CN105998117B - 冬虫夏草复合人参壳寡糖胶囊及其制备方法 - Google Patents
冬虫夏草复合人参壳寡糖胶囊及其制备方法 Download PDFInfo
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/716—Glucans
- A61K31/722—Chitin, chitosan
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/06—Fungi, e.g. yeasts
- A61K36/062—Ascomycota
- A61K36/066—Clavicipitaceae
- A61K36/068—Cordyceps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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Abstract
本发明属于中医领域,具体涉及一种冬虫夏草复合人参壳寡糖胶囊及其制备方法,具体的为,所述冬虫夏草复合人参寡糖胶囊其包括以下组分:30‑90g的壳寡糖、5‑15g的冬虫夏草、2‑10g的人参、5‑15g的植物淀粉,将以上物质经过粉碎、混合均匀后分装至胶囊中。本发明制备的冬虫夏草复合人参壳寡糖胶囊,可应用于预防高血糖、抗肿瘤、增强机体免疫力的中药类保健品养生调理,长期服用,效果显著。
Description
技术领域
本发明属于中医领域,具体涉及一种盐酸莫西沙星透明质酸钠缓释纳米凝胶及其制备方法。
背景技术
我国是糖尿病、肿瘤发病大国,糖尿病肾病是糖尿病患者最重要的微血管并发症之一,是终末期肾衰竭的主要病因,也是糖尿病致死、致残的主要原因。糖尿病肾病早期以微量白蛋白尿为特征,病情逐步进展出现大量白蛋白尿以及血肌酐水平升高,如果得不到及时诊治,糖尿病肾病展至终末期肾病,将只能依赖透析治疗甚至肾移植,由此给患者带来巨大心理负担和经济负担。尿病肾病为慢性进展性疾病,在糖尿病肾病的早期阶段,通过严格控制血压和血糖,可防止和延缓其进展,但是糖尿病肾病发病隐匿,早期无典型症状及体征,容易被患者忽略导致延误病情,有很大一部分患者发现肾脏问题时已经进入肾功能减退期。
世界癌症报告估计,2012年中国癌症发病人数为306.5万,约占全球发病的五分之一;癌症死亡人数为220.5万,约占全球癌症死亡人数的四分之一。伴随着老龄化加剧、生态环境遭受破坏、不健康生活方式及食品安全问题凸现,我国肿瘤发病率多年持续上升,已成为一个必须高度重视的公共卫生问题,乃至社会问题。肿瘤防治专家认为,癌症死亡率居高不下,一个重要原因在于我国癌症发现较多处于中晚期。中国工程院院士、中国抗癌协会副理事长程书钧说,美国近些年来癌症的发病率有所下降,其5年生存率大约在60%至70%,而我国肿瘤患者5年生存率大约在30%左右。世界卫生组织(WHO)认为40%以上的癌症是可以 预防的。恶性肿瘤的发生是机体与外界环境因素长期相互作用的结果,因此肿瘤预防应该贯穿于日常生活中并长期坚持。肿瘤预防的目的是降低恶性肿瘤的发病率和死亡率,从而减少恶性肿瘤对国民健康、家庭的危害以及对国家医疗资源的消耗,减轻恶性肿瘤导致的家庭和社会的经济负担。
壳寡糖是带正电荷的膳食纤维,会在癌细胞表面形成密集的包裹体,起到以下作用:
(1)杜绝癌细胞的养分供应,使其分裂减少,制约癌细胞的分裂;
(2)减少癌细胞代谢产生的酸性废弃物,从另一方面改善癌细胞周围的酸性环境,创造一个癌细胞很难生存和分裂转移的环境条件;
