CN111700974A - 一种石斛滋阴降糖丸及其制备方法 - Google Patents
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Abstract
本发明公开了一种石斛滋阴降糖丸及其制备方法，其特征在于，包括以下重量份原料组成：霍山石斛3～8份、连翘5～12份、白术8～15份、金银花8～15份、花椒4～10份、葱白4～10份、甘草4～10份、天冬8～15份、百合8～15份、咖啡粉3～8份、盐3～8份。本发明石斛滋阴降糖丸具有滋阴降糖、保肝健脾、补血益气、生津润肺、抗病毒功能。
Description
技术领域
本发明属于保健食品领域，具体涉及一种石斛滋阴降糖丸的制备方法及应用。
背景技术
中医学内容里的中医养生学千年不衰，尤其是在化学技术迅猛发展的今天，西药滥用所产生的人体对细菌病毒的抗药性不但无法控制病情，而且药物残留也严重污染环境，危害着人体健康，所以当今人们都呼唤回归大自然，至此，中医“治未病”技术尤为重要，医药工作者都试图从天然动植物中寻找能增强人体免疫力的调节剂以防治一些罕见和多发性疾病。几千年来，中药(尤其是植物药)在体现中医技术方面突出了它的重要性。中国是中草药的故乡和药性了解及药理使用的发源地，不乏抗病菌、病毒的中草药配方、提高人体的免疫力。
健康是和谐人生的基石，身体是美好生活的本钱。现代社会由于生活节奏快，特别是中老年人群体感受工作和生活的巨大压力，导致精神处于高度紧张之中，很多人都出现了亚健康状态，特别是身体免疫力的下降，给自身及家庭带来一定程度的伤害。
从中医角度分析产生亚健康症状的主要原因；阳精过于旺盛、引起阴精严重亏损、致使身体各器官机能减退、阴阳长期失去平衡、导致气血两亏、使免疫力下降很厉害，反之，滋阴潜阳、益气养血、气血两旺、什么毛病都会消除。西医多采用激素类药物，普遍存在治标不治本现象，停药后易复发。随着人们的生活水平提高，对健康问题越来越重视，从传统中药中发掘毒副作用小的、功能性强的温肾潜阳、强身健体、延缓衰老类药物，已成为研究的热点。
因此研发一种利用霍山石斛等中药材的有效成分，实现调理、治疗、保健三合一效果的保健食品，十分有必要。
发明内容
本发明的目的是根据中医学的基础理论和辨证施治原则，研制出一种既能提高人体机体免疫力，又能促进虚弱机体康复、兼治阴阳失调的慢性疾病的中药配方的保健食品。本发明乃一种采用名贵中草药霍山石斛、白术、连翘、金银花、花椒、葱白、甘草、天冬、百合等进行组合，经特殊工艺加工而成，具有滋阴降糖、保肝健脾、补血益气、生津润肺、抗病毒功能，这些药物组合使各药物功效产生协同作用，从而能够有效提高免疫力，促进机体康复、兼治一些阴阳失调的慢性疾病。处方中以名贵中草药霍山石斛为主，霍山石斛，又称“米斛”，是石斛中的极品，性微寒，味甘、淡，清热生津、滋养肝肺、开胃健脾，益精强阴、生津止渴、补虚赢、除胃中虚火；大补阴虚，对于虚劳失血、咯血、肠风血痔、盗汗夏季热、热性病和结核病后期及恢复期具有很好的滋阴清热、强肝、滋肺、补肾作用，对高热病症、脏腑劳损及病后虚弱有显著的疗效和修复作用。连翘，性苦、凉，归心、肝、胆经。清热，解毒，散结，消肿。