CN105878764B - 一种蛹虫草冲剂及其制备方法 - Google Patents
一种蛹虫草冲剂及其制备方法 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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Abstract
一种蛹虫草冲剂，其药材组方由以下重量分的原料组成：蛹虫草20～40份；铁皮石斛15～25份；黄芪3～8份；枸杞8～12份；山药12～17份；去核大枣25～35份。一种蛹虫草冲剂的制备方法，该发明专利采用蛹虫草为主原料，辅以铁皮石斛、山药、大枣、黄芪等药材，经反复验证，科学配伍，制备的一种具有滋肝益肾、提高免疫、补气血的保健型固体饮品。
Description
技术领域
本发明涉及中药制剂领域，特别涉及一种蛹虫草冲剂及其制备方法。
背景技术
蛹虫草(Cordyceps.militaris(L.)Link)又名北冬虫夏草，俗称北虫草、虫草花。隶属于子囊菌亚门、麦角菌目、麦角菌科，虫草属真菌，是虫草属的模式种。它是由子座(即草部分)与菌核(即虫的尸体部分)两部分组成的复合体。冬季幼虫蛰居土里，菌类寄生其中，吸取营养，幼虫体内充满菌丝而死。到了夏季，自幼虫尸体之上生出幼苗，形似草，夏至前后采集而得。中国于1958年在吉林省首次发现蛹虫草，通过鉴定，认为它与冬虫夏草是同一个属，定名为蛹草。主产于云南(昆明、安宁、江川)、吉林(安图、永吉)、辽宁(沈阳)、内蒙古(哲里木盟)，生于针、阔叶林或混交林地表土层中鳞翅目昆虫的蛹体上。能采用家蚕和柞蚕蛹人工批量培育，药效、药理与野生种相似甚至更好。
中医认为，虫草入肺肾二经，既能补肺阴，又能补肾阳、主治肾虚、阳痿遗精、腰膝酸痛、病后虚弱、久咳虚弱、劳咳痰血、自汗盗汗等，是唯一的一种能同时平衡、调节阴阳的中药。中医认为，虫草入肺肾二经，既能补肺阴，又能补肾阳、主治肾虚、阳痿遗精、腰膝酸痛、病后虚弱、久咳虚弱、劳咳痰血、自汗盗汗等，是唯一的一种能同时平衡、调节阴阳的中药。但是单纯服用蛹虫草，由于其服用量低，营养成分单一，达不到预期的养生保健功效，再加上蛹虫草的多纤维性，服用不方便。
发明内容
为解决上述现有技术存在的问题，本发明的目的在于提供一种蛹虫草冲剂及其制备方法。本发明针对蛹虫草特点，发明了一种蛹虫草冲剂及其制备方法，该发明专利采用蛹虫草为主原料，辅以铁皮石斛、山药、大枣、黄芪等药材，经反复验证，科学配伍，制备的一种具有滋肝益肾、提高免疫、补气血的保健型固体饮品。
为达到上述目的，本发明的技术方案为：
一种蛹虫草冲剂，其药材组方由以下重量分的原料组成：
蛹虫草20～40份
铁皮石斛15～25份
黄芪3～8份
枸杞8～12份
山药12～17份
去核大枣25～35份。
一种蛹虫草冲剂的制备方法，由如下步骤构成：
步骤一蛹虫草子实体处理
蛹虫草干子实体粗粉碎过80目，后经真空气流粉碎机粉碎到过1000目筛，粉碎的蛹虫草粉按照料水质量比1:20的比例加水，搅拌混合均匀后按照蛹虫草粉质量的0.15％加入纤维素酶，柠檬酸调节pH值至5.0，50℃条件下酶解120min，即可得到蛹虫草酶解液；
步骤二铁皮石斛处理
