CN105582133A - 一种治疗前列腺炎的中药组合物 - Google Patents
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Abstract
本发明公开了一种治疗前列腺炎的中药组合物,涉及中医药技术领域。本发明以南沙参、白芥子、石瓜子、海决明、月见草、山香圆叶、金龙胆草、柳叶为原料制得中药组合物颗粒剂。本发明中药组合物通过降低患者前列腺组织中TNF-α和IL-8水平发挥对慢性非细菌性前列腺炎的治疗作用,降低炎症反应程度,从而促进前列腺组织结构的修复。
Description
本申请是申请人山东卫康生物医药科技有限公司提出的发明专利申请(发明名称为:一种治疗前列腺炎的中药组合物及其应用,申请号为:2014104612187,申请日为:2014年9月12日)的分案申请。
技术领域
本发明属于中医药技术领域,涉及一种治疗前列腺炎的中药组合物。
背景技术
慢性非细菌性前列腺炎是一种常见的男性泌尿外科疾病,主要表现为骨盆区域疼痛,可见于会阴、阴茎、肛周部、尿道、耻骨部以及腰骶部部位。排尿异常可表现为尿急、尿频、尿痛和夜尿增多等。由于慢性疼痛久治不愈,患者生活质量下降,并可能有性功能障碍、焦虑、抑郁、失眠、记忆力下降的症状。目前临床上多用抗生素、镇痛药进行治疗,但是抗生素、镇痛药都有一定的副作用,且治疗过程患者十分痛苦。
祖国医学对慢性前列腺炎治疗具有优势。经典的方法主要包括有中药内服、外用贴敷、中药灌肠以及栓剂直肠给药等方法,纵观目前的治疗思路与方法,以活血化瘀、清热利湿通淋、补肾等为治疗法则在临床慢性前列腺炎的治疗中已普遍运用。并且,中医药治疗前列腺炎,具有价廉易得、不良反应小等优点,因此成为当前的研究热点与趋势之一。
发明内容
现代医学认为,慢性非细菌性前列腺炎的发病机制与前列腺的特殊解剖结构、后尿道平滑肌痉挛、前列腺内尿液反流、细胞因子介导的免疫反应等因素相关,其中细胞因子作用愈加显著。本发明人在细胞因子理论的基础上,运用祖国医学的方法,找到了一条治疗慢性非细菌性前列腺炎的新方法。基于此治疗方法,本发明的目的在于提供一种抗前列腺炎的中药组合物及其应用。
为了实现本发明的目的,发明人通过大量试验研究和不懈探索,最终获得了如下技术方案:
一种治疗前列腺炎的中药组合物,包括中药提取物和药用辅料,所述的中药提取物由如下重量份的中药材原料经水提醇沉法制备而成:南沙参9-15份、白芥子9-15份、石瓜子17-24份、海决明10-18份、月见草20-30份、山香圆叶20-30份、金龙胆草9-15份、柳叶6-10份。
优选地,如上所述治疗前列腺炎的中药组合物,所述的中药提取物由如下重量份的中药材原料经水提醇沉法制备而成:南沙参11-13份、白芥子11-13份、石瓜子19-21份、海决明13-15份、月见草23-26份、山香圆叶23-26份、金龙胆草11-13份、柳叶7-9份。
在本发明的一个最优选的实施例中,如上所述的中药提取物由如下重量份的中药材原料经水提醇沉法制备而成:南沙参12份、白芥子12份、石瓜子20份、海决明14份、月见草25份、山香圆叶25份、金龙胆草12份、柳叶8份。
优选地,上述的治疗前列腺炎的中药组合物是口服制剂。再进一步优选地,所述的口服制剂包括口服液、颗粒剂、片剂和胶囊剂。
