CN116210901A - 一种益气养血的保健品及制备方法和含量测定 - Google Patents
一种益气养血的保健品及制备方法和含量测定 Download PDFInfo
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Abstract
本发明涉及一种益气养血的保健品及制备方法和含量测定,该益气养血保健品合物由黄精、红景天、山茱萸、白扁豆、阿胶、白芍、黑木耳、大枣、黄豆、荞麦、粳米组成,制备方法简单,成本低,无副作用,口感和色泽俱佳的药食同源保健食品,对气血不足引起的乏力、畏寒、心悸、失眠、手脚冰凉、头晕等症状的具有缓解的作用。该保健品含量检测方法结果显示分离度,峰形,峰纯度均良好,重现性好,适用于益气养血的保健品无水葡萄糖和红景天苷含量的检验。
Description
技术领域
本发明涉及医药发明领域,具体涉及一种益气养血的保健品及制备方法和含量测定。
背景技术
气血不足即中医学中的气虚和血虚。气为血之帅,血为气之母,气能生血,血能载气,两者是相互依存,互根互用的关系。气是运行在人体内的一种精微物质。具有极强的能量的活动力,激发和推动机体器官的功能活动,因此也代表五脏之气和经脉之气。气的作用主要是温养机体和抵御外邪的入侵,同时参与脏腑功能的新陈代谢。血即流动于经脉中的红色液体。血的功能有两方面。其一,即调养脏腑形体经络和骨窍。血盛则形健,面红润、皮肤光滑、毛发润泽、关节灵活。其二,血液是精神活动的物质基础。血盛则神清气爽、思维敏捷。血不足则精神恍惚、心悸不安。
气血不足的原因,主要有生成不足和消耗太过两个方面。生成不足主要指的是无法从饮食物中,获取水谷精微从而生成气血,一个原因是饮食物量不足,种类单一,营养价值低。另外一个原因是饮食物供给正常,但是脾胃无法将食物中的营养物质转化为气血,主要是因为脾胃功能欠佳。消耗太过主要与起居生活习惯有关,对于压力过大、精神紧张、脾气暴躁者,多会造成肝郁克脾,影响气血生成,过度劳累、起居无常、经常熬夜者,多会造成气血的消耗而引起气血不足。
目前,很多气血不足患者都是通过药物来进行治疗,但长期使用药物,对身体产生副作用大,影响身体的正常机能。本明团队结合人体正常所需的营养物质,通过正确的中医辨证论治,选用了药食同源的药物为原料,制备了一种益气养血的保健品,该保健品组方精炼、配伍严格、工艺简单、质量保证,口感和色泽俱佳的药食同源保健食品,经功能试验证明,具有改善气血不足引起的乏力、畏寒、心悸、失眠、手脚冰凉、头晕等症状。
发明内容
本发明的目的在于提供一种益气养血的保健品。
本发明的另一目的在于提供一种益气养血的保健品的制备方法。
本发明的再一目的在于提供一种益气养血的保健品的含量检测方法。
本发明所述保健品由以下重量份的原料制成:黄精20~50份、红景天5~10份、山茱萸4~8份、白扁豆4~8份、阿胶5~10份、白芍5~10份、黑木耳2~8份、大枣2~8份、黄豆2~8份、荞麦2~8份、粳米2~8份。
优选的,
本发明所述保健品由以下重量份的原料制成:黄精30~40份、红景天6~8份、山茱萸5~8份、白扁豆5~8份、阿胶6~8份、白芍6~8份、黑木耳5~8份、大枣5~8份、黄豆5~8份、荞麦5~8份、粳米5~8份。
进一步优选的,
本发明所述保健品由以下重量份的原料制成:黄精30份、红景天8份、山茱萸6份、白扁豆6份、阿胶8份、白芍8份、黑木耳5份、大枣5份、黄豆5份、荞麦5份、粳米5份。
本发明所述制备方法为:
(1)取黄精、山茱萸、红景天、白芍,加4~6倍量50~70%乙醇加热回流提取1~3次,每次1小时,收集提取液,浓缩至相对密度为1.20~1.30的稠膏,备用;
(2)取白扁豆、阿胶、黑木耳、大枣、黄豆、荞麦、粳米分别炒熟后打成细粉,混合均匀,制得混合细粉,备用;
(3)取稠膏,加入混合细粉,混匀,干燥,粉碎,过100~120目筛即得。
优选的,
本发明所述制备方法为:
(1)取黄精、山茱萸、红景天、白芍,加5倍量60%乙醇加热回流提取2次,每次1小时,收集提取液,浓缩至相对密度为1.20的稠膏,备用;
