CN107519434A - 蒲苓盆炎康颗粒及其质量检测方法 - Google Patents
蒲苓盆炎康颗粒及其质量检测方法 Download PDFInfo
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Abstract
本发明属于中药技术领域，公开了蒲苓盆炎康颗粒，其包括如下重量的原料药：土茯苓1000g，丹参533.4g，夏枯草533.4g，蒲公英666.6g，车前子533.4g，粉萆薢333.4g，杜仲333.4g，三七 133.4g，川芎200g。本发明制剂有效成分高，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。
Description
技术领域
本发明属于药物技术领域，具体地，涉及蒲苓盆炎康颗粒及其质量检测方法。
背景技术
盆腔炎即盆腔炎症是指女性盆腔生殖器官、子宫周围的结缔组织及盆腔腹膜的炎症。主要病因为产后或流产后感染、宫腔内手术操作后感染、经期卫生不良、邻近器官的炎症直接蔓延、慢性盆腔炎的急性发作等。分为输卵管积水与输卵管卵巢囊肿、输卵管炎和慢性盆腔结缔组织炎。盆腔炎症的临床表现有急性和慢性两类，急性盆腔炎症的症状是下腹痛、发热、阴道分泌物增多，腹痛为持续性，活动或性交后加重，病情严重的可有寒战、高热、头痛、食欲不振，急性盆腔炎进一步发展可引起弥漫性腹膜炎、败血症、感染性休克，严重者可危及生命。慢性盆腔炎症的症状是下腹部坠胀，疼痛及腰骶部酸痛，常在劳累、性交后及月经前后加剧，病程长时可出现精神不振、周身不适、失眠等神经衰弱症状，近年来其发病率有升高趋势，本病发病诱因复杂，病情顽固，易反复发作，症状时好时坏，严重影响妇女的身心健康及工作。
蒲苓盆炎康颗粒是申请人独立研发，具有药品批号的药物制剂，上市以来取得了巨大成就，据此，申请人也申请了关于蒲苓盆炎康颗粒的专利技术，例如“2006101525479，一种治疗慢性盆腔炎的药物及其制备方法”，对在售蒲苓盆炎康颗粒进行保护；后期的专利“2015103361326，一种用于盆腔炎的蒲苓盆炎康药物制剂及其检测方法”在已知蒲苓盆炎康颗粒的基础上进行了改进，包括蒲公英40份、土茯苓35份、杠板归35份、葛根35份、百合30份、香附30份、赤芍30份、败酱草25份、黄柏25份、血竭25份、肉桂25份、三棱20份、蒲黄20份、枳壳20份、没药17份、桔梗17份、白芷15份、茜草10份、茯苓10份、连翘10份、百部10份、金银花5份，其效果优于已知药物，但是存在原料种类多，成本高等缺陷。
发明内容
为了克服现有技术的缺陷，本发明提出蒲苓盆炎康颗粒，该药物制剂在已有产品的基础上，对工艺技术做了改进，提高了药效，避免了原料的浪费。
本发明还提供了蒲苓盆炎康颗粒的质量检测方法。
本发明是通过如下技术方案来实现的：
蒲苓盆炎康颗粒，其包括如下重量的原料药：
土茯苓1000g，丹参533.4g，夏枯草533.4g，蒲公英666.6g，车前子533.4g，粉萆薢333.4g，杜仲333.4g，三七 133.4g，川芎200g。
具体地，所述蒲苓盆炎康颗粒按照如下工艺制备而得：
1）取丹参，粉碎成80目粗粉，用1.5倍重量的90％(v/v)的乙醇浸渍24小时，再加90％(v/v)乙醇溶液渗漉，漉速1-3ml/min，收集渗漉液，渗漉液回收乙醇后得到药液，药渣备用；
