CN114569680B - 一种治疗热淋的组合物及其制备方法和应用 - Google Patents
一种治疗热淋的组合物及其制备方法和应用 Download PDFInfo
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Abstract
本发明属于中药技术领域,具体涉及一种治疗热淋的组合物及其制备方法和应用。所述组合物,按照重量份数计,包括以下原料:金银花130‑180份、半枝莲65‑90份、瞿麦45‑55份、扁蓄40‑55份、石韦40‑55份、川木通20‑25份、车前子40‑50份、淡竹叶40‑55份、灯芯草16‑30份、桑寄生80‑90份。其制备方法简单,能够显著提高组合物治疗热淋的效果。
Description
技术领域
本发明属于中药技术领域,具体涉及一种治疗热淋的组合物及其制备方法和应用。
背景技术
热淋(Heat strangury),属于中医学淋症的范围,其中包括现代医学的急慢性前列腺炎、前列腺增生肥大、急慢性肾盂肾炎、膀胱炎、尿道炎等疾患。中医学认为,前列腺炎、前列腺增生、前列腺肥大等亦属于热淋范畴,病机为湿热毒邪客于膀胱,气化失司,水道不利;盖火性急治疗质量故溲频而急;湿热壅盛,气机失宣,故尿难涩;湿热蕴蒸,灼热刺痛,故尿黄赤。尿路感染是以尿液内有大量细菌繁殖,引起尿路炎症,并以尿频、尿急、尿痛、尿路刺激症状等为临床特点。尿路感染分为上尿路感染和下尿路感染,是最常见的泌尿系统疾病,也是成年人最常见的感染性疾病。
现有技术中相关的治疗产品多种多样,如中国专利申请CN101274086A一种泻热通淋膏,解决目前缺乏用膏药治疗急慢性膀胱炎的问题。它是由元参、麦冬、当归、赤芍、知母、黄柏、生地、黄连等中药原料在香油中浸泡后,油炸、过滤得到药油,然后下丹继续熬制而成的。主要治疗由膀胱积热所引起之尿疼、尿频、尿急、尿血等症。
中国专利申请CN104758680A公开一种清热解毒通淋酒,配方选用的原料药材分别是:黄芪18、黄精15、熟地黄20、党参15、杜仲15、枸杞子18、川芎20、大枣25、何首乌20、菟丝子20、当归10、车前草30、陈皮15、龙胆草15、地榆45、白茅根50、木通35份、白酒5000份。具有清热活血、消肿止痛、渗湿利水的功效,用于血淋疼痛、热淋、小腹胀痛有明显效果。
但现有技术中的治疗效果仍有待提高,同时,部分原料中由于存在的原料之间的相互作用,使得药物制剂具有较大的副作用。
如中国专利申请CN1404868A公开一种中药制剂,特别是一种治疗热淋的中药制剂,该中药制剂的配方组成为:金银花,半枝莲,瞿麦,扁蓄,石韦,木通,车前子,淡竹叶,灯心草,桑寄生,能够有效治疗热淋病。但该处方中木通为关木通,即马兜铃科植物东北马兜铃Aristolochia manshuriensis Kom.的干燥藤茎。现代研究发现,关木通含有马兜铃酸,具有肾毒性,可引起急性肾功能衰竭,甚至死亡。中毒症状表现为上腹不适,继而呕吐、头痛、胸闷、腹胀隐痛、腹泻,或面部浮肿、尿频、尿急、尿量减少、渐起周身浮胂,神志不清等。关木通已于2005年从《中国药典》中删除。该发明最优选的处方中,关木通比例较高,致使产品的毒性较高,危害患者的健康。该方中金银花具有较好的清热解毒作用,可以很好的抑制细菌生长,尿路感染为细菌感染导致的疾病。金银花的有效成分脂溶性较好,但该发明的提取方法,不利于其有效成分的充分提出,且提取时间过长,高温下会破坏部分有效成分,从而导致药品效果下降;且该发明的药材配比非最佳配比,药物疗效有限;常规的调整并不能较好的提高其药物中的活性成分发挥作用,同时还造成原料的浪费。
为解决以上问题,本发明旨在提供一种效果更好、毒副作用更小的治疗热淋的组合物,其制备方法简单,能够显著提高组合物治疗热淋的效果。
发明内容
为克服以上技术问题,本发明提供了一种治疗热淋的组合物,其制备方法简单,能够显著提高组合物治疗热淋的效果。
为实现以上目的,本发明提供的技术方案如下:
一种组合物,按照重量份数计,包括以下原料:金银花130-180份、半枝莲65-90份、瞿麦45-55份、扁蓄40-55份、石韦40-55份、川木通20-25份、车前子40-50份、淡竹叶40-55份、灯芯草16-30份、桑寄生80-90份。
优选地,按照重量份数计,包括以下原料:金银花150-174份、半枝莲68-88份、瞿麦45-50份、扁蓄46-53份、石韦42-50份、川木通22-25份、车前子45-50份、淡竹叶45-53份、灯芯草16-20份、桑寄生80-85份。