(2)取白扁豆、阿胶、黑木耳、大枣、黄豆、荞麦、粳米分别炒熟后打成细粉,混合均匀,制得混合细粉,备用;
(3)取稠膏,加入混合细粉,混匀,干燥,粉碎,过120目筛即得。
本发明所述含量检测方法包括以下步骤:
(1)色谱条件与系统适用性试验:以十八烷基硅烷键合硅胶为填充剂;以甲醇为流动相A,以0.05~0.08%磷酸溶液为流动相B,流速为0.8~1.2mL/min;检测波长为220~240nm,按下表中的规定进行梯度洗脱;
(2)对照品溶液的制备:取无水葡萄糖对照品适量,精密称定,置100ml量瓶中,加水溶解并稀释至刻度,摇匀加水溶解成每1ml中含无水葡萄糖0.2mg,得无水葡萄糖对照品溶液;取红景天苷对照品适量,精密称定,加甲醇制成每1ml含0.5mg的溶液,得红景天苷对照溶液;
(3)供试品溶液的制备:取本品1~3g,精密称定,置具塞锥形瓶中,精密加入50~80%的乙醇100ml,密塞,称定重量,回流提取30~60分钟,放冷,再称定重量,用50~80%的乙醇补足减失的重量,摇匀,滤过,取续滤液,即得;
(4)测定法:分别精密吸取对照品溶液与供试品溶液各5μl,注入液相色谱仪,测定,即得。
优选的,
本发明所述(1)色谱条件与系统适用性试验为:以十八烷基硅烷键合硅胶为填充剂;以甲醇为流动相A,以0.06%磷酸溶液为流动相B,流速为1.0mL/min;检测波长为236nm,按下表中的规定进行梯度洗脱:
优选的,
本发明所述(3)供试品溶液的制备为:取本品1~2g,精密称定,置具塞锥形瓶中,精密加入55~75%的乙醇100ml,密塞,称定重量,回流提取40~
50分钟,放冷,再称定重量,用55~75%的乙醇补足减失的重量,摇匀,滤过,取续滤液,即得。
进一步优选的,
本发明所述(3)供试品溶液的制备为:取本品2g,精密称定,置具塞锥形瓶中,精密加入60%的乙醇100ml,密塞,称定重量,回流提取45分钟,放冷,再称定重量,用60%的乙醇补足减失的重量,摇匀,滤过,取续滤液,即得。
本发明所述保健品在益气养血方面的应用。
本发明所述的“份”可以是kg、g等本领域公知的单位。
有益效果
1、本发明保健品具有益气养血之功效。用于气血不足引起的乏力、畏寒、心悸、失眠、手脚冰凉、头晕等症状,制备方法简单,成本低,口感和色泽俱佳的药食同源保健食品,具有推广的价值。
2、本发明制备方法通过了药材提取乙醇浓度的考察,以组方中黄精有效成分无水葡萄糖和红景天有效成分红景天苷提取率为评价指标,结果显示用60%、70%、80%乙醇浓度浸渍时,无水葡萄糖提取率和红景天苷提取率均明显高于50%乙醇,由于60%、70%和80%乙醇浓度提取率相当,为节约生产成本,选择60%乙醇浓度为本发明制备工艺参数。
3、对制备工艺中提取时间考察,结果显示用60%乙醇提取1小时和1.5小时,无水葡萄糖提取率和红景天苷提取率变化缓慢,说明1小时和1.5小时提取率相当,为节约生产成本,选择提取两次,每次1小时为本发明制备工艺参数。
4、本发明临床疗效试验结果表明,治疗总有效率为92.0%,显著高于对照组的80.0%,差异显著,具有统计学意义(P<0.05),说明本发明制备得的益气养血的保健品对气血不足引起的乏力、畏寒、心悸、失眠、手脚冰凉、头晕等症状有较好的治疗效果。
5、本发明通过了对黄精和红景天含量测定方法的考察,参照2020年版药典黄精和红景天药材检测标准,暂定的含量检测方法,结果出现分离度差,峰形不好、精确度差、稳定性差等问题,针对此问题,对含量方法中流动相及其比例、波长、提取溶剂及提取方法等进行考察,优选后的含量测定方法显示无水葡萄糖和红景天苷峰的分离度、峰形均较好,精确度、稳定性均符合规定。
6、本发明对无水葡萄糖和红景天苷含量测定方法进行了方法验证考察,线性考察结果表明:无水葡萄糖进样浓度在20.016mg/ml~2001.60mg/ml范围内呈良好的线性关系;红景天苷进样浓度在50.032mg/ml~
