CN116350686B - 一种治疗口腔溃疡的药食同源中药组合物及其制备方法 - Google Patents
一种治疗口腔溃疡的药食同源中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种治疗口腔溃疡的药食同源中药组合物,该组合物包括黄芪1~60重量份、人参1~20重量份、炙甘草1~20重量份、葛根1~30重量份、白芷1~20重量份、栀子1~30重量份,其余为常用固体或液体制剂所需的辅料。可以制成固体制剂如片剂、胶囊剂、颗粒剂、丸剂、散剂;可以制成液体制剂如饮料、糖浆剂、合剂、膏滋剂。本发明在中医理论指导下组方,发挥补脾益气、升发阳气、清泻阴火的功效,用于治疗口腔溃疡,尤其适用于脾虚阴火证口疮,可伴有腹胀,纳呆,自汗,大便偏稀,倦怠乏力,口腔溃疡反复发作的症状。
Description
技术领域
本发明涉及一种具有补脾益气、升发阳气、清泻阴火功能的治疗口腔溃疡的组合物,是以食品(同时也是中药材)为原料制备的食品或药品,属于食品、保健品和药品领域。
背景技术
复发性口腔溃疡(recurrent oral ulcer,ROU)以周期性反复发作为特点的口腔黏膜局限性溃疡,可发生在口腔黏膜的任何部位。病程多呈自限性,一般持续7~10d,但容易复发,往往迁延多年。该病是口腔黏膜疾病中最常见的溃疡类疾病,居口腔黏膜病之首位。在一般人群中的发病率不低于10 %,在特定人群中患病率可高达60%。本病不受年龄限制,起病年龄大约在10~20岁,好发于青壮年,女性较多,一年四季均能发生。溃疡疼痛明显,且反复发作,影响患者进食、言语、情绪,给患者的生活和工作造成了较大困扰。发生机制可能与机体的免疫功能紊乱、口腔菌群失调、微量元素缺失、微循环障碍等有关,病因尚不十分明确。
现代医学主要采用化学药物治疗,主要方法为消炎止痛、补充微量元素、促进溃疡愈合、免疫调节等对症治疗,常用的药物有维生素类、免疫调节类,以及局部使用消炎类、激素类、止痛类药物,尚缺乏有效的根治方法,且易复发,治疗效果欠佳。
在中医学中,复发性口腔溃疡属“口疮”“口糜”“口疳”等病的范畴。本病多因平素饮食不节、过食辛辣厚味、嗜好烟酒或情志内伤、劳倦过度而致病。中医认为,脾开窍于口,其华在唇,舌为心之苗。本病病位在口腔,与心、脾关系最为密切。《杂病源流犀烛•卷二十三》曰:“凡口疮者,皆病之标也,治者当推求其本焉。” 口疮的病理因素多与“火”相关,又分实火、虚火。刘清臣在《医学集成》中说“口疮初起,多属实火,凉药不应,多属虚火”。《寿世保元》曰“口疮连年不愈者此虚火也”。而虚火口疮的病因多为脾胃虚弱,如《圣济总录》曰“又有胃气弱,谷气少,虚阳上发,而为口疮”;朱丹溪在《丹溪心法•口齿》中曰“口疮服凉药不愈者,因中焦土虚,且不能食,相火冲上无制”。由此可见,复发性口腔溃疡多由脾胃虚弱易致虚火内生,虚火上炎,导致口疮。脾虚是口疮反复发作的根本原因。
很多人都认为口腔溃疡是上火导致的,大量使用清热解毒类药物,没有治病求本,在发病期间使用清热解毒类药物又加重了脾胃虚寒,导致寒湿困脾,伤及脾胃,此类患者常因口腔溃疡是局部症状而被忽视,被给予错误的治疗,导致病情加重或恶化,迁延不愈,反复发作,为健康埋下隐患。
当前人们社会生活方式多表现为,不专心吃饭,以难消化、耗损脾胃之气的高蛋白食物为主,或贪食寒凉,或工作压力大,思虑过度,脾胃虚弱是现代人常见体质。脾胃为后天之本,“阴火”的根本病机在于脾胃虚弱,运化失常,气机升降失调,清阳不升,浊阴不降,疲浊食积内生,积滞日久,则郁而化热,火热上灼于口,可见口舌生疮。又因脾胃虚弱,元气不足,起于下焦之相火离其本位,上系于心,形成阴火,来乘土位,火热上炎于口舌,可表现为口疮。其病机与脾和心关系密切。因此,其治疗原则应为补脾益气,升阳,泻心火。
