CN1277552C - 五味牵牛胶囊及其制备工艺 - Google Patents
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Abstract
一种五味牵牛胶囊是由牵牛子、穿山甲等五种中药材制成的治疗前列腺增生症和慢性前列腺炎的中成药制剂,其加工由穿山甲制粉、小茴香提取挥发油并包和、其余中草药煎煮后浓缩清膏、混制软材、过筛制粒、烘干装囊等工艺组成,其制剂生产成本低廉,加工工艺简便,质量稳定,无毒副作用,口服方便,疗效突出。
Description
所属技术领域
本发明五味牵牛胶囊及其制备工艺属纯中药复方制剂,尤其涉及治疗前列腺增生症和慢性前列腺炎纯中药制剂及其制备工艺。
背景技术
前列腺增生症和慢性前列腺炎是最常见的威胁男性健康的疾病。前列腺增生症又称前列腺肥大,是男性老年病,40岁以上男子病理上均有不同程度的前列腺增生,50岁以后才逐渐出现症状,发病率随年龄而逐渐增加。随着我国人民生活水平和健康水准不断提高,医疗条件的不断改善,居民的平均寿命相应延长,本病的发病率显著升高。据国内统计资料,50岁以上的老年人36~38%有前列腺增生。由于前列腺增生引起尿路梗阻,排尿不利,其中60%可出现急性尿潴留,直接威胁肾功能,对患者的生活和健康带来严重的危害。前列腺增生症约占泌尿外科住院病人的8~11%,仅次于尿路结石而居第二位。慢性前列腺炎则是更为常见和多发的男性病,占泌尿外科男性患者的35~40%,多发于20~40岁的青壮年。被世界卫生组织称为“21世纪病”。目前一般将慢性前列腺炎分为细菌性和无菌性两类,但无论细菌性和无菌性两者都有慢性前列腺炎的症状和体征,前列腺都有一定的异常改变,且发病缓慢、症状多样、临床疗效欠佳,以致病程迁延、经久难愈,甚至导致阳痿、不育等许多继发疾病,给患者造成很大的精神压力甚至悲观失望。
前列腺增生症和慢性前列腺炎作为慢性病、疑难病,不少医家都进行了理论与临床探索,但是,明确前列腺增生症和慢性前列腺炎属于本虚而标实,但以标实为主,且以下焦湿热积滞,肝经痰气瘀阻,壅塞胞内为主要病机的报道尚未见到,由于前列腺增生症的患者年龄偏大,而且往往伴有心、脑、肾等疾病,所以有很大一部分患者不能进行手术治疗。保守治疗有雌激素疗法、α肾上腺能受体阻滞剂疗法(如竹林胺)以及局部注射疗法等效果均难尽如人意,为针对下焦湿热积滞,肝经痰气瘀阻,壅塞胞内为主要病机的前列腺增生症和慢性前列腺炎的新型中成药提供了很大市场。
发明内容
本发明的目的是:选用五种中药材组成组方,生产加工成具有泻湿热、化痰瘀、理气通便功能的复方中药胶囊,用于口服,治疗前列腺增生症和慢性前列性炎,并达到安全、有效、生产成本低廉、无毒副作用。
为了实现上述目的,本发明五味牵牛胶囊及其制备工艺采取的技术方案是:五味牵牛胶囊组方药由27.6%牵牛子、13.8%穿山甲、13.8%川楝子、27.6%黄芪、13.8%小茴香和3.4%β-环糊精辅料组成;五味牵牛胶囊的制备工艺是先把穿山甲于60℃烘干后粉碎过筛,取1/2处方量细粉备用;小茴香加水蒸馏,收集挥发油,以β-环糊精包合备用;将黄芪、牵牛子、川楝子、剩余穿山甲与小茴香药渣,加水煎煮3次,合并3次滤液及收集挥发油后的残滤液,减压浓缩至相对密度为1.28~1.30(60℃)的清膏,加入穿山甲细粉,与β-环糊精包合物混匀,制粒,装入0号胶囊,制成1000粒,即得成药,供患者口服。