将上述各中药材制备成本发明的复方颗粒剂的制备方法,包括如下步骤:称取清洗干净的南沙参9-15份、白芥子9-15份、石瓜子17-24份、海决明10-18份、月见草20-30份、山香圆叶20-30份、金龙胆草9-15份、柳叶6-10份,合并,加水煎煮两次,合并煎液,减压浓缩至浸膏,加乙醇使含醇量达70-80%(v/v),搅拌,静置,过滤,滤液减压浓缩成至65℃时相对密度为1.20-1.30,并回收乙醇,得浓缩液,将浓缩液冷冻干燥,粉碎过80目筛,得到清膏粉;将清膏粉与药学上可接受的辅料一起投入槽型混合机中,搅拌,边搅拌边缓缓加入粘合剂,至制成软材,用12目不锈钢筛制粒,60℃条件下鼓风干燥,取出,放凉即得颗粒剂。
需要说明的是,本发明的中药组合物在制备过程中所采用的的中药材原料来源如下:南沙参选用桔梗科植物轮叶沙参Adenophoratetraphylla(Thunb.)Fisch.的干燥根。白芥子选用十字花科植物白芥SinapisalbaL.的干燥种子。石瓜子选用萝藦科眼树莲属植物眼树莲DischidiachinensisChamp.exBenth.的干燥全草。海决明选用马蹄螺科动物黑凹螺Chlorostomanigerrinma(Gmelin)的壳。月见草选用柳叶菜科月见草OenotheraerythrosepalaBorb的干燥根。山香圆叶选用省沽油科植物锐尖山香圆Turpiniaarguta(Lindl.)Seem.[OchrantheargutaLindl.]的干燥叶。金龙胆草选用菊科假蓬属植物小苦蒿ConyzabliniiLevl.的干燥全草。柳叶选用杨柳科植物垂柳SalixbabylonicaL.的干燥叶。
细胞因子的分泌是组织发生炎症的重要因素,TNF-α和IL-8炎性基因表达物在机体的免疫调节以及慢性非细菌性前列腺炎的发病过程中起着非常重要的作用。炎症在感染、毒素、外伤等作用下可产生TNF-α,这些细胞因子可以增加趋化因子如IL-8的表达,表达产物通过各自的机制对机体组织造成损伤并导致疼痛,调控炎性因子可间接抑制炎症反应。因此本发明人选用前列腺组织中TNF-α、IL-8水平作为对慢性非细菌性前列腺炎大鼠治疗的对照指标,结果发现:与假手术组相比,模型对照组大鼠前列腺组织中TNF-α和IL-8水平增高(P<0.01);与模型对照组相比,采用本发明中药提取物干预的治疗组大鼠前列腺组织中TNF-α和IL-8水平显著降低(P<0.01)。因此,本发明还提供了一种制药用途,即:上述的中药提取物在制备治疗慢性非细菌性前列腺炎的药物中的应用。
与现有技术相比,本发明的中药组合物通过降低患者前列腺组织中TNF-α和IL-8水平发挥对慢性非细菌性前列腺炎的治疗作用,降低炎症反应程度,从而促进前列腺组织结构的修复。
具体实施方式
以下是本发明中药组合物的制备实施例和药效试验例,对本发明的技术方案做进一步作描述,但是本发明的保护范围并不限于这些实施例。
实施例1颗粒剂的制备
备料:南沙参1.2kg、白芥子1.2kg、石瓜子2.0kg、海决明1.4kg、月见草2.5kg、山香圆叶2.5kg、金龙胆草1.2kg、柳叶0.8kg。
制备:按处方量称取清洗干净的上述中药材,合并,粉碎,加水煎煮两次,第一次加水为药材重量的10倍量,煎煮2h,第二次加水为药材重量的8倍量,煎煮1h,合并煎液,0.07MPa、65℃温度下减压浓缩至相对密度为1.15的浸膏,加95%(v/v)乙醇使含醇量达75%(v/v),搅拌,静置24小时,过滤,滤液在0.07MPa、65℃条件下减压浓缩成至相对密度为1.25,并回收乙醇,得浓缩液,将浓缩液冷冻干燥,干燥物粉碎过80目筛,得到清膏粉;称取清膏粉10g,乳糖80g,微晶纤维素80g,羧甲基纤维素钠15g,投入槽型混合机中,搅拌20分钟,边搅拌边缓缓加入55%乙醇(体积浓度为55%的乙醇水溶液),至制成软材,用12目不锈钢筛制粒,60℃条件下鼓风干燥,取出,放凉即得颗粒剂,按每袋10g包装。