现已公布的技术,如中国发明专利CN103751620B所公布的一种治疗心火亢盛型复发性口腔溃疡的中药组合物,其公布的组合物包含灯心草,山禾串等10种药材制成,通过清心利尿,解毒敛疮,清热泻火的功效,促进局部溃疡很快愈合,达到治疗心火亢盛型复发性口腔溃疡的目的,其总有效率为94.8%。中国发明专利CN103705788B所公布的一种治疗胃火灼热型复发性口腔溃疡的中药组合物,其中药组合物是由木虾公,扁樱桃等9种药材制成,通过清胃泄热、滋阴解毒、和胃敛疮的功效,促进局部溃疡很快愈合,达到治疗胃火灼热型复发性口腔溃疡的目的,其总有效率为92.2%。中国发明专利CN104825868A一种治疗脾胃积热型口疮的中药组合物,其公开了黄连、连翘等12种药材制成,通过清热解毒,通腑泻火,治疗脾胃积热型口疮病症。中国发明专利CN110876779B所公布的一种治疗口腔溃疡的中药组合物及其制备方法和应用,其外敷方是由白芨、制没药、无名异、血竭配伍组成,各药按一定剂量研成细粉,用时取适量药粉,涂抹于患处,达到活血化瘀、消肿止痛,收敛生肌;内服方由百合、玄参、生大黄、升麻配伍而成,达到清热凉血、祛瘀散结、发表疮疹,养阴生津。上述公开的专利文献包括治疗心火亢盛型、胃火灼热型、脾胃积热型复发性口腔溃疡的中药组合物,或是传统中成汤药或成药内服,西瓜霜、锡类散、外用溃疡散之类外用的各种治疗方法,在药物组方上及药物的治疗方式上各有不同,其运用的中医理论也是各有不同,均有一定效果。但是,外用药物无法解决复发性口腔溃疡患者阴阳失调、虚实夹杂的本质问题,对于复发性口腔溃疡疗效欠佳;如冰硼散,其味道刺鼻患者难以接受,用药后不适感强,容易复发,针对口腔溃疡证型局限性强,且治标不治本;内服治疗口腔溃疡的药物基本以清热解毒为主,但是针对临床实践观察中发现的脾胃虚寒型复发性口腔溃疡患者,如果再以清热解毒、滋阴清热等为治法治则与之不符,疗效欠佳,并且治疗时间长。因此,如何提供一种标本兼顾、成分温和,安全,用于治疗脾虚型口腔溃疡的组合物,已经成为本领域技术人员亟待解决的技术问题。
2002年国家卫生部公布的《关于进一步规范保健食品原料管理的通知》中规定了既是食品又是药品的物品名单,简称为药食同源物品名单,这是中华民族传承千年的“医食同源,药膳同功”养生方式,指导着人们自我养生保健。该类物品可作为食品原料,同时具有中药功效,亦可作为药品原料。目前市场上大多治疗口腔溃疡的产品为药品,具有同等功效但具有食品属性的产品却很少。
本组合物中,黄芪为君,补益脾气之要药,甘温,入脾经,补中益气,升阳固表,对溃疡具有托毒排脓,敛疮生肌之功;人参、炙甘草为臣,人参益气健脾,炙甘草调和脾胃,使补脾功效持久,君臣三药共奏补脾胃、益气之效,治病求本。葛根、白芷为佐,葛根,性凉味甘辛,于清热之中,又能鼓舞脾胃清阳之气上升;白芷,辛散温通,对疮疡初起、红肿热痛者,具有散结消肿止痛、燥湿之功,入阳明胃经善治口腔牙龈肿痛,同时作为风药,能散能升,助升发清阳,二药共引脾胃清气上行,与补脾胃药相得益彰。栀子,苦寒清降,清泻三焦火邪,泻心火,凉血解毒,善治热毒疮疡、红肿热痛者。全方共奏甘温补脾益气,升发阳气,清泻阴火之功,用于治疗口腔溃疡,尤其适用于脾虚阴火证口疮,可伴有腹胀,纳呆,自汗,大便偏稀,倦怠乏力,口腔溃疡反复发作的症状。方中,有升有降,有补有泻,整体作用缓和,可长期服用,可开发为普通食品、保健品、药品。
发明内容
本发明的目的是提供一种具有补脾益气、升发阳气、清泻阴火功能的药食同源中药组合物,该组合物主要用于治疗口腔溃疡,尤其适用于脾虚阴火证口疮,可伴有腹胀,纳呆,自汗,大便偏稀,倦怠乏力,口腔溃疡反复发作的症状。。可用于口腔溃疡的治疗和保健。
