CN112205494A - 一种生地清热茶及其制备方法 - Google Patents
一种生地清热茶及其制备方法 Download PDFInfo
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- CN112205494A CN112205494A CN201910626719.9A CN201910626719A CN112205494A CN 112205494 A CN112205494 A CN 112205494A CN 201910626719 A CN201910626719 A CN 201910626719A CN 112205494 A CN112205494 A CN 112205494A
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Abstract
本发明公开了一种生地清热茶及其制备方法,所述生地清热茶由以下重量份的清热药物组分组成:白芍、牡丹皮、竹茹、茵陈蒿、百合、石斛、罗汉果、青果、委陵菜、蒲公英、莲子心、连翘、竹叶、芦根、麦冬、知母、密蒙花、野菊花、青蒿、薄荷,以上组分均为1~14份、生地10份、白术4份、茯苓2~3份、陈皮3~5份以及绿茶30~50份。通过烘干、粉碎、筛分、混合、装袋、灭菌等步骤制得,所述生地清热茶成本低、制备简单、饮用非常方便,能达到清热养阴、清肝利胆、清肺润燥,益胃生津,利尿泻火,解毒明目、利咽开音的养生功效,对于上火的亚健康人群具有良好的效果。
Description
技术领域
本发明属于饮料加工技术领域,具体涉及一种生地清热茶及其制备方法。
背景技术
茶叶是世界三大饮料之一,但是日常饮用的茶叶的保健功能有限,尤其面对当今不断加快的生活节奏,压力大的生活方式,人们必然会上火,烦躁,而至今市场上针对不同器官的上火特点的个体化缓解上火症状的茶饮料还不多见,因而急需开发一种功能茶饮料改善因不同原因引发的“实火”与“虚火”的一些令人苦恼的亚健康状态。
发明内容
本发明的目的在于克服现有技术的不足,提供一种生地清热茶。
一种生地清热茶,所述生地清热茶由以下重量份的清热药物组分粉末组成:白芍1~14份、牡丹皮1~14份、竹茹1~14份、茵陈蒿1~14份、百合1~14份、石斛1~14份、罗汉果1~14份、青果1~14份、委陵菜1~14份、蒲公英1~14份、莲子心1~14份、连翘1~14份、竹叶1~14份、芦根1~14份、麦冬1~14份、知母1~14份、密蒙花1~14份、野菊花1~14份、青蒿1~14份、薄荷1~14份、生地10份、白术4份、茯苓2~3份、陈皮3~5份以及绿茶30~50份。
在上述技术方案中,所述生地清热茶为袋装,每袋含量为2~5克。
本发明的另一个目的是,提供一种生地清热茶的制备方法,包括如下步骤:
(1)药物组分预处理:将白芍、牡丹皮、竹茹、茵陈蒿、百合、石斛、罗汉果、青果、委陵菜、蒲公英、莲子心、连翘、竹叶、芦根、麦冬、知母、密蒙花、野菊花、青蒿、薄荷、生地、白术、茯苓以及陈皮分别清洗、干燥,得到预处理后各单一药物组分;
(2)破碎筛选:将所述预处理后各单一药物组分破碎为40目以下粉末得到白芍粉末、牡丹皮粉末、竹茹粉末、茵陈蒿粉末、百合粉末、石斛粉末、罗汉果粉末、青果粉末、委陵菜粉末、蒲公英粉末、莲子心粉末、连翘粉末、竹叶粉末、芦根粉末、麦冬粉末、知母粉末、密蒙花粉末、野菊花粉末、青蒿粉末、薄荷粉末、生地粉末、白术粉末、茯苓粉末以及陈皮粉末;
(3)将杀青后的绿茶揉捻然后炒干,再破碎为30目以下的粉末,得到绿茶粉末;
(4)将上述步骤(2)处理后得到的各药物组分粉末与步骤(3)处理后得到的所述绿茶粉末按照如下重量份数混合:白芍粉末1~14份、牡丹皮粉末1~14份、竹茹粉末1~14份、茵陈蒿粉末1~14份、百合粉末1~14份、石斛粉末1~14份、罗汉果粉末1~14份、青果粉末1~14份、委陵菜粉末1~14份、蒲公英粉末1~14份、莲子心粉末1~14份、连翘粉末1~14份、竹叶粉末1~14份、芦根粉末1~14份、麦冬粉末1~14份、知母粉末1~14份、密蒙花粉末1~14份、野菊花粉末1~14份、青蒿粉末1~14份、薄荷粉末1~14份、生地粉末10份、白术粉末4份、茯苓粉末2~3份、陈皮粉末3~5份以及绿茶粉末30~50份,得到所述生地清热茶;
所述步骤(3)与步骤(1)(2)无先后之分。
在上述技术方案中,所述步骤(1)的干燥过程为在45-55℃下干燥7-8小时后,冷却至室温20~25℃,称重记W1,继续干燥1-2小时后,冷却至室温20~25℃,称重记W2,若W2/W1>95%则干燥结束,若W2/W1<95%则继续干燥直至Wn/Wn-1>95%,n为称重次数。
在上述技术方案中,所述步骤(3)的炒干过程将绿茶含水率炒至5wt%以下。
在上述技术方案中,所述步骤(3)杀青后的绿茶为一、二级鲜叶。
在上述技术方案中,所述步骤(3)揉捻采用揉捻机,揉捻时间为40~45分钟。
在上述技术方案中,所述步骤(3)揉捻成条率在80%以上,叶细胞组织破坏率为45%~55%。
在上述技术方案中,所述制备方法还包括(5)将所述生地清热茶按计量2~5克装入过滤袋中,通过真空密封后用伽马射线辐射灭菌,得到所述袋装生地清热茶。
本发明的另一个目的是提供上述制备方法获得的生地清热茶。
本发明的另一个目的是,提供一种生地清热茶的饮用方法,将2~5克所述生地清热茶放于85~95℃的水中冲泡10~30min,所述单次加水量为80~100毫升,冲泡次数为8~10次。
本发明的有益效果为:
本发明提供了一种生地清热茶,其成本低、配方合理、制备简单、易保存、四季皆宜、饮用非常方便、口感好,使人们在日常饮用中,能达到清热养阴、清肝利胆、清肺润燥,益胃生津,利尿泻火,解毒明目、利咽开音的养生功效,对于上火的亚健康人群具有良好的效果。
具体实施方式
为了使本技术领域的人员更好地理解本发明方案,下面结合具体实施例进一步说明本发明的技术方案。
本发明的清热药物组分选用绿茶,白芍,牡丹皮,竹茹,茵陈蒿,百合,石斛,罗汉果,青果,委陵菜,蒲公英,莲子心,连翘,竹叶,芦根,麦冬,知母,密蒙花,野菊花,青蒿,薄荷,生地,白术,茯苓以及陈皮进行组合,将这些清热药物组分组合使得各清热药物的功效产生协同的作用,从而实现有效的清热养阴、清肝利胆、清肺润燥,益胃生津,利尿泻火,解毒明目、利咽开音的养生功效。
热证在中药组方临床应用中效果优良,不过总体而言不离虚实两类,若按照脏腑辩证分型,则又各有侧重。对于肝经有热,重点在于柔肝敛阴,疏肝清热,但是考虑到循经传变,需要考虑到肝火犯肺,肝火犯心,肝火炽盛,伤及肾阴虚等证,因此其他脏器需要兼顾,因此宜选用白芍、牡丹皮作为君药,其他臣药与佐使药随证加减;而对于胆火炽盛型,则又有不同,应该治以疏肝利胆,清热利湿,同时考虑到胆火循经传三焦,胆火犯胃,胆火犯心等证,因此选用竹茹、茵陈蒿作为君药,其他臣药与佐使药随证加减;当用于肺阴亏耗患者时,应该注重滋阴润肺,但要考虑到肺火传于大肠,肺火传于肝,肺火传心引起上焦炽热等,所以应该以百合、石斛为君药,其他臣药与佐使药随证加减;而当咽喉嘶哑,无论属于金实不鸣或者是金破不鸣,罗汉果和青果都可应用,既可清实热,又可补阴虚,因此当为君药,其他臣药与佐使药随证加减;而对湿热滞留肠胃患者,应当清热利湿,凉血解毒,因此以委陵菜和蒲公英为君药十分恰当,同时考虑到胃肠为阳明多气多血之经,不但要清热,也要滋阴,因此加入少许滋阴之药,也无不可,因此其他臣药与佐使药随证加减;而对火扰心神,失眠烦躁的人员,应该加大清心除烦的作用,故而以莲子心、连翘为君药,其他臣药与佐使药随证加减;而对膀胱热盛或者,应该清心泻火,利尿通淋,因此以大竹叶、芦根共为君药,考虑到心火移于小肠,因此使用竹叶,而芦根利尿除烦,十分恰当,其他臣药与佐使药随证加减;而对胃火牙痛,胃脘嘈杂人群,应该治以清胃泻火,益胃生津,故而使用知母和麦冬共为君药其他臣药与佐使药随证加减;对于肝火目赤患者,应该清肝泻火,祛风明目,因此以野菊花、密蒙花共为君药,其他臣药与佐使药随证加减;针对轻度中暑人员,尚无意识模糊者,可使用本品清暑利湿,因此青蒿、薄荷共为君药,其他臣药与佐使药随证加减;以上组方,明确君药的地位,而臣药均为生地,这是因为,无论实火还是虚火,皆有热=象,因此热邪必伤及人体阴液,因此使用生地较为适宜,但生地滋腻,易于阻碍脾气的运化,因此加入白术、茯苓、陈皮助脾气运化。而对于长期熬夜,阴血耗伤人员,应当滋阴补血,加大生地用量,同时考虑到阴虚血亏与个人体质偏盛偏衰,其他药物均平衡增加些许剂量。若不如上随证调整君臣药的种类与药量的变化,难以实现个体化治疗,因此应该辨证论治,随证加减。