实施例2颗粒剂的制备
备料:南沙参1.5kg、白芥子1.2kg、石瓜子1.8kg、海决明1.8kg、月见草2.0kg、山香圆叶3.0kg、金龙胆草1.0kg、柳叶1.0kg。
制备:按处方量称取清洗干净的上述中药材原料,合并,粉碎,加水煎煮两次,第一次加水为药材重量的10倍量,煎煮2h,第二次加水为药材重量的8倍量,煎煮1h,合并煎液,0.07MPa、65℃下减压浓缩至相对密度为1.15的浸膏,加95%(v/v)乙醇使含醇量达75%(v/v),搅拌,静置24小时,过滤,滤液在0.07MPa、65℃条件下减压浓缩成至相对密度为1.25,并回收乙醇,得浓缩液,将浓缩液冷冻干燥,粉碎过80目筛,得到清膏粉;称取清膏粉10g,乳糖80g,微晶纤维素80g,羧甲基纤维素钠15g,投入槽型混合机中,搅拌20分钟,边搅拌边缓缓加入55%乙醇(体积浓度为55%的乙醇水溶液),至制成软材,用12目不锈钢筛制粒,60℃条件下鼓风干燥,取出,放凉即得颗粒剂,按每袋10g包装。
实施例3中药颗粒剂对慢性非细菌性前列腺炎大鼠模型的疗效试验研究
2月龄雌性SD大鼠6O只,初始体质量210-250g,自由进食、饮水并保持12h明暗交替光照,室内温度18~25℃,湿度45%-65%,通风良好,实验前在该饲养环境适应1周。采用随机数字表法分为模型对照组、治疗组及假手术组各2O只。采取腹腔注射10%水合氯醛麻醉大鼠后,无菌条件下于下腹部正中切口,暴露两侧精囊腺和前列腺,假手术组大鼠于前列腺侧叶注射生理盐水0.2mL/只,其余大鼠以25%消痔灵注射液0.2mL分别注射至前列腺侧叶,关腹。5周后即可形成慢性非细菌性前列腺炎模型。病理变化为腺体内炎症细胞浸润,分泌物减少,腺腔梗阻、缩小,间质纤维化。术后第5天各组开始相应地灌胃如下剂量的受试物:模型对照组为生理盐水10mL/kg;假手术组为生理盐水10mL/kg;治疗组为实施例1制备的清膏粉0.75g/kg(清膏粉溶于生理盐水)。各组均按1次/d给药,共5周。
末次给药60min后将大鼠断颈处死,分离出前列腺组织,剪碎,按每100mg前列腺组织加生理盐水400μL的比例混匀。吸取20μL混悬液,加入白细胞计数液0.38mL,混匀,充池,在细胞计数板上计数四角4个大方格内的白细胞总数。ELISA试剂盒检测大鼠血清和前列腺组织匀浆内TNF-α、IL-8表达量。
给药结束后观察大鼠的一般情况,模型对照组大鼠与假手术组大鼠比较,活动减少,毛发稀疏无光泽;治疗组大鼠与模型对照组大鼠比较,毛发相对有光泽,一般情况尚可。造模过程中,治疗组意外死亡1只,模型对照组死亡2只。
另外,各组大鼠前列腺组织中TNF-α和IL-8水平统计结果见表1。通过表1的试验结果可以看出,与假手术组相比,模型对照组大鼠前列腺组织中TNF-α和IL-8水平增高(P<0.01)。与模型对照组相比,治疗组大鼠TNF-α和IL-8水平显著降低(P<0.01)。
表1各组大鼠前列腺组织中TNF-α和IL-8水平比较
组别 | 样本量 | TNF-α(ng/L) | IL-8(ng/L) |
假手术组 | 20 | 3.71±0.46 | 24.15±2.94 |
模型对照组 | 18 | 149.28±1.02★★ | 98.20±17.33★★ |
治疗组 | 19 | 12.40±1.69▼▼ | 37.09±5.18▼▼ |
模型对照组与假手术组比较,★ P<0.05;★★ P<0.01;治疗组与模型对照组比较,▼ P<0.05,▼▼ P<0.01。