治温热，丹毒，斑疹，痈疡肿毒，瘰疬，小便淋闭。白术，性味苦温辛烈，归脾胃经，健脾益气，燥湿利水，止汗，安胎。用于脾虚食少，消化不良，泄泻，水肿，自汗，胎动不安。金银花，正名忍冬花，性甘寒，归肺、胃经，主温病发热，热毒血痢，痈肿疔疮，喉痹及多种感染性疾病，功能清热解毒、消炎退肿，对细菌性痢疾和各种化脓性疾病都有效。花椒，味辛，性温，归脾、胃、肾经。温中散寒，除湿，止痛，杀虫止痒，解鱼腥毒，治积食停饮，心腹冷痛，呕吐，噫呃，咳嗽气逆，风寒湿痹，泄泻，痢疾，疝痛，齿痛，蛔虫病，蛲虫病，阴痒，疮疥。葱白，味辛，性温，归肺、胃经。发汗解表，散寒通阳，主要用于外感风寒，阴寒内盛，格阳于外，脉微，厥逆，腹泻，外敷治疗疮痈疔毒。甘草，味甘、性平，归心、肺、脾、胃经，补脾益气，清热解毒、祛痰止咳，甘草三萜及葡萄糖醛苷都很好地抑制病毒再生。天冬，味甘、苦，性寒，归肺、肾经，养阴润燥，清肺生津，用于肺燥干咳，顿咳痰黏，腰膝酸痛，骨蒸潮热，内热消渴，热病津伤，咽干口渴，肠燥便秘。百合，性味甘，微苦，微寒，归心、肺经。养阴润肺；清心安神。主阴虚久嗽；痰中带血；热病后期；余热未清，或情志不遂所致的虚烦惊悸、失眠多梦、精神恍惚；痈肿；湿疮。
上述名贵诸药与咖啡合用，能有机地配合，共奏清热泻火、凉血解毒、抗菌、消炎、提高机体免疫力，以达到防疫、抗病毒，康复机体之功能。本处方的配伍严谨，没有十八反、十九畏的配伍禁忌，实验证明本处方为安全、毒副作用很小的制剂。咖啡，味甘甜，微苦涩，十分适合消费者的口味。处方中用咖啡粉做药引的原因，主要是利用咖啡含有的咖啡因兴奋人体中枢神经的功效，迅速将各种中药的有效成分引入到人体的各器官，达到迅速治病的效果。
为解决上述技术问题，本发明采用的技术方案是：
一种石斛滋阴降糖丸，包括以下原料组成：
霍山石斛、连翘、白术、金银花、花椒、葱白、甘草、天冬、百合、咖啡粉、盐。
优选的，一种石斛滋阴降糖丸，包括以下重量份原料组成：
霍山石斛3～8份、连翘5～12份、白术8～15份、金银花8～15份、花椒4～10份、葱白4～10份、甘草4～10份、天冬8～15份、百合8～15份、咖啡粉3～8份、盐3～8份。
石斛滋阴降糖丸制备方法，包括以下步骤：
S1将霍山石斛、连翘、白术、金银花、花椒、葱白、甘草、天冬、百合、盐混合均匀，备用；
S2将步骤S1混合均匀的原料倒入铁锅中，加热翻炒5～10分钟至焦黄色，加水煎煮两次，每次1～4小时，合并煎液，过滤，浓缩为稠膏；
S3将稠膏与咖啡粉混匀，干燥后粉碎成颗粒，加入淀粉混匀制成素丸，然后包衣，即得所述石斛滋阴降糖丸。
更优选的，所述一种石斛滋阴降糖丸，还包括重量份原料：茶树菇多糖提取物或改性茶树菇多糖提取物0.5～1份。
研究表明茶树菇多糖具有多种保健作用，如降血糖、抗氧化、抗肿瘤及免疫调节等。茶树菇多糖通过抗氧化作用和增强葡萄糖激酶的活性来有效降低血糖。肾上腺素、甲状腺素和胰高血糖素等都可使血糖升高，并加速肝糖原的分解，而能使血糖下降的只有胰岛素，所以茶树菇多糖的降血糖作用与其保护和刺激胰岛素细胞的分泌活动有关。
所述茶树菇多糖提取物制备方法，包括以下步骤：
