CN106344676A - 一种具有降血糖功效的中药片剂及其制作方法 - Google Patents
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- Medicines Containing Plant Substances (AREA)
Abstract
本发明属于中药加工技术领域,尤其是涉及一种具有降血糖功效的中药片剂及其制作方法。所述片剂包括以下重量份原料组分:苦参60~80份,黄连20~30份,麝香0.1~0.3份。制作方法包括:原料粉碎、乙醇提取、高速分散乳化、加压提取、超声结合电场处理。本发明针对不同的原料,采用不同的提取方式,争取提取效率最大化,提供的片剂对降血糖治疗效果明显,而且对身体无毒副作用,患者使用后对药物不产生依赖感,而且本中药价格较低,是普通百姓能够接受的。
Description
技术领域
本发明属于中药加工技术领域,尤其是涉及一种具有降血糖功效的中药片剂及其制作方法。
背景技术
随着人们生活水平的提高,日常饮食中摄入大量的脂肪、淀粉等营养物质,造成了大量的超重、肥胖人群,进而出现了高血糖、高血脂、高血压等“三高”类疾病,给人们的生活和经济状况带来了较为不利的影响。我国目前“三高”人群比例处于高位,需要通过饮食等方法进行控制。具有降低血糖、调节血脂的复方保健食品显示了良好的降“三高”效果。
发明内容
基于此,本发明提供一种用于中药片剂及其制作方法,提供一种口感适宜,功效成分保留充分、有利人体吸收的中药片剂。
本发明技术方案为:
一种具有降血糖功效的中药片剂,所述片剂包括以下重量份原料组分:
苦参60~80份,黄连20~30份,麝香0.1~0.3份。
优选地,所述片剂还包括以下重量份原料组分:
半柱花2~8份,绿段草4~8份,首乌藤10~15份,湖北海棠3~10份,竹酢液8~13份。
优选地,所述片剂还包括以下重量份原料组分:
葛根5~15份,玉竹3~12份,黄精5~7份。
制作所述中药片剂的方法,所述方法包括以下步骤:
1)称取原料组分,用中药粉碎机依次对原料分别进行粉碎,每次粉碎时间2-10分钟,过100目筛后再以超微粉碎机进行粉碎,备用;
2)将上述步骤1)粉碎后的苦参、黄连,用5-10倍量的80%~95%乙醇进行搅拌提取,提取后进行固液分离,去除滤渣减压浓缩、干燥,将干燥物进行粉碎,得到物料1;
3)将上述步骤1)粉碎后的麝香,以5-10倍量的纯净水加热回流提取2-3次,合并浸提液,将所得浸提液减压浓缩、干燥,粉碎,得到物料2;
4)将上述步骤1)粉碎后的半柱花、绿段草、首乌藤、湖北海棠加入冷蒸馏水溶液,然后进行超低温冷冻干燥至水分低于7%,得物料3;
5)将物料1、物料2、物料3混合,打碎,加入混合物相同重量的水,放入高速分散乳化机处理,得到高速分散乳化物;
6)加压提取:将步骤5)处理后的乳化物,放入高压罐中,加入混合物相同重量的水,加压然后恢复常压,过滤,得到提取液,并浓缩成浸膏,减压浓缩、干燥,得到提取物;
7)葛根在10~20℃下堆放2-6天,冻干粉碎;加入其5~10重量倍的有机溶剂,进行超声-微波协同提取,过滤得到的滤液低温浓缩得到浓缩液,再进行干燥,将干燥物进行粉碎,得到物料4;
8)将玉竹、黄精切片后进行冷冻干燥、粉碎处理,得到玉竹粉、黄精粉;
9)将竹酢液以超声结合电场处理,并浓缩成浸膏,减压浓缩、干燥,过80~90目筛,得到竹酢提取物;
10)将所述步骤6)得到的提取物、所述步骤7)物料4、步骤8)玉竹粉、黄精粉、步骤9)竹酢提取物混合、压片;
完成片剂的制作。
优选地,所述方法还包括原料绿段草、首乌藤、湖北海棠在粉碎前进行药力发酵预处理,其处理方法为:将绿段草、首乌藤、湖北海棠冷冻处理,再蒸汽处理、干燥形成药力发酵绿段草、首乌藤、湖北海棠再进行所述步骤1)粉碎处理。
优选地,所述干燥温度为50-60℃,干燥至水分含量6%以下。
优选地,所述步骤4)冷蒸馏水中还包含浓度为3%~20%的抗性糊精、12%~18%的三氯蔗糖,冷蒸馏水温度为4~25℃,冷冻干燥温度-8℃~-45℃。