优选地,按照重量份数计,包括以下原料:金银花500份、半枝莲250份、瞿麦150份、扁蓄150份、石韦150份、川木通75份、车前子150份、淡竹叶150份、灯芯草50份、桑寄生250份。
优选地,所述川木通与车前子和桑寄生的质量比为:川木通:车前子:桑寄生=4-5:8-10:16-18份;
优选地,所述川木通与车前子和桑寄生的质量比为:川木通:车前子:桑寄生=3:6:10份。
本发明的另一目的在于提供所述组合物的制备方法,包括以下步骤:
(1)取金银花,加乙醇提取,过滤,浓缩,制得金银花浸膏;
(2)将川木通、车前子和桑寄生粉碎后、与半枝莲、淡竹叶加水混合提取,过滤,制得滤液1;
(3)取瞿麦、扁蓄、石韦、灯芯草,加入水中,浸泡后,阶梯升温至煮沸提取,过滤,制得滤液2;
(4)合并滤液1和滤液2,浓缩,制得水提浸膏;
(5)将金银花浸膏、水提浸膏合并,干燥,即得组合物。
优选地,步骤(1)中,所述乙醇为体积分数为75-80%的乙醇水溶液,所述乙醇水溶液的量为金银花质量的8-10倍;所述提取先在30-40℃下预热30-60min,再升温至60℃提取1-2h,所述提取的次数为1-3次。
优选地,所述金银花浸膏在50℃下的相对密度为1.30-1.35。
优选地,步骤(2)中,所述加水的量为川木通、车前子和桑寄生、半枝莲和淡竹叶混合物总质量的8-12倍;所述混合提取在80-100℃下提取1-2h。
优选地,步骤(2)中,所述提取过程中加入聚乙二醇400,所述聚乙二醇400的用量为水质量的0.08-0.2wt%。
优选地,步骤(2)中,所述过滤前加入壳聚糖处理,壳聚糖的使用量为水量的0.1-0.5wt%。
优选地,所述壳聚糖的处理时间为0.5-1h。
优选地,步骤(3)中,所述浸泡过程中,加入酒石酸钠,所述酒石酸钠在水中的浓度为0.1-0.3wt%。
优选地,步骤(3)中,所述浸泡的温度为30-45℃,所述浸泡的时间为30-60min。
优选地,步骤(3)中,所述阶梯升温的速率为5-10℃/min,每升高10℃稳定温度10-20min。
优选地,步骤(3)中,所述煮沸提取的时间为1-3h。
优选地,步骤(4)中,所述水提浸膏在50℃下的相对密度为1.30-1.35。
本发明的目的还在于提供所述组合物在制备治疗热淋的药物中的应用。
本发明的另一目的还在于提供一种中药制剂,所述中药制剂包括所述组合物。
优选地,所述中药制剂为片剂、胶囊剂、口服液、口含片、颗粒剂、冲剂、丸剂、散剂、混悬剂、粉剂、溶液剂、滴剂或滴丸剂中的任一种。
本发明的目的还在于提供所述中药制剂的制备方法,包括以下步骤:取制备好的组合物,制成干粉,过筛,得到活性成分,加入药物中可接受的辅料,制成制剂即可。
与现有技术比,本发明的技术优势在于:
(1)本发明提供了一种治疗热淋的组合物,其制备方法简单,疗效好,能够有效治疗热淋、前列腺炎。热淋因湿热下注膀胱所致,湿热下注蕴于膀胱,水道不利,故尿频尿急、溺时涩痛、淋沥不畅,甚则癃闭不通;湿热蕴蒸,故尿色浑赤;湿热郁遏,气机不畅,则少腹急满;津液不布,则口燥咽干。治宜清热解毒,利水通淋。方中以金银花、川木通为君药。金银花清热解毒、疏散风热,血痢水痢兼治,风气湿气咸除;川木通上清心火,下利湿热,使湿热之邪从小便而去。半枝莲、石韦、扁蓄、瞿麦、车前子为臣药。半枝莲清热利湿,解毒化瘀;石韦、扁蓄、瞿麦、车前子均为清热利水通淋之常用品;五药合用,增强清热解毒、利水通淋作用。佐以淡竹叶清热除烦,利尿通淋;桑寄生补而兼通,祛邪而使正气留守无伤。使以灯心草清心利水,导热下行,并引导诸药下行。诸药共用,清热解毒,利湿通淋。
(2)本发明中使用川木通与车前子和桑寄生混合提取,在减少毒性的同时,能够有效促进活性成分的溶出,提高三者的协同作用。
(3)本发明中在提取过程中加入聚乙二醇能有效促进活性成分的提取,同时过滤前加入壳聚糖处理可有效除杂,随着壳聚糖的除杂过程,副产物被沉淀,活性成分可以进一步溶出,溶出含量大大提高,进而药物的药效得到有效的发挥利用,副作用降低。
(4)本发明中在瞿麦、扁蓄、石韦和灯芯草混合浸泡过程中加入酒石酸钠,能够有效促进瞿麦、扁蓄、石韦和灯芯草中活性成分的溶解,提高提取效率;同时,更能促进药物活性成分的抗氧化性和稳定性,促进活性成分的高效利用和药效。
(5)本发明避免了有毒药物木通的使用,降低了药物毒性的同时提高了药物活性,能更好的促进药物在治疗热淋方面的功效。
(6)本发明中采用阶梯升温的方式进行提取,有利于促进有效成分的溶出,提高提取效率,同时,还可以降低因升温过快而导致的有效成分被破坏的概率。同时,金银花的提取过程中,先进行预热升温后短时提取,在降低有效成分破坏率的前提下提升了提取效率。
具体实施方式