称取粉碎的茶树菇粉末5～10g，按液料比1：(30～50)g/mL加入蒸馏水后，用0.1～0.3mol/L的HCl调节pH至5.5，放入40～60℃水浴中预热至温度稳定后，加入0.1～0.2g的酶进行提取2～5h后；90～100℃灭活15～20min，即得到多糖提取液；多糖提取液经离心15～20min，转速3000～5000r/min，取上清液进行浓缩、加入30～50mL、95％乙醇产生沉淀，静置12～15h后，离心沉淀15～20min，转速3000～5000r/min，沉淀物在30～50℃下干燥5～8h，即得所述茶树菇多糖提取物。
所述酶为木瓜蛋白酶、中性蛋白酶、真菌漆酶、果胶酶、葡萄糖淀粉酶、纤维素酶一种或两种以上。
优选的，所述酶由木瓜蛋白酶、中性蛋白酶、纤维素酶按质量比(1～3)：(1～3)：(1～3)混合而成。
茶树菇多糖经乙酰化修饰后，多糖主链和支链的空间结构发生改变，多糖链中的支链上的羟基暴露，提高了茶多糖的水溶性，从而使降血糖活性增强。多糖的乙酰化是一种重要的多糖支链修饰方法。乙酰化多糖的乙酰基能改变多糖分子的定向性和横次序，从而改变多糖的物理性质，甲基磺酸作为催化剂加速乙酰化反应，提高乙酰基取代度，乙酰基的引入使分子的伸展状态发生变化，导致多糖羟基暴露，增加多糖在水中的溶解度，从而改善多糖的生理活性，使多糖得到有效利用。
所述改性茶树菇多糖提取物制备方法，包括以下步骤：
称取茶树菇多糖提取物3～5g加入到20～50mL蒸馏水中搅拌溶解，用2～3mol/L的NaOH调pH＝9.0，在30～50℃下保温4～6h，加入30～50mL乙酸酐以及0.2～0.5mL甲基磺酸，然后用2～3mol/L的NaOH调节pH为8.0，搅拌反应2～3h，转速300～500r/min，反应结束后，用3～5mol/L的HCl调溶液的pH为7.0；浓缩至原体积1/2，再加20～50mL的95％乙醇沉淀，冷却静置10～15h后离心15～20min，转速3000～5000r/min，50～60℃真空干燥5～8h，即得所述改性茶树菇多糖提取物。
优选的，石斛滋阴降糖丸制备方法，包括以下步骤：
S1将霍山石斛、连翘、白术、金银花、花椒、葱白、甘草、天冬、百合、盐、茶树菇多糖提取物或改性茶树菇多糖提取物混合均匀，备用；
S2将步骤S1混合均匀的原料倒入铁锅中，加热翻炒5～10分钟至焦黄色，加水煎煮两次，每次1～4小时，合并煎液，过滤，浓缩为稠膏；
S3将稠膏与咖啡粉混匀，干燥后粉碎成颗粒，加入淀粉混匀制成素丸，然后包衣，即得所述石斛滋阴降糖丸。
所述稠膏相对密度为1.05～1.20。
所述淀粉的用量为稠膏质量的20～30％。
本发明的有益效果
(1)本发明将霍山石斛等中药材与咖啡合用，能有机地配合，共奏清热泻火、凉血解毒、抗菌、消炎、提高机体免疫力，以达到防疫、抗病毒，康复机体之功能。本处方的配伍严谨，没有十八反、十九畏的配伍禁忌，实验证明本处方为安全、毒副作用很小的制剂。
(2)利用咖啡含有的咖啡因兴奋人体中枢神经的功效，迅速将各种中药的有效成分引入到人体的各器官，达到迅速治病的效果。
(3)石斛滋阴降糖丸原材料中还包含茶树菇多糖或改性茶树菇多糖提取物，茶树菇多糖具有多种保健作用，如降血糖、抗氧化、抗肿瘤及免疫调节等。进一步的茶树菇多糖经乙酰化修饰后，多糖主链和支链的空间结构发生改变，多糖链中的支链上的羟基暴露，提高了茶多糖的水溶性，从而使降血糖活性增强。