本发明是根据中医理论,利用中药独特的药性,制备本发明组合物的原料药组成及配比如下:黄芪1~60份、人参1~20份、炙甘草1~20份、葛根1~30份、白芷1~20份、栀子1~30份。
一种含有黄芪、人参、炙甘草、葛根、白芷、栀子的制品,由以下方法制成:
方法一:对原料黄芪、人参、炙甘草、葛根、白芷、栀子分别用粉碎机粉碎并过30-120目筛,将原料投入混合机中混匀5-90分钟,混合均匀后过30-120目筛,加入适合的辅料制得相应的固体制剂或液体制剂;
方法二:将原料黄芪、人参、炙甘草、葛根、白芷、栀子分别用粉碎机粉碎并过10-40目筛,分别加3-20倍量的水,煎煮提取15-180分钟,过滤,滤渣加3-20倍量的水,煎煮提取15-180分钟,过滤,合并两次滤液,干燥得到提取物,备用;将以上所有提取物粉碎,过40-200目筛,按份称取后,混合机混合5-90分钟,混合均匀后,加入适合的辅料按常规制剂成型方法制备成固体或液体制剂;
方法三:将原料黄芪、人参、炙甘草、葛根、白芷、栀子分别用粉碎机粉碎并过10-40目筛,按份称取后,混合,加3-20倍量的水提取15-180分钟,滤过,滤渣加3-20倍量的水,煎煮提取15-180分钟,过滤,合并两次滤液,浓缩,加入适合的辅料按常规制剂成型方法制备成固体或液体制剂。
该组合物具有补脾益气,升发阳气,清泻阴火的功效,用于治疗口腔溃疡,尤其适用于脾虚阴火证口疮,可伴有腹胀,纳呆,自汗,大便偏稀,倦怠乏力,口腔溃疡反复发作的症状。
该组合物可以制成固体制剂如片剂、胶囊剂、颗粒剂、丸剂、散剂、糖果;可以制成液体制剂如饮料、糖浆剂、合剂、膏滋剂。
本发明以黄芪、人参、炙甘草、葛根、白芷、栀子干粉直接制成固体制剂或者提取后制成固体制剂或液体制剂,完全地保存了原料的有效成分,更好地发挥其功效。
本发明进行了动物急性毒性试验,结果表明无明显毒性反应及其它异常;开展了对小鼠脾虚型口腔溃疡模型的影响实验,结果表明本发明对脾虚型口腔溃疡模型小鼠起到明显的治疗作用;开展人体试食研究,结果表明本发明药物组合物在口腔溃疡愈合率、中医证候症状改善及减少复发方面疗效优势明显。
1.小鼠灌胃给药急性毒性试验
目的:用SPF级昆明种小鼠进行24 h内三次灌胃给药急性毒性试验,观察本发明对小鼠的急性毒性反应和死亡情况,为本发明的安全性提供实验依据。方法:将小鼠40只随机分为2组,即溶媒对照组和本发明实施例2的组合物组(三次灌胃给药剂量分别为11.06g/kg.bw、11.00g/kg.bw、10.97g/kg.bw),每组20只,雌雄各10只。动物禁食不禁水12h后,按40mL/kg体重24 h内三次灌胃给予相应供试品,观察其急性毒性反应和死亡情况,以后每天观察1次,连续14d;于给药第3、7、14d称量体重;观察至第14 d结束处死动物,大体解剖观察各组动物脏器、器官的体积、颜色、质地等有无明显异常。结果:小鼠灌胃给予本发明后连续观察4h,均未发现腹泻、惊厥、竖毛、俯卧等毒性反应。本发明组动物给药后至试验结束均未见动物死亡,小鼠灌胃最大给药量为33.00g/kg.bw;给药后3、7、14天,与溶媒组比较,本发明组动物体重均无明显差异(P>0.05);试验结束后颈椎脱臼处死动物,解剖后肉眼大体观察,结果发现,本发明组动物各脏器组织、器官的体积、颜色、质地等肉眼未见异常。结论:在本试验条件下,本发明给予小鼠灌胃最大给药量为33.00g/kg.bw,相当于成人临床剂量333倍。解剖后发现本发明组动物主要脏器未见明显异常。
2. 对小鼠脾虚型口腔溃疡模型的影响实验
动物:KM小鼠50只,体重20~28g。