优选地,所述步骤7)有机溶剂是体积浓度为50%~85%的乙醇,超声-微波协同提取的条件为:微波功率210~460W,超声波功率310~550W,温度26~36℃,进行超声-微波协同提取400~1300s。
优选地,所述步骤5)乳化处理转速2000-3000r/min,时间10-20min。
优选地,所述步骤6)加压至3.5~4kg/cm2,并保持10-15min,然后在1-3s内恢复常压。
优选地,所述步骤9)超声结合电场处理方法是:先以频率40~60kHz,超声处理5~20min,再用强度5~10kV/cm的电脉冲处理5~10min。
所述的中药片剂或所述的方法在降血糖中的应用。
所述片剂剂载体包括:稳定剂、稀释剂、崩解剂、溶剂、粘合剂和润滑剂。其中稀释剂包括但不限于淀粉、微晶纤维素、聚乙二醇-1000、聚乙二醇-4000、聚乙二醇-6000、蔗糖、糊精、乳糖、糖粉、葡萄糖、低分子右旋糖苷、氯化钠或甘露醇等等。所述粘合剂包括但不限于水、乙醇、淀粉浆、糖浆、明胶、甲基纤维素、羟丙基甲基纤维素、羧甲基纤维素钠、海藻酸钠或聚乙烯吡咯烷酮等。所述润滑剂包括但不限于硬脂酸镁、硬脂酸、硼酸、氯化钠、油酸钠、月桂醇硫酸钠、泊洛沙母等。所述崩解剂包括但不限于淀粉、羧甲基淀粉钠、碳酸氢钠和枸橼酸、酒石酸或低取代羟丙基纤维素等。所述稳定剂包括但不限于多糖如琼脂、丙烯酸树脂、纤维素醚和羧甲基纤维素等等。所述溶剂包括水、磷酸盐缓冲液、甘露醇、平衡的盐溶液等等。
苦参,中药名。为豆科植物苦参的干燥根,春、秋二季采挖,除去根头和小支根,洗净,干燥,或趁鲜切片,干燥。其苦,寒。有清热燥湿,杀虫,利尿之功。用于热痢,便血,黄疸尿闭,赤白带下,阴肿阴痒,湿疹,湿疮,皮肤瘙痒,疥癣麻风,外治滴虫性阴道炎。
黄连清热燥湿,泻火解毒。用于湿热痞满,呕吐吞酸,泻痢,黄疸,高热神昏,心火亢盛,心烦不寐,血热吐衄,目赤,牙痛,消渴,痈肿疔疮;外治湿疹,湿疮,耳道流脓。
麝香:开窍醒神,活血通经,止痛,催产。麝香性温、无毒、味苦。入心、脾、肝经,有开窍、辟秽、通络、散淤之功能。主治中风、痰厥、惊痫、中恶烦闷、心腹暴痛、跌打损伤、痈疽肿毒。
半柱花:微苦、辛、凉。清热解毒,利湿止痒,消肿止痛。临床用于痢疾,湿疹,皮肤瘙痒,跌打等症。
绿段草:甘、淡、凉。凉血除蒸,解毒消肿。用于烦热,劳嗽,胃痛,目赤,骨折,带状疱疹等。
首乌藤:味甘,性平,归心、肝经,具有养血安神,祛风通络的功效,主治失眠多梦,血虚身痛,风湿痹痛;皮肤瘙痒等证。飞扬草:拉丁名Euphorbiae Hirate Herba,味微苦、微酸,性凉,具有清热解毒,利湿止痒的功效,用于细菌性痢疾,阿米巴痢疾,肠炎,肠道滴虫,消化不良,支气管炎,肾盂肾炎;外用治湿疹、皮炎、皮肤瘙痒等证。
葛根,中药名。为豆科植物野葛的干燥根,习称野葛。干燥。甘、辛,凉。有解肌退热,透疹,生津止渴,升阳止泻之功。主要有解酒、降脂、降压、降火、清热解毒、升阳解肌、解痉镇痛、透疹止泻、增加脑和冠状血糖、改善脑微循环等功效,是防治高血压、高血脂、冠心病、心绞痛、糖尿病、脑血栓、肠胃病等多种疾病的药品的重要原料,同时对女性美容健身等具有特殊功效。
玉竹又名藏羹、女萎,为百合科植物玉竹的干燥根茎。玉竹性微寒,味甘平,归肺、胃经,具有养阴润燥,生津止渴之功。玉竹中含有多糖、甾体皂苷、黄酮、生物碱、强心苷等多种成分,其中含量最高的玉竹多糖,作为玉竹的有效药用成分之一,玉竹多糖具有免疫调节、降血糖、抗衰老、调血脂和抗脂质过氧化、增强小鼠耐缺氧能力、抗肿瘤作用等药理活性。
湖北海棠含有茶多酚、黄酮、蛋白后及Fe、Cu、Zn、Mn等多种矿物质,具有抗菌消炎、耐缺氧、抗疲劳、降血糖等作用。
黄精,又名:鸡头黄精、黄鸡菜、笔管菜、爪子参、老虎姜、鸡爪参。为黄精属植物,具有补脾,润肺生津的作用。黄精性味甘甜,食用爽口。其肉质根状茎肥厚,含有大量淀粉、糖分、脂肪、蛋白质、胡萝卜素、维生素和多种其他营养成分,生食、炖服既能充饥,又有健身之用,可令人气力倍增、肌肉充盈、骨髓坚强,对身体十分有益。现代研究证明,黄精水提出液对伤寒杆菌、金黄色葡萄球菌、抗酸杆菌有抑制作用;对肾上腺素引起的血糖过高呈显着抑制作用;具有较强的抗疲劳、抗氧化和延缓衰老作用;有明显增加麻醉犬冠脉流量作用。