下面通过具体实施例对本发明进行说明,以使本发明技术方案更易于理解、掌握,但本发明并不局限于此。下述实施例中所述实验方法,如无特殊说明,均为常规方法;所述试剂和材料,如无特殊说明,均可从商业途径获得。
实施例1
一种组合物,包括以下原料:金银花500g、半枝莲250g、瞿麦150g、扁蓄150g、石韦150g、川木通75g、车前子150g、淡竹叶150g、灯芯草50g、桑寄生250g。
所述组合物的制备方法,包括以下步骤:
(1)取金银花,加8倍75%(体积浓度)的乙醇水溶液先在30℃下预热30min,再升温至60℃提取1h,混合提取液过滤,浓缩,制得50℃下的相对密度为1.30-1.35的金银花浸膏;
(2)将川木通、车前子和桑寄生粉碎后、与半枝莲、淡竹叶加入8倍水中,加入0.1wt%(以水的用量计)的聚乙二醇400,在80℃下混合提取1h,恒定温度,加入0.25wt%(以水的用量计)的壳聚糖,搅拌,继续提取0.5h,停止加热,冷却过滤,制得滤液1;
(3)取瞿麦、扁蓄、石韦、灯芯草,加入水中,加入0.1wt%(在水中的质量浓度)的酒石酸钠在40℃下浸泡30min后,以5℃/min的速率阶梯升温,每升高10℃稳定温度10min,直至煮沸,煮沸后继续提取1h,过滤,制得滤液2;
(4)合并滤液1和滤液2,浓缩,制得50℃下的相对密度为1.30-1.35的水提浸膏;
(5)将金银花浸膏、水提浸膏合并,干燥,即得组合物。
实施例2
一种组合物,包括以下原料:金银花468g、半枝莲234g、瞿麦162g、扁蓄144g、石韦144g、川木通75g、车前子144g、淡竹叶144g、灯芯草57.6g、桑寄生288g。
(1)取金银花,加10倍80%(体积浓度)的乙醇水溶液先在40℃下预热60min,再升温至60℃提取2h,混合提取液过滤,浓缩,制得50℃下的相对密度为1.30-1.35的金银花浸膏;
(2)将川木通、车前子和桑寄生粉碎后、与半枝莲、淡竹叶加入12倍水中,加入0.08wt%(以水的用量计)的聚乙二醇400,在80℃下混合提取2h,恒定温度,加入0.1wt%(以水的用量计)的壳聚糖,搅拌,继续提取0.5h,停止加热,冷却过滤,制得滤液1;
(3)取瞿麦、扁蓄、石韦、灯芯草,加入水中,加入0.3wt%的酒石酸钠在45℃下浸泡60min后,以10℃/min的速率阶梯升温,每升高10℃稳定温度20min,直至煮沸,煮沸后继续提取3h,过滤,制得滤液2;
(4)合并滤液1和滤液2,浓缩,制得50℃下的相对密度为1.30-1.35的水提浸膏;
(5)将金银花浸膏、水提浸膏合并,干燥,即得组合物。
实施例3
一种组合物,包括以下原料:金银花540g、半枝莲270g、瞿麦165g、扁蓄165g、石韦165g、川木通72g、车前子150g、淡竹叶165g、灯芯草90g、桑寄生270g。
(1)取金银花,加9倍75%(体积浓度)的乙醇水溶液先在35℃下预热40min,再升温至60℃提取1h,共提取3次,混合提取液过滤,浓缩,制得50℃下的相对密度为1.30-1.35的金银花浸膏;
(2)将川木通、车前子和桑寄生粉碎后、与半枝莲、淡竹叶加入10倍水中,加入0.2wt%(以水的用量计)的聚乙二醇400,在90℃下混合提取1h,恒定温度,加入0.5wt%(以水的用量计)的壳聚糖,搅拌,继续提取1h,停止加热,冷却过滤,制得滤液1;
(3)取瞿麦、扁蓄、石韦、灯芯草,加入水中,加入0.2wt%的酒石酸钠在30℃下浸泡45min后,以5℃/min的速率阶梯升温,每升高10℃稳定温度15min,直至煮沸,煮沸后继续提取1-3h,过滤,制得滤液2;
(4)合并滤液1和滤液2,浓缩,制得50℃下的相对密度为1.30-1.35的水提浸膏;
(5)将金银花浸膏、水提浸膏合并,干燥,即得组合物。
实施例4
一种组合物,包括以下原料:金银花500g、半枝莲250g、瞿麦150g、扁蓄150g、石韦150g、川木通75g、车前子150g、淡竹叶150g、灯芯草50g、桑寄生250g。
所述组合物的制备方法,包括以下步骤:
(1)取金银花,加8倍75%(体积浓度)的乙醇水溶液先在30℃下预热30min,再升温至60℃提取1h,混合提取液过滤,浓缩,制得50℃下的相对密度为1.30-1.35的金银花浸膏;
(2)将川木通、车前子和桑寄生粉碎后、与半枝莲、淡竹叶加入8倍水中在80℃下混合提取1h,停止加热,冷却过滤,制得滤液1;
(3)取瞿麦、扁蓄、石韦、灯芯草,加入水中,加入0.1wt%的酒石酸钠在40℃下浸泡30min后,以5℃/min的速率阶梯升温,每升高10℃稳定温度10min,直至煮沸,煮沸后继续提取1h,过滤,制得滤液2;