具体实施方式
试验例、实施例、对比例中各原料来源：
霍山石斛、连翘、白术、金银花、花椒、葱白、甘草、天冬、百合均从中国药材集团公司购买得到，符合中华人民共和国药典2005版标准。
茶树菇：原产地江西广昌县。
咖啡粉：选自雀巢(Nestle)纯黑咖啡醇品咖啡粉。
木瓜蛋白酶：酶活力6-240万u/g，购于南宁东恒华道生物科技有限责任公司。
中性蛋白酶：酶活力5-40万u/g，购于南宁东恒华道生物科技有限责任公司。
纤维素酶：酶活力1万u/g，购于南宁东恒华道生物科技有限责任公司。
甲基磺酸：CAS；75-75-2，纯度99％，购于上海迈瑞尔化学技术有限公司。
乙基磺酸：CAS；594-45-6，纯度99％，购于上海迈瑞尔化学技术有限公司。
实验例1-8使用同种一种石斛滋阴降糖丸。
所述石斛滋阴降糖丸制备方法，包括以下步骤：
S1将5g霍山石斛、8g连翘、10g白术、10g金银花、8g花椒、6g葱白、6g甘草、10g天冬、10g百合、5g精粉碘盐混合均匀，备用；
S2将步骤S1混合均匀的原料倒入铁锅中，加热翻炒10分钟至焦黄色，加水煎煮两次，每次加水500g，每次2小时，合并煎液，过滤，浓缩为稠膏；
S3将稠膏与5g咖啡粉混匀，干燥后粉碎成颗粒，加入淀粉混匀制成素丸，然后包衣，即得所述石斛滋阴降糖丸。
所述稠膏相对密度为1.05。
所述淀粉的用量为稠膏质量的20％。
上述石斛滋阴降糖丸是一剂的量，每天一剂，每剂分成3份、用温水吞服，分早、中、晚饭前半小时以上服用。
实验例1：慢性乙肝患者伴随病毒膜增殖性肾炎，每天服用一剂石斛滋阴降糖丸，配合其它激素药物巩固治疗，观察和对比，服用石斛滋阴降糖丸的病例共20例，一个月为一疗程，2-3个疗程，20例中，显效者(症状消失，尿常规正常)12例，有效者6例，无效者2例，总有效率达90％，随访2年，没任何不良反应，疗效稳定。故可判定石斛滋阴降糖丸对慢性乙肝患者伴随的病毒膜增殖性肾炎有很好的疗效。
实验例2：气虚型肺功能低下，每天服用本石斛滋阴降糖丸一剂，2个月为一疗程，用药期间停用他法。嘱咐患者禁烟，严禁使用其它各药，作息有度，适当运动，清除心理因素对本病的影响。结果，用石斛滋阴降糖丸对气虚型肺功能低下患者86例，其中疗效显著者53例，好转者22例，无效者11例，总有效率达到87％，有效病例中，服用时间最短者28天，最长者56天，用药治疗气虚型肺功能低下，具有服用方便，口感好，毒副作用很小，没任何不良反应，患者乐于接受。
实验例3：慢性糖尿病伴随病毒性肺气肿和积水，每天服用本石斛滋阴降糖丸一剂。2个月为一疗程，配合正常减半量的胰岛素给药、严格控制饮食。结果：本石斛滋阴降糖丸对慢性糖尿病伴随病毒性肺气肿和积水患者26例，用1个疗程后，其中疗效显著者23例，血糖值平均由12.27mmol/L(221mg)降低至10.43mmol/L(188mg)，好转者2例，无效者1例，总有效率达到96％。与那些只采用正常量的胰岛素给药、没用石斛滋阴降糖丸的糖尿病患者的对照组相比，尤其是消肿去水的效果，差异非常显著。