竹酢是由竹材经高温蒸馏的天然贵重精华,其含有200多种天然有机成分及矿物质,具有消炎抗菌、防虫保鲜、消臭美容等效果。
本发明有益效果如下:
1、本发明提供的片剂治疗效果明显,可降血糖,而且对身体无毒副作用,患者使用后对药物不产生依赖感,而且本中药价格较低,是普通百姓能够接受的;
2、本发明对原料进行提取处理,最后浓缩的成分再进行制剂处理,提高制剂的活性成分浓度,提高药效;
3、针对不同的原料,采用不同的提取方式,争取提取效率最大化,并对提取后的物料进行减压浓缩、干燥处理,保持活性成分。
4、本发明将绿段草、首乌藤、湖北海棠冷冻处理,冷冻可以迅速使细胞破损,在一定程度上破损细胞的目的,并相对提高了细胞的损伤率,提高提取率;并采用蒸汽熏蒸,去除不好的味道,提高绿段草、首乌藤、湖北海棠中功能性成分的提取效率;
5、本发明采用的高压处理,在高压下,其结果是蛋白质变性、淀粉糊化、酶失活、微生物死亡,营养成份损失很少,而且通过瞬间将压力降为0,使得活性物质分离出,相比现有技术,效果好,时间短;
6、对物料进行乳化处理,高速分散乳化机的转子在高速旋转时,产生很大的离心力使被处理的物料从旋转的细长切口(狭缝)中喷出,并在定子的共同作用下,使被处理的物料受到两方面的作用力:迫使它通过狭缝的正作用力和阻止它通过的阻力。同时,被处理的物料从狭缝中喷出时,还受到狭缝的剪切作用,以及由转定子相对运动而产生的旋转剪切力在多种作用力的作用下使物料得到均质、乳化。处理过的物料具有颗粒分布范围窄,均匀度好,无死角,物料100%通过分散乳化的特点。
7、本发明通过超声结合电场处理,将竹酢液中的醛等有害成分去除,将竹酢液加入到茶中,可以起到抗菌杀菌消毒的作用,同时能在茶中保留对人体有益的成分。本发明可清楚体内自由基垃圾,延缓促进新陈代谢,清热降糖,无添加。
8、冷冻温度能够保证玉竹、黄精中的水分充分形成冰粒,便于后续的冰晶的升华,另外,在该冷冻的环境中,还有效抑制微生物的滋生,保证卫生条件。同时还能有效抑制玉竹、黄精的酶的活性,避免其营养和功能性成分的氧化和分解,冷冻之后的真空干燥的温度和无氧条件能够有效避免营养成分被破坏,且能防止玉竹、黄精特定的风味成分被挥发,也即是说该真空干燥的温度下,不仅能使得冰晶能有效的升华,还能有效的保留甘草、玉竹、黄精中特定的风味成分。
9、冷冻干燥使葛根内部形成大量空洞,有利于后期萃取剂等成分的渗入;葛根中的活性成分在乙醇水溶液中的溶解度较高,同时采用低温超声-微波协同提取技术,提取温度较低、时间较短,能有效避免在提取过程中葛根活性成分被氧化。
10、在冷蒸馏水中加入抗性糊精、三氯蔗糖,抗性糊精是一种低热量葡聚糖,以天然淀粉为原料制备的低分子水溶性膳食纤维,相对于其他膳食纤维产品,抗性糊精具有良好的酸、热稳定性,高消化耐受性,低血糖指数,低胰岛素指数,热量低,防止龋齿等优异的特性,本发明通过添加抗性糊精至冷蒸馏水中,使得营养物质不会在冻干过程中遭到破坏,并且可以降低降低高热量物质。抗性糊精为GI(升糖指数)值<5,具有抑制血糖上升的生理功效,能有效降低其他产品的GI值,从而有效的帮助糖尿病患者控制升糖指数。三氯蔗糖还可以调节甜味,适用于糖尿病患者使用。
7、本发明利用竹酢液以及其他物质的组合,显著提高抑菌消炎的效果。
具体实施方式
下面结合实施例来进一步说明本发明,但本发明要求保护的范围并不局限于实施例表述的范围。
实施例1
一种具有降血糖功效的中药片剂,所述片剂包括以下重量份原料组分:
苦参70份,黄连25份,麝香0.2份,半柱花6份,绿段草5份,首乌藤14份,湖北海棠8份,竹酢液12份,葛根13份,玉竹8份,黄精6份。
制作所述中药片剂的方法,所述方法包括以下步骤:
1)称取原料组分,用中药粉碎机依次对原料分别进行粉碎,每次粉碎时间8分钟,过100目筛后再以超微粉碎机进行粉碎,备用;
2)将上述步骤1)粉碎后的苦参、黄连,用7倍量的85%乙醇进行搅拌提取,提取后进行固液分离,去除滤渣减压浓缩、干燥,将干燥物进行粉碎,细度可达0.2μm,得到物料1;