(4)合并滤液1和滤液2,浓缩,制得50℃下的相对密度为1.30-1.35的水提浸膏;
(5)将金银花浸膏、水提浸膏合并,干燥,即得组合物。
实施例5
一种组合物,包括以下原料:金银花500g、半枝莲250g、瞿麦150g、扁蓄150g、石韦150g、川木通75g、车前子150g、淡竹叶150g、灯芯草50g、桑寄生250g。
所述组合物的制备方法,包括以下步骤:
(1)取金银花,加8倍75%(体积浓度)的乙醇水溶液先在30℃下预热30min,再升温至60℃提取1h,混合提取液过滤,浓缩,制得50℃下的相对密度为1.30-1.35的金银花浸膏;
(2)将川木通、车前子和桑寄生粉碎后、与半枝莲、淡竹叶加入8倍水中在80℃下混合提取1h,恒定温度,加入0.25wt%(以水的用量计)的壳聚糖,搅拌,继续提取0.5h,停止加热,冷却过滤,制得滤液1;
(3)取瞿麦、扁蓄、石韦、灯芯草,加入水中,加入0.1wt%的醋酸在40℃下浸泡30min后,以5℃/min的速率阶梯升温,每升高10℃稳定温度10min,直至煮沸,煮沸后继续提取1h,过滤,制得滤液2;
(4)合并滤液1和滤液2,浓缩,制得50℃下的相对密度为1.30-1.35的水提浸膏;
(5)将金银花浸膏、水提浸膏合并,干燥,即得组合物。
实施例6
一种组合物,包括以下原料:金银花500g、半枝莲250g、瞿麦150g、扁蓄150g、石韦150g、川木通75g、车前子150g、淡竹叶150g、灯芯草50g、桑寄生250g。
所述组合物的制备方法,包括以下步骤:
(1)取金银花,加8倍75%(体积浓度)的乙醇水溶液先在30℃下预热30min,再升温至60℃提取1h,混合提取液过滤,浓缩,制得50℃下的相对密度为1.30-1.35的金银花浸膏;
(2)将川木通粉碎后、与半数的半枝莲、半数的淡竹叶加入8倍水中,加入0.1wt%(以水的用量计)的聚乙二醇400,在80℃下混合提取1h,恒定温度,加入0.25wt%(以水的用量计)的壳聚糖,搅拌,继续提取0.5h,停止加热,冷却过滤,制得滤液A;
将车前子粉碎后、与1/4数的半枝莲、1/4数的淡竹叶加入8倍水中,加入0.1wt%(以水的用量计)的聚乙二醇400,在80℃下混合提取1h,恒定温度,加入0.25wt%(以水的用量计)的壳聚糖,搅拌,继续提取0.5h,停止加热,冷却过滤,制得滤液B;
将桑寄生粉碎后、与1/4数的半枝莲、1/4数的淡竹叶加入8倍水中,加入0.1wt%(以水的用量计)的聚乙二醇400,在80℃下混合提取1h,恒定温度,加入0.25wt%(以水的用量计)的壳聚糖,搅拌,继续提取0.5h,停止加热,冷却过滤,制得滤液C;
将滤液A、B、C混合后,制得滤液1;
(3)取瞿麦、扁蓄、石韦、灯芯草,加入水中,加入0.1wt%的酒石酸钠在40℃下浸泡30min后,以5℃/min的速率阶梯升温,每升高10℃稳定温度10min,直至煮沸,煮沸后继续提取1h,过滤,制得滤液2;
(4)合并滤液1和滤液2,浓缩,制得50℃下的相对密度为1.30-1.35的水提浸膏;
(5)将金银花浸膏、水提浸膏合并,干燥,即得组合物。
实施例7
一种组合物,包括以下原料:金银花500g、半枝莲250g、瞿麦150g、扁蓄150g、石韦150g、川木通75g、车前子150g、淡竹叶150g、灯芯草50g、桑寄生250g。
所述组合物的制备方法,包括以下步骤:
(1)取金银花,加8倍75%(体积浓度)的乙醇水溶液先在30℃下预热30min,再升温至60℃提取1h,混合提取液过滤,浓缩,制得50℃下的相对密度为1.30-1.35的金银花浸膏;
(2)将川木通、车前子和桑寄生粉碎后、与半枝莲、淡竹叶加入8倍水中,在80℃下混合提取1.5h,停止加热,冷却过滤,制得滤液1;
(3)取瞿麦、扁蓄、石韦、灯芯草,加入水中,在40℃下浸泡30min后,以5℃/min的速率阶梯升温,每升高10℃稳定温度10min,直至煮沸,煮沸后继续提取1h,过滤,制得滤液2;
(4)合并滤液1和滤液2,浓缩,制得50℃下的相对密度为1.30-1.35的水提浸膏;
(5)将金银花浸膏、水提浸膏合并,干燥,即得组合物。
对比例1
与实施例7相比,原料配比不同。
一种组合物,包括以下原料:金银花270g、半枝莲136g、瞿麦85g、扁蓄85g、石韦85g、川木通85g、车前子85g、淡竹叶85g、灯芯草85g、桑寄生136g。
所述组合物的制备方法,制备过程同实施例7。
对比例2
与实施例7相比,原料配比不同。
处方:金银花250g;半枝莲124g;瞿麦74g;扁蓄74g;石韦74g;川木通44g;车前子74g;淡竹叶74g;灯心草24g;桑寄生122g;所述组合物的制备方法,制备过程同实施例7。