粗粉碎80目，进一步经真空气流粉碎机粉碎到过1000目筛，粉碎的铁皮石斛粉按照料水比1:20的比例加水，搅拌混合均匀后按照石斛粉质量的0.2％加入纤维素酶,柠檬酸调节pH值至5.0，45℃条件下酶解60min，即可得到铁皮石斛酶解液；
步骤三：药材提取
黄芪、枸杞、山药和大枣(去核)四种药材原料按照原料比例混合，混匀后过10目筛进行粉碎，按照四种药材混合原料质量的20倍加入纯水，充分搅拌混匀，98℃提取，提取过程中缓慢搅拌，提取60min后过滤收集滤液，滤渣从新加入药材混合原料质量的20倍的水重复提取，98℃，提取60min，提取过程中缓慢搅拌，提取60min后过滤收集滤液，合并两次提取滤液即可得到四种药材水提取液；
步骤四：澄清、浓缩处理
将蛹虫草酶解液、铁皮石斛酶解液、四种药材提取液按照体积比1:1:2的比例合并，加入0.1％的壳聚糖絮凝剂，静置30min后，过滤澄清处理后，即可得到红棕色的滤液，将滤液采用单效浓缩器70℃条件下浓缩至固形物含量为35％；
步骤五：干燥、成型
将步骤四中浓缩获得的浸膏比重为1.15时，加入浸膏重量10％助干剂，搅拌混匀后，进一步均质处理后，将料液加热到70℃直接进行喷雾干燥处理，即可获得淡黄色粉末，黄色粉末中加入粉末1％的微晶纤维素、5％的乳糖醇，混合均匀经进一步干法制粒后，包装即得成品。
进一步的，所述纤维素酶为食品级4万U/g的纤维素酶。
进一步的，所述步骤五中，助干剂为DE8-10的麦芽糊精和CMC按照质量比为10:1的混合物。
进一步的，所述步骤五中，喷雾干燥处理的进风口温度为190℃。
进一步的，所述干法制粒所得颗粒直径在5目、10目筛之间。
相对于现有技术，本发明的有益效果为：
本发明针对蛹虫草特点，发明了一种蛹虫草冲剂的制备方法，该发明专利采用蛹虫草为主原料，辅以铁皮石斛、山药、大枣、黄芪等药材，经反复验证，科学配伍，制备的一种具有滋肝益肾、提高免疫、补气血的保健型固体饮品。
本发明各组分配伍的药理为：
蛹虫草经临床验证效果，与天然的冬虫夏草相同，同样能够调节全身功能、提高免疫能力、增强巨噬细胞的吞噬功能、促进抗体的形成，主要有保肺益肾养肝、止咳平喘祛痰、润肤防皱抗衰老、抗菌抗炎、镇静、扩张血管、降低血压、降低血糖、抗疲劳、耐缺氧等作用。人工北冬虫夏草主治：虚痨咳血、腰膝酸痛、阳痿遗精、神经衰弱、心悸失眠、盗汗、心率失常、食欲不振、鼻咽癌、肺气肿、肺结核、气管炎、哮喘症、肝炎、肾炎、肾虚、糖尿病、尿频及放、化疗后白细胞减少等症。
铁皮石斛具有斛降血糖作用：铁皮石斛对可降低链脲霉素诱发糖尿血糖值；具有生津作用，主要表现为促进腺体分泌和脏器运动；增强机体免疫力：铁皮石斛颗粒(TPSH)可促进荷瘤动物巨噬细胞的吞噬功能，增强T淋巴细胞的增殖和分化及NK细胞的活性，并能明显提高荷瘤动物的血清溶血素值，提示TPSH无论是对非特异性免疫功能，或是特异性细胞免疫以及体液免疫功能，均有一定的提高作用。
黄芪：现代医学研究表明，黄芪有增强机体免疫功能、保肝、利尿、抗衰老、抗应激、降压和较广泛的抗菌作用。能消除实验性肾炎蛋白尿，增强心肌收缩力，调节血糖含量。黄芪不仅能扩张冠状动脉，改善心肌供血，提高免疫功能，而且能够延缓细胞衰老的进程。黄芪食用方便，可煎汤，煎膏，浸酒，入菜肴等。