造模与给药:随机分为两组,正常组(10只)和模型组(40只)。正常组自由饮水,正常饮食;模型组限制饮食,隔日游泳致过度劳倦,连续8日,然后氨甲喋呤MTX(1.4mg/mL)腹腔注射,正常饮食0.5mL,1次1日,连续5天。造模成功后,将模型组随机分为本发明(实施例2的组合物)高剂量组(10只)、本发明(实施例2的组合物)低剂量组(10只)、阳性对照组(10只)和模型对照组(10只),低剂量组、高剂量组分别每天灌胃给予本发明组合物相当于1.66g生药/kg.bw、3.29g生药/kg.bw,阳性对照组每天予以西瓜霜喷剂喷涂覆盖全部创面,模型对照组每天灌胃给予等体积生理盐水,1次1日,连续14天。
观察及指标检测:(1)体重:造模成功后给药第3、7、14天称体重,观察体重变化;(2)口腔溃疡症状:给药后每天观察口腔溃疡数目、溃疡持续时间。(3)口腔溃疡疗效:对各组小鼠治疗后的疗效评价,痊愈:治疗后口腔溃疡面完全愈合;显效: 治疗后口腔溃疡面缩小>2/3,局部红肿消退;无效:治疗后,口腔溃疡面及症状均未改善;将痊愈、显效合并为总有效率。(4)IL-2、TNF-α及IFN-γ水平:第14天各组小鼠用眼球后动脉取血,颈椎脱臼法处死,血标本用离心机离心,3000 r /min,15min,移液管取上清液,用ELISA法和MODEL-550酶标仪测IL-2、TNF-α及IFN-γ的含量。
统计学分析:使用SPSS 22. 0软件对数据进行分析,以均数±标准差(±s)表示, 组间比较采用单因素方差分析,P<0. 05为差异有统计学意义。
实验结果:
(1)体重变化:与正常组比较,给药后第3天,低剂量组小鼠体重明显减少(P<0.05);与模型对照组比较,给药后第3天、第7天、第14天,低剂量、高剂量组小鼠体重增长明显(P<0.05);与阳性对照组比较,给药后第3天、第7天,低剂量、高剂量组小鼠体重增长无统计学差异(P>0.05),给药后第14天,低剂量、高剂量组小鼠体重增长明显较快(P<0.05)。说明与模型对照组、阳性对照组比较本发明低、高剂量组体重增长快。各组动物体重变化情况见表1。
表1.小鼠体重变化(±s,n=10)
体重(g) | 体重(g) | 体重(g) | 体重(g) | ||
组别 | 剂量(g/kg.bw) | 给药前 | 给药后第3天 | 给药后第7天 | 给药后第14天 |
正常组 | -- | 23.45±2.19 | 26.09±1.99 | 31.93±2.19 | 37.54±4.38 |
模型对照组 | -- | 20.73±1.04 | 20.63±2.63 | 25.98±1.49 | 32.48±3.13 |
阳性对照组 | -- | 21.06±0.63 | 22.79±2.27 | 28.29±2.36 | 33.94±5.01 |
本发明低剂量组 | 1.66 | 20.71±0.94# | 23.45±2.19#* | 30.70±3.25* | 36.30±6.93*△ |
本发明高剂量组 | 3.29 | 20.41±0.91# | 24.74±1.98* | 31.10±3.10* | 37.43±4.26*△ |
备注:与正常组比较:#P<0.05;与模型对照组比较:*P<0.05;与阳性对照组比较:△P<0.05
(2)口腔溃疡症状:与模型对照组相比,低、高剂量组小鼠溃疡数目明显减少(P<0.05),低剂量组小鼠溃疡持续时间明显减少(P<0.05),高剂量组小鼠溃疡持续时间显著减少(P<0.01);与阳性对照组比较,低剂量组小鼠溃疡数目无统计学差异(P>0.05),高剂量组小鼠溃疡数目明显减少(P<0.05),低、高剂量组小鼠溃疡持续时间无统计学差异(P>0.05)。说明与模型对照组比较本发明低剂量、高剂量组口腔溃疡数量少、愈合快,与阳性对照组比较高剂量组口腔溃疡数量更少。
