CN107137522A - 辅助降血糖保健食品 - Google Patents
辅助降血糖保健食品 Download PDFInfo
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- CN107137522A CN107137522A CN201710435206.0A CN201710435206A CN107137522A CN 107137522 A CN107137522 A CN 107137522A CN 201710435206 A CN201710435206 A CN 201710435206A CN 107137522 A CN107137522 A CN 107137522A
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
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Abstract
本发明涉及一种辅助降血糖保健食品。其有效成分由以下重量份数的原料制成:枸杞子220‑250份,茯苓170‑200份,山楂130‑160份,桑椹130‑160份,栀子130‑160份,藿香100‑130份。功能:益气养阴,清热利湿,具有辅助调节血糖之功效。经临床试验,大部分食用者都认为是一款比较好的辅助降血糖保健产品。性能良好,效果突出,食用后血糖平稳。
Description
技术领域
本发明涉及一种辅助降血糖保健食品。商品名称:佰生堂牌佰生堂胶囊。
背景技术
在现有技术中,糖尿病是一组以高血糖为特征的代谢性疾病。高血糖则是由于胰岛素分泌缺陷或其生物作用受损,或两者兼有引起。糖尿病时长期存在的高血糖,导致各种组织,特别是眼、肾、心脏、血管、神经的慢性损害、功能障碍。降糖食品组方种类繁多,疗效各异。
发明内容
本发明的目的是针对上述不足而提供一种降糖疗效确切的辅助降血糖保健食品。
本发明的技术解决方案是:辅助降血糖保健食品,其特征在于其有效成分由以下重量份数的原料制成:枸杞子220-250份,茯苓170-200份,山楂130-160份,桑椹130-160份,栀子130-160份,藿香100-130份。
辅助降血糖保健食品,其特征在于由以下重量份数的原料制成胶囊:枸杞子250份,茯苓170份,山楂150份,桑椹130份,栀子150份,藿 香104份。
辅助降血糖保健食品,其特征在于由以下重量份数的原料制成胶囊:枸杞子220份,茯苓200份,山楂130份,桑椹150份,栀子130份,藿 香124份。
辅助降血糖保健食品,其特征在于由以下重量份数的原料制成胶囊:枸杞子233份,茯苓187份,山楂140份,桑椹140份,栀子140份,藿 香114份。
药物剂型不限于此,按上述各药用原料与制药上常用的药用载体,如赋形剂或辅料可以混合制成片剂、胶囊剂(软胶囊剂)、颗粒剂、散剂、丸剂、液体制剂或其它常规制剂。
枸杞子:其性味甘、平,归脾、肾经, 具有养肝补血,益精明目之作用。
茯苓:有利水渗湿、宁心安神、散发脂肪热量,降低血糖等作用。
山楂其主要成分:酒石酸、柠檬酸、山楂酸、黄酮类,有消食健脾行气散瘀功效。
桑葚:《唐本草》记:“单食,主消渴”。
栀子:其主要成分黄酮类栀子素有利胆降压作用;
藿香:《药品化义》记:“藿香,其气芳香,善行胃气,用之助胃而进食,有醒脾开胃之功”。
综上分析,本发明以枸杞子为君,茯苓、山楂为臣,君臣相须为用。佐以桑葚、栀子、藿香。创制了以益气养阴兼以清热活血以达到调节血糖之功效。