(3)减少癌细胞向周围释放的各种酶(溶脂酶、水解酶、蛋白酶等),减少因各种酶对周围健康细胞的催化。
另外,壳寡糖能使体液PH值碱性化,能激活免疫细胞,增强攻击癌细胞的能力;癌细胞周围一般呈酸性,壳寡糖能中和肿瘤周围的酸性物质,加速代谢体内自由基等有毒物质,起到配合化疗、改善病症、减轻痛苦、延长生命的作用。
冬虫夏草是富含多糖、氨基酸、脂肪酸、甘露醇及多种微量元素的中药材。研究显示,人工发酵冬虫夏草可以降低糖尿病肾病患者尿白蛋白排泄率水平,抑制糖尿病肾病的发生发展,具有明显的肾脏保护作用[1]。
冬虫夏草是我国传统名贵中药材,为真菌界子囊菌纲肉座菌目麦角菌科冬虫夏草属的冬虫夏草菌寄生在蝙蝠娥科昆虫幼虫上的子座及幼虫尸体的复合体,主要分布在中国的青藏高原西南部地区,因其具有独特的药用价值而被誉为“百药之王”。冬虫夏草富含多糖、氨基酸、脂肪酸、甘露醇及多种微量元素,其药效成分主要有虫草素、虫草多糖、虫草酸、腺苷、麦角甾醇、脂肪酸、 氨基酸等,传统医学认为其味甘、性温,入肺经、肾经,有补肺益肾、益虚损、扶精气等功效。现代医学研究发现,冬虫夏草具有调节免疫、抗氧化、抗纤维化、抗肿瘤、抗细胞凋亡等多种药理作用,对呼吸系统、肝脏、肾脏、心血管系统及神经系统均有很好的保健作用。由于冬虫夏草生长条件苛刻,对宿主要求具有特异性,产量很低,加上被长期过量采挖,野生冬虫夏草资源已濒临灭绝。近年来人工培养出冬虫夏草菌丝,经试验证明与天然虫草有相似的化学成分和药理作用,从而解决了数量稀少和价格昂贵的问题。
参考文献
[1]贺小华,葛振远.百令胶囊防治糖尿病肾病疗效观察的Meta分析[J].临床荟萃,2012,27(13):1164—1166.
发明内容
本发明主要提供了冬虫夏草复合人参壳寡糖胶囊及其制备方法,可应用于预防高血糖、抗肿瘤、增强机体免疫力的中药类保健品养生调理,长期服用,效果显著。
其技术方案如下:一种冬虫夏草复合人参壳寡糖胶囊及其制备方法,其包括以下组分:所述冬虫夏草复合人参寡糖胶囊其包括以下组分:30-90g的壳寡糖、5-15g的冬虫夏草、2-10g的人参、5-15g的植物淀粉,将以上物质经过粉碎、混合均匀后分装至胶囊中。。
优选的,所述冬虫夏草复合人参壳寡糖胶囊,其包括以下组分:60g的壳寡糖、10g的冬虫夏草、5g的人参、10g的植物淀粉。
一种冬虫夏草复合人参壳寡糖胶囊及其制备方法,包括以下步骤:
(1)称取配方量的壳寡糖、植物淀粉粉末置于搅拌器内,将配方量的冬虫夏草、人参粉碎后加入搅拌器;
(2)称取配方量的辅料、配料加入搅拌器;
(3)将步骤(2)中的混合物充分搅拌支均匀;
(4)将混匀的物质进行胶囊分装。。
采用上述冬虫夏草复合人参壳寡糖胶囊及其制备方法,本发明具有以下优点:
本发明的冬虫夏草复合人参壳寡糖胶囊,其所含人生不仅具有保健作用,壳寡糖长期服用可抗菌抗病毒,并且可显著抑制肿瘤的发生发展,冬虫夏草可调理机体内分泌,有效减轻糖尿病及其带来的并发症,该胶囊食用方便、卫生、安全。
具体实施方式
1.胶囊配方
其包括以下组分:30-90g的壳寡糖、5-15g的冬虫夏草、2-10g的人参、5-15g的植物淀粉。
2.胶囊制备方法
包括以下步骤:
(1)称取配方量的壳寡糖、植物淀粉粉末置于搅拌器内,将配方量的冬虫夏草、人参粉碎后加入搅拌器;
(2)称取1~2g辅料、1~2g配料加入搅拌器;
(3)将步骤(2)中的混合物充分搅拌支均匀;
(4)将混匀的物质进行胶囊分装。
一、具体实施例
实施例1
1.胶囊配方
其包括以下组分:30g的壳寡糖、5g的冬虫夏草、2g的人参、5g的植物淀粉。
2.胶囊制备方法
包括以下步骤:
