CN116672422A - 一种用于治疗胆囊炎和/或胰腺炎的中药组合物及应用 - Google Patents
一种用于治疗胆囊炎和/或胰腺炎的中药组合物及应用 Download PDFInfo
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Abstract
本发明提供一种用于治疗胆囊炎和/或胰腺炎的中药组合物及制备方法。由包括如下质量份的组分制成:白芍15份;大黄10‑15份;川芎6‑9份;香附6‑9份;丹参15‑20份;柴胡10份;木香10‑15份;枳实10g;草豆蔻10‑15份;川楝子20‑30份;黄芩10‑15份;黄连6‑9份;甘草6份;延胡索(元胡)10‑15份;没药(制)6‑9份;乳香(制)6‑9份;花椒(川椒)6‑9份;干姜6‑9份;蒲公英15‑20份;败酱草15‑20份;金钱草15‑20份;白花蛇舌草15‑20份;半枝莲15‑20份。在临床应用过程中反复推敲验证形成本方剂,临床上广泛应用于胆囊炎和/或胰腺炎,临床实践证实,该药物安全性高,副作用小,疗效确切。
Description
技术领域
本发明涉及一种用于治疗胆囊炎和/或胰腺炎的中药组合物及应用,属于中药复方领域。
背景技术
胆囊炎是急性胆囊炎和慢性胆囊炎的统称,是指由胆囊结石或其他原因引起的胆囊内发生急、慢性炎症反应的过程,慢性胆囊炎常与胆囊结石长期并存,发作时患者存在腹胀痛、发热等现象,甚至有癌变的危险,严重影响患者的身体健康[张静喆,余奎.急、慢性胆囊炎的中西医结合治疗进展[J].临床肝胆杂志,2017,33(5):838-842]。胰腺炎是胰腺因胰蛋白酶的自身消化作用而引起的疾病。胰腺有水肿、充血,或出血、坏死。临床上出现腹痛、腹胀、恶心、呕吐、发热等症状。化验血和尿中淀粉酶含量升高等[中华医学会消化病学分会胰腺疾病学组.中国急性胰腺炎诊治指南(草案)《现代消化及介入诊疗》,2007.]。两种疾病都是临床上最常见的消化系统疾病之一,其发病机制复杂且尚未完全明确,治疗不及时容易进展为重症急性胰腺炎,病情凶险且病死率高。近年来随着经济的进步,人民的生活水平和饮食习惯发生了显著的变化,导致消化道疾病的发病率不断上升。过量饮酒、代谢性疾病(如高脂血症)、胆道结石相关病症等成为引起上述疾病的常见原因[LU WW,CHEN X,NI JL,et al.The role ofgut microbiota in the pathogenesis and treatment ofacutepancreatitis:a narrative review[J].Ann Palliat Med,2021,10(3):3445-3451]。目前西医对胆囊炎、急性胰腺炎多采用手术及抗生素治疗,但术后患者生活质量受到一定影响,且部分患者错失手术时机或失治误治发展为慢性胰腺炎和/或胆囊炎,西医缺乏有效治疗措施,而中医中药辩证论治在本病的治疗过程中发挥了巨大优势。
在2021《指南》[刘凤斌,胡玲,陈苏宁,唐旭东,劳绍贤,陈斌,李培武,侯政昆,庄昆海,文艺,姚思梦,黄远程,张长荣,温艳东,王凤云,吕林.消化系统常见病慢性胰腺炎中医诊疗指南(基层医生版)[J].中华中医药杂志,2019,34(12):5785-5789]中,胰腺炎急性期建议中医药与西药联合使用,旨在提高临床疗效,减少并发症和后遗症的发生,协同渡过危重期。恢复期建议中医药与西药联合使用,以中医药治疗为主,并逐步过渡到中医药替代西药治疗,旨在保证临床疗效的同时减少西药的使用,充分发挥中医药治疗本病的优势和特色。通过整体调理、辨证论治,改善临床症状,减少并发症和防止复发,提高患者的生活质量,节约医疗资源。
