 | 50 | 50 |
治愈(n%) | 36(72%) | 34(68%) | 32(64%) |
有效(n%) | 12(24%) | 12(24%) | 13(26%) |
无效(n%) | 2(4%) | 4(8%) | 5(10%) |
总有效率(n%) | 96% | 92% | 90% |
本发明药效持续时间长,疗效显著,无副作用,有利于病患及时减轻病状。
具体实施方式
下面给出的实施例拟对本发明作进一步说明,但不能理解为是对本发明保护范围的限制,本领域技术人员根据本发明内容对本发明的一些非本质的改进和调整,仍属于本发明的保护范围。
实施例1
取生地300克、熟地300克、牡丹皮300克、枸杞子300克、葛根150克、补骨脂300克、茯苓300克、炒淮山药300克、山茱萸300克、泽泻300克、五味子150克、党参300克、炒芡实300克、黄柏150克、知母150克、肉桂100克、炒远志150克、当归150克、牡蛎300克、柴胡100克、巴戟天300克、沙苑子150克、炙甘草150克,经流通蒸汽灭菌,在35℃下烘干后混合,粉碎加工成100目以上的药粉,装入2号胶囊。每粒装量0.25克。
使用方法:服用本发明的胶囊剂,一日2-3次,一次4-6粒。
实施例2
取生地150克、熟地150克、牡丹皮150克、枸杞子150克、葛根100克、补骨脂150克、茯苓150克、炒淮山药150克、山茱萸150克、泽泻150克、五味子120克、党参150克、炒芡实150克、黄柏120克、知母120克、肉桂60克、炒远志120克、当归120克、牡蛎150克、柴胡60克、巴戟天150克、沙苑子120克、炙甘草120克,经流通蒸汽灭菌,在40℃下烘干后混合,粉碎加工成过100目以上的药粉,装入2号胶囊。每粒装量0.26克。
使用方法:服用本发明的胶囊剂,一日2-3次,一次4-6粒。
实施例3
取生地450克、熟地450克、牡丹皮450克、枸杞子450克、葛根200克、补骨脂450克、茯苓450克、炒淮山药450克、山茱萸450克、泽泻450克、五味子180克、党参450克、炒芡实450克、黄柏180克、知母180克、肉桂140克、炒远志180克、当归180克、牡蛎450克、柴胡140克、巴戟天450克、沙苑子180克、炙甘草180克,经流通蒸汽灭菌,在50℃下烘干后混合,粉碎加工成100目以上的药粉,装入2号胶囊。每粒装量0.27克。
使用方法:服用本发明的胶囊剂,一日2-3次,一次4-6粒。
Claims (4)
1.一种治疗男性更年期综合征的胶囊剂,是由以下重量份数的中药为原料药制备获得的:
生地150~450牡丹皮150~450枸杞子150~450
熟地150~450补骨脂150~450茯苓150~450
泽泻150~450山茱萸150~450炒淮山药150~450
党参150~450五味子120~180炒芡实150~450
黄柏120~180巴戟天150~450炒远志120~180
知母120~180沙苑子120~180肉桂60~140
当归120~180炙甘草120~180牡蛎150~450
葛根100~200柴胡60~140。
2.根据权利要求1所述的治疗男性更年期综合征的胶囊剂,其特征在于:所述原料药的重量份数为:
生地300牡丹皮300枸杞子300
熟地300补骨脂300茯苓300
泽泻300山茱萸300炒淮山药300
党参300五味子150炒芡实300
黄柏150巴戟天300炒远志150
知母150沙苑子150肉桂100
当归150炙甘草150牡蛎300
葛根150柴胡100。
3.根据权利要求1或2所述的治疗男性更年期综合征的胶囊剂,其特征是将所述药物制成胶囊剂。
4.根据权利要求3所述的治疗男性更年期综合征的胶囊剂的制备方法:将生地、牡丹皮、枸杞子、熟地、补骨脂、茯苓、泽泻、山茱萸、炒淮山药、党参、五味子、炒芡实、黄柏、巴戟天、炒远志、知母、沙苑子、肉桂、当归、炙甘草、牡蛎、葛根、柴胡按上述重量份数混合经流通蒸汽灭菌、烘干、均匀混合、粉碎成100目以上的药粉、装入2号胶囊制成胶囊剂。
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