5003.2mg/ml范围内呈良好的线性关系;精密度试验结果表明重复进样6次,计算相对标准偏差验证方法的精密度,计算RSD%值为1.91%,表明仪器精密度好;重复性试验结果表明制得6份供试品溶液,测定红景天苷峰面积,RSD值1.80%,表明此红景天苷的测定方法具有良好的重复性;稳定性试验结果表明,红景天苷在24h内相对稳定。
7、本发明的含量测定方法是在同一色谱条件下同时检测无水葡萄糖和红景天苷的含量,节约了检测成本。
具体实施方式
以下实施例用于说明本发明,但不用来限制本发明的范围。
实施例1
组方:黄精30g、红景天8g、山茱萸6g、白扁豆6g、阿胶8g、白芍8g、黑木耳5g、大枣5g、黄豆5g、荞麦5g、粳米5g。
实施例2
组方:黄精20g、红景天5g、山茱萸4g、白扁豆4g、阿胶5g、白芍5g、黑木耳2g、大枣2g、黄豆2g、荞麦2g、粳米2g。
实施例3
组方:黄精50g、红景天10g、山茱萸8g、白扁豆8g、阿胶10g、白芍10g、黑木耳8g、大枣8g、黄豆8g、荞麦8g、粳米8g。
实施例4
组方:黄精25g、红景天6g、山茱萸5g、白扁豆5g、阿胶6g、白芍6g、黑木耳3g、大枣3g、黄豆3g、荞麦3g、粳米3g。
实施例5
组方:黄精35g、红景天7g、山茱萸7g、白扁豆7g、阿胶7g、白芍7g、黑木耳4g、大枣4g、黄豆4g、荞麦4g、粳米4g。
实施例6
组方:黄精40g、红景天8g、山茱萸8g、白扁豆5g、阿胶9g、白芍9g、黑木耳5g、大枣5g、黄豆5g、荞麦5g、粳米5g。
实施例7
组方:黄精45g、红景天9g、山茱萸7g、白扁豆4g、阿胶6g、白芍8g、黑木耳7g、大枣5g、黄豆3g、荞麦5g、粳米5g。
实施例8
组方:黄精30g、红景天10g、山茱萸8g、白扁豆8g、阿胶10g、白芍8、黑木耳5g、大枣3g、黄豆3g、荞麦5g、粳米7g。
实施例1~8的组方分别按实施例9~12任一种制备方法制备。
实施例9制备方法
(1)取黄精、山茱萸、红景天、白芍,加5倍量60%乙醇加热回流提取2次,每次1小时,收集提取液,浓缩至相对密度为1.20的稠膏,备用;
(2)取白扁豆、阿胶、黑木耳、大枣、黄豆、荞麦、粳米分别炒熟后打成细粉,混合均匀,制得混合细粉,备用;
(3)取稠膏,加入混合细粉,混匀,干燥,粉碎,过120目筛即得。
实施例10制备方法
(1)取黄精、山茱萸、红景天、白芍,加4倍量50%乙醇加热回流提取1次,每次1小时,收集提取液,浓缩至相对密度为1.20的稠膏,备用;
(2)取白扁豆、阿胶、黑木耳、大枣、黄豆、荞麦、粳米分别炒熟后打成细粉,混合均匀,制得混合细粉,备用;
(3)取稠膏,加入混合细粉,混匀,干燥,粉碎,过100目筛即得。
实施例11制备方法
(1)取黄精、山茱萸、红景天、白芍,加6倍量70%乙醇加热回流提取3次,每次1小时,收集提取液,浓缩至相对密度为1.30的稠膏,备用;
(2)取白扁豆、阿胶、黑木耳、大枣、黄豆、荞麦、粳米分别炒熟后打成细粉,混合均匀,制得混合细粉,备用;
(3)取稠膏,加入混合细粉,混匀,干燥,粉碎,过120目筛即得。
实施例12制备方法
(1)取黄精、山茱萸、红景天、白芍,加5倍量65%乙醇加热回流提取2次,每次1小时,收集提取液,浓缩至相对密度为1.25的稠膏,备用;
(2)取白扁豆、阿胶、黑木耳、大枣、黄豆、荞麦、粳米分别炒熟后打成细粉,混合均匀,制得混合细粉,备用;
(3)取稠膏,加入混合细粉,混匀,干燥,粉碎,过100目筛即得。
实施例9~12制备的保健品按实施例13~18任一种含量检测方法进行检测。
实施例13含量检测
(1)色谱条件与系统适用性试验:以十八烷基硅烷键合硅胶为填充剂;以甲醇为流动相A,以0.06%磷酸溶液为流动相B,流速为1mL/min;检测波长为236nm,按下表中的规定进行梯度洗脱;
(2)对照品溶液的制备:取无水葡萄糖对照品适量,精密称定,置100ml量瓶中,加水溶解并稀释至刻度,摇匀加水溶解成每1ml中含无水葡萄糖0.2mg,得无水葡萄糖对照品溶液;取红景天苷对照品适量,精密称定,加甲醇制成每1ml含0.5mg的溶液,得红景天苷对照溶液;