目前,在治疗中较常用的用于治疗胰腺炎和/或胆囊炎的中药大多来源于中医师随辩证潜方,其临床疗效随医师辨病辨证是否准确、潜方用药是否精准,中药材质量优劣及中药的煎法正确与否而表现各异。与此同时,目前市场上用于治疗胰腺炎的中成药制剂寥寥数种,可供患者选择的中药制剂品种单一。治疗胆囊炎的中药制剂如胆康胶囊、消炎利胆片等,单康胶囊主要和西药联合使用[朱龙柏.胆康胶囊联合头孢哌酮钠舒巴坦钠治疗慢性胆囊炎的临床研究[J].现代药物与临床,2018,33(07):1686-1690],多用于治疗胆囊炎合并胆结石,尤适用于湿热内阻挟瘀患者[刘丽娟,田雪秋.胆康胶囊治疗湿热内阻挟淤型胆囊炎25例疗效观察[J].中国实用乡村医生杂志,2006(11):39-40]。为补充市场空缺,迫切需要研发能给患者带来临床服用方便和临床疗效确切的中药制剂。
发明内容
本发明的目的是提供一种用于治疗胆囊炎和/或胰腺炎的中药组合物及制备方法,该中药组合物源于甘肃正学中医研究院内制剂胆胰颗粒,经裴正学教授博采众方,精准辩证,在临床应用过程中反复推敲验证,形成本方剂,临床应用多年,疗效明确,副作用小。但现有制剂需现配现煎,耗时耗力,成本高昂,且患者服药易失去耐心,依存性差。为了解决上述问题,对本方制剂进行改进,在保证药物有效性的前提下,采用现代先进工艺,对药物有效成分浓缩包装。颗粒剂制作过程简单,成品率高,含量稳定,所定工艺稳定可行。实现批量化生产加工,有效控制生产成本,节约社会资源,且制成独立包装后,干净卫生,服用方便,为患者带来福音。
本发明的中药组合物由包括如下质量份的组分制成:
白芍15份;大黄10-15份;川芎6-9份;香附6-9份;丹参15-20份;柴胡10份;木香10-15份;枳实10g;草豆蔻10-15份;川楝子20-30份;黄芩10-15份;黄连6-9份;甘草6份;延胡索(元胡)10-15份;没药(制)6-9份;乳香(制)6-9份;花椒(川椒)6-9份;干姜6-9份;蒲公英15-20份;败酱草15-20份;金钱草15-20份;白花蛇舌草15-20份;半枝莲15-20份(均为常规的用药部位)。
具体地,所述中药组合物由包括如下质量份的组分制成:白芍15份、大黄15份、川芎6份、香附6份、丹参20份、柴胡10份、木香10份、枳实10份、草豆蔻10份、川楝子20份、黄芩10份、黄连6份、甘草6份、延胡索(元胡)10份、没药(制)6份、乳香(制)6份、花椒(川椒)6份、干姜6份、蒲公英15份、败酱草15份、金钱草15份、白花蛇舌草15份、半枝莲15份。
所述中药组合物的剂型可为颗粒剂。
上述的中药组合物的颗粒剂采用如下方法制备而成:将配方药材加水煎煮两次。第一次加8倍量的水,煎煮1小时;第二次加6倍量的水,煎煮1小时,合并两次煎煮液,滤过,减压浓缩,浓缩至相对密度为1.01-1.05(55℃-60℃测定),喷雾干燥,干法制粒,即得。
本发明所述的中药组合物应用于制备治疗胆囊炎和/或胰腺炎的药物中。
本发明还提供了一种治疗胆囊炎和/或胰腺炎的药物,其活性成分为上述的中药组合物。
本发明具有以下优点:
1.本发明具有疏肝和胃,活血化瘀,清热解毒的功效。在临床应用过程中反复推敲验证,形成本方剂,临床上广泛应用于胆囊炎和/或胰腺炎,临床实践证实,该药物安全性高,副作用小,疗效确切。
