CN107519355A - 一种治疗咽喉疾病的青梅及其制备方法 - Google Patents
一种治疗咽喉疾病的青梅及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗咽喉疾病的青梅及其制备方法,步骤1)、按重量比取岗梅430~530份,土牛膝580~710份,姜半夏430~530份,制天南星430~530份,桔梗800~1000份,甘草1400~1700份,白芷430~530份;煎煮三次,过滤,合并滤液,浓缩,得到提取物,提取物在60℃的条件下相对密度不低于1.1;步骤2)、在提取物中加入防腐剂1‑3份,再加入薄荷素油80~100份、薄荷香精80~100份和青梅胚16000~20000份,混合均匀,密闭储存72h后,将青梅胚包装即得。本案所述的青梅在治疗咽喉不适症状的作用较好。
Description
技术领域
本发明涉及咽喉疾病类治疗领域,尤其涉及一种治疗咽喉疾病的青梅及其制备方法。
背景技术
咽喉疾病是一种常见的上呼吸系统疾病,多为上呼吸道感染所致,表现为咽部粘膜及粘膜下组织的急性炎症,常累及咽部淋巴组织,可单独发生,亦可继发于急慢性鼻炎、急慢性扁桃体炎。目前的研究认为其主要病因有病毒、细菌及非感染因素(如张口呼吸、变应性反应、胃食管反流、抽烟、酒精、高温、粉尘、烟雾、刺激性气体等)。其中病毒感染为咽喉疾病的主要病因,然而,目前临床病人仍广泛接受着抗生素治疗,存在极大的过度治疗风险。
发明内容
综上所述,本发明有必要提供一种治疗咽喉疾病的青梅,有效的缓解咽喉疼痛症状,且副作用小。
有必要提供一种治疗咽喉疾病的青梅的制备方法。
一种治疗咽喉疾病的青梅的制备方法,
步骤1)、按重量比取岗梅430~530份,土牛膝580~710份,姜半夏430~530份,制天南星430~530份,桔梗800~1000份,甘草1400~1700份,白芷430~530份;加水4-6倍重量份,煎煮30-60min,过滤,将滤渣加4-6倍水煎煮30-60min,过滤,将滤渣继续加水4-6倍重量份,煎煮30-60min;合并滤液,浓缩,得到提取物,提取物在60℃的条件下相对密度不低于1.1;
步骤2)、在提取物中加入防腐剂2-3份,再加入薄荷素油80~100份、薄荷香精80~100份和青梅胚16000~20000份,混合均匀,密闭储存72h后,将青梅胚包装即得。
其中,步骤1)、按重量比取岗梅430~530份,土牛膝580~710份,姜半夏430~530份,制天南星430~530份,桔梗800~1000份,甘草1400~1700份,白芷430~530份;加水5倍重量份,煎煮45min,过滤,将滤渣加5倍水煎煮45min,过滤,将滤渣继续加水5倍重量份,煎煮45min;合并滤液,浓缩,得到提取物,提取物在60℃的条件下相对密度不低于1.1;
步骤2)、在提取物中加入防腐剂2-3份,再加入薄荷素油、薄荷香精和青梅胚16000~20000份,混合均匀,密闭储存72h后,将青梅胚包装即得。
其中优选地,步骤1)、按重量比取岗梅486份,土牛膝648份,姜半夏486份,制天南星486份,桔梗900份,甘草1620份,白芷486份;加水5倍重量份,煎煮45min,过滤,将滤渣加5倍水煎煮45min,过滤,将滤渣继续加水5倍重量份,煎煮45min;合并滤液,浓缩,得到提取物,提取物在60℃的条件下相对密度不低于1.1;
