CN106491747A - 虫草芪参胶囊的制备及质量标准检测方法 - Google Patents
虫草芪参胶囊的制备及质量标准检测方法 Download PDFInfo
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Abstract
本发明属于中草药提取技术领域，公开了虫草芪参胶囊的制备及质量标准检测方法，其包括如下步骤：步骤1）制备冬虫夏草细粉，步骤2）制备黄芪浸膏，步骤3）制备丹参红花浸膏，步骤4）制备酸枣仁浸膏，步骤5）混匀、干燥以及制粒。本发明制备方法能够充分提取原料中的有效成本，避免原料浪费，药效效果优于现有的胶囊制剂。
Description
技术领域
本发明属于中草药提取技术领域，具体的，涉及虫草芪参胶囊的制备及质量标准检测方法。
背景技术
虫草芪参胶囊主要由冬虫夏草、黄芪、丹参、红花以及酸枣仁制备而得，具有补肺益肾，活血化瘀等功效。适用于慢性肾炎患者导致的肺肾气虚、瘀血阻滞等证候。虫草芪参胶囊是一种有效治疗慢性肾炎的药物，其原料成分相对简单，效果好，毒副作用小，备受患者青睐。申请人在制药过程中发现，该药物制备方法比较单一，对多种原料采用相同提取工艺，存在有效成分流失的缺陷，而且虫草芪参胶囊每次需要服用4粒，每天三次，服药量过大，部分病人很难接受，容易出现排斥情绪。如何通过改进工艺，来最大限度的利用原料，提高药效，是我们需要研究的问题。
举例来说，目前市售的黄芪注射液一般采用水提醇沉的方法制备，注射剂中有效成分为黄芪皂苷，不含黄芪多糖或含量极少，而黄芪多糖也是黄芪的有效成分，具有增强免疫力、抗病毒、抗肿瘤、抗辐射、抗应激、抗氧化等作用。
发明内容
为了克服现有技术的缺陷，本发明提出虫草芪参胶囊的制备方法，该方法简单可行、最大限度提取了原料药材的有效成分，提高了药效，减少了药物服用量。
本发明还公开了虫草芪参胶囊的质量标准检测方法。
本发明是通过如下技术方案来实现的：
虫草芪参胶囊的制备方法，其包括如下步骤：步骤1）制备冬虫夏草细粉，步骤2）制备黄芪浸膏，步骤3）制备丹参红花浸膏，步骤4）制备酸枣仁浸膏，步骤5）混匀、干燥以及制粒。
具体地，所述制备方法包括如下步骤：
步骤1）制备冬虫夏草细粉：取冬虫夏草140g，粉碎成冬虫夏草细粉；
步骤2）制备黄芪浸膏：取黄芪1400g，粉碎，过200目筛，置于容器中，添加两倍重量的85%（v/v）的乙醇，200rpm搅拌提取，提取过程中控制微波功率为600W，提取时间为50min；然后置于4℃放置12h，过滤，滤渣备用；滤液减压蒸发回收乙醇，并浓缩滤液至密度为1.2g/ml的浸膏A；
将上述滤渣加两倍重量的水，搅拌均匀，然后加入0.5wt%的中性蛋白酶，在37℃酶解120min，然后煮沸5min，然后加入占滤渣两倍重量的无水乙醇，300rpm搅拌5min，然后静置12h，去除上清液，收集沉淀，加水溶解，-20℃放置12h，然后3000rpm离心，过滤去除沉淀，将滤液减压浓缩至密度为1.2g/ml的浸膏B；合并浸膏A和浸膏B得到黄芪浸膏；
步骤3）制备丹参红花浸膏：取丹参560g，粉碎，过200目筛，然后铺成3mm厚度的平层，置于紫外线下照射15min，收集粉末；取红花560g，将红花和上述粉末混合，置于容器中，添加两倍重量的75%（v/v）乙醇，300rpm搅拌提取，提取过程中控制微波功率为600W，提取时间为30min；过滤，收集滤液，减压回收乙醇，浓缩成1.3g/ml的丹参红花浸膏；