(3)供试品溶液的制备:取本品2g,精密称定,置具塞锥形瓶中,精密加入60%的乙醇100ml,密塞,称定重量,回流提取45分钟,放冷,再称定重量,用60%的乙醇补足减失的重量,摇匀,滤过,取续滤液,即得;
(4)测定法:分别精密吸取对照品溶液与供试品溶液各5μl,注入液相色谱仪,测定,即得。
实施例14含量检测
(1)色谱条件与系统适用性试验:以十八烷基硅烷键合硅胶为填充剂;以甲醇为流动相A,以0.05%磷酸溶液为流动相B,流速为0.8mL/min;检测波长为220nm,按下表中的规定进行梯度洗脱;
(2)对照品溶液的制备:取无水葡萄糖对照品适量,精密称定,置100ml量瓶中,加水溶解并稀释至刻度,摇匀加水溶解成每1ml中含无水葡萄糖0.2mg,得无水葡萄糖对照品溶液;取红景天苷对照品适量,精密称定,加甲醇制成每1ml含0.5mg的溶液,得红景天苷对照溶液;
(3)供试品溶液的制备:取本品1g,精密称定,置具塞锥形瓶中,精密加入50%的乙醇100ml,密塞,称定重量,回流提取30分钟,放冷,再称定重量,用50%的乙醇补足减失的重量,摇匀,滤过,取续滤液,即得;
(4)测定法:分别精密吸取对照品溶液与供试品溶液各5μl,注入液相色谱仪,测定,即得。
实施例15含量检测
(1)色谱条件与系统适用性试验:以十八烷基硅烷键合硅胶为填充剂;以甲醇为流动相A,以0.08%磷酸溶液为流动相B,流速为1.2mL/min;检测波长为240nm,按下表中的规定进行梯度洗脱;
(2)对照品溶液的制备:取无水葡萄糖对照品适量,精密称定,置100ml量瓶中,加水溶解并稀释至刻度,摇匀加水溶解成每1ml中含无水葡萄糖0.2mg,得无水葡萄糖对照品溶液;取红景天苷对照品适量,精密称定,加甲醇制成每1ml含0.5mg的溶液,得红景天苷对照溶液;
(3)供试品溶液的制备:取本品3g,精密称定,置具塞锥形瓶中,精密加入80%的乙醇100ml,密塞,称定重量,回流提取60分钟,放冷,再称定重量,用80%的乙醇补足减失的重量,摇匀,滤过,取续滤液,即得;
(4)测定法:分别精密吸取对照品溶液与供试品溶液各5μl,注入液相色谱仪,测定,即得。
实施例16含量检测
(1)色谱条件与系统适用性试验:以十八烷基硅烷键合硅胶为填充剂;以甲醇为流动相A,以0.06%磷酸溶液为流动相B,流速为0.9mL/min;检测波长为230nm,按下表中的规定进行梯度洗脱;
(2)对照品溶液的制备:取无水葡萄糖对照品适量,精密称定,置100ml量瓶中,加水溶解并稀释至刻度,摇匀加水溶解成每1ml中含无水葡萄糖0.2mg,得无水葡萄糖对照品溶液;取红景天苷对照品适量,精密称定,加甲醇制成每1ml含0.5mg的溶液,得红景天苷对照溶液;
(3)供试品溶液的制备:取本品2g,精密称定,置具塞锥形瓶中,精密加入55%的乙醇100ml,密塞,称定重量,回流提取40分钟,放冷,再称定重量,用55%的乙醇补足减失的重量,摇匀,滤过,取续滤液,即得;
(4)测定法:分别精密吸取对照品溶液与供试品溶液各5μl,注入液相色谱仪,测定,即得。
实施例17含量检测
(1)色谱条件与系统适用性试验:以十八烷基硅烷键合硅胶为填充剂;以甲醇为流动相A,以0.07%磷酸溶液为流动相B,流速为1.1mL/min;检测波长为236nm,按下表中的规定进行梯度洗脱;
(2)对照品溶液的制备:取无水葡萄糖对照品适量,精密称定,置100ml量瓶中,加水溶解并稀释至刻度,摇匀加水溶解成每1ml中含无水葡萄糖0.2mg,得无水葡萄糖对照品溶液;取红景天苷对照品适量,精密称定,加甲醇制成每1ml含0.5mg的溶液,得红景天苷对照溶液;
(3)供试品溶液的制备:取本品1~3g,精密称定,置具塞锥形瓶中,精密加入75%的乙醇100ml,密塞,称定重量,回流提取55分钟,放冷,再称定重量,用75%的乙醇补足减失的重量,摇匀,滤过,取续滤液,即得;
(4)测定法:分别精密吸取对照品溶液与供试品溶液各5μl,注入液相色谱仪,测定,即得。
实施例18含量检测