2.本发明对方剂剂型制作工艺进行改造,便于批量生产和质量把控,制作过程简单,成品率高,含量稳定,所定工艺稳定可行。实现批量化生产加工,有效控制生产成本,节约社会资源。
3.制成独立包装后,干净卫生,服用方便,为患者带来福音。
具体实施方式
下述实施例中所使用的实验方法如无特殊说明,均为常规方法。
下述实施例中所用的材料、试剂等,如无特殊说明,均可从商业途径得到。
实施例:
1.资料与方法
1.1病例来源
2012年1月-2019年3月,门诊就诊于甘肃正学中医研究院,明确诊断为胆囊炎或胰腺炎的100例门诊患者。
1.2入选标准
1.2.1西医诊断标准
主要参照《黄家驯外科学》第7版和由中华医学会外科学分会胰腺外科学组于2014年发布的《慢性胰腺炎诊治指南》。
①临床表现:典型的发作性上腹部疼痛,由间歇性疼痛逐渐转变为持续性疼痛,疼痛位置多位于上腹部剑突下或偏左,也可呈束腰带状放射至背部或两胁。后期可出现营养吸收障碍、消化不良、脂肪泻、糖尿病症状体重下降等内、外分泌不全症状。体征:可有轻度压痛。少数患者可触及包块,由于消化吸收功能障碍导致消瘦、疲乏无力、肠鸣音减弱或消失。
②理化检查:急性发作期:可见血、尿淀粉酶和血脂肪酶升高,白细胞计数及中性粒细胞升高。
③影像学诊断:超声可见胰腺纤维化周围边界不清,或局限性结节或形成囊肿,伴随胰管扩张,合并结石者可于胰管内见强回声。
综上所述,在排除其他恶性疾病的基础上,将以下4项作为本研究入组的主要诊断依据。
(1)腹部疼痛,胰腺内分泌、外分泌功能不全等典型的临床表现。
(2)病理学检查。
(3)影像学检查,有典型的慢性胰腺炎特征及形态改变。
(4)实验室化学检查,血淀粉酶、尿淀粉酶及脂肪酶异常。
第(1)项为诊断所必须;第(2)项阳性可确诊;(1)+(3)可基本确诊;(1)+(4)为疑似患者,待查。
1.2.2中医诊断标准
慢性胰腺炎证型辨证:参考2002年5月发布实施的《中药新药临床研究指导原则》中消化系统疾病和中医证候的症状分级量化表,以及2006版的《中医消化病诊疗指南》。湿热证:主症:①腹胀;②口渴少饮;③食少纳呆;④大便搪而不爽;舌质红,苔黄腻。次症:①肢体困重;②身热不扬或汗出不解;③腹胀满,恶心欲吐;④身热发黄色鲜明;⑤脉濡数。证候确定:主症+次症各2项即可。
1.3纳入标准
⑴符合西医诊断标准。
⑵符合中医诊断标准。
⑶年龄在18至80岁。
⑷签定知情同意书。
1.4排除标准
(1)辨证不明确或有过多兼证者。
(2)急性发作腹痛剧烈的患者,且存在顽固性疼痛。
(3)影像学检查及病理结果疑似胰腺癌患者或有其他脏器严重病变。
(4)合并胆结石,胆管狭窄,胰屡,消化道梗阻及并发胰腺假性囊肿者。
(5)过敏体质或孕妇。
(6)未按规定服药,拒绝对饮食控制。
1.5脱落及剔除标准
(1)不能坚持治疗者。
(2)出现严重不良反应者。
(3)出现严重的并发症者。
认真记录研究中自行退出试验与终止试验的原因,并分析其与试验的关系。
1.6伦理学要求
本研究应严格遵循赫尔辛基宣言和中国有关临床实验研究的法规,每位受试者都应认真阅读知情同意书,并且签署知情同意书。
2试验方案
2.1分组方法
对照组50例:患者入院后,给予常规临床严格禁食、禁水,胃肠减压,肠外营养,抑酸、抑酶,解痉镇痛,维持电解质平衡,抗炎及灌肠等单用西医治疗方法治疗。
治疗组50例:患者在西医治疗方法基础上加服本发明中药组合物颗粒剂。服用方法:每次服用10-12g,每天2次,颗粒以10g为最小包装量,每次服用1袋,每天2次。