2）取川芎、杜仲、三七和车钱子，每次加生药5倍重量的70％(v/v)的乙醇浸渍24小时，在室温下浸渍3次，合并浸渍液，回收乙醇，药液及药渣备用；
3）取土茯苓和蒲公英，粉碎，过80目筛，置于容器中，添加两倍重量的85%（v/v）的乙醇，300rpm搅拌提取，提取过程中控制微波功率为500W，提取时间为120min；然后置于4℃放置12h，过滤收集滤液，滤渣备用；
4）取粉萆薢和夏枯草，粉碎，过200目筛，投入超声提取罐，加入三倍重量的75%（v/v）的乙醇，超声提取30min，过滤收集滤液；
5）合并步骤1、步骤2）以及步骤3）所得药渣，加10倍重量的水，煎煮3次，每次1小时，合并煎液，滤过，然后添加步骤1）所得药液、步骤2）所得药液、步骤3）所得滤液以及步骤4）所得滤液，混匀，减压浓缩至在50℃时的密度为1.20g/ml的清膏，继续减压干燥，得干浸膏，干燥，粉碎，加入辅料适量，混匀，装入胶囊，制成1000粒，即得。
优选地，所述超声提取的条件为：温度为50℃，频率50KHz。
优选地，所述辅料为蔗糖粉和糊精的混合物。
本发明药材的鉴定与来源：
（1）土茯苓 购自平邑县瑞康中药饮片有限公司，产地广东。经山东翔宇健康制药有限公司鉴定为百合科植物光叶菝葜Smilax glabra Roxb.的干燥根茎。药材除去杂质。
（2）丹参 购自平邑县瑞康中药饮片有限公司，产地山东。经山东翔宇健康制药有限公司鉴定为唇形科植物丹参Salvia miltionrrhiza Bge.的干燥根及根茎。药材除去杂质。
（3）夏枯草 购自亳州奉天药业有限责任公司，产地河南。经山东翔宇健康制药有限公司鉴定为唇形科植物夏枯草Prunella vulgaris L.的干燥果穗。药材除去杂质，切段。
（4）蒲公英 购自平邑县瑞康中药饮片有限公司，产地山东。经山东翔宇健康制药有限公司鉴定为菊科植物蒲公英Taraxacum mongolicum Hand.-Mazz.的干燥全草。药材除去杂质，切段。
（5）车前子 购自平邑县瑞康中药饮片有限公司，产地江西。经山东翔宇健康制药有限公司鉴定为车前科植物车前Ptantago asiatica L.的干燥成熟种子。药材除去杂质。
（6）粉萆薢 购自平邑县瑞康中药饮片有限公司,产地浙江。经山东翔宇健康制药有限公司鉴定为薯蓣科植物粉背薯蓣Dioscorea hypogtauca Palibin 的干燥根茎。药材切成薄片。
（7）杜仲 购自平邑县瑞康中药饮片有限公司,产地四川。经山东翔宇健康制药有限公司鉴定为杜仲科植物杜仲Eucommia ulmoides Oliv.的干燥树皮。药材除去杂质。
（8）三七 购自亳州奉天药业有限责任公司，产地云南。经山东翔宇健康制药有限公司鉴定为五加科植物三七Panax notoginseng(Burk.)F.H.Chen的干燥根及根茎。药材除去杂质。
（9）川芎 购自平邑县瑞康中药饮片有限公司,产地四川。经山东翔宇健康制药有限公司鉴定为伞形科植物川芎Ligusticum chuanxiong Hort.的干燥根茎。药材除去杂质。
相对于现有技术，本发明的出发点以及有益效果主要包括以下几个方面：