步骤2)、在提取物中加入剂苯甲酸钠2份,再加入薄荷素油90份、薄荷香精90份和青梅胚18100份,混合均匀,密闭储存72h后,将青梅胚包装即得。
其中优选地,步骤1)、按重量比取岗梅430份,土牛膝580份,姜半夏430份,制天南星430份,桔梗800份,甘草1400份,白芷430份;加水5倍重量份,煎煮45min,过滤,将滤渣加5倍水煎煮45min,过滤,将滤渣继续加水5倍重量份,煎煮45min;合并滤液,浓缩,得到提取物,提取物在60℃的条件下相对密度不低于1.1;
步骤2)、在提取物中加入剂苯甲酸钠2份,再加入薄荷素油80份、薄荷香精80份和青梅胚20000份,混合均匀,密闭储存72h后,将青梅胚包装即得。
其中优选地,步骤1)、按重量比取岗梅530份,土牛膝710份,姜半夏530份,制天南星530份,桔梗1000份,甘草1700份,白芷530份;加水5倍重量份,煎煮45min,过滤,将滤渣加5倍水煎煮45min,过滤,将滤渣继续加水5倍重量份,煎煮45min;合并滤液,浓缩,得到提取物,提取物在60℃的条件下相对密度不低于1.1;
步骤2)、在提取物中加入剂苯甲酸钠2份,再加入薄荷素油100份、薄荷香精100份和青梅胚16000份,混合均匀,密闭储存72h后,将青梅胚包装即得。
一种由上述方法所制得的青梅。
与现有技术相比较,本案所述的青梅所用的中药进行合理配伍,中药有效成分的协同作用使药效最大化,可以使所述青梅加工制品缓解咽喉不适症状的作用大与任一单方或其他配比的复方,可用于治疗急、慢性咽炎、喉炎,扁桃体炎及上呼吸道感染等症状。
具体实施方式
下面结合一些具体实施方式对本发明所述的一种治疗咽喉疾病的青梅及其制备方法,具体实施例为进一步详细说明本发明,非限定本发明的保护范围。
以下各实施例和对比例中使用的青梅胚为蔷薇科植物梅Prunus mume(Sieb.)Sieb.et Zucc.的干燥近成熟果实,更具体的,将夏季近成熟的青梅果实,以食盐腌制脱水,取出后晒干既得。
本发明未特别说明的“份”均指重量份。
实施例1-3
步骤1)、按表1所示的配方备料,按重量份取岗梅、桔梗、制天南星、甘草、土牛膝、白芷和姜半夏,加5倍质量的水,煎煮45min,过滤,将滤渣加5倍质量的水,煎煮45min,过滤,再将滤渣加5倍质量的水,煎煮45min;
合并浓缩,得到提取物,提取物在60℃的相对比密度为1.1;
步骤2)、在步骤1)所得的提取物加入苯甲酸钠,再加入薄荷素油、薄荷香精和青梅胚,混合均匀,密闭储存72h后,取出青梅胚,包装即得。
对比例1-3
步骤1)、按表1所示的配方备料,按重量份取岗梅、桔梗、制天南星、甘草、土牛膝、白芷和姜半夏,加5倍质量的水,煎煮45min,过滤,将滤渣加5倍质量的水,煎煮45min,过滤,再将滤渣加5倍质量的水,煎煮45min;
合并浓缩,得到提取物,提取物在60℃的相对比密度为1.1;
步骤2)、在步骤1)所得的提取物加入苯甲酸钠,再加入薄荷素油、薄荷香精和青梅胚,混合均匀,密闭储存72h后,取出青梅胚,包装即得。
对比例4
将天南星15份,半夏15份,桔梗30份,白芷15份,防风15份,甘草15份水提2次,过滤浓缩成60℃的相对比密度为1.1的浓缩物,加入0.2份薄荷油与青梅胚270份,混合72小时,即得。