(1)称取配方量的壳寡糖、植物淀粉粉末置于搅拌器内,将配方量的冬虫夏草、人参粉碎后加入搅拌器;
(2)称取配方量的1~2g辅料、1~2g配料加入搅拌器;
(3)将步骤(2)中的混合物充分搅拌支均匀;
(4)将混匀的物质进行胶囊分装。
实施例2
1.胶囊配方
其包括以下组分:60g的壳寡糖、10g的冬虫夏草、5g的人参、10g的植物淀粉。
2.胶囊制备方法
包括以下步骤:
(1)称取配方量的壳寡糖、植物淀粉粉末置于搅拌器内,将配方量的冬虫夏草、人参粉碎后加入搅拌器;
(2)称取配方量的辅料、配料加入搅拌器;
(3)将步骤(2)中的混合物充分搅拌支均匀;
(4)将混匀的物质进行胶囊分装。
实施例3
1.胶囊配方
其包括以下组分:90g的壳寡糖、15g的冬虫夏草、10g的人参、15g的植物淀粉。
2.胶囊制备方法
包括以下步骤:
(1)称取配方量的壳寡糖、植物淀粉粉末置于搅拌器内,将配方量的冬虫夏草、人参粉碎后加入搅拌器;
(2)称取配方量的辅料、配料加入搅拌器;
(3)将步骤(2)中的混合物充分搅拌支均匀;
(4)将混匀的物质进行胶囊分装。
二、内分泌调理试验
1.患者入组
选择2014年10月~2015年10月第二军医大学长海医院就诊的糖尿病肾病患者272例,随机分为8组,8组分别如下:
1)对照组:34例,男性17例,女性17例,年龄40~75岁,平均(58.7±6.9)岁,体质量指数(body mass index,BMI)19.9~30.7,平均24.04±3.55,病程5~25年,平均(12.9±4.0)年;
2)治疗组:34例,男性18例,女性16例,年龄41~75岁,平均(54.6±6.6)岁,BMI19.8~29.9;平均23.47±3.04,病程4~24年,平均(13.0±4.1)年;
3)冬虫夏草治疗组:34例,男性16例,女性18例,年龄42~76岁,平均(58.3±6.5)岁,体质量指数(body mass index,BMI)19.7~30.3,平均24.04±3.55,病程5~26年,平均(14.7±4.3)年;
4)人参治疗组:34例,男性15例,女性19例,年龄37~71岁,平均(54.5±6.5)岁,体质量指数(body mass index,BMI)18.7~30.0,平均23.44±4.13,病程4~23年,平均(13.5±4.0)年;
5)壳寡糖治疗组:34例,男性14例,女性20例,年龄40~75岁,平均 (58.7±6.9)岁,体质量指数(body mass index,BMI)21.1~33.9,平均24.04±3.55,病程5~25年,平均(13.3±3.9)年。
6)冬虫夏草联合壳寡糖组:34例,男性15例,女性19例,年龄38~76岁,平均(57.0±7.3)岁,体质量指数(body mass index,BMI)21.7~35.3,平均28.50±3.81,病程6~30年,平均(18.0±3.9)年。
7)冬虫夏草联合人参组:34例,男性17例,女性17例,年龄35~70岁,平均(52.5±6.8)岁,体质量指数(body mass index,BMI)24.6~35.3,平均29.95±4.62,病程6~27年,平均(16.5±5.2)年。
8)壳寡糖联合人参组:34例,男性20例,女性14例,年龄33~75岁,平均(54.0±6.9)岁,体质量指数(body mass index,BMI)21.1~33.9,平均24.04±3.55,病程5~27年,平均(16.0±4.4)年。
八组性别、年龄、BMI、病程差异均无统计学意义(P>0.05),具有可比性。
2.诊断标准