表2.小鼠口腔溃疡症状(±s,n=10)
组别 | 溃疡数目(个) | 持续时间(d) |
正常组 | 0 | 0 |
模型对照组 | 5.45±0.98 | 6.87±1.54 |
阳性对照组 | 3.87±0.52 | 2.90±0.87 |
本发明低剂量组 | 3.35±0.61* | 3.17±1.32* |
本发明高剂量组 | 2.17±0.53*△ | 2.86±1.05** |
备注:与模型对照组比较:*P<0.05;与阳性对照组比较:△P<0.05
(3)口腔溃疡疗效:低、高剂量组小鼠治疗总有效率显著优于模型对照组(P<0.01),与阳性对照组比较无统计学差异,说明本发明低剂量组、高剂量组口腔溃疡疗效较好,与阳性对照药相当。
表3.小鼠口腔溃疡疗效(单位:只,n=10)
组别 | 痊愈 | 显效 | 无效 | 总有效率 |
模型对照组 | 1(10.0%) | 3(30.0%) | 6(60.0%) | 40.0% |
阳性对照组 | 4(50.0%) | 3(30.0%) | 3(20.0%) | 70.0% |
本发明低剂量组 | 3(30.0%)* | 4(40.0%)* | 3(20.0%)** | 70.0%** |
本发明高剂量组 | 4(50.0%)* | 4(40.0%)* | 2(10.0%)** | 80.0%** |
备注:与模型对照组比较:*P<0.05,**P<0.01;与阳性对照组比较:△P<0.05
(4)血清IL-2、TNF-α及IFN-γ水平:模型对照组血清 IL-2、TNF-α、IFN-γ水平与正常组比较显著升高(P<0.01);低剂量组血清 IL- 2水平与模型对照组比较明显降低(P<0.05),高剂量组IL - 2水平、低和高剂量组TNF-α水平、低和高剂量组IFN-γ水平与模型对照组比较显著降低(P<0.01);低和高剂量组血清 IL - 2水平、低剂量组IFN-γ水平与正常组比较明显升高(P<0.05),低和高剂量组TNF-α水平与正常组比较显著升高(P<0.01);低和高剂量组血清 IL - 2水平、高剂量组TNF-α水平、低和高剂量组IFN-γ水平与阳性对照组比较明显升高(P<0.05)。说明与模型对照组比较本发明低剂量、高剂量组能显著降低促进炎症因子表达水平,与阳性对照组比较本发明低剂量、高剂量组能明显降低促进炎症因子表达水平。
表4.小鼠血清IL-2、TNF-α及IFN-γ水平(±s,n=10,pg/ml)
组别 | IL-2 | TNF-α | IFN-γ |
正常组 | 25.62±2.46 | 63.15±7.59 | 77.48±8.24 |
模型对照组 | 36.04±4.27△△ | 101.45±12.13△△ | 126.95±5.53△△ |
阳性对照组 | 34.17±2.22 | 93.23±9.75 | 91.39±5.76 |
本发明低剂量组 | 31.86±3.14*#& | 91.84±8.96**## | 86.01±4.47**#& |
本发明高剂量组 | 29.76±3.36**#& | 86.38±5.61**##& | 79.83±6.25**& |
备注:模型对照组与正常组比较: △△P<0.01;低、高剂量组与模型对照组比较:*,P<0.05,**P<0.01;低、高剂量组与正常组比较:#P<0.05,## P<0.01;低、高剂量组与阳性对照组比较:&P<0.05
实验结论:本发明组可以促进脾虚小鼠的体重增长,减少小鼠口腔溃疡数量并加快愈合,对口腔溃疡治疗效果较好,降低促进炎症因子表达水平,从而对脾虚型口腔溃疡模型小鼠起到明显的治疗作用。