现有技术对土茯苓、蒲公英、粉萆薢和夏枯草四种原料药简单采用水提处理，会造成不溶于水的黄酮类以及皂苷类物质流失；蒲公英中的黄酮类物质一般难溶于水，其具备广谱抗菌、清热解毒，散结消肿，而多糖易溶于水具备抗菌，抗氧化，抗疲劳，免疫调节等功能；土茯苓以及蒲公英黄酮，夏枯草中熊果酸、齐墩果酸为主的三萜类成分，粉萆蘚甾体类化合物具备较好的抗菌消炎功能，水提法难以获得上述有效成分；本发明针对已有产品的不足，制备工艺简单可行，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；土茯苓、蒲公英提取时，采用煎煮的方式，容易导致酚酸以及酮类物质的分解，而且黄酮类化合物不能溶于水，无法有效提取，本发明采用微波醇提获得黄酮苷类化合物以及水提获得多糖类，避免了成分的流失；粉萆薢和夏枯草采用超声罐醇提方式，能够获得醇溶有效组分；本发明制剂有效成分高，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。
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
蒲苓盆炎康颗粒，其包括如下重量的原料药：
土茯苓1000g，丹参533.4g，夏枯草533.4g，蒲公英666.6g，车前子533.4g，粉萆薢333.4g，杜仲333.4g，三七 133.4g，川芎200g。
其按照如下工艺制备而得：
1）取丹参，粉碎成80目粗粉，用1.5倍重量的90％(v/v)的乙醇浸渍24小时，再加90％(v/v)乙醇溶液渗漉，漉速1-3ml/min，收集渗漉液，渗漉液回收乙醇后得到药液，药渣备用；
2）取川芎、杜仲、三七和车钱子，每次加生药5倍重量的70％(v/v)的乙醇浸渍24小时，在室温下浸渍3次，合并浸渍液，回收乙醇，药液及药渣备用；
3）取土茯苓和蒲公英，粉碎，过80目筛，置于容器中，添加两倍重量的85%（v/v）的乙醇，300rpm搅拌提取，提取过程中控制微波功率为500W，提取时间为120min；然后置于4℃放置12h，过滤收集滤液，滤渣备用；
4）取粉萆薢和夏枯草，粉碎，过200目筛，投入超声提取罐，加入三倍重量的75%（v/v）的乙醇，控制提取温度为50℃，频率50KHz，提取30min，过滤收集滤液；
5）合并步骤1、步骤2）以及步骤3）所得药渣，加10倍重量的水，煎煮3次，每次1小时，合并煎液，滤过，然后添加步骤1）所得药液、步骤2）所得药液、步骤3）所得滤液以及步骤4）所得滤液，混匀，减压浓缩至在50℃时的密度为1.20g/ml的清膏，继续减压干燥，得干浸膏，干燥，粉碎，加入辅料适量，混匀，装入胶囊，制成1000粒，即得。每粒填充量为0.45g。
对照例1
蒲苓盆炎康颗粒，其包括如下重量的原料药：
土茯苓1000g，丹参533.4g，夏枯草533.4g，蒲公英666.6g，车前子533.4g，粉萆薢333.4g，杜仲333.4g，三七 133.4g，川芎200g。
其按照如下工艺制备而得：
去上述原料；
丹参粉碎成80目粗粉，用1.5倍重量配比90％(v/v)的乙醇浸渍24小时，再加90％(v/v)乙醇溶液渗漉，漉速1-3ml/min，收集渗漉液为生药重量的5倍量，生药重量1倍量的初漉液备用，其余渗漉液回收乙醇，药液及药渣备用；
取川芎、杜仲、三七和车钱子，每次加生药5倍重量的70％(v/v)乙醇浸渍24小时，在室温下浸渍3次，合并浸渍液，回收乙醇，药液及药渣备用；
取土茯苓、夏枯草、蒲公英、粉萆薢以及上述丹参药渣、川芎等的药渣，加10倍重量的水，煎煮3次，每次1小时，合并煎液，滤过，浓缩，加入上述回收乙醇后的丹参药液和川芎等的药液，继续减压浓缩至在50℃时的密度为1.20的清膏，减压干燥，得干浸膏，
