CN104068391A - 一种罗汉果甙ⅳ含量高的芦荟罗汉果复方胶囊 - Google Patents
一种罗汉果甙ⅳ含量高的芦荟罗汉果复方胶囊 Download PDFInfo
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Abstract
本发明公开了一种罗汉果甙Ⅳ含量高的芦荟罗汉果复方胶囊，该胶囊具有预防治疗丙肝的作用。采用如下配比，以干基重量%计：原色全叶芦荟冷冻干燥粉5-10；罗汉果甙Ⅳ含量为15%-55%的罗汉果提取物8-12；金银花提取物6-12；板蓝根提取物4-8；玉米淀粉30-40；麦芽糊精10-25；微晶纤维素10-15；成品中功效成分含量为：每100g产品中，罗汉果甙Ⅳ含量为1200-6600mg，O-乙酰基含量大于800mg。正常用量是每日2-3次，每次1-2粒。
Description
技术领域
本发明涉及保健食品领域，尤其是一种芦荟罗汉果复方胶囊。
背景技术
芦荟含有蒽醌类化合物、芦荟多糖、氨基酸、有机酸、维生素、矿物质、酶等功效成分，可用于食品、药品、化妆品，具有提高免疫力、减肥、美容等保健功效，还有清热通便、健脾益胃、增进食欲、抗菌抗肿瘤等作用。行业标准QB/T2489-2007 规定了原色全叶芦荟冷冻干燥粉的生产工艺及其质量指标，其中规定了芦荟多糖含量，以O-乙酰基含量计，保留了芦荟的活性成分。张裕民，钟喜光在湖南中医药导报2003,9(9):56公开了一种芦荟(颗粒)胶囊制备工艺研究。
罗汉果是葫芦科多年生草质藤本植物，为***首批公布的药食两用名贵中药材，被人们誉为“神仙果”。罗汉果营养价值很高，含罗汉果甙类，其中罗汉果甙Ⅴ是罗汉果干果的主要成分，约占干果的0.5%。罗汉果甙Ⅳ含量很少，在果龄30-50天时含量较高，在成熟过程中逐渐转化消失。另外含有葡萄糖、果糖、多糖、蛋白质、氨基酸、黄酮甙类、维生素C和多种矿质元素，具有味甘性凉，归肺、大肠经，有润肺止咳，生津止渴的功效，适用于肺热或肺燥咳嗽，百日咳及暑热伤津口渴等，此外还有润肠通便的功效。罗汉果深加工主要是提取罗汉果甙类。中国发明专利申请公开号为CN101007042A，公开了一种脱色、脱苦，含罗汉果甙类的提取物制备方法，但没有提及罗汉果甙Ⅳ含量。
板蓝根，又名：大蓝根。为植物菘蓝或草大青的干燥根。功效有清热，解毒，凉血，利咽；主治温毒发斑；高热头痛；肝炎；流行性感冒，可防治流行性乙型脑炎、急慢性肝炎、流行性腮腺炎、骨髓炎。板蓝根在临床上清热凉血、抗病毒抗菌作用明显，用量大，堪称中成药之最。
金银花，又名忍冬，其功效主要是清热解毒，主治温病发热、热毒血痢、痈疽疔毒等。现代研究证明，金银花含有绿原酸、木犀草素苷等药理活性成分，对溶血性链球菌、金黄葡萄球菌等多种致病菌及上呼吸道感染致病病毒等有较强的抑制力，另外还可增强免疫力、护肝、抗肿瘤、消炎、解热等。
丙型病毒性肝炎，简称为丙型肝炎、丙肝，是一种由丙型肝炎病毒（HCV）感染引起的病毒性肝炎，主要经输血、针刺、吸毒等传播，据世界卫生组织统计，全球HCV的感染率约为3%，估计约1.8亿人感染了HCV，每年新发丙型肝炎病例约3.5万例。丙型肝炎呈全球性流行，可导致肝脏慢性炎症坏死和纤维化，部分患者可发展为肝硬化甚至肝细胞癌（HCC）。未来20年内与HCV感染相关的死亡率（肝衰竭及肝细胞癌导致的死亡）将继续增加，对患者的健康和生命危害极大，已成为严重的社会和公共卫生问题。