3. 人体试食试验
3.1 一般资料
选取100例口腔溃疡症患者。其中女66 例,男 34 例;病程 6个月~2年,年龄 18~65岁,平均年龄35岁。
3.2 入排标准
入组标准:(1)患者诊断标准为《口疮中医临床实践指南( 2018)》中对脾虚阴火证的诊断标准;
(2)具有口腔溃疡复发史半年以上,至少发作过2次,且7天以上才能缓解;
(3)临床分型为轻型,溃疡数目≤5个,疼痛VAS评分≥4分,溃疡直径≤10mm;
(4)本次靶溃疡发生时间在48小时以内,且尚未进行治疗;
(5)年龄在18~65岁之间,性别不限;
(6)全部患者均了解实验内容,签署知情同意书后,加入本次实验。
排除标准:(1)重型复发性口腔溃疡,疱疹型复发性口腔溃疡,白塞病,癌性溃疡,创伤性溃疡,结核性溃疡,糜烂性扁平苔藓,梅毒性溃疡,病毒性口炎,坏死性涎腺化生者及其他疾病或药物引起的溃疡者;
(2)过敏体质或已知对本药成分过敏者;
(3)合并心脑血管、肝、肾等重要脏器严重器质性疾病及造血系统严重原发性疾病。
(4)长期使用激素类药物、或免疫抑制剂治疗的患者;
(5)计划妊娠、妊娠、哺乳期妇女及试验期间不能严格避孕。
3.3 方法
(1)对照组:总共50例,女31例,男19例,采用桂林三金的西瓜霜喷剂,给药方式为外用,喷、吹或敷于患处,一次适量,一日6次,治疗1周。
(2)试验组:总共50例, 女35例,男15例,口服实施例2的组合物,早中晚各温服一次,治疗1周。
3.4 观察指标及方法:
溃疡消失:口腔中没有明显的溃疡面,由患者每天填写日志。
溃疡疼痛变化:使用VAS评分,由患者每天填写评分日志。
中医证候:腹胀,纳呆,自汗,大便偏稀,倦怠乏力单项证候消失占比。
复发率:治疗后1周后开始,随访6个月,再次复发的病例数。
3.5 疗效标准:
3.5.1 目标溃疡愈合率
治疗1周后的溃疡全部消失,疼痛全部消失的占比。
3.5.2 疼痛变化对比
VAS评分的变化比较。
3.5.3 中医证候
治疗1周后,腹胀,纳呆,自汗,大便偏稀,倦怠乏力单项证候消失占比。
3.5.4复发率
治疗后1周后开始,随访6个月,再次复发的病例数。
3.6 统计学分析
使用SPSS 22. 0软件对数据进行分析,以均数±标准差(±s)表示, P<0. 05为差异有统计学意义。
3.7 结果
疗效比较:
(1)目标溃疡愈合率
对照组患者口腔溃疡的愈合率为52%,试验组患者口腔溃疡的愈合率为76%,试验组与对照组相比,差异有统计学意义(P<0.05),见表5。
表5 两组目标溃疡愈合率比较
组别 | 病例数 | 治疗1周后溃疡、疼痛消失/例 | 占比/% |
对照组 | 50 | 26 | 52 |
试验组 | 50 | 38* | 76* |
与对照组比较:*P<0.05
(2)疼痛消失时间
对照组和试验组在给药前口腔溃疡症患者的VAS评分无差异性(P >0.05);治疗后,两组VAS评分均有大幅降低,试验组与对照组比较,无统计学差异(P>0.05),见表6。
表6 两组VAS评分情况比较(±s)
组别 | 病例数 | 基线 | 第5天 | 第6天 | 第7天 |
对照组 | 50 | 6.62±2.59 | 3.94±1.93 | 3.36±1.96 | 2.76±1.87 |
试验组 | 50 | 6.65±2.65 | 3.86±1.97 | 3.44±2.02 | 2.36±1.78 |
与对照组比较:p>0.05
(3)中医证候单项症状消失占比
对照组和试验组在治疗后,单项症状对比,有统计学差异(P<0.05),见表7。
表7 两组中医证候单项症状消失率的比较(消失例数/总例数%)
组别 | 病例数 | 腹胀 | 纳呆 | 自汗 | 大便偏稀 | 倦怠乏力 |