根据传统中药理论,在本方剂中,牵牛子利水通便,祛痰逐饮,除水气虚肿,治痃癖气块为君药;穿山甲活血散结,消痈溃坚,通经脉,消痈肿为臣药;川楝子疏肝泄热,行气止痛,治疝瘕,除痛气,利小便,通大肠,治肾肝气伤,黄芪益气升阳,利水消肿,托毒生肌,助气壮筋骨,长肉补血,益肾气,去肌热,两药共为佐药;小茴香温肾暖肝,行气止痛,除疝气,暖丹田,壮筋骨为使药,诸药协同共奏泻湿热、化痰瘀、理气通便之功能,对证属下焦湿热积滞,肝经痰气瘀阻,有舌苔厚积之前列腺增生症和慢性前列腺炎患者有显著疗效。据中药现代化理论,本制剂中聚穿山甲中多种微量元素和16种游离氨基酸与小茴香中的多种挥发性油和四味中草药中水溶性物质为一体,促进体肠蠕动,抗溃疡,抑菌消炎,促进肝肿蛋白质更新,有效治疗前列腺增生症和慢性前列腺炎,制剂中含有抗微生物的月桂烯、柠檬烯等挥发性油成分,促使制剂质量稳定,保质期长。
本发明五味牵牛胶囊及其制备工艺的有益效果是:配方中五种中药原料来源广泛,价格低廉,均无毒副作用,加工工艺简便,生产成本低廉,质量稳定,口服方便,治疗前列腺增生症和慢性前列腺炎有突出疗效。
具体实施方式
1.五味牵牛胶囊中各组方最佳有效组方量、百分比含量如下表:
| 中药材名称 | 牵牛子 | 穿山甲 | 川楝子 | 黄芪 | 小茴香 | β-环糊精 | 合计 |
| 配方量(克) | 276 | 138 | 138 | 276 | 138 | 34 | 1000 |
| 含量(%) | 27.6 | 13.8 | 13.8 | 27.6 | 13.8 | 3.4 | 100 |
2.五味牵牛胶囊制备工艺:
①取五种中药材筛净除杂后按配方称量备用;
②将穿山甲于60℃烘干后粉碎过80目筛,取一半处方量细粉后与另一半粗粉分别备用;
③把小茴香加5倍水蒸馏,收集挥发油滤过,将滤液和β-环糊精采用饱和水溶液电动搅拌法包合,取包和物与残滤物分别备用;
④把黄芪、牵牛子、川楝子和剩余的穿山甲与小茴香药渣加5倍水煎煮3次,每次1小时,合并3次滤液,加入小茴香残滤物于一体,减压浓缩至相对密度为1.28~1.30(60℃)的清膏备用;
⑤最后将备用穿山甲粉、备用β-环糊精包和物加入备用清膏中混拌均匀,制成软材,并过16目筛制粒,经60℃烘干,装入0号胶囊得成药。
3.用法与用量:口服,一日3次,每次4粒。
Claims (2)
1、一种五味牵牛胶囊,其特征在于原料组成为27.6%牵牛子、13.8%穿山甲、13.8%川楝子、27.6%黄芪、13.8%小茴香和3.4%β-环糊精。
2、如权利要求1所述五味牵牛胶囊的制备工艺,其特征是:先把穿山甲于60℃烘干后粉碎过筛,取1/2处方量细粉备用;小茴香加水蒸馏,收集挥发油,以β-环糊精包合备用;将黄芪、牵牛子、川楝子、剩余穿山甲与小茴香药渣,加水煎煮3次,合并3次滤液及收集挥发油后的残滤液,减压浓缩至60℃时相对密度为1.28~1.30的清膏,加入穿山甲细粉,与β-环糊精包合物混匀,制粒,装入0号胶囊,即得成药。
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