发明内容
本发明所要解决的技术问题是提供一种罗汉果甙Ⅳ含量高的芦荟罗汉果复方胶囊，该胶囊具有预防和治疗丙肝的作用，副作用低。
为了解决这个技术问题，本发明采用符合轻工行业标准QB/T2489-2007 规定的原色全叶芦荟冷冻干燥粉，罗汉果甙Ⅳ含量高的罗汉果提取物，金银花提取物和板蓝根提取物为主要原料，添加玉米淀粉、麦芽糊精，微晶纤维素等辅料；经粉碎、过筛、混合、制粒、包衣、填充，铝塑包装，制得成品。
芦荟罗汉果复方胶囊的配方为，按干基重量%计，
原色全叶芦荟冷冻干燥粉5-10；
罗汉果甙Ⅳ含量为15%-55%的罗汉果提取物8-12；
金银花提取物 6-12；
板蓝根提取物4-8；
玉米淀粉 30-40；
麦芽糊精10-25；
微晶纤维素10-15；
包衣采用按配方比例2.0%羟丙基甲基纤维素(HPMC)，包衣液采用60%的乙醇作溶媒，配成浓度为6.0%-8.0%包衣液。
成品中功效成分含量为：每100g产品中，罗汉果甙Ⅳ含量为1200-6600mg ，O-乙酰基大于800mg。
所述罗汉果甙Ⅳ含量为15%-55%的罗汉果提取物，是采用果龄为30-50天的鲜罗汉果，加2倍重量的水，先用磨碎机磨碎，再加6倍20％乙醇溶液，然后进行超声波回流提取1.5h，过滤，重复3次，合并提取液。将提取液用截留分子得到浓缩液1，将浓缩液1量为1000的超滤膜初步浓缩，得到浓缩液1，将浓缩液1注入AB-8吸附树脂柱，弃去柱流出液；吸附完成后，以2倍柱床体积的20％乙醇溶液洗脱至柱流出液为无色，最后以3.5倍柱床体积的75％乙醇溶液洗脱，收集洗脱液1。将洗脱液1中的乙醇减压蒸发回收后，加入水，经D-280离子交换树脂脱色，将柱流出液减压干燥，得浅黄色产品，即罗汉果甜甙粗品。罗汉果甜甙粗品再用水稀释10-20倍，采用大孔树脂再次吸附，树脂选用D201，或者HPD100进行分离，用70%的乙醇溶液洗脱，洗脱时间为100分钟，得到洗脱液2，将洗脱液2中的乙醇经减压蒸发回收后，得到浓缩液2，将浓缩液2进行减压干燥，得白色或淡黄色产品，即得罗汉果甙Ⅳ含量为15%-55%的罗汉果提取物。
所述金银花提取物和板蓝根提取物是在市场上购买的。
胶囊的重量是每粒0.3g。正常用量是每日2-3次，每次1-2粒。
胶囊制作时，先将各原辅料粉碎，过100目到200目的筛，然后按配方称取原辅料，采用V混合机混合；制粒选用95%的乙醇制软材，振筛机制粒，包衣，然后在35-40℃减压干燥，以进一步除去乙醇和水分，干燥后物料水分控制在3.0%以下。然后用1#胶囊壳填充成0.3g的硬胶囊。
本发明在保持罗汉果提取物、原色全叶芦荟冷冻干燥粉、金银花提取物和板蓝根提取物的基本比例前提下，还可以制成其他口服剂型，比如片剂，颗粒剂。
本发明具有下列优点和特性：
1、品质好。采用的罗汉果提取物是一种脱色、脱苦，罗汉果甙Ⅳ含量为15-55%的提取物，罗汉果甙Ⅳ纯度高，对丙肝有预防治疗作用，效果好。采用原色全叶芦荟冷冻干燥粉，含有芦荟乙酰化多糖、氨基酸、有机酸、维生素、矿物质等成分，采用的金银花提取物为白色精细粉末，每克提取物有效成份含量相当于生药材15倍以上，采用的板蓝根提取物为用冷浸渗漉法生产，精氨酸2.7%以上、总氮量达5%，其它活性收率达90%以上；这些组分按照配方复配，浓缩了各种活性物质精华，品质好。
