CN116509966A - 一种发酵中药制剂、其制备方法及应用 - Google Patents
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Abstract
本发明提供了一种发酵中药制剂、其制备方法及应用,涉及中药技术领域,由如下重量份数的原料组分制备而成:桔梗10~15份、金银花10~15份、连翘叶10~15份、灵芝1~5份、陈皮1~5份、杏仁1~5份、鱼腥草1~5份、蒲公英1~5份、薄荷1~3份、甘草1~5份、芦根1~5份、百合1~5份。本发明所述发酵中药制剂的制备方法以桔梗、金银花、陈皮、鱼腥草、芦根为发酵原料,利用益生菌发酵对药材进行生物转化,使得本发明所述药材经发酵后与剩余药材结合既能提高药物的活性,又能保持益生菌的功效,从而使本发明所述发酵中药制剂具有镇咳、促进患者胃肠道微生态平衡、增强患者机体免疫力等多种功能。
Description
技术领域
本发明涉及中药技术领域,特别涉及一种发酵中药制剂、其制备方法及应用。
技术背景
过敏性疾病是目前发病率较高的疾病之一,大约有20%-30%的人群曾经或正在被这种疾病所困扰,在过敏性疾病中,又以吸入性过敏最常见,大约占过敏性疾病的65%,过敏性疾病的发病率逐年升高。由吸入性过敏源引起的主要疾病为:过敏性哮喘、过敏性鼻炎、过敏性湿疹、荨麻疹、变应性皮炎、过敏性结膜炎等等。在吸入性过敏疾病中,以花粉、螨虫、真菌、动物皮毛等引起的病例最多。
对于上呼吸道过敏性咳嗽的治疗,以往临床上主要采取应用止咳药、抗生素等西药进行治疗,在一定程度上可缓解患者咳嗽等临床表现,但远期治疗效果不够理想,极易导致该病反复发作。因此,为了选择更好的治疗措施,本发明提供了一种能够有效防治呼吸道过敏性疾病的发酵中药制剂及其制备方法。
发明内容
为了解决现有技术中存在的问题,本发明提供了一种发酵中药制剂、其制备方法及应用。
为实现上述目的,本发明提出如下方案:
本发明提供了一种发酵中药制剂,由如下重量份数的原料组分制备而成:桔梗10~15份、金银花10~15份、连翘叶10~15份、灵芝1~5份、陈皮1~5份、杏仁1~5份、鱼腥草1~5份、蒲公英1~5份、薄荷1~3份、甘草1~5份、芦根1~5份、百合1~5份。
优选的,所述发酵中药制剂由如下重量份数的原料组分制备而成:桔梗13份、金银花13份、连翘叶13份、灵芝3份、陈皮3份、杏仁3份、鱼腥草3份、蒲公英3份、薄荷2份、甘草3份、芦根3份、百合3份。
优选的,还包括药学上可接受的辅料。
本发明还提供了一种所述发酵中药制剂的制备方法,包括如下步骤:
1)将中药原料桔梗、金银花、陈皮、鱼腥草、芦根依次粉碎、混匀、磨粉后先添加水和果胶酶进行初次酶解,酶解完成后再添加纤维素酶进行二次酶解,二次酶解完成后将酶解液依次灭酶、离心,取上清液为中药提取液Ⅰ;
2)准确称量剩余中药原料,按照步骤1)所述方法制得中药提取液Ⅱ;
3)利用步骤1)所述中药提取液Ⅰ配制发酵培养基后接种益生菌进行发酵,将所得发酵产物灭菌、过滤后,得到滤液;将所述滤液与步骤2)制得的中药提取液Ⅱ混匀即为所述发酵中药制剂。
优选的,所述步骤1)中中药原料与水的重量比为1:4~6,中药原料与果胶酶的重量比为1:0.015~0.025,中药原料与纤维素酶的重量比为1:0.02~0.03。