3)将上述步骤1)粉碎后的麝香,以9倍量的纯净水加热回流提取2次,合并浸提液,将所得浸提液减压浓缩、干燥,粉碎,得到物料2;
4)将上述步骤1)粉碎后的半柱花、绿段草、首乌藤、湖北海棠加入冷蒸馏水溶液,然后进行超低温冷冻干燥至水分低于7%,得物料3;
5)将物料1、物料2、物料3混合,打碎,加入混合物相同重量的水,放入高速分散乳化机处理,得到高速分散乳化物;
6)加压提取:将步骤5)处理后的乳化物,放入高压罐中,加入混合物相同重量的水,加压然后恢复常压,过滤,得到提取液,并浓缩成浸膏,减压浓缩、干燥,得到提取物;
7)葛根在15℃下堆放4天,冻干粉碎;加入其8重量倍的有机溶剂,进行超声-微波协同提取,过滤得到的滤液低温浓缩得到浓缩液,再进行干燥,将干燥物进行粉碎,得到物料4;
8)将玉竹、黄精切片后进行冷冻干燥、粉碎处理,得到玉竹粉、黄精粉;
9)将竹酢液以超声结合电场处理,并浓缩成浸膏,减压浓缩、干燥,粉碎,过70目筛,得到竹酢提取物;
10)将所述步骤6)得到的提取物、所述步骤7)物料4、步骤8)玉竹粉、黄精粉、步骤9)竹酢提取物混合、压片,在片状表面喷涂将溶胀性材料,得到片剂;
所述溶胀性材料包括按重量份的组分:羟丙基甲基纤维素0.5份,羧甲基纤维素钠0.1份,卡拉胶0.4份,加入85℃纯水配制成2%的溶液后喷涂。
完成片剂的制作。
所述方法还包括原料绿段草、首乌藤、湖北海棠在粉碎前进行药力发酵预处理,其处理方法为:将绿段草、首乌藤、湖北海棠冷冻处理,再蒸汽处理、干燥形成药力发酵绿段草、首乌藤、湖北海棠再进行所述步骤1)粉碎处理。
所述干燥温度为55℃,干燥至水分含量6%以下。
所述步骤4)冷蒸馏水中还包含浓度为10%的抗性糊精、13%的三氯蔗糖,冷蒸馏水温度为20℃,冷冻干燥温度-35℃。
所述步骤7)有机溶剂是体积浓度为75%的乙醇,超声-微波协同提取的条件为:微波功率360W,超声波功率450W,温度32℃,进行超声-微波协同提取1200s。
所述步骤6)加压至3.8kg/cm2,并保持12min,然后在2s内恢复常压。
所述步骤9)超声结合电场处理方法是:先以频率50kHz,超声处理15min,再用强度8kV/cm的电脉冲处理9min。
本实施例对于降血糖临床观察效果:
1.1一般资料:选择市人民医院门诊2型糖尿病患者60例,随机分成两组。治疗组30例,男16例,女14例,年龄30~70岁,平均(50±1.5)岁,病程6个月~15年,平均(8.0±1.2)年;对照组30例;男18例;女12例,年龄29~70岁。两组一般资料比较差异无统计学意义(P>0.05),具有可比性。
1.2病例选择:参照1999年世界卫生组织(WHO)糖尿病诊断及分型标准:糖尿病症状+任意时间血浆葡萄糖水平≥11.1mmol/L(200mg/dl)。将符合上述标准的患者随机分组进行观察研究,部分服中药的患者停原中药2周后纳入观察,未服中药的患者直接纳入观察。两组患者均予糖尿病基础治疗,包括饮食控制、运动疗法和口服降糖西药,降糖西药采用二甲双胍,根据血糖情况进行药物用法和药量调整。
1.3治疗方法:治疗组在服用二甲双胍的基础上服用本实施例中药片剂。每天分三次服用,每次5克。对照组常规服用二甲双胍。两组在饮食控制、运动疗法上保持一致,
两组疗程均为2个月。
1.4观察指标:治疗前后分别测定空腹血糖(FPG)、餐后血糖(2hBG)、糖化血红蛋白(HbA1c)、空腹胰岛素(FINS),血糖用葡萄糖氧化酶法测定,胰岛素用放免法测定,血脂用全自动生化分析仪测定,HOMA-IR采用Haffner等在Homa模型中计算IR的公式,即HOMA-IR=FPG×FINS/22.5(FPG单位为mmol/L,FINS单位为mU/L)。
1.5统计学方法:采用SPSS 14.0统计分析软件进行统计学处理。计量资料采用t检验,计数资料用χ2检验。