选用白芍:①对中枢神经系统有抑制作用:小鼠腹腔注射芍药甙能减少自发活动,延长环己巴比妥钠的睡眠时间,抑制因腹腔注射醋酸所引起的扭体反应和对抗戊四唑所致惊厥。②芍药甙对狗的冠状血管及后肢血管有扩张作用。③芍药甙能抑制大鼠的胃液分泌,并能预防发生大鼠应激性溃疡病。④对平滑肌的抑制作用。⑤抗炎作用。⑥抗肝损伤。⑦抗菌作用。
选用牡丹皮:①抑菌作用:牡丹皮提取物在试管内对白色葡萄球菌、金黄色葡萄球菌、枯草杆菌、大肠杆菌、伤寒杆菌和痢疾杆菌有明显的抑制作用,牡丹皮对痢疾杆菌、伤寒杆菌等有较强的抑制作用牡丹酚在试管内对大肠杆菌、枯草杆菌、金黄色葡萄球菌亦有抑制作用。牡丹皮浸液在使馆内对铁锈色小芽孢杆菌等10种皮肤真菌也有抑制作用。②消炎作用:对由鹿角菜胶、右旋糖酐、醋酸作致炎剂时引起的大鼠右足跖肿,有明显的抑菌作用。口服牡丹酚对右旋糖酐与醋酸性足足跖肿胀的抑制作用更强;牡丹皮甲醇提取物及水溶部、正丁醇提取物与硅胶层析得的芍药甙衍生物部分,均对大鼠足跖鹿菜肿胀,有明显的抑制作用;牡丹酚磺酸钠对大鼠甲醛性关节肿有明显的抑制作用。③对心血管系统作用:牡丹皮乙醇提取物对蛙心有洋地黄样作用。④对中枢的作用:牡丹酚可使动物自发活动明显减少,并随剂量加大而作用增强;对咖啡因引起的小鼠自发活动的增加也有明显的抑制作用。⑤解热作用:牡丹酚与氨基比林一起使用,能明显降低小鼠直肠温度,牡丹酚随剂量增大而降温作用加强;伤寒疫苗静脉注射引起小鼠发热,口服牡丹酚有明显的解热作用。⑥抗惊厥作用:牡丹酚对大鼠最大电休克的强直性痉挛有明显的抑制作用;牡丹酚、眠尔通均能明显抑制戊四氮引起的强直,但对其引起的痉挛无明显的抑制作用,牡丹酚尚能使戊四氮致死的时间延长;烟碱诱发的小鼠产生痉挛,大多数出现强直,牡丹酚与苯巴比妥均明显抑制强直作用,并使致死时间延长,但对烟碱诱发无影响。⑦对免疫功能的影响:牡丹皮甲醇提取物、牡丹酚、正丁醇可溶部分及可溶部分分离得到的单萜甙类,能增强雄小鼠肝脏枯否氏细胞吞噬碳粒的作用,增强腹腔浸出液的细胞数;与阳性对照药网状内皮系统激活剂酵母多糖一样,能明显缩短体内碳粒子廓清时间。
选用竹茹:①增加尿中氯化物量:有增加尿中氯化物量的作用。②抗菌作用:竹茹粉在平皿上对白色葡萄球菌、枯草杆菌、大肠杆菌及伤寒杆蓖等有较强的抗菌作用。
选用茵陈蒿:①利胆作用:茵陈煎剂、茵陈栀子煎剂、茵陈蒿汤(茵陈、栀子、大黄以3:1.5:1)及其醇提取物均有促进大白鼠胆汁分泌的作用。②保肝作用:茵陈蒿汤、茵陈蒿及栀子大黄煎剂均能降低小白鼠四氯化碳中毒性肝炎的死亡率茵陈蒿汤煎剂对家兔有促进肝细胞再生作用。③解热作用:茵陈蒿汤、蒿陈浸剂对家兔人工发热有解热作用。④降压作用:茵陈的水浸剂及精制浸液均有降压作用。⑤利尿作用:茵陈的水浸液、精制浓缩浸液以及6,7-二甲氧基香豆精对犬均表现利尿作用;茵陈挥发油对中毒性肝炎之家兔能使尿量增加,尿色由黄变清。⑥对心血管系统的作用:茵陈水煎剂对主动脉弓的病变及内脏脂肪沉着均表现保护作用。⑦兴奋平滑肌:茵陈水浸液对犬在位肠管与兔离体肠管均有抑制作用,而济南茵陈的浸剂、煎剂及酒精浸出液,对离体兔肠却略有兴奋作用。茵陈浸液对未孕家兔及产后豚鼠的离体子宫有兴奋作用。
选用百合:①增强免疫功能:百合中的蛋白质、氨基酸和多糖可提高人体的免疫力。可显著促进DNA和RNA的合成,同时淋巴细胞存活率也增加。②镇静催眠:百合中含有百合苷,有镇静和催眠的作用。试验证明,每晚睡眠前服用百合汤,有明显改善睡眠作用,可提高睡眠质量。③抗疲劳、抗应激:百合中含有多种营养物质,如矿物质、维生素等,这些物质能促进机体营养代谢,使机体抗疲劳、耐缺氧能力增强,同时能清除体内的有害物质,延缓衰老。④保护胃黏膜:百合中含有果胶及磷脂类物质,服用后可保护胃黏膜,治疗胃病。
选用石斛:①石斛能促进胃液的分泌而助消化,使其蠕动亢进而通便。②可提高小鼠巨噬细胞吞噬作用:用氢化可的松抑制小鼠的免疫功能之后,石斛多糖能恢复小鼠免疫功能。③对半乳糖性白内障不仅有延缓作用,而且有一定的治疗作用。
选用罗汉果:①止咳作用:罗汉果含有D-甘露醇有止咳作用。②降低颅内压,又可用于脑水肿,能提高血液渗透压,且持续时间长。③促进表皮以及真皮组织修复,还可用于大面积烧伤和烫伤的水肿,防治急性肾功能衰竭病和降低眼球内压。④降低眼压,治疗急性青光眼。⑤对肠管作用:罗汉果对肠管运动机能有双向调节作用。
选用青果:①抗微生物作用:柠檬烯、对-聚伞花素、莰烯、橙花醇、龙牛儿醇、s-杜松烯、b-石竹烯对一些致病微生物有抑制作用。②肝细胞保护作用。③促进唾液分泌。
选用委陵菜:①抗病原体作用:委陵菜中含有的没食子酸、槲皮素具有抗菌活性。②止血作用:对子宫功能性出血、月经过多、鼻出血、咯血、血尿有效。
选用蒲公英:①抗菌作用:本品注射液试管内对金黄色葡萄球菌耐药菌株、溶血性链球菌有较强的杀菌作用。对肺炎双球菌、脑膜炎球菌、白喉杆菌、绿脓杆菌、痢疾杆菌、伤寒杆菌等及卡他球菌也有一定杀菌作用。本品能抑制结核菌,杀死钩端螺旋体,对幽门弯曲杆菌有良好的杀灭作用。②利胆作用:国外研究,本品有利胆作用,临床上治疗慢性胆囊痉挛及结石症有效。③利尿健胃,轻泻等作用。
选用莲子心:①莲心碱的降压作用:从莲子心提出莲心碱结晶,有短暂降压之效,改变为季铵盐,则出现强而持久的降压作用。
选用连翘:①抗菌作用:连翘浓缩煎剂在体外有抗菌作用,可抑制伤寒杆菌、副伤寒杆菌、大肠杆菌、痢疾杆菌、白喉杆菌及霍乱弧菌、葡萄球菌、链球菌等。②抑制呕吐:连翘能抑制洋地黄对鸽静脉注射的催吐作用,减少呕吐次数。③连翘的果皮中含齐墩果酸(又名洋橄榄叶酸),故有强心、利尿作用。
选用竹叶:①解热作用:对人工发热的大白鼠经口给予淡竹叶1~20克/公斤有退热作用,有效成分溶于水而难溶于醇。②利尿作用。
选用芦根:①解热。②降脂。③降压。④抗癌。⑤保肝作用。
选用麦冬:①血糖调节作用:家兔用麦冬煎剂肌内注射,能升高血糖;正常兔口服麦冬的水、醇提取物则有降血糖作用。②对免疫系统的作用麦冬能增强网状内皮系统吞噬能力,升高外周白细胞,提高免疫功能。③对内分泌的作用能增强垂体肾上腺皮质系统作用,提高机体适应性。④抗缺氧:能显著提高实验动物耐缺氧能力。⑤增加冠脉流量,对心肌缺血有明显保护作用。⑥能抗心律失常及改善心肌收缩力;有改善左心室功能与抗休克作用。⑦还有一定镇静和抗菌作用。
选用知母:①抗病原微生物作用:知母在体外对痢疾杆菌、伤寒杆菌、副伤寒杆菌、霍乱弧菌、大肠杆菌、变形杆菌、绿脓杆菌等革兰氏阴性菌及葡萄球菌、溶血性链球菌、肺炎双球菌、百日咳杆菌等革兰氏阳性菌均有较强抗菌作用。②抑制Na+,K+-ATP酶活性:体外实验证明,知母皂甙元(菝葜皂甙元)是Na+-K+-ATP酶抑制剂,它对提纯的兔肾Na+,K+-ATP酶有极明显的抑制作用,其活性同专一性Na+,K+-ATP酶抑制剂乌本甙相比,两者在2×10-5mol/L时抑制程度相近。以甲状腺素速诱导小鼠肝脏Na+,K+-ATP酶增量,知母皂甙和皂甙元可使这些小鼠肝脏切片的过高耗氧率抑制到接近正常小鼠的水平;对正常小鼠肝切片的耗氧率虽有降低趋势,但无统计意义。大鼠整体实验也表明,知母皂甙元25mg/只灌胃可抑制因同时灌胃甲状腺素引起的肝、肾和小肠粘膜中Na+,K+-ATP酶活性升高。③对交感-肾上腺功能的影响:以50%知母水煎剂给大鼠灌胃,每日4ml,连续3周,可使肾上腺内多巴胺-β-羟化酶活性明显降低,提示儿茶酚胺合成减少,与此同时,肾上腺重量较生理盐水对照组明显减轻,心率逐周降低,至第3周明显低于给药前。此外,按人体常用剂量5倍给家兔灌胃,连续5天,对正常动物血浆皮质酮水平未见明显影响,但可拮抗外源性皮质激素制剂地塞米松引起的反馈性血浆皮质酮水平降低。进一步研究证明,其机理之一是知母抑制了肝脏对皮质醇的分解代谢。④降血糖作用:可减轻胰岛萎缩。血糖明显下降。知母并可促进大鼠横膈和脂肪组织摄取葡萄糖,并使横膈内糖元含量增加,但肝内糖元量却减少,尿中酮体含量减少。⑤解热作用:对知母是否具有解热作用的报导不一。有报导知母对大肠杆菌引起的发热家兔有解热作用,但也有报导白虎汤在去掉石膏后的知母、甘草煎剂灌胃给药对实验性发热家兔未见明显退热作用。知母根茎中的皂甙具有明显降低由甲状腺素造成的耗氧率增高及抑制Na+,K+-ATP酸活性的作用,其中总皂甙对Na+,K+-ATP酶的抑制率达59.8%,其半琥珀酸衍生物抑制率为89.8%,故认为与清热泻火的功效有关。⑥其它作用:知母果甙有明显的利胆作用和抑制血小板聚集作用。知母中的烟酸有维持皮肤与神经健康及促进消化道功能的作用。知母提取物对逆转录酶和各种脱氧核糖核酸聚合酶活性有抑制作用。