对比例3
与实施例7相比,原料配比不同。
处方:金银花312g;半枝莲156g;瞿麦93g;扁蓄93g;石韦93g;川木通47g;车前子93g;淡竹叶93g;灯心草31g;桑寄生156g;
所述组合物的制备方法,制备过程同实施例7。
对比例4
以专利CN1404868A的实施例1记载的方法进行制药。
处方:金银花270g;半枝莲136g;瞿麦85g;扁蓄85g;石韦85g;木通85g;车前子85g;淡竹叶85g;灯心草28g;桑寄生136g;
制备方法:金银花的80%,用70%乙醇回流提取2次,每次3小时,加乙醇量依次为生药量的8倍、6倍,合并提取液,滤过,回收乙醇,浓缩至相对密度为1.2-1.5(60℃)时备用,另取半枝莲、瞿麦等9味加水煎煮提取3次,煎煮时间依次为1.5小时、1.5小时、1小时,加水量依次为生药量的10倍、8倍、6倍合并提取液,滤过,浓缩至相对密度为1.10-1.35(60℃)时备用。再取金银花的半量、去杂质、粗粉碎,同以上二个备用的稠膏合并,干燥,粉碎成细粉,过筛,制成颗粒,干燥,即得组合物。
效果评价
1、药效试验
(1)受试药物:本发明实施例1-7及对比例1-4组合物,使用淀粉做赋形剂,制成颗粒剂,其中赋形剂含20%。临用时将颗粒剂以蒸馏水分散开,用时摇匀,4℃保存。
(2)剂量选择:按照有效成分计,高剂量200mg/kg、中剂量100mg/kg、低剂量50mg/kg;试验过程中,除特殊说明外,实施例1-7及对比例1-4均按低剂量(50mg/kg)给药。
(3)试验动物和菌株
SPF级Wistar大鼠,体重200~220g,雌雄间用。由吉林大学基础医学院实验动物中心提供[生产许可SCXK(吉)2007-0003,使用许可SYXK(吉)2007-0011]。大鼠饲养室,温度:23±1℃,湿度:50-70%,光照:150-200Lx,12小时明暗交替(早6:00-晚18:00);噪音:<50dB;设有环境自动控制系统。自由饮水,喂养基础饲料(符合GB 14924.3-2001要求);自由饮食。
标准菌株(American Type Culture Collection ATCC):大肠埃希氏菌ATCC44102、金黄色葡萄球菌ATCC26003。均由吉林大学病原生物学教研室提供。
临床分离菌株(Clinical Isolated Bacterial Strain CIBS):大肠杆菌菌株CIBS872、金黄色葡萄球菌株CIBS831、绿脓杆菌株CIBS868。均由长春中医药大学附属医院细菌室提供。
(4)试剂
左氧氟沙星片,临床成人每日口服本品50mg,临用时研碎,选择剂量大鼠25mg/kg,由成都恒瑞制药有限公司生产,批号:200701。
前列通片,本品为糖衣片,除去糖衣后显浅褐色至褐色,基片重0.34g,成人每天3次,每次6片,按人体与动物体表面积等效剂量比值计算,选择大鼠剂量为2.75g/kg,相当于5倍等效剂量,临用时去糖衣,研碎,以蒸馏水配成所需浓度,动物均灌胃给药,由广州白云山中一药业有限公司生产,批号:20200801。
(5)数据统计方法
运用SPSS 16.0进行统计分析,其中符合正态分布的计量资料运用方差分析检验,以表示;等级资料及不符合正态分布的计量资料采用非参数检验方法,以Mean Ranks表示。以P<0.05为差异有统计学意义。
(6)体外抑菌试验
取液体LB培养基:天平分别称量胰蛋白胨10g、酵母提取物5g、氯化钠5g,加入无菌水定容至1L;固体LB培养基:除液体LB培养基组分外,加入琼脂25g,加入无菌水定容1L。经磁力搅拌充分后取出磁子,放入灭菌锅121℃高压15min灭菌。待稍加冷却但固体培养基尚未凝固时将固体LB培养基倒入培养皿中制作平面培养基;液体LB培养基则分装入100m L无菌瓶中备用。
将冻存的细菌水浴稍加融化后倒入液体LB培养基,37℃250rpm/min震荡培养至600nm波长处的可见光吸收值(OD600)约为0.2-0.6,接种环经酒精灯外焰消毒并冷却后蘸取菌液,用平板划线法涂布于平面培养基上,然后放入孵箱继续培养。
挑取平板培养的单克隆菌落溶入100m L LB(Luria-Bertani)液体培养基中,并放入37℃孵箱持续震荡培养12小时。最后离心收获下层细菌。将细菌重新溶入无菌的LB液体培养基中,放入37℃孵箱继续震荡培养(220rpm)12h,然后取菌液涂布平板;再将已灭菌的圆形滤纸片(直径为11mm)分别置于已稀释的各实验药液中(以水稀释各组药物,稀释后的各组药物剂量浓度具体见各菌种实验数据表格中的记载),浸泡10min,将滤纸片放入已涂菌的平板中,37℃培养过夜后,观察培养皿中的抑菌圈,并测量抑菌圈的直径。