2结果:两组治疗前后FPG、2hBG、HbAIc、FINS及HOMA-IR的变化详见表1。由表1中我们可以看到,治疗前两组患者FPG、2hBG、HbAlc、FINS、HOMA-IR水平比较差异无统计学意义(P>0.05);治疗后两组FPG、2hBG、HbAlc、FINS、HOMA-IR水平与治疗前比较差异有统计学意义(P<0.05或P<0.01),治疗组患者上述指标与治疗前比较有显著性差异(P<0.01)。治疗组和对照组均能够降低糖尿病血糖,但以治疗组改善血糖更为明显。
表1两组患者治疗前后FPG、2hBG、HbAlc、FINS及HOMA-IR的变化
注:各项指标与治疗前相比:*P<0.05,**P<0.01;治疗后两组FINS及HOMA-IR相比^P<0.05,^^P<0.01。
病例介绍1:
张某,男,57岁,私营店主,糖尿病病史有8年。早期,症状较轻,空腹全血血糖为6.8毫摩尔/升,较为平稳,但最近三年,病症较为严重,空腹全血血糖达到9.7毫摩尔/升,并伴有脱水现象。多年多方面求医,只能较为缓慢的控制病症发展,但没有较好的将血糖的效果。服用本实施例的制剂两个疗程,血压得到明显降低,空腹全血血糖将为6.6毫摩尔/升,未脱水现象。继续服用本制剂,2个月之后血糖将为正常水平。本制剂得到明显的降血糖效果。
病例介绍2:
王某,男,50岁,退休在家,高血糖时间有4年,症状较轻,空腹全血血糖为6.7毫摩尔/升。较为明显的症状为起夜多,每晚起夜2-4次。服用本实施例制剂两个疗程后起夜现象得到改善,空腹全血血糖降到5.9毫摩尔/升。本制剂的降血糖效果明显,并且无副作用。
病例介绍3:
郭某,女,62岁,公务员,糖尿病史有16年时间。其空腹全血血糖浓度在13.0毫摩尔/升左右,并伴有尿多,脱水、口渴、恶心、呕吐等明显症状,是较为严重的病例。服用本制剂两个疗程之后空腹全血血糖降到9毫摩尔/升以下,恶心、呕吐症状减轻,继续服用5个疗程之后空腹全血血糖控制在7.3毫摩尔/升左右,并且尿多、口渴的现象也明显减轻,未有其他不适的感觉。疗效明显,调查结束之前一直在服用本制剂。
病例介绍4:
吴某,男,51岁,患糖尿病8年,空腹全血血糖9.3毫摩尔/升。另检查其血压,舒张压92、收缩压155,伴有高血压症状。服用其他降血糖的药物之后,血糖得到降低,但起伏很大,不稳定,全血血糖浓度时而偏高于正常值,时而达到最大值的9.1毫摩尔/升,停药之后一直是居高不下的状态。服用本制剂3个疗程之后,血糖控制在5.8毫摩尔/升,有明显降血糖的效果,并且,其高血压的现象也得到改善,舒张压85,收缩压137,并且无其他的副作用。
病例介绍5:
易某,男,49岁,无业,因常年酗酒并过度肥胖,导致高血糖,4年前检查出其血糖偏高,其空腹全血血糖一般在8.8毫摩尔/升左右,明显并发症为尿多,皮肤干燥,控制饮酒并适量运动后,其血糖降到8.3毫摩尔/升,但是没有降到正常值,且有反复的现象,为将其降到正常值服用本中药制剂。两个疗程之后,空腹全血血糖降到6.9毫摩尔/升,再继续服用两个疗程之后降到6.1毫摩尔/升,并得到控制尿量减少,皮肤干燥症状减轻,断药后没有反弹,也没有其他不适感。该制剂疗效明显。
结合以上临床数据及本实施例的理论依据,可见本实施例有益效果在于,本实施例制成的制剂,降血糖效果明显,而且无毒,无副作用,效果稳定,制取工艺简便易行。
实施例2
一种具有降血糖功效的中药片剂,所述片剂包括以下重量份原料组分:
苦参70份,黄连25份,麝香0.2份,半柱花6份,绿段草5份,首乌藤13份,湖北海棠8份,竹酢液11份,葛根12份,玉竹10份,黄精6份。
制作所述中药片剂的方法,所述方法包括以下步骤:
1)称取原料组分,用中药粉碎机依次对原料分别进行粉碎,每次粉碎时间2-10分钟,过100目筛后再以超微粉碎机进行粉碎,备用;
2)将上述步骤1)粉碎后的苦参、黄连,用5-10倍量的80%~95%乙醇进行搅拌提取,提取后进行固液分离,去除滤渣减压浓缩、干燥,将干燥物进行粉碎,得到物料1;
3)将上述步骤1)粉碎后的麝香,以5-10倍量的纯净水加热回流提取2-3次,合并浸提液,将所得浸提液减压浓缩、干燥,粉碎,得到物料2;
4)将上述步骤1)粉碎后的半柱花、绿段草、首乌藤、湖北海棠加入冷蒸馏水溶液,然后进行超低温冷冻干燥至水分低于7%,得物料3;
