CN116688070A - 中药组合物、中药制剂及制备方法和应用 - Google Patents
中药组合物、中药制剂及制备方法和应用 Download PDFInfo
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Abstract
本发明涉及中医药技术领域,尤其涉及一种中药组合物、中药制剂及制备方法和应用。在本发明中,所述中药组合物由包括以下重量份的原料药制得:黄芪5‑50份,金银花5‑50份,青翘0‑30份,椿皮0‑15份,熟大黄3‑15份,厚朴3‑15份,苏木3‑15份,土茯苓3‑30份。所述中药组合物可补中益气活血,扶正祛邪解毒而通淋。用于治疗湿热下注型尿路感染,组方配伍体现标本同治的中医传统理念。西医的药效研究表明所述中药组合物能用于治疗尿路感染,并可减少复发率,从而有效预防和治疗再发性尿路感染。
Description
技术领域
本发明涉及中医药技术领域,尤其涉及一种中药组合物、中药制剂及制备方法和应用。
背景技术
尿路感染是一种常见的多发性疾病,也是成年人中最常见的感染性疾病之一。据统计,约1/3的成年女性在其一生中曾经历过有症状的尿路感染,27%-28%的健康女性可反复发生尿路感染。
目前西医尚无有效治疗尿路感染特别是再发性尿路感染,并能减少复发率的方法。
临床上,通常选择磺胺类、喹诺酮类、半合成青霉素或头孢菌素类等抗生素药物,以一种或多种联合的形式进行治疗,目的是杀死或抑制病原菌、控制感染。此类方法对初发性尿路感染患者表现出较高的治愈率,但存在治疗不彻底、病情反复等问题。另外,对于免疫功能较差的尿路感染患者,使用广谱抗生素的治疗方式无法有效控制感染,患者长期反复使用广谱抗生素,容易导致霉菌感染和耐药菌株的产生以及菌群失调,进而给临床治疗带来了更大的困难。
现有技术中公开了一些适于尿路感染的中医药治疗方法。
例如,《通淋化瘀方治疗复发性下尿路感染热瘀证的临床研究》中公开了一种适于复发性下尿路感染的通淋化瘀方,原料药包括蒲黄、滑石、金银花、扁蓄、瞿麦、土茯苓、桃仁、大黄、当归、浙贝母、桂枝、柴胡和黄岑。《国医大师卢芳应用泌感汤治疗肾盂肾炎临床经验》中公开了一种用于治疗肾盂肾炎的自拟方药“泌感汤”,原料药包括金银花、连翘、蒲公英、紫花地丁、厚朴、苏木、土茯苓、酒大黄、马鞭草、积雪草、败酱草、接骨木和坤草。这些中药配方对复发性尿路感染虽具有一定的治疗作用,但存在组方药味较多,药量较大,起效慢,疗程长等问题。
有鉴于此,特提出本发明。
发明内容
为解决上述技术问题,本发明提供一种用于治疗尿路感染,并可有效减少复发率,从而预防和治疗再发性尿路感染的中药组合物。组方配伍体现标本同治的中医传统理念,可补中益气活血,扶正祛邪解毒而通淋。西医的药效研究表明所述中药组合物能有效治疗尿路感染,抗菌抗炎,消除泌尿系统炎症反应,调节机体免疫功能,减少复发率。
具体的,本发明的技术方案如下。
本发明提供了一种中药组合物,所述中药组合物由包括以下重量份的原料药制得:黄芪5-50份,金银花5-50份,青翘0-30份,椿皮0-15份,熟大黄3-15份,厚朴3-15份,苏木3-15份,土茯苓3-30份。
本发明所述中药组合物对尿路感染及再发性尿路感染具有良好的治疗作用。
具体而言,在本发明所述中药组合物中,各原料药功效及配伍原则如下:
黄芪为君药。性甘,微温,归肺、脾经,具有补气升阳,固表止汗,利水消肿,生津养血,行滞通痹,托毒排脓,敛疮生肌之功。方中重用黄芪补中益气,升阳固表,统帅诸药可起到扶正祛邪,标本同治的功效。