对比例5
按比例将岗梅53g、土牛膝77g和甘草10g,加4倍重量水煎煮两次,提取2次,第一次2小时,第二次2小时,过滤,合并两次滤液,浓缩成60℃的相对比密度为1.1的提取物。
表1实施例配方(单位:g)
实验例1抗炎作用药效评价
1.实验目的
比较各实施例和对比例(相同剂量)的抗炎作用,为其治疗咽喉炎药物疗效提供理论依据。
2.实验原理
二甲苯作为化学致炎剂,可引起组胺、激肽、纤维蛋白溶解酶等炎症介质的释放。这些介质的释放可引起局部毛细血管通透性的增加及炎症细胞的浸润,造成耳部急性渗出性炎性水肿。上述炎症反应实验常用于评价受试药物的抗炎作用。
3.实验动物及饲养条件
3.1实验动物
等级、种系:SPF级昆明种小鼠
动物管理:动物由取得实验动物管理资格认可的人员饲养管理
购入时体重、数量、性别:18~20g,144只,雄性。
繁育单位:中山大学实验动物中心,实验动物生产许可证号为:SCXK(粤)2011-0029;实验动物质量合格证号:44008500012088。
检疫过程:动物检疫观察5天。在此期间,观察动物的外观体征、行为活动、粪便性状、体重及饮食等指标。
动物标识方法:用饱和苦味酸溶液,在动物体表不同部位的被毛涂染斑点,以示不同号码。
笼标记法,将填好的标签卡(标明实验名称、专题负责人、动物种系、性别、编号、组别、喂食开始日期等)挂在笼正面。
3.2饲养条件
饲养房间:中山大学肿瘤防治中心动物实验中心。实验动物使用许可证号:SYXK(粤)2015-0102。环境合格证号:00128827。
温、湿度:20~25℃;湿度:40%~70%
换气次数:大于10次/小时
饲养密度:6只/笼
照明时间:12小时(上午7:00开灯~下午7:00关灯)
3.3饲料
种类:SPF级大小鼠饲料
给料方法:自由摄取
饲料常规营养成分指标:经广东省实验动物监测所(参照中华人民共和国国家标准GB14924.3-2010)检测,检测频度:每年两次。
饲料的保存:保存在专门的饲料间里,保持通风、清洁、干燥
3.4饮用水
饮用水种类:经121℃(1.0kg/cm2)、30min灭菌高质水,符合《饮用净水水质标准》(CJ94-2005)。
给水方法:经动物饮用瓶自由摄取
3.5动物尸体处理
动物尸体暂存于动物暂存间内的-20℃专用冰箱内,集中交给广东生活环境无害化处理中心进行无害化处理。
4.主要仪器及试剂
4.1主要仪器
TLE 104电子天平,梅特勒-托利多仪器(上海)有限公司;
457A电子天平,深圳市安普特电子科技有限公司;
其他:手术器械、注射器、移液器、打孔器等。
4.2主要试剂
二甲苯,广州化学试剂厂,分析纯,批号:20140302-2。
5.实验方法
5.1受试药物剂量设计
实施例:实施例的人日服用量为6粒×0.8g,通过体表面积折算得小鼠日服用量为4.8g/60kg*12.3=1g/kg作为中剂量;以中剂量的1/2即0.5g/kg设为低剂量;以中剂量的2倍即2g/kg设为高剂量。
泼尼松片:6mg/kg。
空白溶媒:20mL/kg。
给药体积:0.2mL/10g小鼠。
5.2动物分组与给药
小鼠经检疫期后按体重随机分为:模型对照组,实施例1低剂量组,实施例1中剂量组,实施例1高剂量组,实施例2-3中剂量组,对比例1-5中剂量组,泼尼松组,共12组,每组12只。各组分别按5.1设计剂量灌胃给予受试药物3天,每天1次。