枸杞具有滋肝益肾、清肝明目的药理活性，用于肝肾阴虚证枸杞甘平质润，平补肝肾，有滋补强壮作用，凡肝肾阴虚诸证均可应用。
山药主治脾虚腹泻、肺虚咳、糖尿病消渴、小便短频、遗精、妇女带下及消化不良的慢性肠炎。
红枣味甘性温、归脾胃经，有补中益气、养血安神、缓和药性的功能；而现代的药理学则发现，红枣含有蛋白质、脂肪、糖类、有机酸、维生素A、维生素C、多种微量钙以及氨基酸等丰富的营养成分。
本方中利用蛹虫草的保肝护肾、提高免疫的功能、辅以黄芪、大枣补气血；枸杞的清肝明目；山药、红枣的改善脾胃虚弱的功能，再辅以铁皮石斛的降血糖、降血压功能，利用多种药材功效间的优势互补，使得本专利产品滋肝益肾、降血压等效果明显。
具体实施方式
下面结合具体实施方式对本发明技术方案做进一步详细描述：
实施例1：
一种蛹虫草冲剂的制备方法
原料组分为：蛹虫草20份、铁皮石斛20份、黄芪5份、枸杞10份、山药15份、大枣(去核)30份。
步骤一蛹虫草子实体处理
蛹虫草干子实体粗粉碎过80目，进一步经真空气流粉碎机粉碎到过1000目筛，粉碎的蛹虫草粉按照料水比1:20的比例加水，搅拌混合均匀后按照蛹虫草粉质量的0.15％加入纤维素酶(食品级4万U/g)、按照蛹虫草粉质量的0.1％加入纤维素酶(食品级10万U/g),柠檬酸调节pH值在5.0，50℃，酶解120min，即可得到蛹虫草酶解液。
步骤二铁皮石斛处理
粗粉碎80目，进一步经真空气流粉碎机粉碎到过1000目筛，粉碎的铁皮石斛粉按照料水比1:20的比例加水，搅拌混合均匀后按照石斛粉质量的0.2％加入纤维素酶(食品级4万U/g),柠檬酸调节pH值在5.0，45℃，酶解60min，即可得到铁皮石斛酶解液。
步骤三：药材提取
黄芪、枸杞、山药和大枣(去核)四种药材原料按照质量比为1:1:3:7的比例混合，混匀后进行粉碎(过10目筛)，按照四种药材混合原料质量的20倍加入纯水，充分搅拌混匀，98℃提取，提取过程中缓慢搅拌，提取60min后过滤收集滤液，滤渣从新加入药材混合原料质量的20倍的水重复提取，98℃，提取60min，提取过程中缓慢搅拌，提取60min后过滤收集滤液，合并两次提取滤液即可得到四种药材水提取液。
步骤四：澄清、浓缩处理
将蛹虫草酶解液、铁皮石斛酶解液、四种药材提取液按照体积比1:1:2的比例合并，加入0.1％的壳聚糖絮凝剂，静置30min后，过滤澄清处理后，即可得到红棕色的滤液，将滤液采用单效浓缩器70℃条件下浓缩至固形物含量为35％。
步骤五：干燥、成型
将步骤四中浓缩获得的浸膏，加入40％的麦芽糊精(DE8-10)搅拌混匀后，进一步均质处理后，将料液加热到70℃直接进行喷雾干燥处理(进风口温度180℃)，即可获得淡黄色粉末，黄色粉末中加入1％的微晶纤维素、5％的乳糖醇，混合均匀经进一步干法制粒后(颗粒直径在5目、10目筛之间)，包装即可。
实施例2
一种蛹虫草冲剂的制备方法
原料组分为：蛹虫草40份、铁皮石斛15份、黄芪8份、枸杞8份、山药17份、大枣(去核)25份。
步骤一蛹虫草子实体处理