糖尿病诊断标准依据1999年世界卫生组织糖尿病诊断标准:典型的糖尿病症状加任意时间静脉血浆葡萄糖≥11.1mmol/L,或空腹血糖(fasting plasma glucose,FPG)≥7.0mmol/L,或75g葡萄糖负荷后2h血糖(postprandial two hour plasma glucose,2hPG)≥11.1mmol/L。早期糖尿病肾病持续性微量白蛋白尿期诊断依据“中国2型糖尿病防治指南(2013年版)”诊断标准:尿微量白蛋白肌酐比值(urinary albumin to creatinine ratio,ACR)男性2.5~30.0mg/mmol,女性3.5~30.0mg/mmol。需排除原发性肾脏病史、泌尿系结石、感染、糖尿病酮症、心力衰竭、脑血管病及近期应用肾毒性药物史等可能影响检测结果的情况。
3.治疗方法
八组均给予糖尿病教育、饮食和运动指导、优质蛋白饮食、积极控制血糖、降压、调脂、改善微循环等常规治疗,治疗组在此基础上加用冬虫夏草复合人参壳寡糖胶囊5粒,3次/d;冬虫夏草治疗组在此基础上服用冬虫夏草胶囊5粒,3次/d;人参治疗组在此基础上服用人参胶囊5粒,3次/d;壳寡糖治疗组在此基础上服用壳寡糖囊5粒,3次/d;12周后观察治疗效果。
4.观察指标
糖化血红蛋白(Hemoglobin A1C,HbAl c)以及尿ACR应用Siemens DCA Vantage糖化血红蛋白/尿微量白蛋白分析仪测定,FPG、2hPG、肾功能等应用美国Beckman X20全自动生化分析仪测定。
5.统计学方法
应用SPSS l9.0统计软件进行数据处理,对所有资料进行正态性检验及方差齐性检验。计量资料以X±s表示,组间比较采用成组设计的方差分析进行统计学检验;计数资料以百分率表示,组间比较采取卡方检验,其中P<0.05为该差异有统计学意义。
6.结果(见表1)
治疗后八组FPG、2hPG、HbA,C差异均无统计学意义(P>0.05),治疗后治疗组(冬虫夏草复合人参壳寡糖)中患者尿ACR低于对照组(P<0.05),单独使用冬虫夏草、人参、壳寡糖治疗及冬虫夏草联合壳寡糖、冬虫夏草联合人参、壳寡糖联合人参两两组合治疗亦并不能显著降低患者尿ACR值,表明冬虫夏草、人参、壳寡糖三者可能在调理糖尿病患者内分泌上存在协同作用。
表1八组治疗前后FPG、2hPG、HbAl c、尿ACR比较Table 1Change of FPG,2hPG,HbAl e and urine ACR before and after treatment in eight groups
*P<0.05,冬虫夏草复合人参壳寡糖治疗与其他七组间比较(方差分析)。
Claims (3)
1.一种冬虫夏草复合人参壳寡糖胶囊,其由30-90重量份的壳寡糖、5-15重量份的冬虫夏草、2-10重量份的人参、5-15份重量份的植物淀粉、1-2重量份辅料和1-3重量份配料组成,其中辅料为胶质类衍生物、糊精类衍生物、糖酯类衍生物,配料为BHA抗氧化剂。
2.根据权利要求1所述的冬虫夏草复合人参壳寡糖胶囊,其特征在于:所述冬虫夏草为脱水干燥安全级,壳寡糖、人参为食品级。
3.根据权利要求1所述的冬虫夏草复合人参壳寡糖胶囊,其特征在于:其包括以下步骤:
(1)称取配方量的壳寡糖、植物淀粉粉末置于搅拌器内,将配方量的冬虫夏草、人参粉碎后加入搅拌器;
(2)称取配方量的辅料、配料加入搅拌器;
(3)将步骤(2)中的混合物充分搅拌支均匀;
(4)将混匀的物质进行胶囊分装。
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