产品有科学的标志性中药成分即粗多糖和总黄酮,高血糖人群食用后明显改善了病人多食、多饮、口渴、多尿、疲乏无力、腰膝酸软等病症,
总之,佰生堂牌佰生堂胶囊有显著的辅助降血糖功效,是祖国医学又一个发展创举,佰生堂牌佰生堂胶囊将会给祖国中医中药在治疗糖尿病方面开创新的历史篇章。
功能:益气养阴,清热利湿,具有辅助调节血糖之功效。
用法用量:0.36g/粒,每日三次,每次6粒,一个月即可见效,可以长期服用。
制备方法:
1、选材和预处理:选材、水洗,60℃烘干,时间8h。
2、提取处理:按配方比例准确称取各味药材,藿香、3/5茯苓粉碎成细粉,过100目筛,混合均匀,备用。取枸杞子、2/5茯苓、山楂、桑椹、栀子加水10倍,煎煮2h,过滤滤液待用;滤渣加水8倍,煎煮1.5h,得滤液,弃滤渣,合并两次滤液,减压浓缩至相对密度1:1.06~1.08,温度65℃,得流浸膏;拌入藿香、茯苓细粉,真空干燥,粉碎,过100目筛,得粉末备用。
3、灌装:在无菌条件下装0号胶囊,每粒胶囊装0.36克粉末,用钴60 6KGY辐照消毒。装瓶:每瓶70粒,铝塑封口。
本发明的优点是: 1、以祖国医学对消渴有两虚的认识为基础,以中药枸杞子、茯苓、山楂、桑葚、栀子、藿香为原料,通过现代高科技技术炮制而成。没有西药,对糖尿病病人有根本调节机体恢复气阴两虚达到降血糖又没有任何副作用。2、经临床试验,大部分食用者都认为是一款比较好的辅助降血糖保健产品。性能良好,效果突出,食用后血糖平稳。据统计(见实验例1),食用该产品一个月后血糖平均下降均超过10%,说明该产品辅助降血糖功效良好;食用者体检,血红蛋白、红细胞、白细胞、血清总蛋白、白蛋白、谷丙转氨酶、谷草转氨酶、肌酐、尿素及尿常规各项等检查指标均在正常范围,说明食用该产品人群身体健康没有不良影响。
下面将结合实施例对本发明的实施方式作进一步详细描述。
具体实施方式
实施例1
辅助降血糖保健食品,由以下重量克数的原料制成1000粒胶囊:枸杞子250g,茯苓170g,山楂150g,桑椹130g,栀子150g,藿 香104g。0.36g/粒。
实施例2
辅助降血糖保健食品,由以下重量克数的原料制成1000粒胶囊:枸杞子220g,茯苓200g,山楂130g,桑椹150g,栀子130g,藿 香124g。0.36g/粒。
实施例3
辅助降血糖保健食品,由以下重量克数的原料制成1000粒胶囊:枸杞子233g,茯苓187g,山楂140g,桑椹140g,栀子140g,藿 香114g。0.36g/粒。
实施例4
制备方法:
1、选材和预处理
根据《中国药典》一部2000年版品名项下要求选材、水洗,低温烘干(60℃、8h)。
2、提取处理
按配方比例准确称取各味药材,藿香、3/5茯苓粉碎成细粉,过100目筛,混合均匀,备用。
取枸杞子、2/5茯苓、山楂、桑椹、栀子加水10倍,煎煮2h,过滤滤液待用;滤渣加水8倍,煎煮1.5h,得滤液,弃滤渣,合并两次滤液,减压浓缩至相对密度1:1.06~1.08(65℃),得流浸膏,拌入藿香、茯苓细粉,真空干燥,粉碎,过100目筛,得粉末备用(上述水提部分得粉率约18%)。
3、灌装:
在无菌条件下装0号胶囊,每粒胶囊装0.36克粉末,用钴60 6KGY辐照消毒。装瓶:每瓶70粒,铝塑封口。
实验例1
佰生堂牌佰生堂胶囊辅助降血糖功能人体试食试验报告
1.材料与方法:
1.1.样品
降糖胶囊Ⅰ号、Ⅱ号全部由西安中医脑病医院提供,为硬胶囊,内容物为棕色粉末,两者外观、色泽及口感相同,其中一个为佰生堂牌佰生堂胶囊(实施例3配方),另一个为安慰剂胶囊。
1.2.受试者选择:
1.2.1.选择经饮食控制或口服降糖药治疗后病情较稳定,不需要更换药物品种及剂量,仅服用维持量的成年Ⅱ型糖尿病病人,空腹血糖≥7.8mmol/L(140mg/d1)或餐后2h血糖≥11.1mmol/L(200mg/d1);也可选择7.8mmol/L≥空腹血糖≥6.7mmol/L(120mg/d1)或11.1mmol/L(200mg/d1)≥餐后2h血糖≥7.8mmol/L高血糖人群。
1.2.2.受试者无心,肝、肾等主要脏器的并发症,肝肾功能良好,无服用糖皮质激素和其它影响血糖药物史。
1.2.3.排除者标准:
1.2.3.1. Ⅰ型糖尿病患者。
1.2.3.2. 年龄在18岁以下或65岁以上者,妊娠或哺乳期妇女。
1.2.3.3. 有严重心、肝、肾等并发症,或合并有其它严重原发性疾,精神病患者。
1.2.3.4. 不合作者,无法判断疗效或资料不全者。
1.3. 试验设计及分组。
采用组间和自身两种对照设计。根据上述标准选择106例受试者,按照血糖水平随机分为试食组和对照组,每组53例。
1.4 试验方法
试验前按每一位受试者的年龄、性别、劳动强度、体重,参照原来生活习惯规定相应的饮食,试验期间各组坚持饮食控制,原用药物种类和剂量不变。试食组加服佰生堂牌佰生堂胶囊,用量为每日3次,每次6粒;对照组服普通安慰胶囊,用法相同,连续观察32天。
1.5. 仪器与试剂:F-820型血球计数仪,MIDIRON 尿十项分析仪(德国产),Olympus全自动生化分析仪型号AU600(日本产),生化试剂盒全部由中生公司提供。
1.观察指标:
各项指标于试食实验开始及结束时各测试一次。
2.1. 功效性观察:
2.1.1. 症状观察:
详细询问病史,了解患者饮食情况,用药情况,活动量,观察主要临床症状:多食、多饮、口渴、多尿、疲乏无力、腰膝酸软等。按症状轻重(重症3分、中度、轻症1分)在试食前后统计积分值,并就其主要症状改善(每一症状改善2分显效,改善1分以上为有效),观测症状改善率。
2.1.2. 血糖测定:试餐物统一为100g精粉馒头,测空腹血糖及餐后2小时血糖。
2.1.3. 尿糖检测:空腹晨尿定性,按-、±、+、++、+++、++++分别积0、0.5、2、3、4、分,于试食前后统计积分值。
2.1.4 血脂测定:总胆固醇(TC)、甘油三脂(TG)高密度脂蛋白(HDL-C)
2.2. 安全性观察:
2.2.1. 血尿常规检查:
红细胞计数,血红蛋白,白细胞计数,尿十项测定。
2.2.2. 生化指标测定:
血清白蛋白ALB,总蛋白TP,心肝肾功能(谷草转氨酶ALT,尿素UREA,肌苷Cr)。
2.2.3. 腹部B超,心电图,X线胸部透视。
2.功效判定标准:
3.1. 空腹血糖结果判定:1)空腹血糖试验前后自身比较,差异有显著性,且试验后平均血糖下降≥10%,2)试验后试食组血糖值或血糖下降百分率与对照组比较,差异有显著性,满足上述两个条件,可判定为该受试样品空腹血糖指标结果阳性。
3.2 餐后2H血糖结果判定:1)餐后2H血糖试验前后自身对照,差异有显著性,且试验后平均血糖下降≥10%,2)试验后试食组血糖值或血糖下降百分率与对照组比较,差异有显著性。满足上述两个条件,可判定为该受试样品餐后2H血糖指标结果阳性。
3.结果:
观察结束双盲揭晓:服食Ⅰ号者为佰生堂牌佰生堂胶囊,服食Ⅱ号者为安慰剂胶囊。
4.1. 一般资料:
共观察106例,试食组男性28例,女性25例,年龄最小34岁,年龄最大65岁,平均51.5岁,平均病程5.4年;对照组男性26例,女姓27例,年龄最小32岁,最大64岁,平均50.8岁,平均病程4.9年。