金银花、连翘、椿皮、熟大黄为臣药。其中,金银花甘,寒。归肺、心、胃经。具有清热解毒,疏散风热的功效。连翘苦,微寒。归肺、心、小肠经。具有清热解毒,消肿散结,疏散风热的功效。大黄苦,寒。归脾、胃、大肠、肝、心包经。具有泻下攻积,清热泻火,凉血解毒,逐瘀通经,利湿退黄的功效。椿皮苦、涩,寒。归大肠、胃、肝经。具有清热燥湿,收涩止带,止泻,止血的功效。金银花、连翘、大黄均为寒性药物,诸药合用清热泻火、凉血解毒,却太过寒凉,会过度伐伤久病机体的正气。椿皮有助其清热之功,也有收涩燥湿之效,却不是燥热之品,不会化燥伤阴。椿皮与金银花、连翘、大黄联用可起到协同增效,却泻中有收,凉中有涩,阴阳调补,以达阴平阳密。在本发明中,金银花和连翘专助清热解毒;椿皮清热燥湿;熟大黄清热泻火,凉血解毒,导滞。四味臣药相须为用,可迅速解除尿频、尿涩痛、尿急、尿短赤、尿淋沥等症状。
厚朴、苏木同为佐药。苏木活血祛瘀,消肿止痛;厚朴燥湿消痰,下气除满。两味佐药共凑行气活血而止痛之功。
土茯苓解毒,除湿,通利关节,引经报使,在方中为使药,起到引领诸药以达病所的功效。
本发明所述中药组合物的上述配伍可补中益气活血,扶正祛邪解毒而通淋,切中病机,具有标本同治之能。
基于上述治法治则,在本发明优选的实施方式中,所述中药组合物由包括以下重量份的原料药制得:黄芪15-25份,金银花10-40份,青翘10-25份,椿皮3-10份,熟大黄3-10份,厚朴6-15份,苏木5-12份,土茯苓5-15份。
或者,所述中药组合物由以下重量份的原料药制得:黄芪20-30份,金银花10-20份,青翘10-20份,椿皮3-9份,熟大黄3-9份,厚朴8-12份,苏木6-12份,土茯苓8-12份。
更优选的,本发明所述中药组合物由包括以下重量份的原料药制得:黄芪25份,金银花15份,青翘15份,椿皮6份,熟大黄6份,厚朴10份,苏木9份,土茯苓10份。
本发明对上述各原料药的来源不作特别限定,本领域常规市售来源的原料药均可。
本发明提供的中药组合物为纯中药配方,具有补中益气活血,扶正祛邪解毒而通淋的作用。用于治疗湿热下注型尿路感染,证见尿急、尿频、尿痛、尿黄浑浊,少腹拘急,腰痛,或伴有恶寒发热,口苦,恶心呕吐,大便干结。再发性尿路感染见上述证候者。
第二方面,本发明提供了一种中药制剂,该中药制剂由所述中药组合物单独制成,或由所述中药组合物与药学上可接受的载体和/或赋形剂制成。
本发明对所述中药制剂的具体剂型不作特别限定。在本发明可选的实施方式中,所述中药制剂的剂型为片剂、丸剂、胶囊剂、颗粒剂、冲剂、散剂、膏剂、口服液或合剂。
第三方面,本发明提供了所述中药制剂的制备方法,包括如下步骤:
S1、按重量份称取各原料药,炮制,得中药饮片;
S2、将所述中药饮片置于提取溶媒中,得提取物;
S3、将所述提取物与所述载体和/或赋形剂结合,得到中药制剂。
优选的,步骤S2所述提取溶媒为水。
优选的,所述中药制剂为颗粒剂。
在本发明中,所述颗粒剂的制备方法优选包括如下步骤:各组方中的药材经净选、切制后,按照配比称量,加入8倍量的水,浸泡0.5h后,煎煮提取2次,第一次提取时间为1h,第二次提取时间为0.5h,过滤后在60℃下浓缩至相对密度1.10-1.30,加入适量糊精,制粒,干燥,整粒,分装即得颗粒剂。
本发明提供的制备方法工艺简单。经上述制备方法制得的颗粒剂,其生产成本低,生产工艺过程安全无污染,工艺简单,质量稳定,保质期长。以水为溶媒提取的有效成分溶解度高,易于机体吸收利用。
第四方面,本发明提供了所述中药组合物,或者所述中药制剂在制备用于治疗尿路感染及预防和/或治疗再发性尿路感染疾病药物中的应用。
在本发明中,所述尿路感染及再发性尿路感染疾病的症状优选包括尿频、尿急、尿痛、夜尿、耻骨上疼痛、少腹拘急、尿黄浑浊、脓尿、血尿、腰酸乏力、恶寒发热、恶心呕吐、排尿后减轻中的至少一种。
有益效果:
本发明提供了一种中药组合物、中药制剂及制备方法和应用。所述中药组合物以黄芪为君药,金银花、连翘、椿皮和熟大黄为臣药,厚朴、苏木为佐药,土茯苓为使药。其中,君臣佐使相互配伍,尤其是四味臣药收涩有度,相得益彰,祛邪解毒的同时兼顾辅助君药黄芪扶正的功效,正气存内,邪不可干。本发明所述中药组合物不仅能治疗尿路感染,还能减少其复发率,对再发性尿路感染具有治疗和预防的双重作用。