优选的,所述步骤1)中的初次酶解温度为40~55℃,时间为50~60h,二次酶解温度为45~55℃,时间为40~50h。
优选的,所述步骤3)中益生菌为嗜酸乳杆菌、植物乳杆菌、粪链球菌和保加利亚乳杆菌中的一种或多种。
优选的,所述益生菌的菌种个数为0.9~2.4×108个/ml。
优选的,所述步骤3)中发酵培养基的组成为:
1L发酵培养基包括小米42~48g、麦麸8~12g、葡萄糖20~24g、硫酸镁0.6~0.8g、酵母膏2.2~2.7g、蛋白胨3~5g、VB1 0.06~0.1g、K2HPO4 0.3~0.5g、KH2PO4 0.8~1.2g、白砂糖1~3g、VB6 0.01~0.02g、其余为中药提取液Ⅰ。
优选的,所述步骤3)中发酵温度为35~38℃,发酵时间为16~24h。
本发明还提供了一种所述发酵中药制剂在制备防治呼吸道过敏性疾病的药物中的应用。
本发明公开了以下技术效果:
1、以下为各原料组分的具体介绍和功用:
桔梗:味苦、辛,性平;归肺经,用于宣肺,利咽,祛痰,排脓;主治咳嗽痰多,胸闷不畅,咽痛音哑,肺痈吐脓。
金银花:味甘、性寒;归肺、胃经,用于清热解毒,消炎退肿;主治外感风热或温病发热,中暑,热毒血痢,痈肿疔疮,喉痹,多种感染性疾病。
连翘叶:味苦,性凉;归心、肝、胆经,用于清热,解毒,散结,消肿。主治温热,丹毒,斑疹,痈疡肿毒,瘰疬,小便淋闭。
灵芝:味甘,性平;归心、肺、肝、肾经,用于补气安神,止咳平喘。主治:心神不宁,失眠,惊悸:本品味甘性平,入心经,能补心血、益心气、安心神,故可用治气血不足、心神失养所致心神不宁、失眠、惊悸、多梦、健忘、体倦神疲、食少等症。咳喘痰多:味甘能补,性平偏温,入肺经,补益肺气,温肺化痰,止咳平喘,常可治痰饮证,见形寒咳嗽、痰多气喘者,尤其对痰湿型或虚寒型疗效较好;虚劳证:有补养气血作用,故常可用治虚劳短气、不思饮食、手足逆冷、或烦躁口干等症。
陈皮:味苦、辛,性温;归肺、脾经,用于理气健脾,燥湿化痰。主治:脘腹胀满,食少吐泻,咳嗽痰多。
杏仁:性温,味苦;有小毒。归肺、大肠经。用于降气止咳平喘,润肠通便。
鱼腥草:味辛,性微寒;归肺经;用于清热解毒,消痈排脓,利尿通淋;主治肺痈吐脓,痰热喘咳,热痢,热淋,痈肿疮毒。
蒲公英:味苦、甘,性寒;归肝、胃经,用于清热解毒,消肿散结,利尿通淋。主治疔疮肿毒,乳痈,瘰疬,目赤,咽痛,肺痈,肠痈,湿热黄疸,热淋涩痛。
薄荷:味辛,性凉;归肺、肝经,用于疏散风热,清利头目,利咽透疹,疏肝行气。主治外感风热,头痛,咽喉肿痛,食滞气胀,口疮,牙痛,疮疥,瘾疹,温病初起,风疹瘙痒,肝郁气滞,胸闷胁痛。
甘草:味甘,性平;归心、肺、脾、胃经,用于补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。主治脾胃虚弱,倦怠乏力,心悸气短,咳嗽痰多,脘腹、四肢挛急疼痛,痈肿疮毒,缓解药物毒性、烈性。
芦根:味甘,性寒。归肺经、胃经;用于清热生津,除烦,止呕,利尿;主治热病烦渴、胃热呕吐、肺热咳嗽、肺痈吐脓、热淋涩痛。
百合:味甘,性寒;归心、肺经,用于养阴润肺,清心安神;主治阴虚燥咳,劳嗽咳血,虚烦惊悸,失眠多梦,精神恍惚。