5.3耳肿胀的诱导与测定
末次给药后1h,用二甲苯均匀涂抹于小鼠右耳两面,每面10uL,左耳不作处理。涂二甲苯1h后处死各组小鼠,剪下双耳,用打孔器取下直径6mm的耳片,称重,计算肿胀率=(右耳片重量-左耳片重量)×100%/左耳片重量。
6.数据处理
实验数据由GraphPad Prism 6.0生物统计学软件进行统计学处理:数据以Mean±SD表示,组间比较采用单因素方差分析结合Dunnett′s多重比较法。
7.实验结果
表2各实施例和对比例对二甲苯致小鼠耳廓肿胀的影响(n=12)
注:与模型对照组比较,*p<0.05,**p<0.01,与对比例4比较,#p<0.05,##p<0.01;与对比例5比较,$p<0.05,$$p<0.01。
8.结论
实施例1高、中、低剂量组可抑制对二甲苯诱发小鼠耳廓肿胀,且随着药物剂量的增加,抑制作用增强。对比例1及不含制天南星和姜半夏的对比例2的抑制肿胀作用比实施例1中剂量组弱,但仍有一定的抑制作用。对比例4及对比例5抑制肿胀作用比对实施例1弱。
实验例2镇痛作用药效评价
1.实验目的
比较实施例和对比例镇痛作用,为其治疗咽喉炎药物疗效提供理论依据。
2.实验原理
热板法是筛选镇痛药的经典方法,小白鼠的足部接触热板后会因受热刺激而产生疼痛反应(即舔后足)。从接触热板到舔后足所需要的时间(产生痛反应)为痛闽值,以痛阂值的改变作为镇痛的评价指标,所以可通过测量给药后小鼠痛闭值的改变而反映药物的镇痛作用。
3.实验动物及饲养条件(同“一、抗炎作用药效评价”)
4.实验方法
4.1受试药物剂量设计
实施例:实施例的人日服用量为6粒×0.8g,通过体表面积折算得小鼠日服用量为4.8g/60kg*12.3=1g/kg作为中剂量;以中剂量的1/2即0.5g/kg设为低剂量;以中剂量的2倍即2g/kg设为高剂量。
阿司匹林片:200mg/kg。
空白溶媒:20mL/kg。
给药体积:0.2mL/10g小鼠。
4.2动物分组与给药
小鼠经检疫期后按体重随机分为:模型对照组,实施例1低剂量组,实施例1中剂量组,实施例1高剂量组,实施例2-3中剂量组,对比例1-5中剂量组,阿司匹林组,共12组,每组12只。各组分别按5.1设计剂量灌胃给予受试药物3天,每天1次。
4.3实验方法
将水浴箱加满水,使热板接触水面,在室温为15~20℃的情况下(过高反应太敏感,过低则反应迟钝),调节恒温水浴箱的水温在55士0.5℃,预热金属盘10分钟。每次取健康雌性小鼠一只放入金属盘内。记录自放入金属盘内至出现舔后脚所需时间(秒),作为该鼠的痛阈值。弃舔后足时间小于5秒或30秒内仍不舔足者不用,选出痛阈值在5~30秒的小鼠90只,随机分成9组,每组10只,重新测定其正常痛阈一次,取2次测定的平均值作为该小鼠的基础痛阈值(给药前的痛阈值)。
测定末次给药后60、90、120min时的痛阈值。以小鼠舔后足反应作为痛阈指标,并剔除发生其他反应的小鼠。为防足部烫伤,设截止时间为60秒,若其在热板上60秒仍无痛觉反应,应立即取出,按60秒计其痛阈值。
4.4数据处理
比较各组各时段的痛阈值,计算用药后痛阈提高的百分率。用t检验比较给药组与正常对照组之间痛阈差异的显著性。
痛阈提高的百分率(%)=(用药后平均痛阈值-用药前平均痛阈值)/用药前平均痛阈值×100%