选用密蒙花:①有维生素P样作用:给小鼠口服25-100mg/kg,能减轻甲醛性炎症;50-100mg/kg还能降低皮肤、小肠血管的通透性及脆性。②对胆管平滑肌有松弛作用:对兔静脉注射25mg/kg能在25-30分钟内使尿量略有增加(75%)。
选用野菊花:①降压。②抗病毒。③抗菌。
选用青蒿:①抗疟作用:青蒿乙醚提取中性部分和其稀醇浸膏对鼠疟、猴疟和人疟均呈显著抗疟作用。体内试验表明,青蒿素对疟原虫红细胞内期有杀灭作用,而对红细胞外期和红细胞前期无效。青蒿素具有快速抑制原虫成熟的作用。②抗菌作用:青蒿水煎液对表皮葡萄球菌、卡他球菌、炭疽杆菌、白喉杆菌有较强的抑菌作用,对金黄色葡萄球菌、绿脓杆菌、痢疾杆菌、结核秆菌等也有一定的抑制作用。③解热作用:用蒸馏法制备的青蒿注射液,对百、白、破三联疫苗致热的家兔有明显的解热作用。青蒿与金银花组方,利用蒸馏法制备的青银注射液,对伤寒、副伤寒甲、乙三联菌苗致热的家兔,有比单味青蒿注射液更为显著的退热效果,其降温特点迅速而持久,优于柴胡和安痛定注射液对照组。金银花与青蒿有协同解热作用。④免疫作用:用小鼠足垫试验、淋巴细胞转化试验、兔疫特异玫瑰花试验和溶血空斑试验等4项免疫指标观察青蒿素的免疫作用,发现青蒿素对体液免疫有明显的抑制作用,对细胞免疫有促进作用,可能具有免疫调节作。青蒿素、蒿甲醚有促进脾TS细胞增殖功能。肌肉注射蒿甲醚对Begle大外周血T、B、Tu及Tr淋巴细胞亦有明显抑制作用。亦明显降低正常小鼠血清IgG含量、增加脾脏重量。降低鸡红细胞致敏小鼠血清IgG含量。静脉注射青蒿素50-100mg/kg能显著提高小鼠腹腔巨噬细胞吞噬率(50.2-53.1%)和吞噬指数(1.58-1.91)。青蒿素还可提高淋巴细胞转化率,促进细胞免疫作用。青蒿琥酯可促进Ts细胞增殖,抑制TE细胞产生,阻止白细胞介素及各种炎症介质的释放,从而起到免疫调节作用。⑤对心血管系统的作用:兔心灌注表明,青蒿素可减慢心率,抑制心肌收缩力,降低冠脉流量。静脉注射有降血压作用,但不影响去甲肾上腺素的升压反应,认为主要系对心脏的直接抑制所改。静脉注射20mg/kg青蒿素可抗乌头碱所致兔心律失常。⑥其它作用:青蒿琥酯能显著缩短小鼠戊巴比妥睡眼时间。青蒿素对实验性矽肺有明显疗效。蒿甲醚对小鼠有辐射防护作用。
选用薄荷:①抗病毒作用:薄荷水煎剂1:20浓度,对病毒ECHO11株有抑制作用。②镇痛、止痒作用:薄荷脑主要作外用止痒、微弱的局麻及对抗刺激剂,涂于局部由于刺激神经而引起凉感,并抑制痛觉神经。③抗刺激、止咳作用:薄荷脑的抗刺激作用导致气管产生新的分泌,而使稠厚的粘液易于排出,故有祛痰作用,亦有报道薄荷脑对豚鼠及人均有良好的止咳作用。④杀菌作用:薄荷脑有很强的杀菌作用,d-薄荷脑比1-薄荷脑的抑菌作用强。⑤利胆作用:实验证明,除挥发油中主要成分薄荷醇具有很强的利胆作用外,薄荷油中还含有其他利胆作用成分。此外,把薄荷醇的醇羟基乙酰化后,其利胆作用也减弱了,说明醇羟基在利胆作用的产生上起着重要的作用。
选用生地:①强心、利尿。②升高血压。③降低血糖等作用。④生地黄的提取物能促进血液的凝固,小鼠口服生地炭,能缩短出血时间。⑤地黄煎剂还有保护肝脏,防止肝糖原减少的作用。⑥有一定的抗辐射损伤作用。⑦对多种真菌的生长有抑制作用。
选用白术:①降血糖作用:家兔灌胃煎剂或浸膏,血糖稍有降低。大鼠灌胃煎剂有加速体内葡萄糖的同化因而降低血糖。小鼠内服煎剂有保护肝脏,防止四氯化碳引起的肝糖元减少作用。②利尿作用:具有明显而持久的利尿作用,均能产生明显而持久的利尿作用。白术不仅增加水的排泄,也促进电解质特别是钠的排出,并且钠的排泄还胜于水的排泄。它也不影响垂体后叶激素的抗利尿作用,因此白术增加水的排泄可能主要不是影响水的主动性重吸收,而是续发于电解质重吸收的减少,既有汞撒利样排泄氯、钠的作用;又有增高尿中二氧化碳容量、pH值以及增加钾排泄,减少铵排泄的醋唑磺胺样的特点。对人的利尿作用有少数试验,不能最后肯定。③抗菌作用:水浸液在试管内对絮状表皮癣菌、星形奴卡氏菌有抑制作用。煎剂对脑膜炎球菌亦有抑制作用。近报道白术煎剂和四君子汤对伤寒杆菌、甲型副伤寒杆菌、福氏痢疾杆菌、大肠杆菌、绿脓杆菌等均有不同程度的抑菌作用,而无杀菌作用。④促进造血功能:白术煎剂能促进小鼠骨髓红系造血祖细胞(CFU-E)的生长。对于用化学疗法或放射疗法引起的白血球下降,有使其升高的作用。⑤对胃肠平滑肌的作用:白术能增强兔离体小肠自发性收缩活动,使其收缩幅度加大,白术对乙酰胆碱、二氯化钡所致的家兔离体小肠强直性收缩有明显的拮抗作用,对加入肾上腺素所致的离体家兔小肠活动的抑制,白术可以拮抗此作用。但亦有报道没有明显的拮抗作用。白术煎剂每天10g(生药/kg连续给小鼠灌胃能明显促进小肠蛋白质的合成。白术提取物50mg和200mg/kg灌胃给药,对动物水浸束缚应激性溃疡,有显著抑制效果。⑥促进蛋白质合成:白术煎剂10g/kg灌胃,连续7天,明显促进小鼠小肠蛋白质的合成。⑦白术对呼吸有短暂的兴奋作用。⑧强壮作用:白术能促进小鼠体重增加和增强游泳耐力,白术能增强网状内皮系统的吞噬功能,对小鼠网状内皮系统呈活化作用,促进小鼠腹腔巨噬细胞的吞噬功能,使巨噬细胞的吞噬百分率,吞噬指数及其溶酶体消化平均较对照组显著增加。在白细胞减少症时,白术有升白作用。促进细胞免疫功能,且明显增高IgG。说明白术有健脾胃、壮身体和提高抗病能力的作用。⑨抗凝血作用:白术对血小板聚集有明显的抑制作用。
选用茯苓:①利尿作用:将茯苓生药用70%酒精冷浸,使用时将浸得液的酒精蒸发,加蒸馏水稀释,至一定浓度,然后选择健康兔按体重注射给药,慢性实验结果表明,用药后尿量有明显增加。②抗菌作用:茯苓的100%煎剂用平板打洞法对金黄色葡萄球菌、大肠杆菌、变形杆菌等均有抑制作用。茯苓对用试管法的抑菌试验结果是无抑菌作用。茯苓的乙醇提取物在体外能杀死钩端螺旋体,但水煎液无效。③对消化系统的影响:茯苓对家兔离体肠管有直接松弛作用,对大鼠幽门结扎所形成的溃疡有预防效果,并能降胃酸。另对CCl4所致大鼠肝损伤有明显的保护作用,使谷丙转氨酶活性明显降低,防止肝细胞坏死。④茯苓多糖体对免疫功能的影响:茯苓多糖增加巨噬细胞的细胞毒性作用。
选用陈皮:①调节胃肠道:对胃肠平滑肌具有解痉作用。橙皮苷对离体肠肌具有先兴奋、后抑制的作用。甲基橙皮苷对大鼠皮下注射后可明显抑制胃溃疡的发生,而且还有抗胃液分泌的作用。但大鼠口服后无效。②调节胆囊功能:用甲基橙皮苷对大鼠皮下注射可增加胆汁和胆汁内固体物的排泄量。③祛痰、镇咳、平喘:陈皮挥发油有刺激性祛痰作用。化州橘红多糖具有显著的镇咳作用。④抗过敏、抗炎:橘皮类黄酮成分有很强的抑制人体嗜碱性白细胞释放组胺,以及中性白细胞释放β-尿甘酸化物酶的活性,在体内具有抗过敏和抗炎作用。橙皮苷和甲基橙皮苷均具有维生素P样的作用。⑤对心血管作用,双向调节血压,兴奋心脏。⑥降脂,并能明显减轻其主动脉粥样硬化病变。⑦抑制子宫:陈皮煎剂对小鼠离体子宫有抑制作用,高浓度则使之完全松弛。⑧抑制真菌:橙皮苷、柚苷等在低浓度下即有抑制真菌的作用。⑨止血:陈皮散剂对兔灌胃可缩短出血和凝血时问。陈皮炒炭止血作用更强。⑩升糖:含有氧化物的橙皮苷具有升高兔血糖的作用。
选用绿茶:①抗衰老。②抗菌。③降血脂。④瘦身减脂。⑤防龋齿、清口臭。⑥防癌。⑦美白及防紫外线作用。⑧可改善消化不良情况。