2、本发明通过将果胶酶和纤维素酶用于中草药的提取,可将中药原料中的有效功能性物质充分释放出来,以提高对有效药用成份的提取率;另外本发明以桔梗、金银花、陈皮、鱼腥草、芦根的提取液为发酵原料,利用益生菌发酵对药材进行生物转化,优化发酵培养配方,并通过控制发酵温度和时间,能进一步优化中药提取液中有效活性成分的含量,如金银花经过发酵后其所含有的绿原酸含量显著增加,同时将部分生物活性较低的物质,转化为生物活性更强的物质,还能将中药的大分子物质,后经过微生物转化成为能够被机体肠道直接吸收的小分子成分,更易被机体利用,同时发酵过程中会产生大量有机酸、乳酸菌素等有益代谢产物,也有助于提高机体免疫力。
3、本发明所述药材经发酵后与剩余中药原料结合既能提高有效活性成分的含量,又能保持益生菌的功效,从而使最终制备的发酵中药制剂中各原料组分有效成分含量得到提升,使得本发明所述发酵中药制剂具有宣降肺气,清热解毒,镇咳、促进患者胃肠道微生态平衡、增强患者机体免疫功能等多种功效;同时通过益生菌发酵作用,还能保护中药活性成分不被破坏,增强药效,节省药材资源。
4、本发明所述发酵中药制剂从整体观着眼,根据辨证论治原则,应用辨证与辨病结合,扶正与祛邪结合,从多靶点综合考虑全面改善患者咳嗽等临床表现,改善其预后水平;与西药相比,本发明所述发酵中药制剂对于过敏性疾病的治疗不仅可以抗过敏反应,还对免疫系统能起到调节作用,如灵芝、甘草、百合等所具有的补脾益气、养阴润肺,清心安神的功能,达到标本兼治的效果;且本发明所述的发酵中药制剂是由12味中草药组成的复方制剂,不是只有单一成分,具有多靶位点,作用广泛的特点,所以耐药性少,这与西药靶点单一、比较容易耐药、临床上长期用药需不断加量相比较,具有明显优势;另外,本发明所述发酵中药制剂对动物和人无毒性,操作简单、使用安全,对防治反复呼吸道过敏复发效果显著,更容易被患者所接受,因此具有有较高的临床应用和推广价值。
具体实施方式
以下将结合实施例对本发明作进一步说明,本发明实施例仅用于描述本发明的技术方案,并非限定于本发明。
实施例1
一种发酵中药制剂的制备方法
1、制备中药提取液:
制备中药提取液Ⅰ:
(1)准确称量10重量份的桔梗、10重量份的金银花、1重量份的陈皮、1重量份的鱼腥草、1重量份的芦根后先分别粉碎过60目筛,再将所有物料混匀后研磨至粉末状,制得混合物料Ⅰ;
(2)将步骤(1)所得的混合物料Ⅰ置于酶解罐中,并在酶解罐中添加混合物料Ⅰ总重量4倍的蒸馏水以及混合物料Ⅰ总重量0.015倍的果胶酶,添加完成后将所有物料混匀并加入乳酸调节其pH至4.5,然后将所有物料于40℃的温度下酶解50h,中途不断搅拌,酶解完成后再向酶解罐中加入混合物料Ⅰ总重量0.02倍的纤维素酶,再在45℃的条件下酶解40h,中途不断搅拌,再次酶解完成后将酶解液加热煮沸灭酶10min,3000r/min离心15min,最后取上清液制得中药提取液Ⅰ;
制备中药提取液Ⅱ:
准确称量10重量份的连翘叶、1重量份的灵芝、1重量份的杏仁、1重量份的蒲公英、1重量份的薄荷、1重量份的甘草、1重量份的百合后按照中药提取液Ⅰ的制备方法制得中药提取液Ⅱ。
2、菌种活化:
用接种环挑取嗜酸乳杆菌菌种于灭菌后的活化培养基,在培养基上划线后,将平板倒置后于36℃温度下,培养36h得到活化后的嗜酸乳杆菌。
3、制备种子液
(1)将活化后的嗜酸乳杆菌菌株接种于无菌种子培养基中,在37℃下振荡培养23h,转速为120r/min,作为一级种子液;
(2)按接种量为6vol%吸取一级种子液,接种于扩培培养基中,于培养箱中36℃,静止培养12h,作为二级种子液。
4、种子罐发酵