蛹虫草干子实体粗粉碎过80目，进一步经真空气流粉碎机粉碎到过1000目筛，粉碎的蛹虫草粉按照料水比1:20的比例加水，搅拌混合均匀后按照蛹虫草粉质量的0.15％加入纤维素酶(食品级4万U/g)、按照蛹虫草粉质量的0.1％加入纤维素酶(食品级10万U/g),柠檬酸调节pH值在5.0，50℃，酶解120min，即可得到蛹虫草酶解液。
步骤二铁皮石斛处理
粗粉碎80目，进一步经真空气流粉碎机粉碎到过1000目筛，粉碎的铁皮石斛粉按照料水比1:20的比例加水，搅拌混合均匀后按照石斛粉质量的0.2％加入纤维素酶(食品级4万U/g),柠檬酸调节pH值在5.0，45℃，酶解60min，即可得到铁皮石斛酶解液。
步骤三：药材提取
黄芪、枸杞、山药和大枣(去核)四种药材原料按照质量比为1:1:3:7的比例混合，混匀后进行粉碎(过10目筛)，按照四种药材混合原料质量的20倍加入纯水，充分搅拌混匀，98℃提取，提取过程中缓慢搅拌，提取60min后过滤收集滤液，滤渣从新加入药材混合原料质量的20倍的水重复提取，98℃，提取60min，提取过程中缓慢搅拌，提取60min后过滤收集滤液，合并两次提取滤液即可得到四种药材水提取液。
步骤四：澄清、浓缩处理
将蛹虫草酶解液、铁皮石斛酶解液、四种药材提取液按照体积比1:1:2的比例合并，加入0.1％的壳聚糖絮凝剂，静置30min后，过滤澄清处理后，即可得到红棕色的滤液，将滤液采用单效浓缩器70℃条件下浓缩至固形物含量为35％。
步骤五：干燥、成型
将步骤四中浓缩获得的浸膏，加入40％的麦芽糊精(DE8-10)搅拌混匀后，进一步均质处理后，将料液加热到70℃直接进行喷雾干燥处理(进风口温度180℃)，即可获得淡黄色粉末，黄色粉末中加入1％的微晶纤维素、5％的乳糖醇，混合均匀经进一步干法制粒后(颗粒直径在5目、10目筛之间)，包装即可。
实施例3：
一种蛹虫草冲剂的制备方法
原料组分为：蛹虫草25份、铁皮石斛25份、黄芪3份、枸杞12份、山药12份、大枣(去核)35份。
步骤一蛹虫草子实体处理
蛹虫草干子实体粗粉碎过80目，进一步经真空气流粉碎机粉碎到过1000目筛，粉碎的蛹虫草粉按照料水比1:20的比例加水，搅拌混合均匀后按照蛹虫草粉质量的0.15％加入纤维素酶(食品级4万U/g)、按照蛹虫草粉质量的0.1％加入纤维素酶(食品级10万U/g),柠檬酸调节pH值在5.0，50℃，酶解120min，即可得到蛹虫草酶解液。
步骤二铁皮石斛处理
粗粉碎80目，进一步经真空气流粉碎机粉碎到过1000目筛，粉碎的铁皮石斛粉按照料水比1:20的比例加水，搅拌混合均匀后按照石斛粉质量的0.2％加入纤维素酶(食品级4万U/g),柠檬酸调节pH值在5.0，45℃，酶解60min，即可得到铁皮石斛酶解液。
步骤三：药材提取
黄芪、枸杞、山药和大枣(去核)四种药材原料按照质量比为1:1:3:7的比例混合，混匀后进行粉碎(过10目筛)，按照四种药材混合原料质量的20倍加入纯水，充分搅拌混匀，98℃提取，提取过程中缓慢搅拌，提取60min后过滤收集滤液，滤渣从新加入药材混合原料质量的20倍的水重复提取，98℃，提取60min，提取过程中缓慢搅拌，提取60min后过滤收集滤液，合并两次提取滤液即可得到四种药材水提取液。
步骤四：澄清、浓缩处理
将蛹虫草酶解液、铁皮石斛酶解液、四种药材提取液按照体积比1:1:2的比例合并，加入0.1％的壳聚糖絮凝剂，静置30min后，过滤澄清处理后，即可得到红棕色的滤液，将滤液采用单效浓缩器70℃条件下浓缩至固形物含量为35％。