因此,以上药物合用体现了以下共通药理作用:①调节物质代谢,②抗菌,③降血脂,④降低心率,⑤调节胆囊收缩,⑥调节消化系统,⑦增强免疫,⑧利尿作用。
实施例1
一种生地清热茶的制备方法,该方法包括如下步骤:
(1)药物组分预处理:将白芍、牡丹皮、竹茹、茵陈蒿、百合、石斛、罗汉果、青果、委陵菜、蒲公英、莲子心、连翘、竹叶、芦根、麦冬、知母、密蒙花、野菊花、青蒿、薄荷、生地、白术、茯苓以及陈皮分别挑选去除杂质并清洗然后干燥,得到预处理后各单一药物组分;干燥温度为45~60℃;干燥6~10小时后,冷却至室温,称重记W1,继续干燥1~2小时后,冷却至室温,称重记W2,若W2/W1>95%则干燥结束,若W2/W1<95%则继续干燥直至Wn/Wn-1>95%;
(2)破碎筛选:将预处理后各单一药物组分用破碎机破碎为40目以下粉末得到各单一药物组分粉末,筛后未透过40目的大块物继续破碎;
(3)将杀青后的一、二级鲜叶的绿茶,采用55型揉捻机,一般投叶量在30~35千克,揉捻40~45分钟。揉捻程度要求成条率在80%以上,叶细胞组织破坏率为45%~55%,然后炒干,再用破碎机破碎为粉末,过30~40目筛子筛分,筛后大块物继续破碎,30目以下的粉末即为得到的绿茶粉末;炒干过程采用步进式扁茶炒干机炒干,炒干之茶叶含水率5%以下;
(4)将上述步骤(2)处理后得到的各单一药物组分粉末与步骤(3)处理后得到的绿茶粉末按照重量份数混合,得到生地清热茶;
步骤(3)与步骤(1)(2)无先后之分。
生地清热茶为袋装,按计量3克装入小过滤袋中,通过真空密封后用伽马射线辐射灭菌即得成品。取一袋生地清热茶,放于85-95℃的水中冲泡10-30min,加入水量为100毫升,水温为85-95摄氏度,可连续冲泡8-10次,每次浸泡时间以饮茶者可接受饮用为宜,不宜温度度过高,最好是自然冷却至37摄氏度以下饮用为宜。生地清热茶可应用于部分实热证和虚热证引起的机体功能紊乱。
实施例2
在实施例1的基础上,一种生地清热茶,针对肝火偏旺盛,临床表现可见口干而苦,恶心呕吐的人群,应该加大柔肝敛阴,疏肝清热的功效,组方中加大白芍和牡丹皮的用量。其由以下重量份的清热药物组分组成:白芍14份、牡丹皮14份、竹茹1份、茵陈蒿1份、百合1份、石斛1份、罗汉果1份、青果1份、委陵菜1份、蒲公英3份、莲子心1份、连翘1份、竹叶1份、芦根1份、麦冬1份、知母1份、密蒙花2份、野菊花2份、青蒿1份、薄荷1份、生地10份、白术4份、茯苓3份、陈皮3份以及绿茶30份。
制备及应用方法同实施例1除以下记录:
步骤(1):干燥温度为55℃;干燥8小时后,冷却至室温,称重记W1,继续干燥2小时后,冷却至室温,称重记W2,若W2/W1>95%则干燥结束
步骤(3):将杀青后的一级鲜叶的绿茶,采用55型揉捻机,投叶量在30千克,揉捻40分钟。揉捻程度要求成条率在80%以上,叶细胞组织破坏率为45%%,然后炒干,再用破碎机破碎为粉末,过30目筛子筛分,筛后大块物继续破碎,30目以下的粉末即为得到的绿茶粉末;炒干过程采用步进式扁茶炒干机炒干,炒干之茶叶含水率5%以下;
实施例3
在实施例1的基础上,一种生地清热茶,针对胆火炽盛的人群,临床可见胁痛口苦,胃脘痞闷,厌食油腻的人群,应加大疏肝利胆,清热利湿的功效,组方中加大竹茹与茵陈蒿的用量。其由以下重量份的清热药物组分组成:白芍1份、牡丹皮1份、竹茹14份、茵陈蒿14份、百合1份、石斛1份、罗汉果1份、青果1份、委陵菜1份、蒲公英1份、莲子心1份、连翘3份、竹叶1份、芦根1份、麦冬1份、知母1份、密蒙花1份、野菊花1份、青蒿2份、薄荷2份、生地10份、白术4份、茯苓3份、陈皮3份以及绿茶30份。
制备及应用方法同实施例1除以下记录:
(1)干燥温度为55℃;干燥8小时后,冷却至室温,称重记W1,继续干燥1小时后,冷却至室温,称重记W2,W2/W1<95%,继续干燥2小时后,冷却至室温,称重记W3,W3/W2>95%;
(3)将杀青后的一级鲜叶的绿茶,采用55型揉捻机,一般投叶量在35千克,揉捻45分钟。揉捻程度要求成条率在80%以上,叶细胞组织破坏率为55%,然后炒干,再用破碎机破碎为粉末,过30目筛子筛分,筛后大块物继续破碎,30目以下的粉末即为得到的绿茶粉末;炒干过程采用步进式扁茶炒干机炒干,炒干之茶叶含水率5%以下;
实施例4
在实施例1的基础上,一种生地清热茶,针对肺阴亏耗的患者,临床可见干咳,痰少而白声音嘶哑,应该加大滋阴润肺的功效,组方中加大百合与石斛的用量。其由以下重量份的清热药物组分组成:白芍1份、牡丹皮1份、竹茹1份、茵陈蒿1份、百合14份、石斛14份、罗汉果1份、青果1份、委陵菜1份、蒲公英1份、莲子心1份、连翘1份、竹叶1份、芦根1份、麦冬3份、知母2份、密蒙花1份、野菊花1份、青蒿1份、薄荷1份、生地10份、白术4份、茯苓3份、陈皮4份以及绿茶30份。
制备及应用方法同实施例1,除以下记录:
(1)药物组分预处理:干燥温度为60℃;干燥6小时后,冷却至室温,称重记W1,继续干燥1.5小时后,冷却至室温,称重记W2,W2/W1>95%干燥结束;
(3)将杀青后的一级鲜叶的绿茶,采用55型揉捻机,一般投叶量在35千克,揉捻45分钟。揉捻程度要求成条率在80%以上,叶细胞组织破坏率为55%,然后炒干,再用破碎机破碎为粉末,过30目筛子筛分,筛后大块物继续破碎,30目以下的粉末即为得到的绿茶粉末;炒干过程采用步进式扁茶炒干机炒干,炒干之茶叶含水率5%以下;
实施例5
在实施例1的基础上,一种生地清热茶,针对长期以语言表达为职业的人群,如教师,记者,播音员,以及声音嘶哑的人群,临床可见干咳,痰少而白声音嘶哑,应该加大利咽开音的功效,组方中加大罗汉果与青果的用量。其由以下重量份的清热药物组分组成:白芍1份、牡丹皮1份、竹茹1份、茵陈蒿1份、百合1份、石斛1份、罗汉果14份、青果14份、委陵菜1份、蒲公英1份、莲子心1份、连翘1份、竹叶1份、芦根1份、麦冬3份、知母3份、密蒙花1份、野菊花1份、青蒿1份、薄荷1份、生地10份、白术4份、茯苓3份、陈皮3份以及绿茶30份。
制备及应用方法同实施例1,除以下记录:。
(1)药物组分预处理:干燥温度为60℃;干燥8小时后,冷却至室温,称重记W1,继续干燥2小时后,冷却至室温,称重记W2,W2/W1>95%干燥结束;
(3)将杀青后的一级鲜叶的绿茶,采用55型揉捻机,一般投叶量在35千克,揉捻45分钟。揉捻程度要求成条率在80%以上,叶细胞组织破坏率为55%,然后炒干,再用破碎机破碎为粉末,过30~40目筛子筛分,筛后大块物继续破碎,30目以下的粉末即为得到的绿茶粉末;炒干过程采用步进式扁茶炒干机炒干,炒干之茶叶含水率5%以下;
实施例6
在实施例1的基础上,一种生地清热茶,针对湿热留于肠胃人群,临床可见胃脘灼热,或者便秘,或者大便粘滞,肛门灼热,应该加大通腑泻热的功效,组方中加大委陵菜和蒲公英的用量。其由以下重量份的清热药物组分组成:白芍1份、牡丹皮3份、竹茹1份、茵陈蒿1份、百合1份、石斛1份、罗汉果1份、青果1份、委陵菜14份、蒲公英14份、莲子心1份、连翘1份、竹叶1份、芦根1份、麦冬1份、知母3份、密蒙花1份、野菊花1份、青蒿1份、薄荷1份、生地10份、白术4份、茯苓3份、陈皮3份以及绿茶30份。
制备及应用方法同实施例1,除以下记录:
(1)药物组分预处理:干燥温度为55℃;干燥10小时后,冷却至室温,称重记W1,继续干燥1小时后,冷却至室温,称重记W2,W2/W1<95%,继续干燥1小时后,冷却至室温,称重记W3,继续干燥直至W3/W2>95%;
(3)将杀青后的一级鲜叶的绿茶,采用55型揉捻机,一般投叶量在30千克,揉捻45分钟。揉捻程度要求成条率在80%以上,叶细胞组织破坏率为55%,然后炒干,再用破碎机破碎为粉末,过30目筛子筛分,筛后大块物继续破碎,30目以下的粉末即为得到的绿茶粉末;炒干过程采用步进式扁茶炒干机炒干,炒干之茶叶含水率5%以下;
实施例7
在实施例1的基础上,一种生地清热茶,针对心火偏旺人群,临床可见烦躁不安,或者口舌生疮,彻夜难眠,应该加大清心安神的功效,组方中加大莲子心和连翘的用量。其由以下重量份的清热药物组分组成:白芍1份、牡丹皮1份、竹茹1份、茵陈蒿1份、百合1份、石斛1份、罗汉果1份、青果1份、委陵菜1份、蒲公英1份、莲子心14份、连翘14份、竹叶3份、芦根1份、麦冬3份、知母1份、密蒙花1份、野菊花1份、青蒿1份、薄荷1份、生地10份、白术4份、茯苓3份、陈皮3份以及绿茶30份。