将二级种子液按照8vol%的比例接入种子罐中,种子罐发酵过程罐压控制在0.02MPa,压缩空气流量控制在4L/min,转速控制在200rpm,通风比1:0.8,35℃培养16h,制得三级种子液;
其中种子培养基、扩培培养基、种子罐的培养基组分相同,均为:
每1L培养基包括:小米42g、麦麸8g、葡萄糖20g、硫酸镁0.6g、酵母膏2.2g、蛋白胨3g、VB1 0.06g、K2HPO4 0.3g、KH2PO4 0.8g、白砂糖1g、VB6 0.01g,其余为水;调节其pH 5.8,121℃灭菌30分钟。
其中三级种子液中嗜酸乳杆菌的个数为1×109个/ml。
5、发酵中药制剂的制备
(1)制备含中药提取液Ⅰ的发酵培养基
每1L发酵培养基的配方为:小米42g、麦麸8g、葡萄糖20g、硫酸镁0.6g、酵母膏2.2g、蛋白胨3g、VB1 0.06g、K2HPO4 0.3g、KH2PO4 0.8g、白砂糖1g、VB6 0.01g、其余为中药提取液Ⅰ;调节pH为5.8,121℃灭菌30分钟。
(2)制备发酵中药混合物
将三级种子液按照9vol%的接种量接入发酵罐中,发酵罐在发酵过程中罐压控制在0.02MPa,压缩空气流量控制在20L/min,转速控制在150rpm,通风比控制在1:0.5;35℃培养16h,制得发酵中药混合物;
(3)发酵中药制剂的制备
先将步骤(2)所述发酵中药混合物于121℃的温度下高压灭菌30min,使菌种失活,再将发酵中药混合物过滤,后将滤液经3500r/min离心15min,制得上清液,最后将上清液与步骤1制得的中药提取液Ⅱ混匀后,即为本发明所述的发酵中药制剂,制剂内最终生药含量为每1mL含生药0.4g。
6、发酵中药制剂剂型的制备
(1)当本发明中药制剂的剂型为颗粒剂时,其制备方法包括以下步骤:
先将步骤5所述发酵中药制剂于60℃下浓缩至相对密度为1.25的膏体,后将膏体铺入干燥盘中,设定铺盘量5.5kg/盘,物料设定温度90℃,回差温度1℃,真空度-0.08Mpa,进行微波真空干燥得干膏粉;然后将干膏粉中加入其总重量5%的L-阿拉伯糖、10%的燕麦麸粉以及5%的大豆分离蛋白后,置于颗粒机中制成颗粒,按0.5g/颗粒包装制得颗粒剂。
(2)当本发明中药制剂的剂型为片剂时,其制备方法包括以下步骤:
将步骤(1)制得的干膏粉添加其总质量5%的微晶纤维素、10%的山梨糖醇、1%的硬脂酸镁、1%的二氧化硅后混合均匀,置于压片机中压片,一片重0.5g。
(3)当本发明中药制剂的剂型为口服液时,其制备方法包括以下步骤:
将步骤5制得的发酵中药制剂加入其总重量7%的蜂蜜、0.4%的柠檬酸、1.5%的蔗糖以及0.4%甜菊糖苷后制得混合液,先将混合液均质处理,温度为70℃,均质压力为10MPa;再将均质后的混合液经130℃瞬时灭菌后将灭菌后的混合液在真空无菌环境下灌装于10ml瓶中;最后将上述灌装后的成品,经检验合格后,常温下贮藏。
实施例2
一种发酵中药制剂的制备方法
1、制备中药提取液:
制备中药提取液Ⅰ:
(1)准确称量13重量份的桔梗、13重量份的金银花、3重量份的陈皮、3重量份的鱼腥草、3重量份的芦根后分别粉碎过80目筛,再将所有物料混匀后研磨至粉末状,制得混合物料Ⅰ;