5)将物料1、物料2、物料3混合,打碎,加入混合物相同重量的水,放入高速分散乳化机处理,得到高速分散乳化物;
6)加压提取:将步骤5)处理后的乳化物,放入高压罐中,加入混合物相同重量的水,加压然后恢复常压,过滤,得到提取液,并浓缩成浸膏,减压浓缩、干燥,得到提取物;
7)葛根在10~20℃下堆放2-6天,冻干粉碎;加入其5~10重量倍的有机溶剂,进行超声-微波协同提取,过滤得到的滤液低温浓缩得到浓缩液,再进行干燥,将干燥物进行粉碎,得到物料4;
8)将玉竹、黄精切片后进行冷冻干燥、粉碎处理,得到玉竹粉、黄精粉;
9)将竹酢液以超声结合电场处理,并浓缩成浸膏,减压浓缩、干燥,粉碎,过80~90目筛,得到竹酢提取物;
10)将所述步骤6)得到的提取物、所述步骤7)物料4、步骤8)玉竹粉、黄精粉、步骤9)竹酢提取物混合、压片,在片状表面喷涂将溶胀性材料,得到片剂;
所述溶胀性材料包括按重量份的组分:羟丙基甲基纤维素0.5份,羧甲基纤维素钠0.1份,卡拉胶0.4份,加入85℃纯水配制成2%的溶液后喷涂。
完成片剂的制作。
所述方法还包括原料绿段草、首乌藤、湖北海棠在粉碎前进行药力发酵预处理,其处理方法为:将绿段草、首乌藤、湖北海棠冷冻处理,再蒸汽处理、干燥形成药力发酵绿段草、首乌藤、湖北海棠再进行所述步骤1)粉碎处理。
所述减压浓缩和干燥温度为60℃,干燥至水分含量6%以下。
所述步骤4)冷蒸馏水中还包含浓度为10%的抗性糊精、15%的三氯蔗糖,冷蒸馏水温度为20℃,冷冻干燥温度-35℃。
所述步骤7)有机溶剂是体积浓度为75%的乙醇,超声-微波协同提取的条件为:微波功率360W,超声波功率450W,温度22℃,进行超声-微波协同提取1200s。
所述步骤6)加压至3.8kg/cm2,并保持12min,然后在2s内恢复常压。
所述步骤9)超声结合电场处理方法是:先以频率50kHz,超声处理15min,再用强度8kV/cm的电脉冲处理7min。
本实施例治疗结膜炎的临床观察效果:
中医认为角结膜炎为外受风邪,上攻于目,邪气往来流行于睑眦腠理之间,故致目痒。经过临床实践发现,对角结膜炎具有独特的疗效,达到治疗角结膜炎的目的。
本实施例中药于2012年至2014年临床观察角结膜炎71例患者,临床报告如下:
1、一般资料
81例患者中,年龄18-65岁,病程多在1周到3个月,平均年龄36岁。
2、诊断标准
2.1参照《中医病证诊断疗效标准》中的诊断依据进行临床诊断:
上睑结膜乳头增生呈扁平的铺路石样,或角膜缘部胶样结节;结膜分泌物中较多嗜酸粒细胞和散在的嗜酸性粒细胞结节。
3、治疗方法
本实施例片剂,每日9粒,每日3次,7天为1疗程。
4、治疗结果:
4.1治疗评定标准,根据国家中医药管理局制定的《中医病证诊断疗效标准》判定:
治愈:临床症状及体征全部消失,视力恢复正常(或视力恢复至发病前视力);
显效:视力提高,临床症状及体征全部消失;
有效:临床症状及体征全部消失或部分消失或好转,视力无提高;
无效:视力无提高或临床症状及体征无好转或加重。
4.2结果:81例患者中,治愈56例(52.1%),显效14例(25.4%),有效10例(21.1%),无效1(1.4%)例,总有效率为98.8%。
典型病例
1、王某,男,29岁,右眼奇痒,反复发作月余。舌质红,脉弦略数。检查:白睛红赤,黑睛中央及周边有几个芝麻大小之星点。视力:右眼0.12,左眼1.2,诊为:角结膜炎。服药后2个疗程后上述症状减轻,眼部痒减退,检查右眼视力增进至0.8。继续服用本实施例药物,1个疗程后,症状消失,一年后随访无复发。
2、周某,女,26岁,双眼奇痒,现伴有头痛、发热。检查:双眼视力均为1.0,双眼睑轻度肿胀,睑结膜充血明显,下睑穹窿部有滤泡形成,左眼角膜有点状炎性浸润,舌质红。服用本实施例药物1个疗程,每日1剂,症状消失,一年后随访无复发。
3、周某,患者自述,其曾与部分患了“红眼病”同学密切接触,起初两眼有异物感,痒,畏光,流泪,接着眼结膜越来越红,眼屎越来越多。经检查确诊为结膜炎。采用本实施例治疗,3天后痊愈。其父母亦每日服用本实施例1次,每次1丸,连服三天。1月后随访,王某无复发,其父母未见感染。