对照组 | 50 | 20/47(42.55) | 25/50(50.00) | 20/42(47.62) | 20/50(40.00) | 16/42(38.10) |
试验组 | 50 | 46/48(95.83)* | 41/50(82.00)* | 34/38(89.47)* | 42/48(87.50)* | 34/45(75.56)* |
与对照组比较,*P<0.05
(4)复发率占比
随访至6个月,统计3个月内和6个月内的口腔溃疡复发情况,试验组与对照组相比,有统计学差异(P<0.05),见表8。
表8 两组复发率占比比较(复发例数/总例数%)
组别 | 病例数 | 3个月内复发 | 6个月内复发 |
对照组 | 50 | 11/50(22.00) | 16/50(32.00) |
试验组 | 50 | 3/50(6.00)* | 5/50(10.00)* |
与对照组比较,*P<0.05
综上所述,将本发明药物组合物与常用口腔溃疡治疗用药桂林三金的西瓜霜喷剂对比,在口腔溃疡愈合率方面疗效优势明显,有统计学差异;在疼痛缓解方面临床效果显著,两组效果相当。在改善中医证候单项症状,减少复发方面,本发明药物组合物有明显的临床优势,与对照组相比,有统计学差异。总之,本发明药物组合物在治疗脾虚阴火证口腔溃疡时,在愈合率、中医证候单项症状改善及减少复发方面疗效优势明显,能够为患者减轻病痛,提高生活质量。
具体实施方式
以下通过实施例进一步说明本发明,但不作为对本发明的限制。
实施例1
按如下重量份比例称取黄芪1 g、人参1 g、炙甘草1 g、葛根1g、白芷1g、栀子1g,将全部药材拣选洗净干燥后,按量称取后,分别用粉碎机粉碎并过30目筛,将原料投入混合机中混匀5分钟,混合均匀后过30目筛,加入18g微晶纤维素,10.5g淀粉,3g微粉硅胶,1g硬脂酸镁,混合均匀,填装胶囊,即可。本品具有补脾益气,升发阳气,清泻阴火的功效,用于治疗口腔溃疡,尤其适用于脾虚阴火证口疮,可伴有腹胀,纳呆,自汗,大便偏稀,倦怠乏力,口腔溃疡反复发作的症状。
实施例2
按如下重量份比例称取黄芪10g、人参2g、炙甘草3g、葛根12g、白芷3g、栀子5g,将全部药材拣选洗净干燥后,按量称取后,分别用粉碎机粉碎并过10目筛,加20倍量的水,煎煮提取180分钟,过滤,滤渣加20倍量的水,煎煮提取180分钟,过滤,合并两次滤液,干燥,备用;将所有的提取物粉碎,过200目筛,混合机混合90分钟,混合均匀后,加入蔗糖粉8g、糊精2g,混匀,制成颗粒,干燥,过筛,分装,即得颗粒剂。本品具有补脾益气,升发阳气,清泻阴火的功效,用于治疗口腔溃疡,尤其适用于脾虚阴火证口疮,可伴有腹胀,纳呆,自汗,大便偏稀,倦怠乏力,口腔溃疡反复发作的症状。
实施例3
按如下重量份比例称取黄芪15 g、人参12 g、炙甘草10 g、葛根15g、白芷10g、栀子8g,分别用粉碎机粉碎并过20目筛,按份称取后,混合,加10倍量的水提取120分钟,滤过,滤渣加10倍量的水,煎煮提取120分钟,过滤,合并两次滤液,浓缩至稠膏,减压干燥,粉碎成细粉,加入植物油10g,混匀,制成软胶囊。本品具有补脾益气,升发阳气,清泻阴火的功效,用于治疗口腔溃疡,尤其适用于脾虚阴火证口疮,可伴有腹胀,纳呆,自汗,大便偏稀,倦怠乏力,口腔溃疡反复发作的症状。
实施例4
按如下重量份比例称取黄芪30g、人参15g、炙甘草13g、葛根20g、白芷12g、栀子15g,将全部药材拣选洗净干燥后,按量称取后,分别用粉碎机粉碎并过10目筛,加3倍量的水,煎煮提取15分钟,过滤,滤渣加3倍量的水,煎煮提取15分钟,过滤,合并两次滤液,干燥,备用;将所有的提取物粉碎,过40目筛,混合机混合5分钟,混合均匀后,加入淀粉5g,加乙醇适量制丸,干燥,分装,即得丸剂。本品具有补脾益气,升发阳气,清泻阴火的功效,用于治疗口腔溃疡,尤其适用于脾虚阴火证口疮,可伴有腹胀,纳呆,自汗,大便偏稀,倦怠乏力,口腔溃疡反复发作的症状。