(2)将步骤(1)所得的混合物料Ⅰ置于酶解罐中,并在酶解罐中添加混合物料Ⅰ总重量5倍的蒸馏水以及混合物料Ⅰ总重量0.02倍的果胶酶,添加完成后将所有物料混匀并加入乳酸调节其pH至5.0,然后将所有物料于50℃的温度下酶解55h,中途不断搅拌,酶解完成后再向酶解罐中加入混合物料Ⅰ总重量0.025倍的纤维素酶,再在48℃的条件下酶解45h,中途不断搅拌,再次酶解完成后将酶解液加热煮沸灭酶10min,3000r/min离心15min,最后取上清液制得中药提取液Ⅰ;
制备中药提取液Ⅱ:
准确称量13重量份的连翘叶、3重量份的灵芝、3重量份的杏仁、3重量份的蒲公英、2重量份的薄荷、3重量份的甘草、3重量份的百合后按照中药提取液Ⅰ的制备方法制得中药提取液Ⅱ。
2、菌种活化:
用接种环挑取嗜酸乳杆菌菌种于灭菌后的活化培养基,在培养基上划线后,将平板倒置后于37℃温度下,培养36h后得到活化后的嗜酸乳杆菌。
3、制备种子液
(1)将活化后的嗜酸乳杆菌菌株接种于无菌种子培养基中,在37℃下振荡培养24h,转速为120r/min,作为一级种子液;
(2)按接种量为7vol%吸取一级种子液,接种于扩培培养基中。于培养箱中37℃,静止培养20h,作为二级种子液。
4、种子罐发酵
将二级种子液按照9%的比例接入种子罐中,种子罐发酵过程罐压控制在0.04MPa,压缩空气流量控制在14L/min,转速控制在220rpm,通风比1:0.8,36℃培养20h,制得三级种子液;
其中种子培养基、扩培培养基、种子罐的培养基组分相同,均为:
每1L培养基包括:小米45g、麦麸10g、葡萄糖22g、硫酸镁0.7g、酵母膏2.5g、蛋白胨4g、VB1 0.08g、K2HPO4 0.4g、KH2PO4 1g、白砂糖2g、VB6 0.01g、其余为水;调节其pH 6.0,121℃灭菌35分钟。
其中三级种子液中嗜酸乳杆菌的个数为1.5×109个/ml。
5、发酵中药制剂的制备
(1)制备含中药提取液Ⅰ的发酵培养基
每1L发酵培养基的配方为:小米45g、麦麸10g、葡萄糖22g、硫酸镁0.7g、酵母膏2.5g、蛋白胨4g、VB1 0.08g、K2HPO4 0.4g、KH2PO4 1g、白砂糖2g、VB6 0.01g、其余为中药提取液Ⅰ;调节其pH为6.0,121℃灭菌35分钟。
(2)制备发酵中药混合物
将三级种子液按照10%的比例接入发酵罐中,发酵罐在发酵过程中罐压控制在0.04MPa,压缩空气流量控制在50L/min,转速控制在180rpm,通风比控制在1:0.6;37℃培养20h,制得发酵中药混合物;
(3)发酵中药制剂的制备
先将步骤(2)所述发酵中药混合物于121℃的温度下高压灭菌30min,使菌种失活,再将发酵中药混合物过滤,将滤液经3500r/min离心15min,制得上清液,最后将上清液与步骤1制得的中药提取液Ⅱ混匀后,即为本发明所述的发酵中药制剂,制剂内最终生药含量为每1mL含生药0.5g。
6、发酵中药制剂剂型的制备
(1)当本发明中药制剂的剂型为颗粒剂时,其制备方法包括以下步骤:
先将步骤5所述发酵中药制剂于65℃下浓缩至相对密度为1.28的膏体,后将膏体铺入干燥盘中,设定铺盘量5.5kg/盘,物料设定温度90℃,回差温度1℃,真空度-0.08Mpa,进行微波真空干燥得干膏粉;然后将干膏粉中加入其总重量8%的L-阿拉伯糖、15%的燕麦麸粉以及8%的大豆分离蛋白后,置于颗粒机中制成颗粒,按0.5g/颗粒包装制得颗粒剂。
(2)当本发明中药制剂的剂型为片剂时,其制备方法包括以下步骤:
将步骤(1)制得的干膏粉添加其总质量8%的微晶纤维素、15%的山梨糖醇、1.5%的硬脂酸镁、1.5%的二氧化硅后混合均匀,置于压片机中压片,一片重0.5g。
(3)当本发明中药制剂的剂型为口服液时,其制备方法包括以下步骤:
将步骤5制得的发酵中药制剂加入其总重量8%的蜂蜜、0.5%的柠檬酸、2%的蔗糖以及0.5%甜菊糖苷后制得混合液,先将混合液均质处理,温度为72℃,均质压力为13MPa;再将均质后的混合液经130℃瞬时灭菌后将灭菌后的混合液在真空无菌环境下灌装于10ml瓶中;最后将上述灌装后的成品,经检验合格后,常温下贮藏。
实施例3
一种发酵中药制剂的制备方法
1、制备中药提取液:
制备中药提取液Ⅰ
(1)准确称量15重量份的桔梗、15重量份的金银花、5重量份的陈皮、5重量份的鱼腥草、5重量份的芦根后分别粉碎过100目筛,再将所有物料混匀后研磨至粉末状,制得混合物料Ⅰ;
(2)将步骤(1)所得的混合物料Ⅰ置于酶解罐中,并在酶解罐中添加混合物料Ⅰ总重量6倍的蒸馏水以及混合物料Ⅰ总重量0.025倍的果胶酶,添加完成后将所有物料混匀并加入乳酸调节其pH至5.5,然后将所有物料于55℃的温度下酶解60h,中途不断搅拌,酶解完成后再向酶解罐中加入混合物料Ⅰ总重量0.03倍的纤维素酶,再在55℃的条件下酶解50h,中途不断搅拌,再次酶解完成后将酶解液加热煮沸灭酶10min,3000r/min离心15min,最后取上清液制得中药提取液Ⅰ;
制备中药提取液Ⅱ
准确称量15重量份的连翘叶、5重量份的灵芝、5重量份的杏仁、5重量份的蒲公英、3重量份的薄荷、5重量份的甘草、5重量份的百合后按照中药提取液Ⅰ的制备方法制得中药提取液Ⅱ。
2、菌种活化:
用接种环挑取嗜酸乳杆菌菌种于灭菌后的活化培养基,在培养基上划线后,将平板倒置后于38℃温度下,培养36h后得到活化后的嗜酸乳杆菌。
3、制备种子液
(1)将活化后的嗜酸乳杆菌菌株接种于无菌种子培养基中,在37℃下振荡培养25h,转速为120r/min,作为一级种子液;
(2)按接种量为8vol%吸取一级种子液,接种于扩培培养基中。于培养箱中38℃,静止培养24h,作为二级种子液。
4、种子罐发酵
将二级种子液按照10vol%的比例接入种子罐中,种子罐发酵过程罐压控制在0.05MPa,压缩空气流量控制在18L/min,转速控制在250rpm,通风比1:1,37℃培养24h,制得三级种子液;
其中种子培养基、扩培培养基、种子罐的培养基组分相同,均为:
每1L培养基包括:小米48g、麦麸12g、葡萄糖24g、硫酸镁0.8g、酵母膏2.7g、蛋白胨5g、VB1 0.1g、K2HPO4 0.5g、KH2PO4 1.2g、白砂糖3g、VB6 0.02g、其余为水;pH 6.2,121℃灭菌40分钟。
其中三级种子液中嗜酸乳杆菌的个数为2×109个/ml。
5、发酵中药制剂的制备
(1)制备含中药提取液Ⅰ的发酵培养基
每1L发酵培养基的配方为:小米48g、麦麸12g、葡萄糖24g、硫酸镁0.8g、酵母膏2.7g、蛋白胨5g、VB1 0.1g、K2HPO4 0.5g、KH2PO4 1.2g、白砂糖3g、VB6 0.02g、其余为中药提取液Ⅰ;调节其pH为6.2,121℃灭菌40分钟。
(2)制备中药发酵混合物
将三级种子液按照12%的比例接入发酵罐中,发酵罐在发酵过程罐压控制在0.05MPa,压缩空气流量控制在70L/min,转速控制在200rpm,通风比控制在1:0.7;38℃培养24h,制得发酵中药混合物;