体外抗菌试验
试验药物:本实施例中的中药。
方法:采用微量连续二倍稀释法测定本实施例中药对大肠杆菌、金黄色葡萄球菌、绿脓假单胞菌、表皮葡萄球菌、普通变形杆菌、粪链球菌的标注菌株和大肠杆菌、金黄色葡萄球菌、绿脓假单胞菌、表皮葡萄球菌、普通变形杆菌、粪链球菌临床分离株的最小抑菌浓度(MIC),采用平板转染法测定本实施例中的中药对上述细菌的最小杀菌浓度(MBC)。将大肠杆菌、金黄色葡萄球菌、绿脓假单胞菌、表皮葡萄球菌、普通变形杆菌、接种于MH肉汤,置普通培养箱37℃培养24h;粪链球菌接种于TPY肉汤(厌氧菌营养肉汤),置厌氧培养箱37℃培养48h。
能够抑制培养基内细菌生长的最低浓度为最小抑菌浓度(minimal inhibitoryconcentration,MIC)。以杀灭细菌为评定标准时,使活菌总数减少99%或99.5%以上,称为最小杀菌浓度(minimal bactericidal concentration,MBC)。在一批实验中能抑制50%或90%受试菌所需MIC,分别称为MIC50及MIC90。抗菌药的抑菌作用和杀菌作用是相对,有些抗菌药在低浓度时呈抑菌作用,而高浓度呈杀菌作用。
表2本实施例药物组合物对标准菌株的MIC和MBC
菌株 | MIC(mg组合物/ml) | MBC(mg组合物/ml) |
大肠杆菌ATCC25922株 | 11.7 | 23.4 |
金黄色葡萄球菌ATCC25922株 | 0.42 | 0.94 |
绿脓假单胞菌ATCC25922株 | 55 | 109 |
表皮葡萄球菌ATCC25922株 | 0.48 | 0.97 |
普通变形杆菌49010株 | 29 | 64 |
粪链球菌32221株 | 0.43 | 1.70 |
由上表2可知,本实施例药物组合物对试验所选用的大肠杆菌、金黄色葡萄球菌、绿脓假单胞菌、表皮葡萄球菌、普通变形杆菌、粪链球菌临床分离参考株均有较明显的抑制和灭活作用,其MBC为MIC的2~4倍。
表3为本实施例药物组合物对265株临床分离菌株的MIC、MIC50、MIC99和MBC(mg组合物/ml)
表3本实施例药物组合物对标准菌株的MIC和MBC
菌株 | 株数 | MIC | MIC50 | MIC99 | MBC |
金黄色葡萄球菌 | 100 | 0.40~1.47 | 1.032 | 1.31 | 0.75~6.31 |
大肠杆菌 | 110 | 6.39~48 | 17.861 | 22.146 | 30~800 |
表皮葡萄球菌 | 30 | 0.35~3.12 | 0.712 | 1.4808 | 1.58~6.36 |
普通变形杆菌 | 25 | 11.4~49 | 25.454 | 33.0531 | 35~88 |
由上表3可见,本实施例药物组合物对试验所选用的265株临床分离菌株均有一定的抑制和灭活作用,其MBC为MIC的2~4倍。
当本实施例中中药组分中去掉竹酢液或黄连,与本实施例抑菌效果进行比较,测定对菌株的抑制作用MIC(mg组合物/ml)。对比结果见表4。
具体对比例为,
对比例1:一种具有降血糖功效的中药片剂,所述片剂包括以下重量份原料组分:
苦参70份,黄连25份,麝香0.2份,半柱花6份,绿段草5份,首乌藤13份,湖北海棠8份,葛根12份,玉竹10份,黄精6份。
对比例2:一种具有降血糖功效的中药片剂,所述片剂包括以下重量份原料组分:
苦参70份,麝香0.2份,半柱花6份,绿段草5份,首乌藤13份,湖北海棠8份,竹酢液11份,葛根12份,玉竹10份,黄精6份。
对比例3:一种具有降血糖功效的中药片剂,所述片剂包括以下重量份原料组分:
苦参70份,麝香0.2份,半柱花6份,绿段草5份,首乌藤13份,湖北海棠8份,葛根12份,玉竹10份,黄精6份。
表4本实施例组分中对标准菌株的MIC的效果对比
菌株 | 实施例10 | 对比例1 | 对比例2 | 对比例3 |