制备及应用方法同实施例1,除以下记录:
(1)药物组分预处理:干燥温度为50℃;干燥10小时后,冷却至室温,称重记W1,继续干燥2小时后,冷却至室温,称重记W2,W2/W1>95%干燥结束;
(3)将杀青后的二级鲜叶的绿茶,采用55型揉捻机,一般投叶量在30千克,揉捻45分钟。揉捻程度要求成条率在80%以上,叶细胞组织破坏率为55%,然后炒干,再用破碎机破碎为粉末,过30目筛子筛分,筛后大块物继续破碎,30目以下的粉末即为得到的绿茶粉末;炒干过程采用步进式扁茶炒干机炒干,炒干之茶叶含水率5%以下;
实施例8
在实施例1的基础上,一种生地清热茶,针对膀胱湿热人群,临床可见小便短赤,或者尿淋涩痛,甚至血尿,应该加大利尿通淋的功效,组方中加大竹叶和芦根的用量。其由以下重量份的清热药物组分组成:白芍1份、牡丹皮1份、竹茹1份、茵陈蒿1份、百合1份、石斛1份、罗汉果1份、青果1份、委陵菜1份、蒲公英1份、莲子心1份、连翘1份、竹叶14份、芦根14份、麦冬1份、知母5份、密蒙花1份、野菊花1份、青蒿1份、薄荷1份、生地10份、白术4份、茯苓3份、陈皮3份以及绿茶30份。
制备及应用方法同实施例1,除以下记录:
(1)药物组分预处理:干燥温度为45℃;干燥6小时后,冷却至室温,称重记W1,继续干燥1小时后,冷却至室温,称重记W2,W2/W1<95%则继续干燥,继续干燥1小时后,冷却至室温,称重记W3,W3/W2<95%则继续干燥,继续干燥1小时后,冷却至室温,称重记W4,W4/W3>95%;
(3)将杀青后的二级鲜叶的绿茶,采用55型揉捻机,一般投叶量在35千克,揉捻45分钟。揉捻程度要求成条率在80%以上,叶细胞组织破坏率为45%%,然后炒干,再用破碎机破碎为粉末,过30目筛子筛分,筛后大块物继续破碎,30目以下的粉末即为得到的绿茶粉末;炒干过程采用步进式扁茶炒干机炒干,炒干之茶叶含水率5%以下;
实施例9
在实施例1的基础上,一种生地清热茶,针对胃火牙痛人群,临床可见口臭,牙龈出血,胃嘈杂灼痛,应该加大益胃生津的功效,组方中加大麦冬和知母的用量。其由以下重量份的清热药物组分组成:白芍1份、牡丹皮1份、竹茹1份、茵陈蒿1份、百合3份、石斛3份、罗汉果1份、青果1份、委陵菜1份、蒲公英1份、莲子心1份、连翘1份、竹叶1份、芦根1份、麦冬14份、知母14份、密蒙花1份、野菊花1份、青蒿1份、薄荷1份、生地10份、白术4份、茯苓3份、陈皮3份以及绿茶30份。
制备及应用方法同实施例1,除以下记录:
(1)药物组分预处理:干燥温度为55℃;干燥6小时后,冷却至室温,称重记W1,继续干燥1小时后,冷却至室温,称重记W2,W2/W1<95%,继续干燥2小时后,冷却至室温,称重记W3,继续干燥直至W3/W2>95%;
(3)将杀青后的二级鲜叶的绿茶,采用55型揉捻机,一般投叶量在35千克,揉捻40分钟。揉捻程度要求成条率在80%以上,叶细胞组织破坏率为45%,然后炒干,再用破碎机破碎为粉末,过30目筛子筛分,筛后大块物继续破碎,30目以下的粉末即为得到的绿茶粉末;炒干过程采用步进式扁茶炒干机炒干,炒干之茶叶含水率5%以下;
实施例10
在实施例1的基础上,一种生地清热茶,针对肝火目赤人群,临床可见视物模糊,眼干涩痛,应该加大清肝明目的功效,组方中加大密蒙花和野菊花的用量。其由以下重量份的清热药物组分组成:白芍1份、牡丹皮1份、竹茹1份、茵陈蒿1份、百合1份、石斛1份、罗汉果1份、青果1份、委陵菜1份、蒲公英1份、莲子心1份、连翘1、份、竹叶3份、芦根1份、麦冬1份、知母3份、密蒙花14份、野菊花14份、青蒿1份、薄荷1份、生地10份、白术4份、茯苓3份、陈皮3份以及绿茶30份。
制备及应用方法同实施例1,除以下记录:
(1)药物组分预处理:干燥温度为50℃;干燥9小时后,冷却至室温,称重记W1,继续干燥2小时后,冷却至室温,称重记W2,W2/W1>95%干燥结束;
(3)将杀青后的一级鲜叶的绿茶,采用55型揉捻机,一般投叶量在35千克,揉捻40分钟。揉捻程度要求成条率在80%以上,叶细胞组织破坏率为50%,然后炒干,再用破碎机破碎为粉末,过30目筛子筛分,筛后大块物继续破碎,30目以下的粉末即为得到的绿茶粉末;炒干过程采用步进式扁茶炒干机炒干,炒干之茶叶含水率5%以下;
实施例11
在实施例1的基础上,一种生地清热茶,针对夏季中暑的人群,表现为头重如裹,甚至意识模糊,应该加大清暑利湿,组方中加大青蒿和薄荷的用量。其由以下重量份的清热药物组分组成:白芍1份、牡丹皮1份、竹茹1份、茵陈蒿1份、百合1份、石斛1份、罗汉果1份、青果1份、委陵菜1份、蒲公英1份、莲子心1份、连翘1份、竹叶1份、芦根1份、麦冬5份、知母1份、密蒙花1份、野菊花1份、青蒿14份、薄荷14份、生地10份、白术4份、茯苓3份、陈皮3份以及绿茶30份。
制备及应用方法同实施例1,除以下记录:
(1)药物组分预处理:干燥温度为50℃;干燥8小时后,冷却至室温,称重记W1,继续干燥2小时后,冷却至室温,称重记W2,W2/W1<95%,继续干燥2小时后,冷却至室温,称重记W3,W3/W2>95%;
(3)将杀青后的二级鲜叶的绿茶,采用55型揉捻机,一般投叶量在35千克,揉捻40分钟。揉捻程度要求成条率在80%以上,叶细胞组织破坏率为45%,然后炒干,再用破碎机破碎为粉末,过30目筛子筛分,筛后大块物继续破碎,30目以下的粉末即为得到的绿茶粉末;炒干过程采用步进式扁茶炒干机炒干,炒干之茶叶含水率5%以下;
实施例12
在实施例1的基础上,一种生地清热茶,针对熬夜人群,电脑程序编写人员,上夜班的各个行业的工作人员,应该注重养阴生津,以防阴血耗伤,组方清热药物均衡配比,凸显生地养阴之功。其由以下重量份的清热药物组分组成:白芍2份、牡丹皮2份、竹茹2份、茵陈蒿2份、百合2份、石斛2份、罗汉果2份、青果2份、委陵菜2份、蒲公英2份、莲子心2份、连翘2份、竹叶2份、芦根2份、麦冬5份、知母2份、密蒙花2份、野菊花2份、青蒿2份、薄荷2份、生地10份、白术4份、茯苓2份、陈皮5份以及绿茶50份。
制备及应用方法同实施例1,除以下记录:
(1)药物组分预处理:干燥温度为45℃;干燥6小时后,冷却至室温,称重记W1,继续干燥2小时后,冷却至室温,称重记W2,W2/W1<95%,继续干燥2小时后,冷却至室温,称重记W3,W3/W2<95%,继续干燥2小时后,冷却至室温,称重记W4,W4/W3>95%;
(3)将杀青后的二级鲜叶的绿茶,采用55型揉捻机,一般投叶量在30千克,揉捻40分钟。揉捻程度要求成条率在80%以上,叶细胞组织破坏率为45%%,然后炒干,再用破碎机破碎为粉末,过30目筛子筛分,筛后大块物继续破碎,30目以下的粉末即为得到的绿茶粉末;炒干过程采用步进式扁茶炒干机炒干,炒干之茶叶含水率5%以下;
临床应用
临床实验1:生地清热茶(实施例8)在湿热下注型急性膀胱炎的应用
1.诊断标准:均发热、下腹胀、尿频、尿急、尿痛,部分有血尿。尿生化检查:白细胞(+)~(+++),红细胞0~(+++)
2.实验入组病人资料:本组90例急性膀胱炎患者均为医院门诊患者,男47例,女43例,年龄21~65岁,初发69例,复发11例。按照门诊号随机分为治疗组和对照组,各45例,两组病例一般情况相似,具有可比性
3.疗效判定标准:参照《中医临床病证诊断疗效标准》拟定。近期治愈:临床症状体征消失,尿常规检查2次恢复正常,尿菌阴性,并于第2、6周复查尿菌均为阴性。显效:临床症状消失或基本消失,尿常规正常或接近正常,尿菌阴性。有效:临床症状减轻,尿常规显著改善,尿培养偶有阳性。无效:症状及尿检改善不明显,尿菌定量检查仍阳性,或于第2、6周复查时尿菌为阳性,且为同一菌种
4.统计学方法采用SPSS 13.0统计学软件进行数据处理,等级资料组间对比采用秩和检验,P<0.05为差异有统计学意义。
5.治疗结果
表1生地清热茶与洛美沙星治疗急性膀胱炎比较
注:与洛美沙星(对照组)比较,*P<0.05.