(1)色谱条件与系统适用性试验:以十八烷基硅烷键合硅胶为填充剂;以甲醇为流动相A,以0.08%磷酸溶液为流动相B,流速为1.0mL/min;检测波长为236nm,按下表中的规定进行梯度洗脱;
(2)对照品溶液的制备:取无水葡萄糖对照品适量,精密称定,置100ml量瓶中,加水溶解并稀释至刻度,摇匀加水溶解成每1ml中含无水葡萄糖0.2mg,得无水葡萄糖对照品溶液;取红景天苷对照品适量,精密称定,加甲醇制成每1ml含0.5mg的溶液,得红景天苷对照溶液;
(3)供试品溶液的制备:取本品2g,精密称定,置具塞锥形瓶中,精密加入50%的乙醇100ml,密塞,称定重量,回流提取30分钟,放冷,再称定重量,用50%的乙醇补足减失的重量,摇匀,滤过,取续滤液,即得;
(4)测定法:分别精密吸取对照品溶液与供试品溶液各5μl,注入液相色谱仪,测定,即得。
为了进一步验证本发明的有效性,发明进行了一系列的验证试验,具体如下:
1处方组成、理论依据
1.1处方组成
黄精: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。黄精根状茎形状有如山芋,山区老百姓常把它当作蔬菜食用。黄精是一个比较常见的补益药,它归为脾肺肾经,它的作用主要有补气养阴、健脾运肺、补肾的作用,它的功效主要包括有健脾养胃的作用,对于脾虚、脾胃气虚、阴虚,黄精有滋养的作用,第二个它有运肺的作用,特别对于肺气虚,肺阴虚导致的干咳、咳血有作用,第三个对于肾精不足的人有作用,比如说是腰酸背疼、腰酸腿疼、不孕不育等等,对于这种肾虚的这种人有补益作用。
红景天:红景天性平、味涩,自古以来就被人们奉为滋补圣品,具有润肺补肾,具有扶正固本、补气养血、滋阴益肺理气养气、益智健脑的功效。
山茱萸:补益肝肾、收敛固涩,具有固精缩尿、止带止崩、止汗,此外还有生津止渴的作用。对于腰膝酸痛、头晕耳鸣、健忘、遗精滑精、遗尿、尿频、崩漏带下、月经不调、大汗虚脱的患者,具有非常良好的疗效。
白扁豆:常用的一个健脾的药,由于它是健脾,所以一般来说我们白扁豆都用炒的白扁豆、它的味甘,性是微温的,归脾胃经。主要功能是健脾、利湿、止泻,对于脾胃特别虚弱、泄泻的患者,炒白扁豆的效果是非常非常好的。
阿胶:甘平,归肺、肝、肾经。质润而黏,既能补血止血,又滋阴润肺。用于虚劳咳血、便血、吐血等多种出血性疾病;改善失血后的头晕、心悸、乏力;改善失眠、虚劳咳喘以及安胎等。现代研究阿胶对血红蛋白和红细胞增长速度的疗效优于铁剂;对因失血而造成的休克有对抗作用;并能促进钙的吸收而有正钙平衡作用;有促进健康人淋巴细胞转化作用;能扩张血管,尤以静脉扩张最为明显;同时伴有代偿性扩容作用;血小板计数也明显增加等等。
白芍:毛黄科植物芍药的干燥根,主产于浙江、安徽等地。白芍性微寒,味苦、酸。归肝经、脾经。具有养血调经,敛阴止汗,柔肝止痛,平抑肝阳的功效,是中药中的补血药。
黑木耳:能够清热、凉血、润燥、活血化瘀,用于咳嗽、咽喉疼痛,有比较明显的作用。但是黑木耳还是食用性比较高,在家庭里主要以食品为主。
大枣:属于一个补益药,它主要是补咱们脾胃之气的,它的功效主要包括以下几个方面:第一它有补中益气、养血安神的作用,所以对于脾虚食少,乏力大便稀薄,然后妇女有脏燥这一类的,大枣有很好的濡养作用;
第二它有保肝作用,可以降低血清的谷丙转氨酶;第三它能够提高免疫力,有抗过敏作用;第四它可以防止一些脑供血不足,有降血压降胆固醇,防止心脑血管疾病的作用;第五它还有其他的一些保健作用,比如美容还有这个抗衰老、改善睡眠、防止脱发等等,总之大枣作为一个补益药,从补气到活血到补血,各个方面都有一定的作用,在我们中药方剂当中,大枣是一个比较常用的一个药物。
黄豆:有促进消化的功效,黄豆含有丰富的膳食纤维,可以促进人体的消化吸收,加快胃肠的蠕动,防止便秘,加快身体里的废物的排泄,可以降低肠癌的发生。黄豆具有填精髓、增力气、补虚开胃、益气养血、长肌肤、益颜色等作用。