步骤五：干燥、成型
将步骤四中浓缩获得的浸膏，加入40％的麦芽糊精(DE8-10)搅拌混匀后，进一步均质处理后，将料液加热到70℃直接进行喷雾干燥处理(进风口温度180℃)，即可获得淡黄色粉末，黄色粉末中加入1％的微晶纤维素、5％的乳糖醇，混合均匀经进一步干法制粒后(颗粒直径在5目、10目筛之间)，包装即可。
该发明专利中不同药材的比例是不允许超出本发明专利的范围，因为原料间的效果互补，一旦超出比例，产品将达不到应有的效果。如组方中铁皮石斛用量超出本发明专利范围，长期服用将会导致脾胃不好的人，出现腹泻、消化不良、腹痛等不良效果；再如枸杞的量增大或减少，产品均达不到清肝明目等效果。
试验例：
冲剂对小鼠免疫性肝损伤模型的影响：
小鼠正常饲养3d，随机分成4组，每组10只，即：正常对照组、BCG+LPS模型组。蛹虫草冲剂正常剂量组：120mg/kg；大剂量组：300mg/kg。
制作免疫性肝损伤模型，即由尾静脉注射0.2ml内含BCG 2.5mg的生理盐水悬液，12d后每尾静脉注射LPS 10ug，16h后处死小鼠，取血和肝组织作有关检测。在造模过程中，试验组每天灌胃相应的蛹虫草冲剂(120、300mg/kg)，正常对照组和模型对照组灌胃等量的生理盐水，连续12d。
肝损伤指标的检测：尾静脉注射LPS 16h后摘除小鼠眼球取血，分离血清，比色法测定ALT、AST；同时，脱颈椎处死小鼠，取肝脏左叶相同部位，用10％福尔马林液固定，作病理检查，按肝脏坏死程度分为4级：0级，没有坏死；1级，轻度肝坏死；2级，中级肝坏死；3级，严重坏死。累计每组动物肝坏死级数，计算其平均肝坏死级数与标准差。选肝脏右叶用冷生理盐水漂洗去除积血，拭净后再用冷生理盐水制备10％肝匀浆，分别按TBA法和NBT法测定丙二醛(MDA)和超氧歧化酶(SOD)的含量，用ELISA法测定肝匀浆中TNF-α和IL-Ⅰ的含量
表1冲剂对小鼠对血清转氨酶和MDA、SOD的影响(n＝10)
与正常对照组相比，##P<0.01；与模型组比，*P<0.05，**P<0.01
从表1实验结果中可看出，经过诱导的小鼠肝脏损伤明显，与正常对照组相比，BCG+LPS模型组中血清转氨酶ALT、AST都显著上升，过氧化物歧化酶SOD的活性也大大降低。MDA是肝氧化破坏的产物，经过BCG+LPS诱导的肝匀浆中MDA的水平明显增加，达到18.4nmol/mgprot，是正常对照组的10.8倍，肝细胞也出现明显的坏死现象。当实验组小鼠灌胃相应剂量的药物，12d后小鼠血清中ALT、AST升高的活性和肝匀浆中MDA的水平显著降低，而SOD的活性也有了一定的提高，尤其是大剂量组中SOD的活性几乎已经达到正常对照组的水平。由此可见，蛹虫草冲剂对免疫肝损伤模型中小鼠血清转氨酶和MDA、SOD的影响作用显著。
临床病例：
安徽省萧县退休教师肖XX，男，55岁，原本有高血压(低压105mmHg，高压160mmHg)、血糖也高(空腹血糖7.2mmol/L，餐后11.5mmol/L)，并且经常感冒，服用本发明虫草30d后，目前血液正常经测量低压85mmHg、高压120mmHg，空腹血糖6.0mmol/L，餐后7.5mmol/L，感冒症状明显减少，故说明本发明冲剂具有一定降血压、降血糖和提高免疫的功能。