6.不良反应治疗组用药后血常规、肝肾功能、心电图均无异常改变,该药无明显毒副作用。
7.复查及随访结果治疗后第2周复查,治疗组45例(无效病例不再复查)中,3例尿菌<10 000/mL,尿白细胞(+)。对照组45例中,4例尿菌<10 000/mL,尿白细胞(+)。治疗后第6周随机抽取治疗组18例(治愈10例,显效6例,有效3例)随访,尿菌培养及尿常规均为阴性,随访结束时测定肝肾功能、血常规及心电图均无异常发现。
8.讨论:生地清热茶在治疗尿路系统急性感染中表现出较好的治愈率洛美沙星的副作用有关,因为洛美沙星治疗副作用太多,常见的不良反应如:洛美沙星常见不良反应主要为:头痛、恶心、呕吐、光过敏、眩晕、腹泻和腹痛等。
2.洛美沙星尚观察到下列不良反应:
自主性的:出汗增多、口渴、面色潮红等;身体:疲劳、背痛、抑郁、衰弱等;心血管:心悸、亢进、高血压、低血压、心肌梗塞、心绞痛等;
中枢神经系统及周围神经系统:震颤、眩晕、感觉异常、抽搐、癫痫发作等;胃肠道:消化不良、呕吐、便秘、胃肠道出血、吞咽困难等;血液学:紫癫、淋巴结病、血小板增多症、贫血病等;肝、肾:血清氨基酸转移酶、BUN值升高;代谢:口渴、高血糖;肌肉骨骼:关节痛、肌痛、腿痛性痉挛;
眼科:视觉异常、结膜炎、惧光等;精神科:失眠症、神经质、幻觉、抑郁;生殖系统:女性:念珠菌病、阴道炎、月经异常等;男性:附睾炎、睾丸炎。
呼吸系统:呼吸道感染、鼻炎、咽炎、呼吸困难等。皮肤/过敏:瘙痒症、风疹、皮肤脱落等;偶可发生渗出性多形性红斑及血管神经性水肿;特殊感觉:味觉异常。尿道:血尿症、结晶尿、尿频、排尿困难、无尿等。[3]
局部:静脉炎因为有上述不良反应,因此很多在治疗两周内,嘱咐服用洛美沙星的患者出现不良反应应该减量服用,因此导致治愈率下降,而生地清热茶无不良反应,因此可以足量服用,在急性膀胱炎中治愈率高。
临床实验2:生地清热茶(实施例11)在中暑患者中的应用
1.入组标准:所有患者符合第八版《内科学》重症中暑分类标准。其中男性23例,女性17例;年龄61~96岁,平均年龄(77.1±7.78)岁。纳入标准:(1)符合《内科学》(第9版)重症中暑分型标准。(2)无明显心、肝、肾重要脏器功能障碍。排除标准:(1)精神异常患者。(2)家属及患者不签署知情同意书。发热(腋下测量法,体温≥37℃)急诊收住院103人,急诊接诊高热死亡5人,住院高热死亡5人。年龄≥60岁45例,体温≥40℃30例。
2.随机分组:患者发病至救医最长时间间隔为120min,最短为30min,平均间隔时间为54.6min。按照发病机制和临床表现分类:热痉挛3例,热衰竭15例,热射病2例。19例为昏迷状态,6例出现休克,19例出现呼吸困难,5例出现呕吐(为胃内容物),16例既
往有基础病史,其中陈旧性脑梗死6例,陈旧性心肌梗死2例,帕金森病2例,精神分裂症3例,房颤1例。
将上述患者按简单随机分为实验组和对照组两组,各20例。实验组男性12例,女性8例;年龄62~85岁,平均年龄(75.8±4.21)岁。对照组男性11例,女性9例;年龄63~89岁,平均年龄(78.4±6.16)岁。两组患者在年龄、性别、生命体征、病情轻重程度、急诊诊疗时间以及临床表现等基本资料方面差异无统计学意义(P>0.05),具有可比性。
3.治疗方案
对照组进行西医常规对症治疗,实验组在西医常规治疗的基础上加用复方中药水煎剂口服或者保留灌肠,比较两组患者的临床治疗效果。
40例重症中暑患者入院后即给予紧急救治,予以物理降温治疗,包括冰袋、冰帽、冰毯等措施;吸氧;早期快速扩溶,尽快补足血容量;早期抗凝,改善微循环。根据病情及时纠正水、电解质紊乱和酸碱平衡失调,防止多器官功能衰竭,甘露醇脱水减轻脑水肿、脑细胞神经营养剂,糖皮质激素及抗生素抗炎对症治疗,予以药物保护胃黏膜以及营养支持等综合治疗。实验组10例患者在上述常规治疗基础上加复方中药水煎剂口服或者保留灌肠。
灌肠,2次/d,连续3d。观察两组患者高热持续时间、体温恢复时间,意识恢复时间及住院时间。通过分析肝功、肾功能、尿常规、多器官功能障碍综合征及死亡人数等脏器损害指标,比较两组治疗的主要脏器功能损害发生情况。
4.临床疗效评定标准重症中暑的临床评定标准为显效,有效和无效。(1)显效:患者在治疗后4h内意识恢复清醒,生命体征均恢复正常,各项化验指标均正常。(2)有效:患者在治疗后4h后,8h内意识恢复清醒,生命体征恢复正常,各项化验指标趋于正常。(3)无效:患者在治疗后8h后仍意识障碍、体温偏高、并有合并症出现,生命体征未恢复正常,各项化验指标出现异常。总有效率为显效和有效率之和。
5.应用SPSS 20.0统计学软件处理数据,正态分布计量资料以x±s表示,两组间比较采用独立样本t检验,检验。非正态分布的计量资料采用秩和检验。计数资料采用Fisher精确概率法,P<0.05为差异有统计学意义。
6.治疗结果:两组重症中暑患者临床疗效比较,实验组总有效率高于对照组(P<0.05)见表2.
表2.两组中暑治疗临床疗效比较
组别 | 例数 | 显效 | 有效 | 无效 | 总有效率(%) |
实验组 | 20 | 13 | 5 | 2 | 90* |
对照组 | 20 | 8 | 6 | 6 | 70% |
P值 | <0.05 |
注:与对照组比较,生地清热茶有显著性差异。
临床实验3:生地清热茶(实施例2)治疗霰粒肿
全部病例来自于佳木斯市中医院眼科2010年1月4日~2013年12月31日的门诊患者。共收治286名霰粒肿患儿,排除年龄、体重、治疗周期不足,后续跟踪回访丢失,观察期不足12个月等客观因素,符合病例选择标准的患者共61例,男30例,女31例,年龄在22.3-8.6岁,平均年龄(5.6士0.25)岁,病程1~24个月,平均(17.39士6.38)个月。随机分为观察组31例,用生地清热茶治疗;对照组30例,用单纯行霰粒肿刮除术。两组均由同一年资医师进行治疗。治疗后12个月对所有患者进行定期回访检查。治疗前两组的性别、年龄、病程、肿物大小差异无统计学意义(P>0.05),可以认为治疗前后两组患者间一般情况差异无统计学意义,具有可比性。
2.治疗方法
对照组:地塞米松眼药水,6/日滴左眼;红霉素眼药膏,1/晚涂左眼;热敷,1/晚。实验组使用生地清热茶(患儿体重标准予基础剂量,药物剂量随体重情况调整,药味不变。)3周为1疗程,服6d,停ld,连续服用3周。
3.统计方法通过S P S S 11.5软件包建立数据库,做数据分析处理,计量资料组内前后比较采用t检验,观察组和对照组之间用两样本t检验,等级资料用WILCOXON秩和检验。
4.治疗结果:治愈:霰粒肿完全消失。显效:霰粒肿减小70%以上。有效:霰粒肿减小50%以上。无效:霰粒肿减小30%以下。其结果见表3
表3.两组治疗霰粒肿临床疗效比较
临床实验4:生地清热茶(实施例12)治疗干眼症
1.一般资料:选取2014年11月至2016年12月北京市健宫医院收治的干眼症患者72例作为研究对象,随机分为对照组及观察组(n=36,72只患眼),每组36例72只患眼。对照组中男13例,女23例;年龄23~66岁,平均年龄(54.9±7.6)岁;病程4~21个月,平均病程(16.3±5.7)个月。观察组中男11例,女25例;年龄21~70岁,平均年龄(56.4±8.2)岁;病程5~20个月,平均病程(15.8±6.3)个月。2组患者主要基线资料比较,差异无统计学意义(P>0.05),具有可比性。本研究已通过本院医学伦理委员会研究批准。
2.诊断剂纳入标准:诊断标准西医诊断标准符合《干眼的诊断与治疗规范》;中医诊断标准符合《中医病证诊断疗效标准》,且辨证为阴虚湿热证。纳入标准符合上述诊断标准者;年龄20~70岁;双眼发病者;伴有典型的异物感、干燥感、视疲劳、烧灼感等不适症状者;泪膜破裂时间≤5s者;治疗依从性好,且可接受定期随访者;患者及家属均对研究内容及目的知情同意。
3.排除标准单眼发病者;伴有严重精神疾病无法配合治疗及随访者;过敏体质,对本研究所用药物具有不良反应者;合并角膜、虹膜严重病变者;伴有眼外伤及眼部手术史者;妊娠或哺乳期妇女等。
4.脱落与剔除标准治疗期间因其他原因不能按期规律服药者;因发生严重不良反应不适宜继续治疗者;主动退出本研究者;失访者等。
5.治疗方法对照组给予人工泪液玻璃酸钠滴眼液(山东博士伦福瑞达制药有限公司,国药准字H20057377)治疗,1~2滴/次,4次/d。观察组在对照组治疗的基础上联合口服生地清热茶及熏蒸治疗,外用,以8倍量水混匀,灌入眼科治疗仪中加热至有蒸汽散出,调节火力,以药液不翻滚、不溅出为宜,进行熏蒸。20min/次,2次/d。2组患者均以2周为1个疗程,且均连续治疗2个疗程。
6.观察指标1)治疗后统计2组患者临床疗效;2)参照《中药新药临床研究指导原则》评估治疗前后2组患者疲劳感、干涩感、异物感及烧灼感等干眼症主要中医症状,据各症状严重程度计0~3分,评分越高,患者临床症状越严重;3)分别采用泪液分泌实验及泪膜破裂实验检测并比较治疗前后2组患者泪液分泌量及泪膜破裂时间;4)采用美国国家眼科研究所视觉相关生命质量量表(NEI-VFQ-25)评价并比较治疗前后2组患者视觉相关生命质量,该量表主要包括一般健康状况、活动障碍及视力障碍3部分,分值越高,则生命质量越高。
7.疗效判定标准据《常见疾病诊断依据与疗效判定结果》评估2组临床疗效:显效:治疗后患者自觉临床症状完全消失,泪液分泌量>10mm/5min,泪膜破裂时间>10s;有效:治疗后患者自觉临床症状基本消失,泪液分泌量5~10mm/5min,泪膜破裂时间5~10s;无效:治疗后患者自觉临床症状无明显改善,甚至有所加重,泪液分泌量<5mm/5min,泪膜破裂时间<5s。总有效率=显效率+有效率。