2、具有预防和治疗丙肝的作用。各种有效成分在一起，互相支持，互相协作，起到了增效作用；通过初步实验表明，该复方胶囊对由HCV感染引起的丙型病毒性肝炎患者具有明显疗效，对HCV病毒有抑制作用。这种抑菌效果比用配方中的单一组分要好很多，也不是各组分简单的叠加，复方胶囊的抑菌作用是芦荟、罗汉果甙Ⅳ含量高的罗汉果提取物、金银花提取物和板蓝根提取物复配后互相支持，共同起的作用，并且副作用低。
具体实施方式
以下所述实例详细地说明了本发明。在实例中，除另有说明外，所有份数和百分比均按重量计。
实施例1
1、将符合要求的罗汉果甙Ⅳ含量为15%的罗汉果提取物、原色全叶芦荟冷冻干燥粉、金银花提取物、板蓝根提取物，用气流粉碎机分别粉碎，过200目筛，得到合格的原料，检测含量，备用；玉米淀粉，麦芽糊精，微晶纤维素分别用超微粉碎机粉碎，过200目筛，备用。
2、称取粉碎好的玉米淀粉3.6kg，罗汉果甙Ⅳ含量为15%的罗汉果提取物1.2kg，原色全叶芦荟冷冻干燥粉1.0kg，金银花提取物1.0kg，板蓝根提取物0.5kg，麦芽糊精1.5kg，微晶纤维素1.2kg。依次投入V混合机内，充分混合，得到10kg混合物。
3、将混合物用95%的乙醇制软材，振动筛制粒。
4、包衣。称取羟丙基甲基纤维素(HPMC)200g，用60%的乙醇配成8%的包衣液，包衣控制包衣锅内温度在35-40℃，控制转速在30-35转/min，用高压喷枪均匀喷人包衣液，并不断翻动颗粒。直至包衣液包完。取出，减压(不加热)干燥2h，得到合格的颗粒。
5、将合格的颗粒用1#胶囊壳在胶囊填充机填充成0.3g每粒的硬胶囊，抛光，然后制成铝塑板，装盒，制成成品。检测该成品：其中罗汉果甙Ⅳ含量为1800mg/100g，O-乙酰基含量为1500mg/100g。经HCV病毒抑菌试验，抑菌试验评分达到7.0分。
实施例2
1、将符合要求的罗汉果甙Ⅳ含量为55%的罗汉果提取物、原色全叶芦荟冷冻干燥粉、金银花提取物、板蓝根提取物，用超微粉碎机分别粉碎，过100目筛，得到合格的原料，检测含量，备用；玉米淀粉，麦芽糊精，微晶纤维素分别用超微粉碎机粉碎，过100目筛，备用。
2、称取粉碎好的玉米淀粉32kg，罗汉果甙Ⅳ含量为55%的罗汉果提取物8kg，原色全叶芦荟冷冻干燥粉5kg，金银花提取物12kg，板蓝根提取物8kg，麦芽糊精25kg，微晶纤维素10kg。依次投入V混合机内，充分混合，得到100kg混合物。
3、将混合物用95%的乙醇制软材，振动筛制粒。
4、包衣。称取羟丙基甲基纤维素2kg，用60%的乙醇配成6%的包衣液，包衣控制包衣锅内温度在35-40℃，控制转速在30-35转/min，用高压喷枪均匀喷人包衣液，并不断翻动颗粒。直至包衣液包完。取出，减压干燥2h，得到合格的颗粒。
5、将合格的颗粒用1#胶囊壳在胶囊填充机填充成0.3g每粒的硬胶囊，抛光，然后制成铝塑板，装盒，制成成品。该成品中，其中罗汉果甙Ⅳ含量为4400mg/100g，O-乙酰基含量为800mg/100g。经HCV病毒抑菌试验，抑菌试验评分达到7.8分。