步骤4）制备酸枣仁浸膏：取酸枣仁280g，加水煎煮两次，第一次加8倍重量的水，煎煮2小时，过滤后得到滤液和药渣；往药渣添加5倍重量的水，煎煮1.5小时，过滤得滤液；合并上述两次的滤液，浓缩成密度为1.1g/ml的清膏，冷却，添加乙醇使含醇量达70％（体积分数），静置24小时，滤过，取上清液，减压回收乙醇，浓缩至密度为1.3g/ml的浸膏，即得酸枣仁浸膏；
步骤5）混匀、干燥以及制粒：将步骤2）所得黄芪浸膏，步骤3）所得丹参红花浸膏，步骤4）所得酸枣仁浸膏，混匀，60℃烘干，然后粉碎，加入步骤1）所得冬虫夏草细粉，混匀，干燥，制粒。
根据上述的制备方法制备的制剂。
上述制剂的质量标准检测方法，其应检出冬虫夏草、原儿茶醛以及大黄，每粒胶囊制剂含黄芪甲苷应不少于0.27mg。
本发明相对于现有技术具有如下的优点及效果：
本发明制备方法简单可行，对不同的中药成分采用不同技术进行处理，提高了各原料的有效成分，增加了药效，减少了原料浪费；丹参提取时，采用煎煮的方式，容易导致酚酸以及酮类物质的分解，本发明方法采用微波醇提的方式，避免了上述缺陷；较小的粒径能够提高黄芪有效组分的浸出率，配合微波醇提等获得苷类化合物以及多糖类，避免了成分的流失；本发明丹参提取方法采用合适强度的紫外线进行辅助破壁，提高了有效成分的溶出度，同时采用微波辅助水提，时间短，提高了提取效率，降低了能耗；红花中的绿原酸等酸类物质、酚类有效物质不易采用煎煮的方式，本发明采用微波辅助醇提，保留了有效成分，避免了绿原酸等有效的丢失；本发明制备的胶囊制剂有效成分高，效果好，动物实验提示其效果优于现有的胶囊制剂，可用于进一步的临床研究。本发明还提出了虫草芪参胶囊质量标准，有助于GMP生产车间的质量控制。
具体实施方式
为了使本技术领域的人员更好地理解本申请中的技术方案，下面将结合本申请具体实施例，对本发明进行更加清楚、完整地描述，显然，所描述的实施例仅仅是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都应当属于本发明保护的范围。
实施例1
虫草芪参胶囊的制备方法，其包括如下步骤：
1）取冬虫夏草140g，粉碎成冬虫夏草细粉；
2）取黄芪1400g，粉碎，过200目筛，置于容器中，添加两倍重量的85%（v/v）的乙醇，200rpm搅拌提取，提取过程中控制微波功率为600W，提取时间为50min；然后置于4℃放置12h，过滤，滤渣备用；滤液减压蒸发回收乙醇，并浓缩滤液至密度为1.2g/ml的浸膏A；采用高效液相色谱法测试黄芪甲苷含量为1.27mg/ml；
将滤渣加两倍重量的水，搅拌均匀，然后加入0.5wt%的中性蛋白酶 (20万U/g)，在37℃酶解120min，然后煮沸5min，然后加入占滤渣两倍重量的无水乙醇，300rpm搅拌5min，然后静置12h，去除上清液，收集沉淀，加水溶解，-20℃放置12h，然后3000rpm离心，过滤去除沉淀，将滤液减压浓缩至密度为1.2g/ml的浸膏B；合并浸膏A和浸膏B得到黄芪浸膏；采用凝胶色谱法测得浸膏B中黄芪多糖分子量多分布于20000～40000，占总糖的70％以上；
3）取丹参560g，粉碎，过200目筛，然后铺成3mm厚度的平层，置于紫外线下照射15min，收集粉末；取红花560g，将红花和上述粉末混合，置于容器中，添加两倍重量的75%（体积份数）乙醇，300rpm搅拌提取，提取过程中控制微波功率为600W，提取时间为30min；过滤，收集滤液，减压回收乙醇，浓缩成1.3g/ml的丹参红花浸膏；所述紫外线强度为3000uW/cm2；