5实验结果
表3各实施例和对比例对热板致小鼠疼痛的抑制作用
与模型对照组比,**P<0.01;与对比例4比较,#p<0.05,##p<0.01;与对比例5比较,$p<0.05,$$p<0.01
表4各实施例和对比例对小鼠痛阈提高百分率比较
与模型对照组比,**P<0.01;与对比例4比较,#p<0.05,##p<0.01;与对比例5比较,$p<0.05,$$p<0.01
6.结论
由于中药发挥作用较缓,故实施例1低剂量组在给药一小时后镇痛作用不明显,但在给药一个半小时至两小时后有明显的镇痛作用。而实施例1中剂量组和高剂量组均一直表现出很好的镇痛作用。对比例1几乎无镇痛作用。不含制天南星和姜半夏的对比例2的镇痛作用弱于实施例。对比例3、对比例4及对比例5也几乎无镇痛作用。
实验例3抗病毒作用效果评价
1.实验目的
考察实施例的抗病毒作用,为其治疗咽喉炎药物疗效提供理论依据。
2.实验原理
病毒属于非细胞型微生物,只含有一种核酸,无产生能量的酶系统,无细胞膜、壁,必须依靠对病毒敏感的活细胞才能进行复制增殖。病毒在敏感细胞中生长繁殖时可引起细胞病变(CPE),更能出现红细胞吸附(HAd),这是因接种病毒后,受感的细胞膜内含有能吸附红细胞的血凝素所致。药物与病毒加入细胞后,若药物有抗病毒作用,则可抑制病毒繁殖,此时产生细胞病变抑制CPEI或血吸附抑制HAdI现象。用普通光学显微镜在100倍视野下能够察见。病毒致细胞的病变表现为细胞变圆,折光增加,空泡形成,细胞融合和细胞溶解,这些变化很容易与药物毒性所造成的细胞损害相区别。
本实验采用先感染病毒后给药(治疗给药)的方法,通过在人喉癌传代细胞Hep-2株接种柯萨奇B族病4型(CoxB4)、副流感病毒(HVJ)、呼吸道合胞病毒(RSV)、单纯疤疹病毒(HSV-1)后在显微镜下观察细胞病变(CPE)的情况来评价体外抗病毒作用。
3.仪器与试剂
3.1主要仪器:CO2培养箱,倒置显微镜
3.2受试药物:
阳性对照药:病毒唑,湖北滨湖制药厂生产,批号:150705,用量为180ug/mL。
实施例:实验时取实施例1-3及对比例1-4的梅肉制品的梅肉1g,55℃烘干后碾碎,用1∶10的乙醇溶液超声提取,提取液浓缩到1mL。实验时用Eagle’S培养液按1∶125-1∶500倍稀释用于实验,对比例5的溶液直接用Eagle’S培养液按1∶125-1∶500倍稀释用于实验。
3.3病毒
柯萨奇B族病4型(CoxB4)、副流感病毒(HVJ)、呼吸道合胞病毒(RSV)、单纯疤疹病毒(HSV-1)分别购自中国预防科学院病毒研究所及儿科研究所。
3.4细胞
人喉癌传代细胞Hep-2株,购自中国预防医学科学院病毒研究所。
4.实验方法
4.1药物对Hep-2培养细胞的毒性试验
实验前将提取好的实施例1-3、对比例1-4所得的浓缩液和对比例5溶液用Eagle’S培养液按1∶2-1∶500倍稀释后,加到己长成单层的Hep-2细胞培养板中,100uL/孔,每个稀释度药液做5个复孔,同时设正常细胞对照。将培养板置37℃5%CO2培养箱中培养四天,置显微镜下观察细胞生长情况,确定细胞不出现明显退变的最低稀释倍数(最大浓度),实验时顺延做到最小有效浓度(即最大稀释倍数)。按Reed-Muench法计算50%毒性浓度(TC50)和最大无毒浓度(TC0)。结果见下表.