本发明中药组合物颗粒剂的成分:白芍15g、大黄15g、川芎6g、香附6g、丹参20g、柴胡10g、木香10g、枳实10g、草豆蔻10g、川楝子20g、黄芩10g、黄连6g、甘草6g、延胡索(元胡)10g、没药(制)6g、乳香(制)6g、花椒(川椒)6g、干姜6g、蒲公英15g、败酱草15g、金钱草15g、白花蛇舌草15g、半枝莲15g。
制备方法:
将配方药材加水煎煮两次。第一次加8倍量的水,煎煮1小时;第二次加6倍量的水,煎煮1小时,合并两次煎煮液,滤过,减压浓缩,浓缩至相对密度为1.01-1.05(55℃-60℃测定),喷雾干燥,干法制粒,即得。
观察病例于1疗程(7天)后停止服药治疗,根据患者自身情况真实行疗效评定。
2.2观察指标
观察、记录患者的腹痛、腹胀缓解时间和肠鸣音恢复时间。
2.2.1实验室指标
所有患者第1天、第3天、第5天、第7天血清淀粉酶、尿淀粉酶、血清脂肪酶情况。
2.2.2临床疗效评价指标
主要症状疗效评定标准参照《慢性胰腺炎诊疗方案》。
(1)无效:患者的症状及体征未减轻或恶化,血、尿淀粉酶等理化检查无变化。
(2)有效:患者的症状及体征有所改善但并未完全消失,血、尿淀粉酶有下降趋势,但变化不明显。
(3)痊愈:患者的症状及体征完全消失,血、尿淀粉酶恢复正常或明显好转。
2.2.3安全性指标
(1)两组患者治疗前后肝功能、肾功能变化情况。肝功能观察以谷丙转氨酶(ALT)、谷草转氨酶(AST)主,肾功能观察以血尿素氮(BUN)、血肌酐(Cr)主。
(2)体温、呼吸、脉搏、血压以及尿常规、粪常规的异常。尿常规观察以尿蛋白(PRO)、尿潜血(BLD)为主,粪常规观察以大便潜血(OB)为主。
2.3统计方法
本次研究收集数据用EXCEL软件进行统计管理,通过SPSS21.0软件,等级资料用秩和检验或者卡方检验,计量资料中符合正态分布或近似正态分布的两样本均数的比较用t检验进行分析。以差异P<0.05为有统计学意义。
3结果
3.1两组患者第1、3、5、7天血淀粉酶的比较
表1两组患者第1、3、5、7天血淀粉酶(mmol/L)的比较(x±s)
由表1得知:两组患者入院时,即第1天血淀粉酶水平无显著差异,具有可比性。此外,从两组患者第3、5、7天血淀粉酶水平的变化可以看到,加用本发明中药组合物颗粒的试验组患者血清淀粉酶下降更快。由此可知本发明中药组合物颗粒治疗慢性胰腺炎作用显著。
3.2两组患者第1、3、5、7天尿淀粉酶的比较
表2两组患者第1、3、5、7天尿淀粉酶(mmol/L)的比较(x±s)
由表2得知:两组患者入院时,即第1天尿淀粉酶水平无显著差异,具有可比性。此外,从两组患者第3、5、7天尿淀粉酶水平的变化可以看到,加用本发明胆胰颗粒的试验组患者尿清淀粉酶下降更快。由此可知本发明胆胰颗粒治疗慢性胰腺炎作用显著。
3.3两组患者第1、3、5、7天血脂肪酶的比较
表3两组患者第1、3、5、7天血脂肪酶(mmol/L)的比较(x±s)
由表3得知:两组患者入院时,即第1天血脂肪酶水平无显著差异,具有可比性。此外,从两组患者第3、5、7天血脂肪酶水平的变化可以看到,加用本发明中药组合物颗粒的试验组患者血脂肪酶下降更快。由此可知本发明中药组合物颗粒治疗慢性胰腺炎作用显著。
3.4试验组与对照组患者治疗后腹痛缓解时间(天)比较
表4试验组与对照组患者治疗后腹痛缓解时间(天)比较(x±s)
表4经统计学分析:两组患者在腹痛缓解时间方面,有显著性差异(t检验x分析,P<0.05)。
3.5试验组与对照组患者治疗后腹胀缓解时间(天)比较