具体实施方式
下面结合实施例对本发明提供的技术方案进行详细说明,但是不能把它们理解为对本发明保护范围的限定。若未特别指明,实施例中所使用的实验方法均为常规方法;所用的材料、试剂等均可从商业途径得到。
实施例1
本实施例提供了一种中药组合物,所述中药组合物按重量份计,配方如下:
黄芪25g、金银花15g、青翘15g、椿皮6g、熟大黄6g、厚朴10g、苏木9g、土茯苓10g。
本实施例同时提供了一种包含上述中药组合物的中药制剂,制备方法为:
各组方中的药材经净选、切制后,按照配比称量,加入8倍量的水,浸泡0.5h后,煎煮提取2次,第一次提取时间为1h,第二次提取时间为0.5h,过滤后在60±10℃下浓缩至100ml(相对密度1.10-1.30)。
实施例2
本实施例提供了一种中药组合物,所述中药组合物按重量份计,配方如下:
黄芪25g、金银花20g、青翘12g、椿皮3g、熟大黄3g、厚朴10g、苏木9g、土茯苓10g。
本实施例同时提供了一种包含上述中药组合物的中药制剂,制备方法同实施例1。
实施例3
本实施例提供了一种中药组合物,所述中药组合物按重量份计,配方如下:
黄芪30g、金银花9g、青翘25g、椿皮9g、熟大黄9g、厚朴12g、苏木3g、土茯苓15g。
本实施例同时提供了一种包含上述中药组合物的中药制剂,制备方法同实施例1。
实施例4
本实施例提供了一种中药组合物,所述中药组合物按重量份计,配方如下:
黄芪5g、金银花30g、青翘5g、椿皮5g、熟大黄5g、厚朴6g、苏木6g、土茯苓6g。
本实施例同时提供了一种包含上述中药组合物的中药制剂,制备方法为:
各组方中的药材经净选、切制后,按照配比称量,加入8倍量的65%乙醇,浸泡1.0h后,回流提取2次,每次时间为1h,过滤后在60±10℃下收醇至无醇味,并浓缩至100ml(相对密度1.10-1.30)。
实施例5
本实施例提供了一种中药组合物,所述中药组合物按重量份计,配方如下:
黄芪50g、金银花15g、椿皮15g、熟大黄3g、厚朴6g、苏木6g、土茯苓6g。
本实施例同时提供了一种包含上述中药组合物的中药制剂,制备方法同实施例4。
实施例6
本实施例提供了一种中药组合物,所述中药组合物按重量份计,配方如下:
黄芪25g、金银花15g、青翘15g、熟大黄6g、厚朴10g、苏木9g、土茯苓10g。
本实施例同时提供了一种包含上述中药组合物的中药制剂,制备方法为:
各组方中的药材经净选、切制后,按照配比称量,加入8倍量的水,浸泡1.0h后,回流提取2次,每次时间为1h,过滤后在60±10℃下浓缩至100ml(相对密度1.10-1.30)。
对比例1
本对比例提供了一种现有技术中已知的用于复发性下尿路感染的通淋化瘀方,配方如下:
蒲黄10g、滑石15g、金银花30g、扁蓄15g、瞿麦15g、土茯苓15g、桃仁10g、大黄10g、当归15g、浙贝母10g、桂枝6g、柴胡12g、黄芩10g。
本对比例同时提供了一种基于上述通淋化瘀方的中药制剂,其制备方法及条件参数同实施例1。
对比例2
本对比例提供了一种现有技术中已知的用于治疗肾盂肾炎的泌感汤中药制剂,配方如下:
金银花50g、连翘50g、蒲公英50g、紫花地丁50g、厚朴25g、苏木25g、土茯苓30g、酒大黄5g、马鞭草30g、积雪草30g、败酱草30g、接骨木20g、坤草30g。
本对比例同时提供了上述泌感汤中药制剂的制备方法,条件参数同实施例1。
对比例3
本对比例为市售三金片中药制剂,处方为:金樱根、菝葜、羊开口、金沙藤、积雪草。生产企业为桂林三金药业股份有限公司,批准文号为国药准字Z45021601。