实施例3
1、将符合要求的罗汉果甙Ⅳ含量为40%的罗汉果提取物、原色全叶芦荟冷冻干燥粉、金银花提取物、板蓝根提取物，用超微粉碎机分别粉碎，过120目筛，得到合格的原料，检测含量，备用；玉米淀粉，麦芽糊精，微晶纤维素分别用超微粉碎机粉碎，过120目筛，备用。
2、称取粉碎好的玉米淀粉3.8kg，罗汉果甙Ⅳ含量为40%的罗汉果提取物1.0kg，原色全叶芦荟冷冻干燥粉1.0kg，金银花提取物1.2kg，板蓝根提取物0.5kg，麦芽糊精1.5kg，微晶纤维素1.0kg。依次投入V混合机内，充分混合，得到10kg混合物。
3、将混合物用95%的乙醇制软材，摇摆制粒，整粒，减压干燥，颗粒的水分为2.8%，得到合格的颗粒。
4、将合格的颗粒用1#胶囊壳在胶囊填充机填充成0.3g每粒的硬胶囊，抛光，然后制成铝塑板，装盒，制成成品。该成品中，其中罗汉果甙Ⅳ含量为4000mg/100g，O-乙酰基含量为1200mg/100g。
Claims (2)
1.一种罗汉果甙Ⅳ含量高的芦荟罗汉果复方胶囊，其特征在于：按干基重量%计，配方为：
原色全叶芦荟冷冻干燥粉5-10；
罗汉果甙Ⅳ含量为15%-55%的罗汉果提取物8-12；
金银花提取物 6-12；
板蓝根提取物4-8；
玉米淀粉 30-40；
麦芽糊精10-25；
微晶纤维素10-15；
包衣采用配方2.0%羟丙基甲基纤维素(HPMC)，包衣液采用60%的乙醇作溶媒，配成浓度为6.0%-8.0%包衣液；
成品中功效成分含量为：每100g产品中，罗汉果甙Ⅳ含量为1200-6600mg，O-乙酰基含量大于800mg。
2.根据权利要求1所述的芦荟罗汉果复方胶囊，其特征在于：所述罗汉果甙Ⅳ含量为15%-55%的罗汉果提取物，是采用如下方法制取：
采用果龄为30-50天的鲜罗汉果，加2倍重量的水，先用磨碎机磨碎，再加6倍重量20％乙醇溶液，然后进行超声波回流提取1.5h，过滤，重复3次，合并提取液；
将提取液用截留分子量为1000的超滤膜初步浓缩，得到浓缩液1；
将浓缩液1注入AB-8吸附树脂柱，弃去柱流出液；吸附完成后，以2倍柱床体积的20％乙醇溶液洗脱至柱流出液为无色，最后以3.5倍柱床体积的75％乙醇溶液洗脱，收集洗脱液1；
将洗脱液1中的乙醇减压蒸发回收后，加入水，经D-280离子交换树脂脱色，将柱流出液减压干燥，得浅黄色产品，即罗汉果甜甙粗品；
罗汉果甜甙粗品再用水稀释10-20倍，采用D201或者HPD100大孔树脂再次吸附，用70%的乙醇溶液洗脱，洗脱时间为100分钟，得到洗脱液2；
将洗脱液2中的乙醇经减压蒸发回收后，得到浓缩液2；将浓缩液2进行减压干燥，得白色或淡黄色产品，即得罗汉果甙Ⅳ含量为15%-55%的罗汉果提取物。
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| CN106261001A (zh) * | 2015-06-02 | 2017-01-04 | 桂林电子科技大学 | 一种罗汉果复方提取物的制备方法 |
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