再按生药重量的4∶1加入辅料，所说辅料为糖粉∶糊精＝3∶1的重量配比，然后粉碎，过80目筛，混匀，得干浸膏粉；用丹参初漉液和80％(v/v)的乙醇制成颗粒，经干燥，整粒，装入胶囊，制成1000粒，即得。每粒填充量为0.45g。
实施例2 动物学实验
建立盆腔炎小鼠动物模型：选用健康昆明品系小鼠，构建小鼠盆腔炎模型。按照小鼠体重的1％腹腔注射4％水合氯醛，全身麻醉，数分钟后将小鼠置于固定台上，减去腹部毛，75％乙醇消毒皮肤，取灭菌的剪刀镊子，剪开小鼠下腹部皮肤以及肌肉层，约1cm的切口，暴露出子宫，取无菌针头刺伤子宫一侧子宫角中间位置，约5-6针，完毕后分层关腹，消毒腹部术区。
实验流程：选用以上造模的小鼠，于7d后随机分为空白对照组(不做任何处理)、假手术组(只做开腹手术，不处理子宫)、模型组、实施例1组 (10mg/d)、对照例1组(10mg/d)，每组10只；除了空白对照组、假手术组和模型组给予等容量的纯水以外，其余均给予相应的受试样品，连续灌胃21d。停药次日，小鼠称重，取血清并处死，解剖后取子宫称重，子宫用4％中性甲醛固定液固定，石蜡包埋，常规切片；HE染色，光镜下观察子宫病理形态学变化。
1、小鼠血清指标细胞因子的检测结果见表1。
表1
| 组别 | 白介素2（pg/ml） | 白介素6（pg/ml） | 肿瘤坏死因子α（pg/ml） |
| 空白对照组 | 509.4 | 41.2 | 213.8 |
| 假手术组 | 496.3 | 40.4 | 217.9 |
| 模型组 | 474.8 | 44.8 | 241.3 |
| 实施例1组 | 598.5 | 36.1 | 188.7 |
| 对照例1组 | 537.6 | 39.7 | 204.0 |
结论：由表1可知，模型组较空白对照组的白介素2的含量降低，而白介素6和肿瘤坏死因子α大幅提高，说明造模成功。实施例1的白介素2含量高于对照例1组，而白介素6和肿瘤坏死因子α含量低于对照例1组，提示对盆腔炎症的改善作用优于对照例1组。
2、子宫病理观察指标及积分标准为：(1)宫腔粘连闭锁或扩张：“—”无病变记0分；“+”＜1/3病变记1分；“++”1/3—2/3病变记2分；“+++”2/3以上病变记3分。(2)腔壁结构病变：“—”各层结构正常记0分；“+”黏膜固有层腺体结构消失记1分；“++”肌层与粘膜层分界不清记2分；“+++”分层结构不清记3分。(3)上皮细胞变性坏死：“—”单层柱状上皮记0分；“+”上皮细胞扁平或脱落＜1/3记1分；“++”上皮细胞扁平或脱落1/3—2/3病变记2分；“+++”全层上皮细胞变性坏死记3分。(4)慢性炎细胞浸润：“—”无慢性炎细胞浸润记0分；“+”小数散在或灶性且仅在黏膜固有层内记1分；“++”散在或灶性但深入肌层记2分；“+++”多数散在或层状浸润并累及全层记3分。(5)内膜充血水肿：“—”无内膜充血水肿记0分；“+”固有层轻微充血水肿记1分；“++”明显充血水肿记2分；“+++”全层充血水肿记3分。子宫病理变化评分结果见表2：
表2
| 组别 | 宫腔粘连闭锁或扩张 | 腔壁结构病变 | 上皮细胞变性坏死 | 慢性炎细胞浸润 | 内膜充血水肿 | 总分数 |
| 空白对照组 | 0 | 0 | 0 | 1 | 0 | 1 |
| 假手术组 | 1 | 1 | 0 | 2 | 2 | 6 |
| 模型组 | 5 | 8 | 3 | 4 | 6 | 26 |