表5实施例对培养细胞的TC0、TC50
4.2对病毒致细胞病变作用的影响
取已长成单层细胞的培养板,倒掉培养液,接种100TCLD50的不同病毒液50μL,置37℃5%CO2培养箱中吸附1小时后,倒掉病毒液,用不含小牛血清的Eagle’S维持液洗细胞2次后,加入相应稀释度的药液100uL/孔。同时设病毒对照、阳性对照药及正常细胞对照。置37℃5%CO2培养箱中培养,每日在倒置显微镜下观察细胞病变,当病毒对照组细胞病变为++++时记录实验结果。细胞病变按六级标准判断,并按Reed-Muench计算50%有效浓度(IC50)和治疗指数(TI)
-:细胞生长正常,无病变出现;
±:细胞病变少于整个单层的10%;
1:细胞病变约占整个单层细胞的25%以下;
2:细胞病变约占整个单层细胞的50%以下;
3:细胞病变约占整个单层细胞的75%以下;
4:细胞病变约占整个单层细胞的75%以上。
治疗指数(TI)=TC50/IC50
5.实验结果:
表6.对比例1体外抗病毒实验
6.结论
实施例1在体外对CoxB4、RSV病毒的致病细胞病变作用有明显抑制作用,其IC50分别为63.0μg/mL、77.3μg/mL,TI分别为5.4和4.4。对HVJ、HSV-1病毒的致病细胞病变作用有一定的抑制作用,其IC50分别为117、136μg/mL,TI分别为2.9和2.5。对比例2在体外对CoxB4、RSV病毒的致病细胞病变作用也有明显抑制作用,但作用弱于实施例1。对比例1、对比例3、对比例4几乎没有体外抗病毒作用。由上表知,实施例的抗病毒性较好。
有研究表明柯萨奇病毒虽说属于肠道病毒,但它可以通过血液循环侵犯其它器官,引起各种临床综合症,现已公认柯萨奇病毒是引起咽喉疾病最常见的一种病毒,但目前还没有有效治疗柯萨奇病毒的药物,本发明中的实施例1在体外能较好地抑制柯萨奇病毒对细胞致病变作用,说明该药在临床上能治疗咽喉疾病有一定的科学依据。
实验例4临床试验数据
按实施例1生产的中药青梅含片在我院已有20余年的应用历史,其疗效和安全性得到专家的确证。本实验将各实施例所制备的青梅制品进行治疗急、慢性咽炎的功效进行评价
1.诊断标准:参照《耳鼻咽喉头颈外科学》第八版:
(1)病因:
急性咽炎:病毒感染,以柯萨奇病毒(Coxsackie virus)、腺病毒、副流感病毒,鼻病毒及流感病毒,通过飞沫和密切接触而传染。细菌感染,以链球菌、葡萄球菌及肺炎链球菌多见。环境因素,如干燥、粉尘、烟雾、刺激性气体等均可引起本病。
慢性咽炎:急性咽炎反复发作所致;各种鼻病及呼吸道慢性炎症,长期张口呼吸及炎性分泌物反复刺激咽部,或受慢性扁桃体炎、牙周炎的影响;烟酒过度、粉尘、有害气体的刺激及辛辣食物等。
(2)症状:
急性咽炎:一般起病较急,先有咽部干燥、灼热、粗糙感、继有明显咽痛,吞咽时尤重,咽侧索受累时疼痛可放射至耳部。全身症状一般较轻,但因年龄、免疫力以及病毒、细菌毒力不同而程度不一,可有发热、头痛、食欲减退和四肢酸痛等。若无并发症者,一般1周内可愈。
慢性咽炎:一般无明显全身症状,咽部异物感、痒感、灼热感或微痛感。常有黏稠分泌物附着于咽后壁,使患者晨起时出现频繁的刺激性咳嗽,伴恶心。无痰或仅有颗粒状藕粉样分泌物咳出。
(3)病理:
急性咽炎:咽黏膜充血,血管扩张及浆液渗出,使黏膜下血管及黏液腺周围有中性粒细胞及淋巴细胞浸润,黏膜肿胀增厚。病变较重者,咽后壁淋巴滤泡增生,隆起并有黄白色点状渗出物。常伴有颈部淋巴结肿大。