大肠杆菌ATCC25922株 | 11.7 | 12.5 | 14.5 | 29 |
金黄色葡萄球菌ATCC25922株 | 0.42 | 0.51 | 0.63 | 63 |
绿脓假单胞菌ATCC25922株 | 55 | 58 | 78 | 135 |
表皮葡萄球菌ATCC25922株 | 0.48 | 0.52 | 8.35 | 没有抑制效果 |
普通变形杆菌49010株 | 29 | 31 | 34 | 没有抑制效果 |
粪链球菌32221株 | 0.43 | 0.48 | 0.89 | 没有抑制效果 |
由表4可知,组方中的黄连、竹酢液对于具有抑菌效果,两者与其他组分配合使用,效果最优。
上述的实施例仅为本发明的优选技术方案,而不应视为对于本发明的限制,本申请中的实施例及实施例中的特征在不冲突的情况下,可以相互任意组合。本发明的保护范围应以权利要求记载的技术方案,包括权利要求记载的技术方案中技术特征的等同替换方案为保护范围。即在此范围内的等同替换改进,也在本发明的保护范围之内。
Claims (8)
1.一种具有降血糖功效的中药片剂,其特征在于,所述中药片剂包括以下重量份原料组分:
苦参60~80份,黄连20~30份,麝香0.1~0.3份。
2.根据权利要求1所述中药片剂,其特征在于,所述片剂还包括以下重量份原料组分:
半柱花2~8份,绿段草4~8份,首乌藤10~15份,湖北海棠3~10份,竹酢液8~13份。
3.根据权利要求2所述中药片剂,其特征在于,所述片剂还包括以下重量份原料组分:
葛根5~15份,玉竹3~12份,黄精5~7份。
4.制作权利要求3所述中药片剂的方法,其特征在于:所述方法包括以下步骤:
1)称取原料组分,用中药粉碎机依次对原料分别进行粉碎,每次粉碎时间2-10分钟,过100目筛后再以超微粉碎机进行粉碎,备用;
2)将上述步骤1)粉碎后的苦参、黄连,用5-10倍量的80%~95%乙醇进行搅拌提取,提取后进行固液分离,去除滤渣减压浓缩、干燥,将干燥物进行粉碎,得到物料1;
3)将上述步骤1)粉碎后的麝香,以5-10倍量的纯净水加热回流提取2-3次,合并浸提液,将所得浸提液减压浓缩、干燥,粉碎,得到物料2;
4)将上述步骤1)粉碎后的半柱花、绿段草、首乌藤、湖北海棠加入冷蒸馏水溶液,然后进行超低温冷冻干燥至水分低于7%,得物料3;
5)将物料1、物料2、物料3混合,打碎,加入混合物相同重量的水,放入高速分散乳化机处理,得到高速分散乳化物;
6)加压提取:将步骤5)处理后的乳化物,放入高压罐中,加入混合物相同重量的水,加压然后恢复常压,过滤,得到提取液,并浓缩成浸膏,减压浓缩、干燥,得到提取物;
7)葛根在10~20℃下堆放2-6天,冻干粉碎;加入其5~10重量倍的有机溶剂,进行超声-微波协同提取,过滤得到的滤液低温浓缩得到浓缩液,再进行干燥,将干燥物进行粉碎,得到物料4;
8)将玉竹、黄精切片后进行冷冻干燥、粉碎处理,得到玉竹粉、黄精粉;
9)将竹酢液以超声结合电场处理,并浓缩成浸膏,减压浓缩、干燥,粉碎,过80~90目筛,得到竹酢提取物;
10)将所述步骤6)得到的提取物、所述步骤7)物料4、步骤8)玉竹粉、黄精粉、步骤9)竹酢提取物混合、压片;
完成片剂的制作。
5.根据权利要求4所述的方法,其特征在于:所述方法还包括原料绿段草、首乌藤、湖北海棠在粉碎前进行药力发酵预处理,其处理方法为:将绿段草、首乌藤、湖北海棠冷冻处理,再蒸汽处理、干燥形成药力发酵绿段草、首乌藤、湖北海棠再进行所述步骤1)粉碎处理。
6.根据权利要求4所述的方法,其特征在于:所述干燥温度为50-60℃,干燥至水分含量6%以下。
7.根据权利要求4所述的方法,其特征在于:所述步骤6)加压至3.5~4kg/cm2,并保持10-15min,然后在1-3s内恢复常压。
8.根据权利要求4所述的方法,其特征在于:所述步骤9)超声结合电场处理方法是:先以频率40~60kHz,超声处理5~20min,再用强度5~10kV/cm的电脉冲处理5~10min。
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