本发明针对蛹虫草特点，发明了一种蛹虫草冲剂的制备方法，该发明专利采用蛹虫草为主原料，辅以铁皮石斛、山药、大枣、黄芪等药材，经反复验证，科学配伍，制备的一种具有滋肝益肾、提高免疫、补气血的保健型固体饮品。
以上所述，仅为本发明的具体实施方式，但本发明的保护范围并不局限于此，任何不经过创造性劳动想到的变化或替换，都应涵盖在本发明的保护范围之内。因此，本发明的保护范围应该以权利要求书所限定的保护范围为准。
Claims (5)
1.一种蛹虫草冲剂，其特征在于，其药材组方由以下重量分的原料组成：
蛹虫草20～40份
铁皮石斛15～25份
黄芪3～8份
枸杞8～12份
山药12～17份
去核大枣25～35份；
所述蛹虫草冲剂的制备方法，为：由如下步骤构成：
步骤一蛹虫草子实体处理
蛹虫草干子实体粗粉碎过80目，后经真空气流粉碎机粉碎到过1000目筛，粉碎的蛹虫草粉按照料水质量比1:20的比例加水，搅拌混合均匀后按照蛹虫草粉质量的0.15％加入纤维素酶，柠檬酸调节pH值至5.0，50℃条件下酶解120min，即可得到蛹虫草酶解液；
步骤二铁皮石斛处理
粗粉碎80目，进一步经真空气流粉碎机粉碎到过1000目筛，粉碎的铁皮石斛粉按照料水比1:20的比例加水，搅拌混合均匀后按照石斛粉质量的0.2％加入纤维素酶,柠檬酸调节pH值至5.0，45℃条件下酶解60min，即可得到铁皮石斛酶解液；
步骤三：药材提取
黄芪、枸杞、山药和去核大枣四种药材原料按照原料比例混合，混匀后过10目筛进行粉碎，按照四种药材混合原料质量的20倍加入纯水，充分搅拌混匀，98℃提取，提取过程中缓慢搅拌，提取60min后过滤收集滤液，滤渣重新 加入药材混合原料质量的20倍的水重复提取，98℃，提取60min，提取过程中缓慢搅拌，提取60min后过滤收集滤液，合并两次提取滤液即可得到四种药材水提取液；
步骤四：澄清、浓缩处理
将蛹虫草酶解液、铁皮石斛酶解液、四种药材提取液按照体积比1:1:2的比例合并，加入0.1％的壳聚糖絮凝剂，静置30min后，过滤澄清处理后，即可得到红棕色的滤液，将滤液采用单效浓缩器70℃条件下浓缩至固形物含量为35％；
步骤五：干燥、成型
将步骤四中浓缩获得的浸膏比重为1.15时，加入浸膏重量10％助干剂，搅拌混匀后，进一步均质处理后，将料液加热到70℃直接进行喷雾干燥处理，即可获得淡黄色粉末，黄色粉末中加入粉末1％的微晶纤维素、5％的乳糖醇，混合均匀经进一步干法制粒后，包装即得成品。
2.如权利要求1所述的蛹虫草冲剂，其特征在于，所述纤维素酶为食品级4万U/g的纤维素酶。
3.如权利要求1所述的蛹虫草冲剂，其特征在于，所述步骤五中，助干剂为DE8-10的麦芽糊精和CMC按照质量比为10:1的混合物。
4.如权利要求1所述的蛹虫草冲剂，其特征在于，所述步骤五中，喷雾干燥处理的进风口温度为190℃。
5.如权利要求1所述的蛹虫草冲剂，其特征在于，所述干法制粒所得颗粒直径在5目、10目筛之间。
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