| 实施例1组 | 1 | 1 | 1 | 2 | 3 | 8 |
| 对照例1组 | 2 | 1 | 2 | 2 | 5 | 12 |
结论：由表2可知，实施例1和对照例1组的产品均能明显改善子宫的病变程度，但是实施例1的产品效果更好。
实施例3
本发明产品质量标准测试：为了验证和完善实验室工艺合理性的研究，我们将产品连续生产三个批次，并按质量标准的规定对中试产品进行了检测，结果见表3。
表3
| 批次 | 落新妇苷含量（mg/粒） | 丹参酮ⅡA含量（mg/粒） | 细菌（cfu/g） | 霉菌（cfu/g） | 大肠埃希菌 |
| 1 | 3.34 | 0.56 | <10 | <10 | 未检出 |
| 2 | 3.36 | 0.57 | <10 | <10 | 未检出 |
| 3 | 3.35 | 0.55 | <10 | <10 | 未检出 |
在本说明书的描述中，参考术语“一个实施例”、“一些实施例”、“示例”、“具体示例”、或“一些示例”等的描述意指结合该实施例或示例描述的具体特征、结构、材料或者特点包含于本发明的至少一个实施例或示例中。在本说明书中，对上述术语的示意性表述不必须针对的是相同的实施例或示例。尽管上面已经示出和描述了本发明的实施例，可以理解的是，上述实施例是示例性的，不能理解为对本发明的限制，本领域的普通技术人员在本发明的范围内可以对上述实施例进行变化、修改、替换和变型。
Claims (5)
1.蒲苓盆炎康颗粒，其包括如下重量的原料药：
土茯苓1000g，丹参533.4g，夏枯草533.4g，蒲公英666.6g，车前子533.4g，粉萆薢333.4g，杜仲333.4g，三七 133.4g，川芎200g。
2.根据权利要求1所述的蒲苓盆炎康颗粒，其特征在于，所述蒲苓盆炎康颗粒按照如下工艺制备而得：
1）取丹参，粉碎成80目粗粉，用1.5倍重量的90％(v/v)的乙醇浸渍24小时，再加90％(v/v)乙醇溶液渗漉，漉速1-3ml/min，收集渗漉液，渗漉液回收乙醇后得到药液，药渣备用；
2）取川芎、杜仲、三七和车钱子，每次加生药5倍重量的70％(v/v)的乙醇浸渍24小时，在室温下浸渍3次，合并浸渍液，回收乙醇，药液及药渣备用；
3）取土茯苓和蒲公英，粉碎，过80目筛，置于容器中，添加两倍重量的85%（v/v）的乙醇，300rpm搅拌提取，提取过程中控制微波功率为500W，提取时间为120min；然后置于4℃放置12h，过滤收集滤液，滤渣备用；
4）取粉萆薢和夏枯草，粉碎，过200目筛，投入超声提取罐，加入三倍重量的75%（v/v）的乙醇，超声提取30min，过滤收集滤液；
5）合并步骤1）、步骤2）以及步骤3）所得药渣，加10倍重量的水，煎煮3次，每次1小时，合并煎液，滤过收集滤液，然后添加步骤1）所得药液、步骤2）所得药液、步骤3）所得滤液以及步骤4）所得滤液，混匀，减压浓缩至1.20g/ml的清膏，继续减压干燥，得干浸膏，干燥，粉碎，加入辅料适量，混匀，装入胶囊，制成1000粒，即得。
3.根据权利要求2所述的蒲苓盆炎康颗粒，其特征在于，所述超声提取的条件为：温度为50℃，频率50KHz。
4.根据权利要求2所述的蒲苓盆炎康颗粒，其特征在于，所述辅料为蔗糖粉和糊精的混合物。
5.权利要求1-4任其一所述的蒲苓盆炎康颗粒质量检测方法。
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