按照以上方法,将实验组分为如下各组:空白组(水)、实施例1-7组(以实施例1-7对应的产物作为各组实验药物)和对比例1-4组(以对比例1-4对应的产物作为各组实验药物)。进行体外抑菌效果试验,菌种分别选择标准株大肠埃希氏菌、标准株金黄色葡萄球菌、临床分离株大肠埃希氏菌、临床分离株金黄色葡萄球菌和临床分离株绿脓杆菌;每组实验做10次平行实验,取均值,结果见以下各表。
组别 | 药物剂量浓度 | 抑菌圈直径(mm) |
空白组 | 水 | 0.04±0.01<sup>a</sup> |
实施例1组 | 3.2mg/ml | 22.06±0.93<sup>b</sup> |
实施例2组 | 3.2mg/ml | 20.06±0.60<sup>b</sup> |
实施例3组 | 3.2mg/ml | 21.39±0.72<sup>b</sup> |
实施例4组 | 3.2mg/ml | 18.19±0.54<sup>c</sup> |
实施例5组 | 3.2mg/ml | 17.87±1.10<sup>c</sup> |
实施例6组 | 3.2mg/ml | 15.31±1.74<sup>d</sup> |
实施例7组 | 3.2mg/ml | 14.32±2.09<sup>e</sup> |
对比例1 | 3.2mg/ml | 12.55±0.85<sup>f</sup> |
对比例2 | 3.2mg/ml | 11.13±0.79<sup>f</sup> |
对比例3 | 3.2mg/ml | 12.74±0.82<sup>f</sup> |
对比例4 | 3.2mg/ml | 10.32±0.93<sup>g</sup> |
注,同一列中,不同字母间表示具有显著性差异P<0.05。
注,同一列中,不同字母间表示具有显著性差异P<0.05。
组别 | 剂量 | 抑菌圈直径(mm) |
空白组 | 水 | 0.04±0.01<sup>a</sup> |
实施例1组 | 3.2mg/ml | 16.71±1.20<sup>b</sup> |
实施例2组 | 3.2mg/ml | 16.65±2.31<sup>b</sup> |
实施例3组 | 3.2mg/ml | 16.60±1.26<sup>b</sup> |
实施例4组 | 3.2mg/ml | 15.22±3.04<sup>c</sup> |
实施例5组 | 3.2mg/ml | 14.71±2.65<sup>d</sup> |
实施例6组 | 3.2mg/ml | 12.61±1.23<sup>e</sup> |
实施例7组 | 3.2mg/ml | 12.30±1.11<sup>e</sup> |
对比例1 | 3.2mg/ml | 10.47±0.75<sup>f</sup> |
对比例2 | 3.2mg/ml | 9.81±1.35<sup>g</sup> |
对比例3 | 3.2mg/ml | 9.67±2.03<sup>g</sup> |
对比例4 | 3.2mg/ml | 9.32±0.81<sup>g</sup> |
注,同一列中,不同字母间表示具有显著性差异P<0.05。
注,同一列中,不同字母间表示具有显著性差异P<0.05。
组别 | 剂量 | 抑菌圈直径(mm) |
空白组 | 水 | 0.04±0.03<sup>a</sup> |
实施例1组 | 12.8mg/ml | 10.17±0.2<sup>b</sup> |
实施例2组 | 12.8mg/ml | 10.04±0.17<sup>b</sup> |
实施例3组 | 12.8mg/ml | 9.91±0.16<sup>b</sup> |
实施例4组 | 12.8mg/ml | 9.18±0.24<sup>c</sup> |
实施例5组 | 12.8mg/ml | 8.90±0.71<sup>c</sup> |
实施例6组 | 12.8mg/ml | 7.22±0.66<sup>d</sup> |
实施例7组 | 12.8mg/ml | 6.37±1.23<sup>e</sup> |
对比例1 | 12.8mg/ml | 5.12±0.13<sup>f</sup> |
对比例2 | 12.8mg/ml | 5.44±0.61<sup>f</sup> |
对比例3 | 12.8mg/ml | 4.32±0.37<sup>g</sup> |
对比例4 | 12.8mg/ml | 4.07±0.11<sup>g</sup> |