(3)发酵中药制剂的制备
先将步骤(2)所述发酵中药混合物于121℃的温度下高压灭菌30min,使菌种失活,再将发酵中药混合物过滤,将滤液经3500r/min离心15min,制得上清液,最后将上清液与步骤1制得的中药提取液Ⅱ混匀后,即为本发明所述的发酵中药制剂,制剂内最终生药含量为每1mL含生药0.55g。
6、发酵中药制剂剂型的制备
(1)当本发明中药制剂的剂型为颗粒剂时,其制备方法包括以下步骤:
先将步骤5发酵中药制剂于70℃下浓缩至相对密度为1.29的膏体,后将膏体铺入干燥盘中,设定铺盘量5.5kg/盘,物料设定温度90℃,回差温度1℃,真空度-0.08Mpa,进行微波真空干燥得干膏粉;然后将干膏粉中加入其总重量10%的L-阿拉伯糖、20%的燕麦麸粉以及10%的大豆分离蛋白后,置于颗粒机中制成颗粒,按0.5g/颗粒包装制得颗粒剂。
(2)当本发明中药制剂的剂型为片剂时,其制备方法包括以下步骤:
将步骤(1)制得的干膏粉添加其总质量10%的微晶纤维素、20%的山梨糖醇、2%的硬脂酸镁、2%的二氧化硅后混合均匀,置于压片机中压片,一片重0.5g。
(3)当本发明中药制剂的剂型为口服液时,其制备方法包括以下步骤:
将步骤5制得的发酵中药制剂加入其总重量9%的蜂蜜、0.6%的柠檬酸、2.5%的蔗糖以及0.6%甜菊糖苷后制得混合液,先将混合液均质处理,温度为75℃,均质压力为15MPa;再将均质后的混合液经130℃瞬时灭菌后将灭菌后的混合液在真空无菌环境下灌装于10ml瓶中;最后将上述灌装后的成品,经检验合格后,常温下贮藏。
实验例1
将实施例2制得的发酵中药制剂应用于上呼吸道过敏性疾病的研究;
1、选取上呼吸道过敏性咳嗽患者120例,随机分为实验组1、实验组2和对照组,每组各40人;每组男女比例相同,两组患者的性别、年龄以及病程等一般资料均没有明显差异,无统计学意义(P﹥0.05)。
2、实验分组:
对照组:给予常规西药治疗,患者口服氨茶碱3mg/kg,一日一次,并根据患者实际情况,应用抗生素进行治疗。
实验组1:给予本发明实施例2制得的发酵中药口服液10ml/支,一日2次。
实验组2:将本发明实施例2制得的中药提取液Ⅰ不经过益生菌发酵直接与中药提取液Ⅱ混合后制得的中药口服液10ml/支,一日2次,其他制备过程相同。
所有患者均坚持用药7d,并随访6个月。
3、治疗结果:
疗效的判断标准:
显效:治疗1周后,患者咳嗽等相关临床表现均消失,随访6个月内,患者没有出现复发等情况;
有效:治疗1周后,患者咳嗽等相关临床表现几乎完全消失,随访6个月内,患者复发出现1~2次,但没有明显的不适表现。
无效:治疗1周后,患者咳嗽等相关临床表现没有任何改变,甚至病情更加严重。
统计学处理采用SPSS 15.0软件处理,(%,n)表示计数资料结果,检验;(x±s)表示计量资料结果,t检验;P<0.05为差异具有统计学意义,其治疗效果的比较如表1所示。
表1治疗效果比较
组别 | n | 显效 | 有效 | 无效 | 总有效率 |
对照组 | 40 | 14 | 16 | 10 | 75% |
实验组1 | 40 | 25 | 13 | 2 | 95% |
实验组2 | 40 | 16 | 17 | 7 | 82.5% |