实验例4：肺结核，每天服用本石斛滋阴降糖丸一剂，2个月为一疗程，结果，石斛滋阴降糖丸对肺结核患者42例，用1个疗程后，其中疗效显著者32例，占76％，好转者6例，无效者4例，总有效率达到90％。大部分患者在用药方后半个月，发热、盗汗、咳嗽、气喘、咳血、食欲缺乏等症状明显好转，至逐渐康复。疗效十分显著。
实验例5：预防非典(SARS)病毒，每天服用本石斛滋阴降糖丸一剂，一个月为一疗程，结果，石斛滋阴降糖丸对200例15周岁至35周岁易感人群预防使用，1个疗程后，没有一例被感染非典病毒。预防成功率达100％。
实验例6：治疗风寒感冒，每天服用本石斛滋阴降糖丸一剂。结果，石斛滋阴降糖丸对风寒感冒者12例，用1个疗程后，全部治愈，总有效率达到100％。大部分患者在用该药方后3天，发热、咳嗽、气喘、呕吐等症状明显好转，至一周后逐渐康复。疗效十分显著。
为便于对本发明石斛滋阴降糖丸的理解
对小鼠增强免疫力和抗病毒能力试验资料，进一步阐述本发明的技术特点：
实验例7：石斛滋阴降糖丸对小鼠增强免疫力的影响
试验设4个组，每组10只，体质量为18-22g，分别为阴性对照组、高低剂量各1组及模型组。以氢化可的松进行肾阳虚证造模，除阴性对照组外，其余小鼠每日肌注氢化可的松25mg/kg，连续注射12天，以畏寒喜暖、四肢发凉、小便清稀、消瘦为造模是否成功指标。造模成功后开始连续口服给药30天，每天以标准体重小鼠剂量＝205.5mg/kg口服给药，高、低剂量组分别为预防期和治疗期石斛滋阴降糖丸。模型组和阴性对照组每次给予同等质量的蒸馏水口服。
表1受试药物对小鼠睾丸重量、睾丸酮及促黄体生产激素的影响
注：与模型组相比，*P<0.01。
由表1可知，模型组小鼠睾丸重量、睾丸酮及促黄体生产激素与阴性对照组相比明显下降，而睾丸酮和促黄体生产激素与小鼠的生殖机能密切相关。石斛滋阴降糖丸能使氢化可的松产生的影响得到显著的缓解。统计学分析表明，阴性对照组、高低剂量组与模型组相比有显著性差异(P<0.01)，而阴性对照组和高低剂量组之间无显著性变化(P>0.05)。
试验例8：受试物对小鼠负重游泳试验、运动后血清尿素和肝糖原测定结果
试验设4个组，每组10只，体质量为18-22g，分别为阴性对照组、高低剂量各1组及不用药组(正常组)。连续口服给药30天，每天以标准体重小鼠剂量＝205.5mg/kg口服给药，高、低剂量组分别为治疗期和预防期石斛滋阴降糖丸。不用药组口服同等剂量的牛奶水。阴性对照组每次给予同等质量的蒸馏水。
负重游泳实验在末次给药1小时后，在小鼠尾根经细线拴住1g的铅块，于游泳箱中游泳，水深为30cm，温度为25士1°，小鼠自开始游泳至死亡时间为负重游泳时间。
血清尿素实验在末次给药后1小时内，在30℃水温水中游泳100min，取出游泳箱休息1小时后摘眼球取血，采用酶法试剂盒测定。
肝糖原实验在末次给药1小时后，处死小鼠，取肝脏，精密称取50mg，采用蒽酮法测定肝糖原值。
表2受试药物对小鼠负重游泳、运动后血清尿素和肝糖原的影响
注：与无药组和阴性对照组相比，*P<0.01。
由表2可知，灌胃石斛滋阴降糖丸组小鼠的负重游泳时间与阴性对照和无药组相比，有显著性差异(P<0.01)。运动后血清尿素值显示，石斛滋阴降糖丸组与阴性对照和无药组明显降低(P<0.01)。但在肝糖原储备中，各组没有显著性变化(P>0.05)。说明本发明的石斛滋阴降糖丸具有增强体质，提高免疫力，抗病毒的功效。