注,同一列中,不同字母间表示具有显著性差异P<0.05。上述试验结果表明,本发明提供的药物对大肠埃希氏菌株ATCC44102、金黄色葡萄球菌株ATCC26003;临床分离大肠杆菌菌株CIBS872、金黄色葡萄球菌株CIBS831、绿脓杆菌株CIBS868体外抑菌实验均有具有一定的抑制作用(P<0.05);且实验药均显著优于各对照药组(P<0.01)。
(7)大肠杆菌所致大鼠尿路感染试验
取大鼠,雄性,随机分为模型组和正常对照组。感染前将大鼠分别装入代谢笼中(笼具经消毒处理),测定10小时尿量并记录,同时抽取尿样(不足10ml尿量的,大鼠继续留尿)。按尿沉淀法测定白细胞数量,按定量接种法,测定尿液中细菌含量。实验时将模型组大鼠预禁水24小时,在乙醚麻醉下,向膀胱内注射大肠埃希氏菌ATCC44102菌液(105个/ml)0.5ml/只,然后关闭腹腔,注射菌液前用丝线将大鼠阴茎扎紧,以免菌液漏出,1h后松开阴茎结扎线。待所有造模大鼠苏醒后,精心饲养,观察7天,第8天测定感染后每只大鼠10小时尿量,尿中细菌数及尿中白细胞数,以每ml尿中细菌超过10万个为感染合格大鼠,去除不合格大鼠,合格大鼠随机分为:阳性对照组(左氧氟沙星)、模型对照组、实施例1-7组(实施例1-7对应的产物)和对比例1-4组(对比例1-4对应的产物)。
每组10只大鼠;各组动物分别灌胃给予相应组的药物溶液,给药量为50mg/kg;另取10只未经感染的正常大鼠作为正常对照组;
模型对照组及正常对照组按给药高剂量给予同体积赋形剂,阳性对照组给药25mg/kg左氧氟沙星;每天给药一次,连续灌胃给药7天。于末次给药后5小时,按上述方法测定用药后7天,使用代谢笼收集10小时尿量、显微镜观察尿中细菌数和尿沉渣中白细胞数/×400,结果见下表。
结果表明,本发明提供的组合物对大肠杆菌所致大鼠尿路感染,尿中白细胞数及尿中细菌含量,均有不同程度的降低作用,同时并可增加10小时尿量。试验组1-7组作用最为明显,无论是自身比较还是与对照比较,均显著优于对比例组(P<0.001)。说明本品具有一定治疗尿路感染作用。
(8)大肠杆菌所致大鼠细菌性前列腺炎试验结果
取大鼠随机分为实施例1-7组,对比例1-4组,阳性药物组和模型组,每组10只,均进行致炎建模:驯养1周后,以10%水合氯醛(3.5mL/kg)腹腔注射麻醉,用75%酒精消毒大鼠腹部皮肤后,在大鼠下腹正中切开1个0.5-1cm左右的切口,切开腹壁和腹膜,暴露前列腺,于前列腺背叶两侧各注入1.5×107cfu/mL浓度大肠埃希菌0.1mL,正常对照组大鼠用同种方法相同部位注射同等剂量0.9%氯化钠溶液,注射后复位前列腺,逐层缝合腹壁肌肉和皮肤后放回鼠笼,自由饮食。另取10只未致炎的大鼠做正常対照组。
实施例1-7组(分别给药实施例1-7对应的产物,50mg/kg),对比例1-4组(分别给药对比例1-4对应的产物,50mg/kg),阳性药物组(给药前列通片,2.75g/kg)各组动物致炎前5天开始按组别与剂量分组灌胃给药;模型组及正常对照组按给药高剂量给予等体积赋形剂。每天1次,致炎后继续给药3天,于末次给药后1h,断头处死大鼠,分别在无菌条件下取前列腺100mg,于1ml生理盐水中,充分混匀,镜下记录白细胞数和卵磷质小体数;同时将前列腺液接种于普通血琼脂平板上,37℃培养48h;记录菌落数,结果见下表。
同一列中,不同字母间表示具有显著性差异P<0.05。
结果表明,与正常对照组相比,模型对照组具有显著性差异,说明建模成功。同时,本发明实施例1-7组与模型组相比,具有显著性差异,说明本发明提供的药物对大鼠细菌性前列腺炎具有较好的改善效果,且效果优于对比例组和对照组。
2、毒性评价
因小鼠口服受给药量的限制,无法测出半数致死量(LD50),最大耐受量(MTD)数据没有差异(各组间给药量基本相当),故改用多次给药毒性数据。
方法:取大鼠,雌雄各半,随机分为正常对照组、实施例1-7组、对比例1-4组,每组动物10只。药物组按高剂量灌胃给药(200mg/kg),每天1次,连续7天,正常对照组按给药高剂量组给予同体积赋形剂。给药期13周,恢复期6周。
检测指标:
肾小管间质损伤(TI)根据肾小管扩张和(或)萎缩、肾间质纤维化、炎症细胞浸润累及小管及间质的程度进行评分:
肾小管无明显改变,间质中无或极少见炎症细胞,无纤维化组织增生,没有肾皮质损害记0分;
肾小管上皮细胞轻度萎缩,变性,坏死轻,呈灶性分布,间质少量炎症细胞浸润,纤维组织增生病变灶性,范围<25%,记1分;
肾小管上皮细胞轻中度萎缩,变性,坏死轻,炎症细胞浸润,纤维组织中度增生病变范围26%~50%,记2分;