4.2. 两组观察前一般情况比较:
4.3. 降糖功效:
4.3.1. 空腹及餐后血糖比较:
一个月后,佰生堂牌佰生堂胶囊组空腹血糖平均下降1.5mmol/L,餐后2小时血糖平均下降1.9mmol/L,血糖平均下降超过10%,对照组空腹血糖及餐后2小时血糖略减低。
4.3.2.空腹血糖、胰岛素及尿糖比较:
4.4. 降血糖功效比较:
#经X2检验,两组总有效率差别显著,P<0.05。
4.5. 症状改善状况:
()对照组
在各主要症状改善方面,试食组均好于对照组。
4.6. 临床症状积分统计:
自身对照**P<0.01
试食组和对照组的临床症状均有改善。
4.7.血脂变化情况:
佰生堂牌佰生堂胶囊组与对照组对血脂各项均无明显影响。
4.8. 试食后血液安全指标观察:
两组试食前后,血液检测各项指标均在正常范围,尿酮体阴性。
4.9. 两组腹部B超、心电图、X-ary 胸透均正常。
4.小结:
5.1.服用佰生堂牌佰生堂胶囊一个月后,试食组空腹血糖值下降1.5±0.7mmol/L,餐后血糖下降1.9±1.4mmol/L,血糖平均下降均超过10%,显效5例,有效27例,总有效率60.4%;对照组空腹血糖及餐后血糖下降不明显,有效13例,总有效率24.5%,两组相比较有显著差异,说明佰生堂牌佰生堂胶囊有辅助降血糖功效。
5.2.服用佰生堂牌佰生堂胶囊一个月后,血红蛋白、红细胞、白细胞、血清总蛋白、白蛋白、谷丙转氨酶、谷草转氨酶、肌酐、尿素及尿常规各项等检验指标均在正常范围,说明本品对受试者身体健康无不良影响。
5.3佰生堂牌佰生堂胶囊在试食过程中未观察到过敏及任何不良反应。
结果与判定
采用双盲自身及组间对照法,将106例高血糖试食者随机分为试食组和对照组,每组53例,观察期间原服用降糖药物品种和剂量不变,试食组加服佰生堂牌佰生堂胶囊,对照组加服安慰剂胶囊。一个月后,其结果表明服佰生堂牌佰生堂胶囊具有调节和降低血糖的功效。空腹血糖下降1.5±0.7mmol/L,餐后血糖下降1.9±1.4mmol/L,血糖平均下降均超过10%,显效5例,有效27例,总有效率60.4%;对照组空腹血糖、餐后血糖下降不明显,有效13例,总有效率24.5%,两组对比有显著差异。试食前后血红蛋白、红细胞、白细胞、血清总蛋白、白蛋白、谷草转氨酶、谷丙转氨酶、尿素、肌苷及尿常规等各项临床检验指标均在正常范围,说明佰生堂牌佰生堂胶囊对试食者身体健康无明显的不良影响。
上面描述,只是本发明的具体实施方式,各种举例说明不对本发明的实质内容构成限制。
Claims (4)
1.辅助降血糖保健食品,其特征在于其有效成分由以下重量份数的原料制成:枸杞子220-250份,茯苓170-200份,山楂130-160份,桑椹130-160份,栀子130-160份,藿香100-130份。
2.按照权利要求1所述的辅助降血糖保健食品,其特征在于由以下重量份数的原料制成胶囊:枸杞子250份,茯苓170份,山楂150份,桑椹130份,栀子150份,藿 香104份。
3.按照权利要求1所述的辅助降血糖保健食品,其特征在于由以下重量份数的原料制成胶囊:枸杞子220份,茯苓200份,山楂130份,桑椹150份,栀子130份,藿 香124份。
4.按照权利要求1所述的辅助降血糖保健食品,其特征在于由以下重量份数的原料制成胶囊:枸杞子233份,茯苓187份,山楂140份,桑椹140份,栀子140份,藿 香114份。
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