各组大鼠白细胞计数统计结果见表2。通过表2的试验统计结果可以看出,假手术组明显低于其他两组;治疗组的白细胞数量显著下降,与模型对照组比较有显著性差异(P<0.01)。
表2各组大鼠白细胞及血磷脂小体数比较
组别 | 样本量 | 白细胞(109个) |
假手术组 | 20 | 1.80±0.21 |
模型对照组 | 18 | 9.49±1.13★★ |
治疗组 | 19 | 4.37±0.66▼▼ |
模型对照组与假手术组比较,★ P<0.05;★★ P<0.01;
治疗组与模型对照组比较,▼ P<0.05,▼▼ P<0.01。
Claims (3)
1.一种治疗前列腺炎的中药组合物,包括中药提取物和药用辅料,其特征在于:所述的中药提取物由如下重量份的中药材原料经水提醇沉法制备而成:南沙参12份、白芥子12份、石瓜子20份、海决明14份、月见草25份、山香圆叶25份、金龙胆草12份、柳叶8份。
2.根据权利要求1所述治疗前列腺炎的中药组合物,其特征在于:所述的中药组合物是口服制剂,所述的口服制剂为口服液、颗粒剂、片剂或胶囊剂。
3.根据权利要求1所述治疗前列腺炎的中药组合物,其特征在于所述中药组合物颗粒剂由如下工艺步骤制得:按重量份称取清洗干净的如下中药材原料:南沙参、白芥子、石瓜子、海决明、月见草、山香圆叶、金龙胆草、柳叶;合并,粉碎,加水煎煮两次,第一次加水为药材重量的10倍量,煎煮2h,第二次加水为药材重量的8倍量,煎煮1h,合并煎液,0.07MPa、65℃温度下减压浓缩至相对密度为1.15的浸膏,加95%v/v乙醇使含醇量达75%v/v,搅拌,静置24小时,过滤,滤液在0.07MPa、65℃条件下减压浓缩成至相对密度为1.25,并回收乙醇,得浓缩液,将浓缩液冷冻干燥,干燥物粉碎过80目筛,得到清膏粉;称取清膏粉10g,乳糖80g,微晶纤维素80g,羧甲基纤维素钠15g,投入槽型混合机中,搅拌20分钟,边搅拌边缓缓加入体积浓度为55%的乙醇水溶液,至制成软材,用12目不锈钢筛制粒,60℃条件下鼓风干燥,取出,放凉即得颗粒剂。
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- 2014-09-12 CN CN201610145710.2A patent/CN105582133A/zh not_active Withdrawn
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Also Published As
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CN105582136A (zh) | 2016-05-18 |
CN105535215A (zh) | 2016-05-04 |
CN105582135A (zh) | 2016-05-18 |
CN105687437A (zh) | 2016-06-22 |
CN104173547A (zh) | 2014-12-03 |
CN105412320A (zh) | 2016-03-23 |
CN105582134A (zh) | 2016-05-18 |
CN105687438A (zh) | 2016-06-22 |
CN105412321A (zh) | 2016-03-23 |
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