实施例1
一种石斛滋阴降糖丸制备方法，包括以下步骤：
S1将5g霍山石斛、8g连翘、10g白术、10g金银花、8g花椒、6g葱白、6g甘草、10g天冬、10g百合、5g精粉碘盐混合均匀，备用；
S2将步骤S1混合均匀的原料倒入铁锅中，加热翻炒10分钟至焦黄色，加水煎煮两次，每次加水500g，每次2小时，合并煎液，过滤，浓缩为稠膏；
S3将稠膏与5g咖啡粉混匀，干燥后粉碎成颗粒，加入淀粉混匀制成素丸，然后包衣，即得所述石斛滋阴降糖丸。
所述稠膏相对密度为1.05。
所述淀粉的用量为稠膏质量的20％。
对比例1
一种石斛滋阴降糖丸制备方法，包括以下步骤：
S1将5g霍山石斛、8g连翘、10g白术、10g金银花、8g花椒、6g葱白、6g甘草、10g天冬、10g百合、5g精粉碘盐混合均匀，备用；
S2将步骤S1混合均匀的原料倒入铁锅中，加热翻炒10分钟至焦黄色，加水煎煮两次，每次加水500g，每次2小时，合并煎液，过滤，浓缩为稠膏；
S3将稠膏干燥后粉碎成颗粒，加入淀粉混匀制成素丸，然后包衣，即得所述石斛滋阴降糖丸。
所述稠膏相对密度为1.05。
所述淀粉的用量为稠膏质量的20％。
实施例2
一种石斛滋阴降糖丸制备方法，包括以下步骤：
S1将5g霍山石斛、8g连翘、10g白术、10g金银花、8g花椒、6g葱白、6g甘草、10g天冬、10g百合、0.5g茶树菇多糖提取物、5g精粉碘盐混合均匀，备用；
S2将步骤S1混合均匀的原料倒入铁锅中，加热翻炒10分钟至焦黄色，加水煎煮两次，每次加水500g，每次2小时，合并煎液，过滤，浓缩为稠膏；
S3将稠膏与5g咖啡粉混匀，干燥后粉碎成颗粒，加入淀粉混匀制成素丸，然后包衣，即得所述石斛滋阴降糖丸。
所述稠膏相对密度为1.05。
所述淀粉的用量为稠膏质量的20％。
所述茶树菇多糖提取物制备方法，包括以下步骤：
称取粉碎的茶树菇粉末8.0g，按液料比1：40g/mL加入蒸馏水后，用0.1mol/L的HCl调节pH至5.5，放入50℃水浴中预热至温度稳定后，加入0.16g的酶进行提取3.5h后；90℃灭活15min，即得到多糖提取液；多糖提取液经离心15min，转速3000r/min，取上清液进行浓缩、加入30mL、95％乙醇产生沉淀，静置12h后，离心沉淀15min，转速3000r/min，沉淀物在50℃下干燥5h，即得所述茶树菇多糖提取物。
所述酶由木瓜蛋白酶、中性蛋白酶、纤维素酶按质量比1:1:1混合而成。
对比例2
与实施例2基本相同，唯一区别仅仅在于：
所述茶树菇多糖提取物制备方法，包括以下步骤：
称取粉碎的茶树菇粉末8.0g，按液料比1：40g/mL加入蒸馏水后，用0.1mol/L的HCl调节pH至5.5，放入50℃水浴中预热至温度稳定后，进行提取3.5h后；90℃灭活15min，即得到多糖提取液；多糖提取液经离心15min，转速3000r/min，取上清液进行浓缩至原体积1/2，加入30mL的95％乙醇产生沉淀，静置12h后，离心沉淀，转速3000r/min，沉淀物在50℃下干燥5h，即得所述茶树菇多糖提取物。
实施例3