本对比例三金片为清热剂,具有清热解毒,利湿通淋,益肾功效。主治下焦湿热所致的热淋、小便短赤、淋沥涩痛、尿急频数;急慢性肾盂肾炎、膀胱炎、尿路感染见上述证候者;慢性非细菌性前列腺炎肾虚湿热下注证。
对比例4
本对比例为市售八正散中药制剂八正颗粒,生产企业陕西东泰制药有限公司,批准文号为国药准字Z20050045。
本对比例八正散为祛湿剂,具有清热泻火,利水通淋之功效。主治湿热淋证;尿频尿急,溺时涩痛,淋沥不畅,尿色浑赤,甚则癃闭不通,小腹急满,口燥咽干,舌苔黄腻,脉滑数;临床常用于治疗膀胱炎、尿道炎、急性前列腺炎、泌尿系结石、肾盂肾炎、术后或产后尿潴留等属湿热下注证。
实验例1
本实验例选择实施例1-6和对比例1-4制备得到的中药制剂,对各中药制剂的药效进行检验。
(1)药物对大肠杆菌致大鼠慢性尿路感染模型影响。
采用大肠杆菌经膀胱逆行感染及单侧输尿管不全梗阻的方法建立慢性尿路感染模型,造模成功后开始灌胃给予相应药物,实施例1-6和对比例1-2的给药量为1mL/100g,每日1次,连续15天。对比例3-4根据产品说明书记载的方法给药。分别于给药后7天收集大鼠膀胱灌洗液,测定尿液中白细胞数量及PH。第15天取大鼠膀胱、肾组织,检测脏器指数以及病理形态学改变(HE染色)。
结果见表1、表2。
表1大鼠膀胱灌洗液对比研究结果
项目 | 白细胞(个/HP) | PH |
空白组 | 0.82±0.61 | 6.89±0.46 |
模型组 | 2.73±0.43 | 6.47±0.48 |
对比例1 | 1.76±1.01 | 6.72±0.63 |
对比例2 | 1.28±1.05 | 6.87±0.55 |
对比例3 | 1.16±1.07 | 6.86±0.35 |
对比例4 | 1.28±1.02 | 6.81±0.47 |
实施例1(高剂量组) | 0.82±0.36 | 6.94±0.36 |
实施例1(中剂量组) | 0.85±0.41 | 6.92±0.36 |
实施例1(低剂量组) | 1.01±0.32 | 6.91±0.55 |
实施例2 | 0.88±0.46 | 6.91±0.42 |
实施例3 | 1.01±0.82 | 6.90±0.31 |
实施例4 | 1.12±1.07 | 6.89±0.48 |
实施例5 | 1.11±0.50 | 6.89±0.43 |
实施例6 | 0.90±0.39 | 6.90±0.37 |
注:实施例1高剂量组:实施例1的2倍给药量;实施例1中剂量组:实施例1的1倍给药量;实施例1低剂量组:实施例1的0.5倍给药量。
与空白对照组相比,模型组大鼠尿路感染后白细胞数量显著增加(P<0.01)。与模型组相比,对比例2、三金片、八正散、实施例各组白细胞数量均明显降低(P<0.01),其中,实施例1组和实施例2组的白细胞数量降低程度最高。
与空白对照组相比,模型组大鼠尿路感染后尿液PH显著降低(P<0.01)。与模型组相比,对比例2、三金片、八正散、实施例各组PH显著升高(P<0.05或P<0.01),其中,实施例1组和实施例2组的PH升高程度最高。
表2脏器指数以及病理形态学改变情况
注:实施例1高剂量组:实施例1的2倍给药量;实施例1中剂量组:实施例1的1倍给药量;实施例1低剂量组:实施例1的0.5倍给药量。
药理试验结果表明,各实施例药效试验结果均明显优于各对比例。说明本发明对尿路感染大鼠的肾脏和膀胱的病理学组织学改变有明显的治疗作用。
实验例2
本实验例使用实施例1制备得到的中药组合物,用于治疗再发性尿路感染患者,同时提供了如下典型案例:
案例1:
于某,男,38岁,既往西医诊断为再发性尿路感染。2019年8月初诊,尿痛、尿频、腰酸乏力1月有余,按照以往就医处方,口服盐酸左氧氟沙星片及三金片5天,症状未好转。医院查尿常规示:红细胞80/μL,白细胞225/μL,白蛋白80mg/L,PH 5.0。前来就医主诉症状有尿频、尿急、尿痛,腰酸乏力,小腹坠胀,舌质红,脉细滑。来就医后诊断主症:小便频数短涩,尿道灼热刺痛,少腹拘急;次症:尿黄混浊,心烦,口苦,大便干结;舌脉:舌质红,苔黄腻,脉细滑。一诊日处方:黄芪25g、金银花15g、连翘15g、椿皮6g、熟大黄6g、厚朴10g、苏木9g、土茯苓10g,水煎服。7日后复诊,各项症状消失,基本痊愈,偶有腰酸乏力,脉细弱,二诊嘱其再继续服用7天。再7日后复诊,二便正常,脉象平稳,已痊愈,医院查尿常规各项指标均在合格范围内,各项体征正常。随访无复发。
案例2:
李女士,52岁,2018年5月初诊。主诉两年前开始尿路感染反复发作,既往就医曾静注和口服抗生素治疗多次,一年内开始愈后多次复发。前来就医诊断主症:小便频数,尿道灼热;次症:尿黄,口苦,腰酸乏力;舌脉:舌质红,苔黄腻,脉细。一诊日处方:黄芪25g、金银花15g、连翘15g、椿皮6g、熟大黄6g、厚朴10g、苏木9g、土茯苓10g,水煎服。7日后复诊,基本痊愈,偶有口苦、乏力,二诊嘱其再继续服用7天。再7日后复诊,各项症状消失,已痊愈。随访无复发。
以上所述实施例仅表达了本发明的几种实施方式,便于具体和详细地理解本发明的技术方案,但并不能因此而理解为对发明专利保护专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。
Claims (10)
1.中药组合物,其特征在于,所述中药组合物由包括以下重量份的原料药制得:黄芪5-50份,金银花5-50份,青翘0-30份,椿皮0-15份,熟大黄3-15份,厚朴3-15份,苏木3-15份,土茯苓3-30份。
2.根据权利要求1所述中药组合物,其特征在于,所述中药组合物由包括以下重量份的原料药制得:黄芪15-25份,金银花10-40份,青翘10-25份,椿皮3-10份,熟大黄3-10份,厚朴6-15份,苏木5-12份,土茯苓5-15份。
3.根据权利要求1所述中药组合物,其特征在于,所述中药组合物由包括以下重量份的原料药制得:黄芪20-30份,金银花10-20份,青翘10-20份,椿皮3-9份,熟大黄3-9份,厚朴8-12份,苏木6-12份,土茯苓8-12份。
4.根据权利要求1-3任意一项所述中药组合物,其特征在于,所述中药组合物由包括以下重量份的原料药制得:黄芪25份,金银花15份,青翘15份,椿皮6份,熟大黄6份,厚朴10份,苏木9份,土茯苓10份。
5.中药制剂,其特征在于,由权利要求1-4任意一项所述中药组合物单独制成,或由权利要求1-4任意一项所述中药组合物与药学上可接受的载体和/或赋形剂制成。
6.根据权利要求5所述中药制剂,其特征在于,所述中药制剂的剂型为片剂、丸剂、胶囊剂、颗粒剂、冲剂、散剂、膏剂、口服液或合剂。
7.权利要求5或6所述中药制剂的制备方法,其特征在于,包括如下步骤:
S1、按重量份称取各原料药,炮制,得中药饮片;
S2、将所述中药饮片置于提取溶媒中,得提取物;
S3、将所述提取物与所述载体和/或赋形剂结合,得到中药制剂。
8.根据权利要求7所述中药制剂的制备方法,其特征在于,步骤S2所述提取溶媒为水。
9.权利要求1-4任意一项所述中药组合物,或者权利要求5或6所述中药制剂,或者权利要求7或8所述制备方法制备得到的中药制剂在制备用于预防或治疗尿路感染及再发性尿路感染疾病药物中的应用。
10.根据权利要求9所述应用,其特征在于,所述尿路感染及再发性尿路感染疾病的症状包括尿频、尿急、尿痛、夜尿、耻骨上疼痛、少腹拘急、尿黄浑浊、脓尿、血尿、腰酸乏力、恶寒发热、恶心呕吐、排尿后减轻中的至少一种。
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