慢性单纯性咽炎:咽黏膜充血,黏膜下结缔组织及淋巴组织增生,鳞状上皮层增厚,上皮下层小血管增多,周围有淋巴细胞浸润,黏液腺肥大,分泌亢进。
2.纳入标准
(1)诊断为急性咽炎或慢性单纯性咽炎患者;
(2)年龄在18-55岁之间;
(3)自愿接受治疗和观测;
(4)近期未用其他方式治疗或服用其他药物者。
3.排除标准
参照《中药新药临床研究指导原则》制定:
(1)有食物或药物过敏者;
(2)经检查证实由于口咽、鼻咽、咽喉、鼻、喉、食管、颈部及全身某些病变引起的咽部症状或炎症;
(3)因麻疹,猩红热,流感及粒细胞缺乏症,传染性单核细胞增多症,白血病等引起的咽部症状或炎症;
(4)年龄在18岁以下或55岁以上;
(5)妊娠期或哺乳期妇女;
(6)血肌酐>150umol/L,尿素>10mmol/L或/和蛋白尿>+,或/和红细胞尿>+(尿Hb不作为判断标准)。ALT超过正常值上限一倍以上。合并有心2管、脑血管、肝肾和造血系统等严重原发性疾病,精神病患者;
(7)病例脱落或剔除标准:观察期间未按规定治疗服用药物及临床资料不全,无法判断疗效者,观察期间自行中断治疗者。
4.研究方法
(1)分组:将纳入试验的急性咽炎及慢性咽炎病例分为实施例1-3组,对比例1-5组,每组30人,共480人,经统计学处理,各组病例在性别、病程、年龄、病情上无显著差异,具有可比性。
(2)研究方案:
实施例对照组:急性咽炎或慢性咽炎病人给予实施例1-3组,对比例1-4组制备的青梅制品,含服,一次1颗,一日5~8次,3日为一个疗程,持续3个疗程;对比例5制备的口服液,一次10mL,一日3次,3日为一个疗程,持续3个疗程。
最后对各组病人进行疗效评价,结果进行统计分析,评价疗效。
(3)观察指标
a.相关症状体征观察。
b.血细胞总数及分类计数
c.体温测试
d.心、肝、肾功能检查
(4)疗效判定标准:
痊愈:咽痛症状、体征及中医临床症状(咽部干燥、灼热、疼痛、吞咽疼痛、咽部充血肿胀、发热恶寒、头痛、周身酸痛、咽后壁淋巴滤泡增生等症状)消失,总积分值减少≥95%;
显效:咽痛症状、体征及中医临床症状(咽部干燥、灼热、疼痛、吞咽疼痛、咽部充血肿胀、发热恶寒、头痛、周身酸痛、咽后壁淋巴滤泡增生等症状)明显改善,总积分值减少≥70%,<95%;
有效:咽痛症状、体征及中医临床症状(咽部干燥、灼热、疼痛、吞咽疼痛、咽部充血肿胀、发热恶寒、头痛、周身酸痛、咽后壁淋巴滤泡增生等症状)均有好转,总积分值减少≥30%,<70%;
无效:咽痛症状、体征及中医临床症状(咽部干燥、灼热、疼痛、吞咽疼痛、咽部充血肿胀、发热恶寒、头痛、周身酸痛、咽后壁淋巴滤泡增生等症状)均无明显改善,甚或加重,总积分值减少<30%。
症状分级量化表
5.统计结果如下表
表7治疗急性咽炎疗效统计表
结果表明本发明中的实施例1-3治疗急性咽炎的有效率明显高于其他实施例(p<0.05)
表8治疗慢性咽炎疗效统计表
结果表明本发明中的实施例1-3治疗慢性咽炎的有效率明显高于其他实施例(p<0.05)
对比例4在治疗急性、慢性咽炎中,分别有4例、5例病人上报出现口腔咽喉麻痹、痒感症状,有1例患者甚至出现味觉丧失、言语不清的严重不良反应症状。经检查发现,9例病人口腔黏膜均出现不同程度的溃疡,伴有轻度水肿。
6.结论
通过临床试验证实,实施例治疗急性、慢性咽炎的疗效、安全性明显高于其他对比例,且治疗急慢性咽炎疗效显著。
以上所述仅为本发明的实施例,并非因此限制本发明的专利范围,凡是利用本发明说明书内容所作的等效结构或等效流程变换,或直接或间接运用在其他相关的技术领域,均同理包括在本发明的专利保护范围内。