一种石斛滋阴降糖丸制备方法，包括以下步骤：
S1将5g霍山石斛、8g连翘、10g白术、10g金银花、8g花椒、6g葱白、6g甘草、10g天冬、10g百合、0.5g改性茶树菇多糖提取物、5g精粉碘盐混合均匀，备用；
S2将步骤S1混合均匀的原料倒入铁锅中，加热翻炒10分钟至焦黄色，加水煎煮两次，每次加水500g，每次2小时，合并煎液，过滤，浓缩为稠膏；
S3将稠膏与5g咖啡粉混匀，干燥后粉碎成颗粒，加入淀粉混匀制成素丸，然后包衣，即得所述石斛滋阴降糖丸。
所述稠膏相对密度为1.05。
所述淀粉的用量为稠膏质量的20％。
所述改性茶树菇多糖提取物制备方法，包括以下步骤：
称取茶树菇多糖提取物3g加入到20mL蒸馏水中搅拌溶解，用2mol/L的NaOH调pH＝9.0，在30℃下保温4h，加入30mL乙酸酐和0.3mL甲基磺酸，然后用2mol/L的NaOH调节pH为8.0，搅拌反应2h，转速300r/min，反应结束后，用5mol/L的HCl调溶液的pH为7.0；浓缩至原体积1/2，再加20mL的95％乙醇沉淀，冷却静置10h后离心15min，转速3000r/min，50℃真空干燥5h，即得所述改性茶树菇多糖提取物。所述茶树菇多糖提取物的制备方法同实施例2中的记载一致，此处不再赘述。
对比例3
与实施例3基本相同，唯一区别仅仅在于：
所述改性茶树菇多糖提取物制备方法，包括以下步骤：
称取茶树菇多糖提取物3g加入到20mL蒸馏水中搅拌溶解，用2mol/L的NaOH调pH＝9.0，在30℃下保温4h，加入30mL乙酸酐，然后用2mol/L的NaOH调节pH为8.0，搅拌反应2h，转速300r/min，反应结束后，用5mol/L的HCl调溶液的pH为7.0；浓缩至原体积1/2，再加20mL的95％乙醇沉淀，冷却静置10h后离心15min，转速3000r/min，50℃真空干燥5h，即得所述改性茶树菇多糖提取物。所述茶树菇多糖提取物的制备方法同实施例2中的记载一致，此处不再赘述。
对比例4
与实施例3基本相同，唯一区别仅仅在于：
所述改性茶树菇多糖提取物制备方法，包括以下步骤：
称取茶树菇多糖提取物3g加入到20mL蒸馏水中搅拌溶解，用2mol/L的NaOH调pH＝9.0，在30℃下保温4h，加入30mL乙酸酐和0.3mL乙基磺酸，然后用2mol/L的NaOH调节pH为8.0，搅拌反应2h，转速300r/min，反应结束后，用5mol/L的HCl调溶液的pH为7.0；浓缩至原体积1/2，再加20mL的95％乙醇沉淀，冷却静置10h后离心15min，转速3000r/min，50℃真空干燥5h，即得所述改性茶树菇多糖提取物。所述茶树菇多糖提取物的制备方法同实施例2中的记载一致，此处不再赘述。
测试例1
降血糖功效测定：
1.实验材料
SD健康小鼠，体重150±5g，购于中国食品药品检定研究院；
易准GA-3血糖检测试纸条、易准GA-3型血糖仪；购于三诺生物传感股份有限公司。
盐酸二甲双胍肠溶片；购于河北天成药业有限公司。
四氧嘧啶；购于sigma-aldrich西格玛奥德里奇(上海)贸易有限公司。
2.实验动物分组建模