表5试验组与对照组患者治疗后腹胀缓解时间(天)比较(x±s)
表5经统计学分析:两组患者在腹胀缓解时间方面,有显著性差异(t检验xs分析,P<0.05)
3.6试验组与对照组患者治疗后肠鸣音恢复时间(天)比较
表6试验组与对照组患者治疗后肠鸣音恢复时间(天)比较
表6经统计学分析:两组患者在肠鸣音恢复时间方面,有显著性差异(t检验xs分析,P<0.05)。
3.7两组临床综合疗效比较
表7试验组与对照组临床综合疗效比较
经统计学分析:两组总有效率比较无显著性差异(P<0.05),但试验组治愈率(70.0%)优于对照组(56.0%)。
病案举例:
柴某,男,50岁,自诉右肋下刺痛拒按,后背胀痛,口苦口干,反酸,纳差。于3月前在某医院行胆囊切除术,查体肝、脾无异常,巩膜无黄染。B超提示:①慢性胰腺炎;②胆囊切除术后改变。胃镜显示:萎缩性胃炎伴糜烂。肝功、血常规未见明显异常。舌质暗红,脉弦数。西医诊断:①慢性胰腺炎②胆囊切除后术综合征;慢性萎缩性胃炎伴糜烂。中医辨证分型:气滞血瘀,湿热郁结。服用本发明中药组合物颗粒(白芍15g、大黄15g、川芎6g、香附6g、丹参20g、柴胡10g、木香10g、枳实10g、草豆蔻10g、川楝子20g、黄芩10g、黄连6g、甘草6g、延胡索(元胡)10g、没药(制)6g、乳香(制)6g、花椒(川椒)6g、干姜6g、蒲公英15g、败酱草15g、金钱草15g、白花蛇舌草15g、半枝莲15g)饭后冲服,忌食肉、鸡蛋、牛奶。半月后患者复诊,肋下疼痛、口苦口干、后背胀均已减轻,舌质淡,脉弦滑,血瘀已消除,但患者仍有反酸。坚持服本发明中药组合物颗粒2月余,上述症状均已减轻。
Claims (6)
1.一种中药组合物,其特征在于:该中药组合物由包括如下质量份的组分制成:白芍15g、大黄10-15g、川芎6-9g、香附6-9g、丹参15-20g、柴胡10g、木香10-15g、枳实10g、草豆蔻10-15g、川楝子20-30g、黄芩10-15g、黄连6-9g、甘草6g、延胡索(元胡)10-15g、没药(制)6-9g、乳香(制)6-9g、花椒(川椒)6-9g、干姜6-9g、蒲公英15-20g、败酱草15-20g、金钱草15-20g、白花蛇舌草15-20g、半枝莲15-20g。
2.根据权利要求1中所述的中药组合物,其特征在于:所述中药组合物由包括如下质量份的组分制成:白芍15份、大黄15份、川芎6份、香附6份、丹参20份、柴胡10份、木香10份、枳实10份、草豆蔻10份、川楝子20份、黄芩10份、黄连6份、甘草6份、延胡索(元胡)10份、没药(制)6份、乳香(制)6份、花椒(川椒)6份、干姜6份、蒲公英15份、败酱草15份、金钱草15份、白花蛇舌草15份、半枝莲15份。
3.根据权利要求1或2所述的中药组合物,其特征在于:所述中药组合物的剂型为颗粒剂。
4.根据权利要求3所述的中药组合物,其特征在于:所述中药组合物颗粒剂采用如下方法制备而成:将配方药材加水煎煮两次;第一次加8倍量的水,煎煮1小时;第二次加6倍量的水,煎煮1小时,合并两次煎煮液,滤过,减压浓缩,浓缩至相对密度为1.01-1.05,喷雾干燥,干法制粒,即得。
5.权利要求1-4中任一项所述的中药组合物在制备治疗胆囊炎和/或胰腺炎药物中的应用。
6.一种治疗胆囊炎和/或胰腺炎的药物,其特征在于:所述治疗胆囊炎和/或胰腺炎的药物的活性成分为权利要求1-4中任一项所述的中药组合物。
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