由表1数据可知,实验组1的总有效率与对照组相比明显升高,差异具有统计学意义(P<0.05)。不经过益生菌发酵的实验组2其治疗上呼吸道过敏性咳嗽的效果远不如实验组1,且患者在服用本发明发酵中药口服液后6个月的时间内,病症也无复发现象。综上,说明本发明的中药发酵制剂可显著改善患者上呼吸道过敏性咳嗽等临床表现,还能避免病症反复发作,提高患者的生活质量。
综上实施例仅用以说明本发明的技术方案,而非对其限制;尽管参照前述实施例对本发明进行了详细的说明,熟悉本领域的技术人员可以轻松理解,并可对前述各实施例所述技术方案进行修改,因此在不背离权利要求及等同范围所限定的一般概念下,本发明并不限于特定的细节或所描述的实施例。
Claims (10)
1.一种发酵中药制剂,其特征在于,由如下重量份数的原料组分制备而成:桔梗10~15份、金银花10~15份、连翘叶10~15份、灵芝1~5份、陈皮1~5份、杏仁1~5份、鱼腥草1~5份、蒲公英1~5份、薄荷1~3份、甘草1~5份、芦根1~5份、百合1~5份。
2.根据权利要求1所述的发酵中药制剂,其特征在于,由如下重量份数的原料组分制备而成:桔梗13份、金银花13份、连翘叶13份、灵芝3份、陈皮3份、杏仁3份、鱼腥草3份、蒲公英3份、薄荷2份、甘草3份、芦根3份、百合3份。
3.权利要求1或2所述发酵中药制剂的制备方法,其特征在于,包括如下步骤:
1)将中药原料桔梗、金银花、陈皮、鱼腥草、芦根依次粉碎、混匀、磨粉后先添加水和果胶酶进行初次酶解,酶解完成后再添加纤维素酶进行二次酶解,二次酶解完成后将酶解液依次灭酶、离心,取上清液为中药提取液Ⅰ;
2)准确称量剩余中药原料,按照步骤1)所述方法制得中药提取液Ⅱ;
3)利用步骤1)所述中药提取液Ⅰ配制发酵培养基后接种益生菌进行发酵,将所得发酵产物灭菌、过滤后,得到滤液;将所述滤液与步骤2)制得的中药提取液Ⅱ混匀即为所述发酵中药制剂。
4.根据权利要求3所述的制备方法,其特征在于,所述步骤1)中中药原料与水的重量比为1:4~6,中药原料与果胶酶的重量比为1:0.015~0.025,中药原料与纤维素酶的重量比为1:0.02~0.03。
5.根据权利要求3所述的制备方法,其特征在于,所述步骤1)中的初次酶解温度为40~55℃,时间为50~60h,二次酶解温度为45~55℃,时间为40~50h。
6.根据权利要求3所述的制备方法,其特征在于,所述步骤3)中益生菌为嗜酸乳杆菌、植物乳杆菌、粪链球菌和保加利亚乳杆菌中的一种或多种。
7.根据权利要求6所述的制备方法,其特征在于,所述益生菌的菌种个数为0.9~2.4×108个/ml。
8.根据权利要求3所述的制备方法,其特征在于,所述步骤3)中发酵培养基的组成为:1L发酵培养基包括小米42~48g、麦麸8~12g、葡萄糖20~24g、硫酸镁0.6~0.8g、酵母膏2.2~2.7g、蛋白胨3~5g、VB1 0.06~0.1g、K2HPO40.3~0.5g、KH2PO4 0.8~1.2g、白砂糖1~3g、VB6 0.01~0.02g、其余为中药提取液Ⅰ。
9.根据权利要求3所述的制备方法,其特征在于,所述步骤3)中发酵温度为35~38℃,发酵时间为16~24h。
10.一种如权利要求1或2所述的发酵中药制剂、权利要求3~9任一项所述发酵中药制剂的制备方法制得的发酵中药制剂在制备防治呼吸道过敏性疾病的药物中的应用。
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