肾小管上皮细胞萎缩,变性,坏死重,片状分布,大量弥散或聚集成灶的炎症细胞浸润,纤维组织增生呈多灶或网状成片,病变范围>50%,记3分。
13周末解剖,对所取组织器官进行组织病理学检查。正常对照组、实施例1-7组大鼠肾脏组织肾小球、肾小管结构正常,小管上皮细胞轻度空泡变性;对比例4组大鼠肾小管间质大量炎性细胞浸润,近曲小管广泛变性坏死,并见有肾小球坏死的现象,小管上皮细胞增生活跃,可见双核细胞,肾间质可观察到纤维细胞增生现象。肾小管间质病理损害(TI)定量评分结果见下表8。
6周恢复期末,对比例1-4组肾小球结构基本正常,大鼠肾小管轻度扩张,呈条带状分布,肾小管间质炎性细胞浸润,纤维细胞轻度增生现象,损伤较轻。正常对照组、实施例1-7组大鼠肾脏组织肾小球、肾小管结构正常。其他未见异常。
组别 | TI评分 |
正常对照组 | 0.2±0.1<sup>a</sup> |
实施例1 | 0.3±0.2<sup>a</sup> |
实施例2 | 0.3±0.1<sup>a</sup> |
实施例3 | 0.2±0.1<sup>a</sup> |
实施例4 | 0.9±0.5<sup>b</sup> |
实施例5 | 0.6±0.3<sup>c</sup> |
实施例6 | 0.5±0.2<sup>c</sup> |
实施例7 | 1.1±0.4<sup>b</sup> |
对比例1 | 1.4±0.5<sup>d</sup> |
对比例2 | 1.6±0.9<sup>e</sup> |
对比例3 | 1.3±1.0<sup>d</sup> |
对比例4 | 2.8±0.7<sup>f</sup> |
同一列中,不同字母间表示具有显著性差异P<0.05。
从中可以看出,与正常对照组比较,实施例1-7组无差异,对比例1-4组大鼠病理损害积分均见升高,有非常显著性差异(P<0.01)。其他未见异常。
由此可知,本发明提供的组合物的毒副作用明显低于对比例1-4的组合物的毒副作用。
上述详细说明是针对本发明其中之一可行实施例的具体说明,该实施例并非用以限制本发明的专利范围,凡未脱离本发明所为的等效实施或变更,均应包含于本发明技术方案的范围内。
Claims (7)
1.一种治疗热淋的组合物,按照重量份数计,由以下原料制成:金银花 500份、半枝莲250份、瞿麦150份、扁蓄150份、石韦150份、川木通75份、车前子150份、淡竹叶150份、灯芯草50份、桑寄生250份。
2.如权利要求1所述的组合物的制备方法,其特征在于,包括以下步骤:
(1)取金银花,加乙醇提取,过滤,浓缩,制得金银花浸膏;所述提取先在30-40℃下预热30-60min,再升温至60℃提取1-2h;
(2)将川木通、车前子和桑寄生粉碎后、与半枝莲、淡竹叶加水混合提取,过滤,制得滤液1;步骤(2)中,所述提取过程中加入聚乙二醇400,所述聚乙二醇400的用量为水质量的0.08-0.2 wt %;所述过滤前加入壳聚糖处理,壳聚糖的使用量为水量的0.1-0.5wt%;
(3)取瞿麦、扁蓄、石韦、灯芯草,加入水中,浸泡后,阶梯升温至煮沸提取,过滤,制得滤液2;步骤(3)中,所述浸泡过程中,加入酒石酸钠,所述酒石酸钠在水中的浓度为0.1-0.3wt%;所述阶梯升温的速率为5-10℃/min,每升高10℃稳定温度10-20min;
(4)合并滤液1和滤液2,浓缩,制得水提浸膏;
(5)将金银花浸膏、水提浸膏合并,干燥,即得组合物。
3.如权利要求2所述的组合物的制备方法,其特征在于,步骤(1)中,所述乙醇为体积分数为75-80%的乙醇水溶液,所述乙醇水溶液的量为金银花质量的8-10倍;所述提取的次数为1-3次。
4.如权利要求2所述的组合物的制备方法,其特征在于,步骤(2)中,所述加水的量为川木通、车前子和桑寄生、半枝莲和淡竹叶混合物总质量的8-12倍;所述混合提取在80-100℃下提取1-2h。
5.如权利要求2所述的组合物的制备方法,其特征在于,步骤(3)中,所述加水的量为瞿麦、扁蓄、石韦和灯芯草总质量的5-10倍;所述浸泡的温度为30-45℃,所述浸泡的时间为30-60min;所述煮沸提取的时间为1-3h。
6.如权利要求1所述的组合物或权利要求2-5任一所述组合物的制备方法制备的组合物在制备治疗热淋的药物中的应用。
7.一种治疗热淋的中药制剂,所述中药制剂包括权利要求1所述的组合物或权利要求2-5任一所述组合物的制备方法制备的组合物,其中,所述中药制剂为片剂、胶囊剂、口服液、颗粒剂、丸剂、散剂、混悬剂、粉剂、溶液剂、滴剂或滴丸剂中的任一种。
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