Claims (6)
1.一种治疗咽喉疾病的青梅的制备方法,其特征在于:
步骤1)、按重量比取岗梅430~530份,土牛膝580~710份,姜半夏430~530份,制天南星430~530份,桔梗800~1000份,甘草1400~1700份,白芷430~530份;加水4-6倍重量份,煎煮30-60min,过滤,将滤渣加4-6倍水煎煮30-60min,过滤,将滤渣继续加水4-6倍重量份,煎煮30-60min;合并滤液,浓缩,得到提取物,提取物在60℃的条件下相对密度不低于1.1;
步骤2)、在提取物中加入防腐剂2-3份,再加入薄荷素油80~100份、薄荷香精80~100份和青梅胚16000~20000份,混合均匀,密闭储存72h后,将青梅胚包装即得。
2.如权利要求1所述的青梅的制备方法,其特征在于:
步骤1)、按重量比取岗梅430~530份,土牛膝580~710份,姜半夏430~530份,制天南星430~530份,桔梗800~1000份,甘草1400~1700份,白芷430~530份;加水5倍重量份,煎煮45min,过滤,将滤渣加5倍水煎煮45min,过滤,将滤渣继续加水5倍重量份,煎煮45min;合并滤液,浓缩,得到提取物,提取物在60℃的条件下相对密度不低于1.1;
步骤2)、在提取物中加入防腐剂2-3份,再加入薄荷素油80~100份、薄荷香精80~100份和青梅胚16000~20000份,混合均匀,密闭储存72h后,将青梅胚包装即得。
3.如权利要求2所述的青梅的制备方法,其特征在于:
步骤1)、按重量比取岗梅486份,土牛膝648份,姜半夏486份,制天南星486份,桔梗900份,甘草1620份,白芷486份;加水5倍重量份,煎煮45min,过滤,将滤渣加5倍水煎煮45min,过滤,将滤渣继续加水5倍重量份,煎煮45min;合并滤液,浓缩,得到提取物,提取物在60℃的条件下相对密度不低于1.1;
步骤2)、在提取物中加入剂苯甲酸钠2份,再加入薄荷素油90份、薄荷香精90份和青梅胚18100份,混合均匀,密闭储存72h后,将青梅胚包装即得。
4.如权利要求2所述的青梅的制备方法,其特征在于:
步骤1)、按重量比取岗梅430份,土牛膝580份,姜半夏430份,制天南星430份,桔梗800份,甘草1400份,白芷430份;加水5倍重量份,煎煮45min,过滤,将滤渣加5倍水煎煮45min,过滤,将滤渣继续加水5倍重量份,煎煮45min;合并滤液,浓缩,得到提取物,提取物在60℃的条件下相对密度不低于1.1;
步骤2)、在提取物中加入剂苯甲酸钠2份,再加入薄荷素油80份、薄荷得精80份和青梅胚20000份,混合均匀,密闭储存72h后,将青梅胚包装即得。
5.如权利要求2所述的青梅的制备方法,其特征在于:
步骤1)、按重量比取岗梅530份,土牛膝710份,姜半夏530份,制天南星530份,桔梗1000份,甘草1700份,白芷530份;加水5倍重量份,煎煮45min,过滤,将滤渣加5倍水煎煮45min,过滤,将滤渣继续加水5倍重量份,煎煮45min;合并滤液,浓缩,得到提取物,提取物在60℃的条件下相对密度不低于1.1;
步骤2)、在提取物中加入剂苯甲酸钠2份,再加入薄荷素油100份、薄荷香精100份和青梅胚16000份,混合均匀,密闭储存72h后,将青梅胚包装即得。
6.一种由权利要求1-5任一方法所制得的青梅。
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