荞麦:荞麦含有丰富的淀粉,蛋白质,脂肪,维生素,矿物质和膳食纤维,能为人体提供营养,保障人体的健康,增强体质,提高免疫力。荞麦能帮助人体控制血糖,血脂,控制体重,经常食用荞麦,对血糖高,血脂高和肥胖症人群有很好的功效。荞麦含有丰富的维生素p,能增加血管的弹性,有保护血管的作用。荞麦还具有药用价值,能消炎抗菌,止咳平喘,祛痰。
粳米:有滋阴补肾、健脾暖胃、明目活血的功效。对于体质虚弱的患者,食用粳米之后能够增强体质,提高抵抗疾病的能力。
1.2理论依据
根据黄精可补气养阴、健脾运肺;红景天可补气清肺、益智养心、收涩止血;散瘀消肿的功效;山茱萸可补益肝肾、收敛固涩;白扁豆可健脾胃、清暑湿;阿胶有补血,止血,滋阴润燥功效;白芍补血,敛阴柔肝,缓急止痛;大枣补中益气,养血安神的功效;多个药食同源合用,共奏益气养血之功;再配上补气养阴的食品黑木耳、黄豆、荞麦和粳米,口感俱佳,可改善气血不足引起的乏力、畏寒、心悸、失眠、手脚冰凉、头晕等症状。
结合各组分的功效,组方定为:黄精30g、红景天8g、山茱萸6g、白扁豆6g、阿胶8g、白芍8g、黑木耳5g、大枣5g、黄豆5g、荞麦5g、粳米5g。
2 制备工艺的研究
2.1 乙醇浓度考察
以组方中黄精有效成分无水葡萄糖和红景天有效成分红景天苷提取率为评价指标,对制备工艺中乙醇浓度进行优选。
按组方比例称取黄精、山茱萸、红景天、白芍,加5倍量不同浓度的乙醇加热回流提取2次,每次1小时,收集提取液,浓缩至相对密度为1.20的稠膏,分别测定滤液中无水葡萄糖和红景天苷的提取率,结果见表1。
表1乙醇浓度考察试验结果表
从表1试验结果可知,用60%、70%、80%乙醇浓度浸渍时,无水葡萄糖提取率和红景天苷提取率均明显高于50%乙醇,由于60%、70%和80%乙醇浓度提取率相当,为节约生产成本,选择60%乙醇浓度为本发明制备工艺参数。
2.2提取时间考察
按组方比例称取黄精、山茱萸、红景天、白芍,加5倍量60%乙醇加热回流提取2次,每次0.5、1、1.5小时,收集提取液,浓缩至相对密度为1.20的稠膏,分别测定滤液中无水葡萄糖和红景天苷的提取率,结果见表2。
表2提取时间考察试验结果表
从表2试验结果可知,用60%乙醇提取1小时和1.5小时,无水葡萄糖提取率和红景天苷提取率变化缓慢,说明1小时和1.5小时提取率相当,为节约生产成本,选择提取两次,每次1小时为本发明制备工艺参数。
3 疗效评价试验
3.1病例来源
根据医生诊断属于气血不足引起的乏力、畏寒、心悸、失眠、手脚冰凉、头晕等症状患者50例,随机平均分为二组(对照组、观察组),每组25人。
3.2治疗方法
采用随机数字表法将患者分为对照组和观察组,两组患者的性别、年龄、病程临床资料比较差异无统计学意义(P>0.05),具有可比性。
对照组:人参归脾丸+正常饮食,每丸重9克,一次1丸,一日2次;观察组:益气养血的保健品+正常饮食,每日早晚各一次,每次10g,一日2次;一个月为一个疗程,连续使用3个疗程后进行治疗效果综合对比,采用SPSS23.0统计软件分析实验数据,计量资料以(±s)表示,采用t检验,计数资料以例(%)表示,采用χ2检验。P<0.05为差异具有统计学意义。
疗效评估标准:总有效率=(痊愈例数+显效例数+有效例数)/总例数×100%。
3.3结果
3.3.1疗效比较,结果见表3。
表3患者临床疗效对比表
由表3结果可知,观察组患者治疗总有效率为92.0%,显著高于对照组的80.0%,差异显著,具有统计学意义(P<0.05)。说明本发明制备得的益气养血的保健品对气血不足引起的乏力、畏寒、心悸、失眠、手脚冰凉、头晕等症状有较好的治疗效果。
4 含量测定方法的考察
4.1 方法来源
参照2020年版药典黄精和红景天检测标准,检阅相关资料综合考虑,暂定含量测定方法为:
(1)色谱条件与系统适用性试验:以十八烷基硅烷键合硅胶为填充剂;以甲醇为流动相A,以水为流动相B,流速为1.0mL/min;检测波长为220nm,按表4中的规定进行梯度洗脱:
表4优化前梯度洗脱
(2)对照品溶液的制备:取无水葡萄糖对照品适量,精密称定,置100ml量瓶中,加水溶解并稀释至刻度,摇匀加水溶解成每1ml中含无水葡萄糖0.2mg,得无水葡萄糖对照品溶液;取红景天苷对照品适量,精密称定,加甲醇制成每1ml含0.5mg的溶液,得红景天苷对照溶液。