为了让小鼠适应环境，需喂养一周。一周后所有小鼠24h内禁食不禁水，随机选取12只作为正常对照组，在腹腔的位置注射100mg/kg生理盐水，按100mg/kg的剂量在216只小鼠的腹腔部位注射四氧嘧啶溶液，每隔1d注射一次，共注射三次。之后的3d正常饲喂，使用血糖仪进行尾部采血时提前禁食12h。统计血糖值，选取血糖值在10～25mmol/L范围内的小鼠，将其随机分成18组，每组12只，苦味酸进行标记，228只小鼠分为18组。
小鼠空腹血糖值测定
实施例1～3和对比例1～3组的实验小鼠每天以220mg/kg(高剂量)、165mg/kg(中剂量)、110mg/kg(低剂量)的剂量口服给药石斛滋阴降糖丸，阴性对照组和正常组的实验小鼠灌胃给药等量的生理盐水，阳性对照组的实验小鼠每天按200mg/kg灌胃给药盐酸二甲双胍。每隔一周检测一次血糖，记录整个实验周期4周的血糖值，记录数值。
血糖下降百分率＝[(灌胃前血糖值-灌胃后血糖值)/灌胃前血糖值]×100％
表3石斛滋阴降糖丸对各组小鼠空腹血糖的影响
注：与阴性对照组相比*P＜0.05，**P＜0.01；
阳性对照组服用盐酸二甲双胍后患病小鼠血糖值每周持续下降，血糖下降率46.3％，有效的控制了血糖值。四周后进行统计学分析，与阴性对照组相比，高剂量组血糖水平差异极显著(P<0.01)，中剂量组和低剂量组血糖水平差异显著(P<0.05)。在实验周期结束后，实施例1～3及对比例1～4组的高、中、低剂量组血糖下降率分别为22.9～48.3％、20.6～43.2％、20.2～40.0％均高于阴性对照组，说明本发明石斛滋阴降糖丸可以有效降低Ⅱ型糖尿病小鼠的血糖值。
以上详细描述了本发明的较佳具体实施例。应当理解，本领域的普通技术人员无需创造性劳动就可以根据本发明的构思作出诸多修改和变化。因此，凡本技术领域中技术人员依本发明的构思在现有技术的基础上通过逻辑分析、推理或者有限的实验可以得到的技术方案，皆应在由权利要求书所确定的保护范围内。
Claims (5)
1.一种石斛滋阴降糖丸，其特征在于，包括以下原料组成：
霍山石斛、连翘、白术、金银花、花椒、葱白、甘草、天冬、百合、咖啡粉、盐。
2.一种石斛滋阴降糖丸，其特征在于，包括以下重量份原料组成：
霍山石斛3～8份、连翘5～12份、白术8～15份、金银花8～15份、花椒4～10份、葱白4～10份、甘草4～10份、天冬8～15份、百合8～15份、咖啡粉3～8份、盐3～8份。
3.如权利要求2所述的石斛滋阴降糖丸，其特征在于，所述石斛滋阴降糖丸制备方法，包括以下步骤：
S1将霍山石斛、连翘、白术、金银花、花椒、葱白、甘草、天冬、百合、盐混合均匀，备用；
S2将步骤S1混合均匀的原料倒入铁锅中，加热翻炒5～10分钟至焦黄色，加水煎煮两次，每次1～4小时，合并煎液，过滤，浓缩为稠膏；
S3将稠膏与咖啡粉混匀，干燥后粉碎成颗粒，加入淀粉混匀制成素丸，然后包衣，即得所述石斛滋阴降糖丸。
4.如权利要求3所述的石斛滋阴降糖丸，其特征在于，所述稠膏相对密度为1.05～1.20。
5.如权利要求3所述的石斛滋阴降糖丸，其特征在于，所述淀粉的用量为稠膏质量的20～30％。
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