4） 取酸枣仁280g，加水煎煮两次，第一次加8倍重量的水，煎煮2小时，过滤后得到滤液和药渣；往药渣添加5倍重量的水，煎煮1.5小时，过滤得滤液；合并上述两次的滤液，浓缩成密度为1.1g/ml的清膏，冷却，添加乙醇使含醇量达70％（体积分数），静置24小时，滤过，取上清液，减压回收乙醇，浓缩至密度为1.3g/ml的浸膏，即得酸枣仁浸膏；
5）将步骤2）所得黄芪浸膏，步骤3）所得丹参红花浸膏，步骤4）所得酸枣仁浸膏，混匀，60℃烘干，然后粉碎，加入步骤1）所得冬虫夏草细粉，混匀，干燥制成1000粒。
用法用量：口服，一次3粒，0.45g/粒，一日3次。
对照例1
一种用于治疗慢性肾炎的虫草芪参胶囊，其由下述重量的原料制备而得：冬虫夏草140g、黄芪 1400g、丹参 560g、红花 560g、酸枣仁280g
所述虫草芪参胶囊的制备方法为：按照重量称取原料药备用
（1）取冬虫夏草粉碎成细粉；
（2）取黄芪、丹参、红花、酸枣仁加水煎煮两次，第一次加10倍量水，煎煮2小时，过滤后得到滤液和药渣；
（3）在步骤（2）中所得到的药渣添加8倍量水，煎煮1.5小时，过滤得滤液；
（4）合并步骤（2）和步骤（3）的滤液，浓缩成相对密度为1.16-1.18（50℃）的清膏，冷却，添加乙醇使含醇量达70％（体积分数），静置24小时，滤过，取上清液，减压回收乙醇，浓缩至密度为1.38-1.40g/ml(50℃)的干浸膏，粉碎，加入步骤（1）制备的细粉混匀，干燥制成1000粒。
用法用量：口服，一次4粒，0.45g/粒，一日3次。
实施例2
本发明虫草芪参胶囊GPM车间处方和质量标准检测见表1-2：
表1
| 名称 | 用量kg | 储存要求 |
| 冬虫夏草 | 67.2 | 置阴凉干燥处，防蛀 |
| 黄芪 | 672 | 置通风干燥处，防潮，防蛀 |
| 丹参 | 268.8 | 置干燥处 |
| 红花 | 268.8 | 置阴凉干燥处，防潮，防蛀 |
| 酸枣仁 | 134.4 | 置阴凉干燥处，防蛀 |
| 淀粉 | 适量 | 密闭，在干燥处保存。 |
| 空心胶囊 | 48万粒 | 密闭，在温度10-25℃，相对湿度35-65%条件下保存。 |
表2
实施例3
动物毒性试验
健康昆明品系小鼠40只，雌雄各半，体重为18.3±1.9g， 将40只小鼠随机分为两组，每组雌雄各半，其中20只为对照组，灌以常水；另外20只小鼠给予实施例1制备的胶囊制剂，剂量为200mg/kg，每天三次，应用小鼠进行毒性实验表明：与对照组比较，给药后小鼠未见明显差异，实验连续观察两周，小鼠全身状况、摄食、饮水、体重增长均正常。给药当天及给药后两周内，未见动物死亡，提示该药毒性低，临床用药安全。
实施例4
药效对比试验
动物：SD雄性大鼠80只，体重218±22g，健康清洁级，本公司实验动物中心饲养。
分组处理：80只SD雄性大鼠，根据体重无显著差异随机选取20只为空白对照组，其余60只进行阿霉素肾病模型制备。将模型大鼠随机分为模型对照组（灌胃生理盐水，剂量100mg/kg）、实施例1组（灌胃实施例1的制剂，剂量100mg/kg）、对照例1组（灌胃对照例1的制剂，剂量100mg/kg），每组20只。每日灌胃一次，连续一月。各组大鼠分别于试验开始时和结束时留取24h尿量以测量24h尿蛋白定量（磺柳酸法）。
观察指标：包括大鼠饮食量、体毛、大便、精神状态及体重、水肿等情况。