(3)供试品溶液的制备:取本品2g,精密称定,置具塞锥形瓶中,精密加入80%的乙醇100ml,密塞,称定重量,超声提取30分钟,放冷,再称定重量,用80%的乙醇补足减失的重量,摇匀,滤过,取续滤液,即得。
(4)测定法:分别精密吸取对照品溶液与供试品溶液各5μl,注入液相色谱仪,测定,即得。
结果:发现该检测结果出现峰分离度差,峰形不好、精确度差、稳定性差等问题,针对此问题,对含量方法中流动相及其比例、波长、提取溶剂及提取方法等进行考察,优化后的方法如下:
4.2优选含量测定方法
(1)色谱条件与系统适用性试验:以十八烷基硅烷键合硅胶为填充剂;以甲醇为流动相A,以0.06%磷酸溶液为流动相B,流速为1.0mL/min;检测波长为236nm,按表5中的规定进行梯度洗脱:
表5优化后梯度洗脱
(2)对照品溶液的制备:取无水葡萄糖对照品适量,精密称定,置100ml量瓶中,加水溶解并稀释至刻度,摇匀加水溶解成每1ml中含无水葡萄糖0.2mg,得无水葡萄糖对照品溶液;取红景天苷对照品适量,精密称定,加甲醇制成每1ml含0.5mg的溶液,得红景天苷对照溶液。
(3)供试品溶液的制备:取本品2g,精密称定,置具塞锥形瓶中,精密加入60%的乙醇100ml,密塞,称定重量,回流提取45分钟,放冷,再称定重量,用60%的乙醇补足减失的重量,摇匀,滤过,取续滤液,即得。
(4)测定法:分别精密吸取对照品溶液与供试品溶液各5μl,注入液相色谱仪,测定,即得。
结果:无水葡萄糖和红景天苷峰的分离度、峰形均较好,精确度、稳定性均符合规定。
5方法学验证考察
5.1线性试验
精密取浓度20.016mg/ml、100.08mg/ml、400.32mg/ml、1000.80mg/ml2001.60mg/ml的无水葡萄糖对照品溶液,以标准工作液的色谱峰面积对其相应浓度进行回归分析,得到线性方程为y=221.55x+2948.6,R2=0.998,表明无水葡萄糖进样浓度在20.016mg/ml~2001.60mg/ml范围内呈良好的线性关系,结果见表6。
表6无水葡萄糖线性试验结果
精密取浓度50.032mg/ml、250.16mg/ml、1000.64mg/ml、2501.6mg/ml、5003.2mg/ml的红景天苷对照品溶液,以标准工作液的色谱峰面积对其相应浓度进行回归分析,得到线性方程为y=28.882x~1856.2,R2=0.999,表明红景天苷进样浓度在50.032mg/ml~5003.2mg/ml范围内呈良好的线性关系,结果见表7。
表7红景天苷线性试验结果
5.2仪器精密度试验
精密取浓度为50.032mg/ml红景天苷对照品溶液,在“4.2”项下的优选色谱条件,重复进样5次,测定红景天苷峰面积,计算RSD%值为1.91%,表明仪器精密度良好,测定结果见表8。
表8仪器精密度试验结果
5.3重复性试验
精密量取保健品1mL,按“4.2”项下优选供试品溶液的制备方法,制得6份供试品溶液,各精密吸取5μL,注入液相色谱仪,按色谱条件进行分析,测定红景天苷峰面积,RSD值1.82%,表明此红景天苷的测定方法具有良好的重复性;结果见表9。
表9重复性试验结果
5.4稳定性试验
取供试品溶液一份,室温放置,按“4.2”项下色谱条件于0,4,8,12,12,16,24h分别进样,测定无水葡萄糖和红景天苷峰面积,无水葡萄糖RSD%为1.68%,红景天苷RSD%为1.20%;表明无水葡萄糖和红景天苷在24h内相对稳定。稳定性试验结果见表10。
表10稳定性试验结果
5.5含量测定
分别取本申请制备的益气养血的保健品6批(021001、021002、021003、021004、021005、021006),每批各取三袋(10g/袋)混合均匀,分别按“4.2”项下的优选方法测定,结果见表11。
表11六批含量测定结果
由表11可知,益气养血的保健品中,无水葡萄糖含量大于0.38mg/袋;红景天苷含量大于0.05mg/袋,暂定为含量标准要求。