8.统计学方法采用SPSS 19.0统计软件进行数据分析,临床疗效以百分比(%)表示,组间比较采用χ2检验;主要中医症状积分、泪液分泌量、泪膜破裂时间及视觉相关生命质量评分均以均数±标准差(mean±SD)表示,2组间比较采用t检验,多组间比较采用单因素方差分析。以P<0.05为差异有统计学意义。
结果
10.两组患者临床疗效比较见表4
表4两组患者临床疗效比较见表4
组别 | 显效 | 有效 | 无效 | 总有效率 |
实验组(n=72) | 25 | 37 | 10 | 86.11** |
对照组(n=72) | 12 | 34 | 26 | 63.89 |
注:与对照组比较**p<0.01
临床实验5:生地清热茶(实施例9)治疗胆汁反流性胃炎
1临床资料
1.1一般资料观察病例为2012年6月~2014年2月本院胆汁反流性胃炎患者,共80例,随机分为2组。治疗组40例,男17例,女23例;年龄19~57岁,平均40.6岁;病程1月~7年,平均2.1年。对照组40例,男14例,女26例;年龄20~56岁,平均39.6岁;病程1月~7年,平均2年。2组一般资料比较,差异均无统计学意义(P>0.05),具有可比性。
1.2诊断标准符合《胃肠动力学组胃食管反流病治疗共识意见(2007·西安)》标准。临床症状:胃脘灼痛,呃逆嗳气,口苦而干,嘈杂呕吐,大便干结,小便黄赤,舌质红、苔黄,脉弦数。均经胃镜检查确诊为胆汁反流性胃炎。中医辨证为胆火犯胃型。
1.3分级标准参照《实用中西医结合诊断治疗学》。Ⅰ级:少量黄色泡沫从幽门口冒出;Ⅱ级:大量黄色泡沫从幽门口冒出;Ⅲ黄色泡沫布满胃内大部。
1.4排除标准不能接受胃镜检查者;有消化道溃疡和其它胃肠道器质性病变者;合并有心血管和血液系统严重原发疾病及精神病患者;妊娠或哺乳期妇女;过敏体质者。
2.治疗方法
2.1治疗组予以生地清热茶。水煎服,每天1剂,每天2次
2.2对照组予铝碳酸镁片0.5g(拜耳医药保健有限公司生产),三餐后1h嚼服;伊托必利分散片50mg(迪沙药业集团有限公司生产),三餐前0.5h服。
4.1疗效标准痊愈:胃镜检查胆汁反流消失,炎症消退或基本消退;症状消失,半年后复查未复发者。显效:胃镜检查胆汁反流减轻1个级度,炎症明显好转;症状基本消失,半年后偶有发作,疼痛症状减轻者。好转:胃镜检查胆汁反流减轻≤1个等级,炎症减轻;主要临床症状减轻。无效:临床症状和胃镜检查无明显改善者或加重。
表5.临床疗效比较。
与对照组比较,**p<0.01
表6.胃镜检查胆汁反流效果比较
与对照组比较,**p<0.01
临床实验6:生地清热茶(实施例4)治疗肺结核(肺阴虚型和阴虚火旺型,)
1.2病例选择标准
1.2.1西医诊断标准参照《中国结核病防治规划实施工作指南》制定的初治继发性肺结核诊断标准。
1.2.2中医证候诊断标准参照《内科常见病诊疗指南中医病证部分》、《中国现代百名中医临床家丛书》、《中医临床诊疗术语证候部分》制定。
1.2.2.1肺阴虚证主症:干咳、盗汗、手足心热;次症:痰中带血丝或血点、胸部隐隐作痛、口燥咽干、咳声短促、咯少量黏痰、颧红、皮肤干灼;舌脉:舌红少津、脉细或细数。
1.2.2.2阴虚火旺证主症:呛咳气急、午后潮热、盗汗;次症:时时咯血色鲜红、骨蒸、五心烦热、形体消瘦、颧红、口渴、心烦、失眠、胸胁掣痛、痰少质黏或痰黄稠量多、口燥
咽干;舌脉:舌红而干、苔薄黄或兼见剥苔、脉细数。
1.2.3纳入标准①符合西医初治继发性肺结核诊断标准(涂阴∶涂阳=1∶1);②符合肺痨肺阴亏虚、阴虚火旺证辨证标准;③胸片证实肺内有活动性结核病变;④年龄18~65岁;⑤肝、肾功能正常,空腹血糖<6.0mmol/L;⑥了解参加本课题的意义及临床试验中可能出现的不良反应,同意参加试验并签署知情同意书。
1.2.4排除标准①不符合上述纳入标准者;②过敏体质或对方案中任何一种药有过敏史者;③合并肝、肾、代谢、自身免疫性疾病,内分泌、血液、神经系统疾病,恶性肿瘤、长期服用免疫抑制剂等患者;④妊娠或哺乳期妇女、精神病患者;⑤慢性纤维空洞性改变者;⑥正在进行标准化疗方案规律用药疗程大于1个月者;⑦同时参加其他临床研究者。
1.3研究方法
采用随机、对照、单盲、多中心临床试验方法。随机化方案设计和实施由中国中医科学院临床医学研究所临床评价中心负责,采用分层区组随机化设计方法,随机化使用中央随机系统,通过网络申请随机号码,实现随机分配。
1.3.1治疗方法对照组:采用西药治疗方案,给予口服2HRZE/4HR(沈阳红旗制药有限公司生产。H:异烟肼;R:利福平;Z:吡嗪酰胺;E:乙胺丁醇),1次/d。试验组:采用中西医结合方案,即中药+西药治疗。①肺阴亏虚:生地清热茶10g/次,2次/d;2HRZE/4HR,1次/d。②阴虚火旺:服用生地清热茶10g/次,2次/d;2HRZE/4HR,1次/d。疗程均为6个月。
1.3.2疗效性指标监测①有效性指标:咳嗽、咳痰、咯血、胸痛、气促等局部症状和潮热、盗汗、发热、食欲不振、倦怠乏力等全身症状,治疗前及治疗后第2、4、6月各记录1次。②一般项目(体温、脉搏、血压、呼吸、体质量):治疗前及治疗后第2、4、6月各记录1次。③痰菌涂片:治疗前及治疗后每月各查1次,每次3份标本,分别为即时痰、夜间痰、清晨痰,采用痰直接涂片检查法。④结核菌培养加菌型鉴定:用药前对入组患者痰标本用罗氏培养方法进行结核菌培养,培养阳性者进行菌型鉴定。⑤DR胸部正位片:治疗前及治疗后1、2、5、6个月各检查1次。
1.3.3安全性指标监测①血、尿常规及尿酸、肝功能、肾功能、空腹血糖于治疗前及治疗后每月检查1次。②心电图、乙肝两对半治疗前检查1次。③红细胞沉降率于治疗前、治疗结束各检查1次。④观察可能出现的不良反应,包括症状、体征、实验室检查等方面的不良反应,分析其原因并作出判断。
1.3.4中医症状计分标准各中医证候的各项主症和次症分别计分。主症按无、轻、中、重分别计0、2、4、6分,次症按无、轻、中、重分别计0、1、2、3分。
1.3.5评价标准参照《中药新药临床研究指导原则(试行)》。①中医证候评价。改善率=(治疗前总积分-治疗后总积分)÷治疗前总积分×100%。治愈:临床症状、体征消失或基本消失,证候改善率≥90%。显效:临床症状、体征明显改善,证候改善率70%~89%。有效:临床症状、体征均有好转,证候改善率30%~69%。无效:临床症状、体征无明显改善,甚或加重,证候改善率不足30%。②不良反应评价。轻度:有症状出现,但能很好耐受,不需对症处理及停药;中度:症状影响正常生活,患者难以耐受,需要停药或对症处理;重度:症状严重,危及患者生命,致死或致残,需立即停药或紧急处理。③安全性评价。1级:安全,无任何不良反应,安全性指标检查无异常。2级:比较安全,有轻度不良反应,不需做任何处理可继续给药。3级:有安全性问题,有中等程度的不良反应,做处理后可继续给药。4级:因严重不良反应终止试验。
1.4统计学方法
采用分层区组随机化设计方法,用SAS9.1.3统计软件完成。采用成组t检验/秩和检验、卡方检验/Fisher进行组间比较,均采用双侧检验。P≤0.05表示差异有统计学意义。
表7.临床疗效比较
临床实验7:生地清热茶(实施例4)治疗慢性咽炎(肺阴虚型)
1.病例选择标准①纳入标准:符合CP西医诊断标准、中医气阴不足辨证标准;年龄18~60岁,有独立行为能力;病程3个月以上;近期未用其他方式或服用其他药物治疗者;自愿接受治疗试验并签署相关知情同意书;本研究通过医院医学伦理委员会审查,伦理号:伦审科研临第(S2016-004-01)号。②排除标准:合并心、肝、肾、造血系统、内分泌系统等严重原发病及精神病患者;妊娠或哺乳期妇女;有消化道梗阻的患者;依从性差或不能顺利完成观察者。③剔除标准:严重违反纳入或排除标准;随机化后未曾用药者;随机化后无任何治疗后访视记录者。病例的最终剔除与否,由主要研究者、数据管理人员、统计分析人员等在盲态核查时确定。
2中医辨证标准:参照《中华人民共和国中医药行业标准中医病证诊断疗效标准》及《中医耳鼻喉科学》制定。①主症:咽干,咽痛,咽痒,梗阻感等不适,咽部黏膜呈弥漫性充血,呈暗红色,局部灼热疼痛,口干口渴;舌质偏红,苔少,脉弦细数。②次症:面红赤、口鼻灼热干燥,心烦燥热,便干便秘,小便黄赤。主证有1项,加次症2项及以上者,结合舌象或脉象支持气阴不足中医辨证标准者,即可诊断。
3一般资料按上述标准选取2016年6月—2017年7月解放军总医院耳鼻喉科及中医科门诊就诊的肺阴亏耗型CP患者180例。按就诊顺序采用随机数字表法分为观察组和对照组,每组90例;其中观察组脱落2例,剔除1例;对照组脱落3例,剔除1例。观察组87例,其中男39例,女48例;年龄(37.50±6.26)岁;病程(5.18±3.24)年。对照
组86例,其中男42例,女44例;年龄(39.01±5.71)岁;病程(4.75±3.51)年。两组的性别、年龄、病程比较差异无统计学意义(P>0.05),具有可比性。
4分组方法本研究采用随机、双盲、安慰剂对照的前瞻性临床研究设计,设立安慰剂对照组以减少试验偏倚。通过对180例患者为期2周的系统临床观察,验证复方竹叶石膏颗粒治疗CP的有效性及安全性,为临床CP的治疗提供有效新药。180例患者按1∶1的治疗原则进行病例分配,并将分组、治疗药品信息放入信封内密封(信封表面显示与药品对应编号),试验时按患者就诊顺序进行随机发放。受试对象选择均为解放军总医院耳鼻喉科及中医科门诊确诊病例。本临床研究遵循赫尔辛基宣言中的伦理原则和中国有关药物临床研究的管理规范与法规。
5治疗方法
5.1用法与疗程:观察组给予生地清热茶,3/d。对照组给予草珊瑚含片3/d。两组均从入组第1天开始服用,7d为1疗程,共2个疗程。
5.2试验用药包装:将生地清热茶和(或)安慰剂颗粒,按试验14d所需的最大数量另加2d的富余量装于大信封中。包装上均注明“生地清热茶”、国家食品药品监督管理局临床研究批准文号、药品编号(即按“处理编码”编制的试验药品顺序号:001~180)、功能主治、包装量、应用方法、贮存条件、生产厂家等。为达到双盲目的,所有药物由北京东升药业有限责任公司进行处理,确保包装外观完全相同,并与信封内药品信息标号对应,试验结束后相关数据才被揭盲。