结果：模型对照组大鼠精神较差，食量减少，体重减轻，体毛蓬松，自第三周开始水肿明显。实施例1组和对照例1组大鼠精神较好，食量较多，体重重于模型对照组，水肿较轻，而实施例1组体重、精神、食量、水肿状况好于对照例1组。各组大鼠尿蛋白定量动态变化比较见表3所示。
表3
| 组别 | 开始时间检测结果 | 结束时间检测结果 |
| 空白对照组 | 22.15±3.97 | 23.28±4.03 |
| 模型对照组 | 228.27±48.35 | 364.53±67.81 |
| 实施例1组 | 231.64±54.33 | 217.65±50.72 |
| 对照例1组 | 226.08±48.69 | 279.04±69.36 |
最后，还需要注意的是，以上列举的仅是本发明的若干个具体实施例。显然，本发明不限于以上实施例，还可以有许多变形。本领域的普通技术人员能从本发明公开的内容直接导出或联想到的所有变形，均应认为是本发明的保护范围。
Claims (4)
1.虫草芪参胶囊的制备方法，其包括如下步骤：步骤1）制备冬虫夏草细粉，步骤2）制备黄芪浸膏，步骤3）制备丹参红花浸膏，步骤4）制备酸枣仁浸膏，步骤5）混匀、干燥以及制粒。
2.根据权利要求1所述的制备方法，其特征在于，所述制备方法包括如下步骤：
步骤1）制备冬虫夏草细粉：取冬虫夏草140g，粉碎成冬虫夏草细粉；
步骤2）制备黄芪浸膏：取黄芪1400g，粉碎，过200目筛，置于容器中，添加两倍重量的85%（v/v）的乙醇，200rpm搅拌提取，提取过程中控制微波功率为600W，提取时间为50min；然后置于4℃放置12h，过滤，滤渣备用；滤液减压蒸发回收乙醇，并浓缩滤液至密度为1.2g/ml的浸膏A；
将上述滤渣加两倍重量的水，搅拌均匀，然后加入0.5wt%的中性蛋白酶，在37℃酶解120min，然后煮沸5min，然后加入占滤渣两倍重量的无水乙醇，300rpm搅拌5min，然后静置12h，去除上清液，收集沉淀，加水溶解，-20℃放置12h，然后3000rpm离心，过滤去除沉淀，将滤液减压浓缩至密度为1.2g/ml的浸膏B；合并浸膏A和浸膏B得到黄芪浸膏；
步骤3）制备丹参红花浸膏：取丹参560g，粉碎，过200目筛，然后铺成3mm厚度的平层，置于紫外线下照射15min，收集粉末；取红花560g，将红花和上述粉末混合，置于容器中，添加两倍重量的75%（v/v）乙醇，300rpm搅拌提取，提取过程中控制微波功率为600W，提取时间为30min；过滤，收集滤液，减压回收乙醇，浓缩成1.3g/ml的丹参红花浸膏；
步骤4）制备酸枣仁浸膏：取酸枣仁280g，加水煎煮两次，第一次加8倍重量的水，煎煮2小时，过滤后得到滤液和药渣；往药渣添加5倍重量的水，煎煮1.5小时，过滤得滤液；合并上述两次的滤液，浓缩成密度为1.1g/ml的清膏，冷却，添加乙醇使含醇量达70％（体积分数），静置24小时，滤过，取上清液，减压回收乙醇，浓缩至密度为1.3g/ml的浸膏，即得酸枣仁浸膏；
步骤5）混匀、干燥以及制粒：将步骤2）所得黄芪浸膏，步骤3）所得丹参红花浸膏，步骤4）所得酸枣仁浸膏，混匀，60℃烘干，然后粉碎，加入步骤1）所得冬虫夏草细粉，混匀，干燥，制粒。
3.根据权利要求1-2所述的制备方法制备的制剂。
4.权利要求3所述制剂的质量标准检测方法，其包括如下步骤：应检出冬虫夏草、原儿茶醛以及大黄，每粒胶囊制剂含黄芪甲苷应不得少于0.27mg。
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