虽然,上文中已经用一般性说明、具体实施方式及试验,对本发明作了详尽的描述,但在本发明基础上,可以对之作出一些修改或改进,这对本领域技术人员而言是显而易见的,因此,在不偏离本发明精神的基础上所做的这些修改或改进,均属于本发明要求保护的范围。
Claims (10)
1.一种益气养血的保健品,其特征在于,所述保健品由以下重量份的原料制成:黄精20~50份、红景天5~10份、山茱萸4~8份、白扁豆4~8份、阿胶5~10份、白芍5~10份、黑木耳2~8份、大枣2~8份、黄豆2~8份、荞麦2~8份、粳米2~8份。
2.根据权利要求1所述的保健品,其特征在于,所述保健品由以下重量份的原料制成:黄精30~40份、红景天6~8份、山茱萸5~8份、白扁豆5~8份、阿胶6~8份、白芍6~8份、黑木耳5~8份、大枣5~8份、黄豆5~8
份、荞麦5~8份、粳米5~8份。
3.根据权利要求2所述的保健品,其特征在于所述保健品由以下重量份的原料制成:黄精30份、红景天8份、山茱萸6份、白扁豆6份、阿胶8份、白芍8份、黑木耳5份、大枣5份、黄豆5份、荞麦5份、粳米5份。
4.一种制备权利要求1~3所述保健品的方法,其特征在于,所述制备方法为:
(1)取黄精、山茱萸、红景天、白芍,加4~6倍量50~70%乙醇加热回流提取1~3次,每次1小时,收集提取液,浓缩至相对密度为1.20~1.30的稠膏,备用;
(2)取白扁豆、阿胶、黑木耳、大枣、黄豆、荞麦、粳米分别炒熟后打成细粉,混合均匀,制得混合细粉,备用;
(3)取稠膏,加入混合细粉,混匀,干燥,粉碎,过100~120目筛即得。
5.根据权利要求4所述的保健品的制备方法,其特征在于,所述制备方法为:
(1)取黄精、山茱萸、红景天、白芍,加5倍量60%乙醇加热回流提取2次,每次1小时,收集提取液,浓缩至相对密度为1.20的稠膏,备用;
(2)取白扁豆、阿胶、黑木耳、大枣、黄豆、荞麦、粳米分别炒熟后打成细粉,混合均匀,制得混合细粉,备用;
(3)取稠膏,加入混合细粉,混匀,干燥,粉碎,过120目筛即得。
6.一种用于权利要求5制备的保健品的含量检测方法,其特征在于,所述含量检测方法包括以下步骤:
(1)色谱条件与系统适用性试验:以十八烷基硅烷键合硅胶为填充剂;以甲醇为流动相A,以0.05~0.08%磷酸溶液为流动相B,流速为0.8~1.2mL/min;检测波长为220~240nm,按下表中的规定进行梯度洗脱:
(2)对照品溶液的制备:取无水葡萄糖对照品适量,精密称定,置100ml量瓶中,加水溶解并稀释至刻度,摇匀加水溶解成每1ml中含无水葡萄糖0.2mg,得无水葡萄糖对照品溶液;取红景天苷对照品适量,精密称定,加甲醇制成每1ml含0.5mg的溶液,得红景天苷对照溶液;
(3)供试品溶液的制备:取本品1~3g,精密称定,置具塞锥形瓶中,精密加入50~80%的乙醇100ml,密塞,称定重量,回流提取30~60分钟,放冷,再称定重量,用50~80%的乙醇补足减失的重量,摇匀,滤过,取续滤液,即得;
(4)测定法:分别精密吸取对照品溶液与供试品溶液各5μl,注入液相色谱仪,测定,即得。
8.根据权利要求6所述的含量检测方法,其特征在于,所述(3)供试品溶液的制备为:取本品1~2g,精密称定,置具塞锥形瓶中,精密加入55~75%的乙醇100ml,密塞,称定重量,回流提取40~50分钟,放冷,再称定重量,用55~75%的乙醇补足减失的重量,摇匀,滤过,取续滤液,即得。
9.根据权利要求8所述的含量检测方法,其特征在于,所述(3)供试品溶液的制备为:取本品2g,精密称定,置具塞锥形瓶中,精密加入60%的乙醇100ml,密塞,称定重量,回流提取45分钟,放冷,再称定重量,用60%的乙醇补足减失的重量,摇匀,滤过,取续滤液,即得。
10.根据权利要求1~3任一项所述保健品,其特征在于所述保健品在益气养血方面的应用。
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