实施例5
按如下重量份比例称取黄芪45g、人参18g、炙甘草18g、葛根25g、白芷18g、栀子25g,将全部药材拣选洗净干燥后,按量称取后,分别用粉碎机粉碎并过30目筛,分别加20倍量的水,煎煮提取180分钟,过滤,滤渣加20倍量的水,煎煮提取60分钟,过滤,合并两次滤液,浓缩至适量,加入蔗糖15g和炼蜜15g,混匀,滤过,滤液浓缩至规定的相对密度,放冷,即得膏滋剂。该组合物具有补脾益气,升发阳气,清泻阴火的功效,用于治疗口腔溃疡,尤其适用于脾虚阴火证口疮,可伴有腹胀,纳呆,自汗,大便偏稀,倦怠乏力,口腔溃疡反复发作的症状。
实施例6
按如下重量份比例称取黄芪60g、人参20g、炙甘草20g、葛根30g、白芷20g、栀子30g,将全部药材拣选洗净干燥后,按量称取后,分别用粉碎机粉碎并过40目筛,加10倍量的水,煎煮提取100分钟,过滤,滤渣加10倍量的水,煎煮提取120分钟,过滤,合并两次滤液,滤液减压浓缩至相对密度为1.1,加入甜菊素2g,,苯甲酸钠3g,搅匀,滤过,灭菌制成合剂。本品具有补脾益气,升发阳气,清泻阴火的功效,用于治疗口腔溃疡,尤其适用于脾虚阴火证口疮,可伴有腹胀,纳呆,自汗,大便偏稀,倦怠乏力,口腔溃疡反复发作的症状。
Claims (7)
1.一种治疗口腔溃疡的药食同源中药组合物,其特征在于该组合物由下述重量份的组分制成:黄芪10~60重量份、人参2~20重量份、炙甘草3~20重量份、葛根12~30重量份、白芷3~20重量份、栀子5~30重量份。
2.根据权利要求1所述的一种治疗口腔溃疡的药食同源中药组合物,其特征在于由以下任一种方法制成:
对原料黄芪、人参、炙甘草、葛根、白芷、栀子分别用粉碎机粉碎并过30-120目筛,将原料投入混合机中混匀5-90分钟,混合均匀后过30-120目筛,加入适合的辅料制得相应的固体制剂或液体制剂;
或,将原料黄芪、人参、炙甘草、葛根、白芷、栀子分别用粉碎机粉碎并过10-40目筛,分别加3-20倍量的水,煎煮提取15-180分钟,过滤,滤渣加3-20倍量的水,煎煮提取15-180分钟,过滤,合并两次滤液,干燥得到提取物,备用;将以上所有提取物粉碎,过40-200目筛,按份称取后,混合机混合5-90分钟,混合均匀后,加入适合的辅料按常规制剂成型方法制备成固体或液体制剂;
或,将原料黄芪、人参、炙甘草、葛根、白芷、栀子分别用粉碎机粉碎并过10-40目筛,按份称取后,混合,加3-20倍量的水提取15-180分钟,滤过,滤渣加3-20倍量的水,煎煮提取15-180分钟,过滤,合并两次滤液,浓缩,加入适合的辅料按常规制剂成型方法制备成固体或液体制剂。
3.根据权利要求1或2所述的药食同源中药组合物,其特征在于该组合物具有补脾益气,升发阳气,清泻阴火的功效,用于治疗口腔溃疡。
4.根据权利要求3所述的药食同源中药组合物,其特征在所述口腔溃疡适用于脾虚阴火证,伴有腹胀,纳呆,自汗,大便偏稀,倦怠乏力,口腔溃疡反复发作的症状。
5.根据权利要求1或2所述的药食同源中药组合物,其特征在于制成固体制剂或液体制剂。
6.根据权利要求5所述的药食同源中药组合物,其特征在于所述固体制剂为片剂、胶囊剂、颗粒剂、丸剂、散剂。
7.根据权利要求5所述的药食同源中药组合物,其特征在于所述液体制剂为糖浆剂、合剂、膏滋剂。
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