6观察指标与方法
6.1观察指标:①一般资料包括年龄、性别、病程、职业等。②临床疗效指标包括总有效率与复发率以及两组治疗前、治疗后1周、治疗后2周中医症状积分差值。③在用药后随时观察和记录可能出现的不良反应症状,以不良反应发生率作为安全性评价指标。
6.2观察时间:于治疗前、治疗后1周和2周共3次,每周固定时间点记录中医症状积分,观察和记录不良事件发生情况,询问试验用药品的应用情况并记录。
6.3疗效判定标准:①总有效率评定:参照《中医新药临床研究指导原则》制定,评定标准分为痊愈:治疗后临床症状消失(减分率≥75%);显效:治疗后临床症状消失或明显减轻(减分率≥50%);有效:治疗后临床症状减轻(减分率≥30%);无效:治疗后临床症状未减轻(减分率<30%)。减分率=(治疗前评分-治疗后评分)/治疗前评分×100%;总有效率=(治愈+显效+有效)/总例数×100%。②复发率分析:治疗结束后对有效患者定期随访2个月,观察长期疗效。复发率=复发例数/总有效例数×100%。③中医证候疗效判定标准:参照《中药新药临床研究指导原则》制定,比较治疗前后各个中医症状积分,症状积分标准见表8。
表8慢性咽炎的中医症状积分标准
1.7统计学方法采用SPSS 20.0软件对所有数据进行统计分析。计量资料以均数±标准差(x±s)表示,采用t检验;计数资料以率(%)表示,采用χ2检验。以α=0.05为检验水准。
注:观察组给予生地清热茶,对照组给予草珊瑚含片;与对照组比较,P<0.05。
表10两组慢性咽炎患者的临床疗效比较
观察组给予生地清热茶,对照组给予草珊瑚含片与对照组比较,**p<0.01
临床实验8:生地清热茶(实施例9)治疗浅表性胃炎(胃阴虚型)
1.一般资料
将慢性浅表性胃炎患者797例,根据中医辩证分型后得到胃阴虚型86例子。随机分为治疗组43例和对照组43例,治疗组43例中,男48例,女38例;年龄最大62岁,最小18岁,平均年龄37岁;病程最长18年,最短3个月。对照组43例中,男30例,女20例;年龄最大61岁,最小19岁,平均年龄35岁,病程最长16年,最小4个月。两组患者的一般资料无显著差异(P<0.05),具有可比性。
2.诊断标准根据中国中西医结合学会消化系统疾病专业委员会制定的诊断(试行)标准。凡有胃胀、胃痛、嗳气、呃逆、食欲不振等症状经电子胃镜检查确诊者,治疗前接受过其他疗法而疗效不理想者。年龄范围18岁~62岁。
3.中医辨证分型:根据辨证将797例分为4型:肝胃不和型433例,脾胃湿热型(含胃火炽盛型102例)分别为219例、脾胃虚寒型99例,胃阴不足型86例,观察临床各组疗效。排除标准①合并消化性溃疡、胃粘膜有重度异型增生或病理诊断疑有恶性者。②合并心、脑、肝、肾和造血系统等严重原发性疾病、精神病患者。③妊娠或准备妊娠妇女、哺乳期妇女。④过敏体质和多种药物过敏者。
4.治疗方法其他分型治疗在此不再列举,因与本专利无关,在脾胃湿热型(胃火炽盛型)中,治疗组采用生地清热茶,对照组采用生芦根饮;在胃阴虚型浅表性胃炎中,治疗组43例用生地清热茶治疗,对照组使用益胃汤治疗。
5.疗效标准参照《中药新药治疗慢性浅表性胃炎的临床研究指导原则》确定。痊愈:症状消失,胃镜复查胃粘膜基本正常;显效:2~3项主要症状消失,胃镜复查胃粘膜糜烂、出血消失,炎症范围明显缩小;有效:症状减少或减轻,胃镜复查胃粘膜炎症范围缩小;无效:症状无改善或加重,镜检无变化。
治疗结果两组治疗临床疗效及辨证分型治疗组各型疗效比较见表11、12
表11胃阴虚型临床疗效比较
组别 | 痊愈 | 显效 | 有效 | 无效 | 总有效率 |
治疗组(n=43) | 12 | 21 | 6 | 4 | 90.69* |
对照组(n=43) | 10 | 15 | 7 | 11 | 74.41 |
观察组给予生地清热茶,对照组给予益胃汤,与对照组比较,*p<0.05
表12胃火炽盛型临床疗效比较
观察组给予生地清热茶,对照组给予生芦根饮,与对照组比较,*p<0.05
临床实验9:生地清热茶(实施例2)治疗女性更年期失眠(肝阴不足型)
1.一般资料:选取2010年12月~2012年12月在我院就诊的100例更年期失眠患者为研究对象,分为观察组和对照组两组,每组50例。观察组患者年龄45~58岁。平均(51±4.2)岁;病程2~20个月,平均(15±7.8)个月。对照组患者年龄45~57岁,平均(51±3.8)岁,病程1~20个月,平均(15±6.9)个月。两组患者均按照失眠症的诊断标准确诊,且两组患者的年龄、病程、病情等方面比较差异无统计学意义,具有可比性(P>0.05)。
2.治疗方法:观察组患者采用生地清热茶进行治疗,对照组采用照组服用谷维素,50mg/次,每天3次;维生素E胶丸,100mg/次,每天1次,4周为1个疗程。两组患者均治疗1个疗程后观察比较临床疗效。
3.疗效标准:痊愈:每晚睡眠时间在6h以上,睡眠程度深,醒后精力充沛;显效:失眠情况好转,每晚睡眠时间较治疗前增加3h以上,睡眠较深;有效:每晚睡眠时间较治疗前延长,但小于3h;无效:失眠情况较治疗前无改善。
4.统计学分析:采用SPSS10.0软件对所得数据进行统计学分析,组间比较采用χ2检验,计量资料采用t检验,P<0.05为差异具有统计学意义。
表13肝阴虚型失眠临床疗效比较
组别 | 痊愈 | 显效 | 有效 | 无效 | 总有效率 |
治疗组(n=50) | 14 | 20 | 11 | 5 | 90* |
对照组(n=50) | 8 | 17 | 12 | 13 | 74. |
观察组给予生地清热茶,对照组给予谷维素和维生素E,与对照组比较,*p<0.05
以上对本发明做了示例性的描述,应该说明的是,在不脱离本发明的核心的情况下,任何简单的变形、修改或者其他本领域技术人员能够不花费创造性劳动的等同替换均落入本发明的保护范围。
Claims (10)
1.一种生地清热茶,其特征在于,由以下重量份的清热药物组分粉末组成:白芍1~14份、牡丹皮1~14份、竹茹1~14份、茵陈蒿1~14份、百合1~14份、石斛1~14份、罗汉果1~14份、青果1~14份、委陵菜1~14份、蒲公英1~14份、莲子心1~14份、连翘1~14份、竹叶1~14份、芦根1~14份、麦冬1~14份、知母1~14份、密蒙花1~14份、野菊花1~14份、青蒿1~14份、薄荷1~14份、生地10份、白术4份、茯苓2~3份、陈皮3~5份以及绿茶30~50份。
2.根据权利要求1所述的生地清热茶,其特征在于,所述生地清热茶为袋装,每袋含量为2~5克。
3.一种生地清热茶的制备方法,其特征在于,包括如下步骤:
(1)药物组分预处理:将白芍、牡丹皮、竹茹、茵陈蒿、百合、石斛、罗汉果、青果、委陵菜、蒲公英、莲子心、连翘、竹叶、芦根、麦冬、知母、密蒙花、野菊花、青蒿、薄荷、生地、白术、茯苓以及陈皮分别清洗、干燥,得到预处理后各单一药物组分;
(2)破碎筛选:将所述预处理后各单一药物组分破碎为40目以下粉末得到白芍粉末、牡丹皮粉末、竹茹粉末、茵陈蒿粉末、百合粉末、石斛粉末、罗汉果粉末、青果粉末、委陵菜粉末、蒲公英粉末、莲子心粉末、连翘粉末、竹叶粉末、芦根粉末、麦冬粉末、知母粉末、密蒙花粉末、野菊花粉末、青蒿粉末、薄荷粉末、生地粉末、白术粉末、茯苓粉末以及陈皮粉末;
(3)将杀青后的绿茶揉捻然后炒干,再破碎为30目以下的粉末,得到绿茶粉末;
(4)将上述步骤(2)处理后得到的各药物组分粉末与步骤(3)处理后得到的所述绿茶粉末按照如下重量份数混合:白芍粉末1~14份、牡丹皮粉末1~14份、竹茹粉末1~14份、茵陈蒿粉末1~14份、百合粉末1~14份、石斛粉末1~14份、罗汉果粉末1~14份、青果粉末1~14份、委陵菜粉末1~14份、蒲公英粉末1~14份、莲子心粉末1~14份、连翘粉末1~14份、竹叶粉末1~14份、芦根粉末1~14份、麦冬粉末1~14份、知母粉末1~14份、密蒙花粉末1~14份、野菊花粉末1~14份、青蒿粉末1~14份、薄荷粉末1~14份、生地粉末10份、白术粉末4份、茯苓粉末2~3份、陈皮粉末3~5份以及绿茶粉末30~50份,得到所述生地清热茶;
所述步骤(3)与步骤(1)(2)无先后之分。
4.根据权利要求3所述的生地清热茶的制备方法,其特征在于,所述步骤(1)的干燥过程为在45~60℃下干燥6~10小时后,冷却至室温,称重记W1,继续干燥1~2小时后,冷却至室温,称重记W2,若W2/W1>95%则干燥结束,若W2/W1<95%则继续干燥直至Wn/Wn-1>95%,n为称重次数。
5.根据权利要求3所述的生地清热茶的制备方法,其特征在于,所述步骤(3)的炒干过程将绿茶含水率炒至5wt%以下。
6.根据权利要求3所述的生地清热茶的制备方法,其特征在于,所述步骤(3)杀青后的绿茶为一、二级鲜叶,所述步骤(3)揉捻采用揉捻机,揉捻时间为40~45分钟。
7.根据权利要求3所述的生地清热茶的制备方法,其特征在于,所述步骤(3)揉捻成条率在80%以上,叶细胞组织破坏率为45%~55%。
8.根据权利要求3所述的生地清热茶的制备方法,其特征在于,所述制备方法还包括(5)将所述生地清热茶按计量2~5克装入过滤袋中,通过真空密封后用伽马射线辐射灭菌,得到袋装生地清热茶。
9.一种根据权利要求8所述的制备方法制备的袋装生地清热茶。
10.一种根据权利要求2所述的生地清热茶的饮用方法,其特征在于,将2~5克的所述生地清热茶置于85~95℃的水中冲泡10~30min,单次加水量为80~100毫升,冲泡次数为8~10次。
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