CN107952033B - 妇炎康软胶囊及其制备方法 - Google Patents
妇炎康软胶囊及其制备方法 Download PDFInfo
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- CN107952033B CN107952033B CN201711228347.1A CN201711228347A CN107952033B CN 107952033 B CN107952033 B CN 107952033B CN 201711228347 A CN201711228347 A CN 201711228347A CN 107952033 B CN107952033 B CN 107952033B
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- Medicinal Preparation (AREA)
Abstract
本发明属于中药技术领域，具体涉及妇炎康软胶囊及其制备方法，其由囊壳和内容物组成，所述内容物由中药提取物和辅料按1：(0.01～0.06)的重量比组成，所述中药提取物由以下重量的原料制备而成：当归80～120份、赤芍50～80份、醋炙莪术50～80份、苦参50～80份、丹参80～120份、炒川楝子50～80份、土茯苓80～120份、醋炙三棱50～80份、醋炙延胡索50～80份、炒芡实80～120份、醋炙香附30～60份、黄柏50～80份和山药80～120份。本发明提供的妇炎康胶囊对治疗细菌性阴道炎和霉菌性阴道炎均有显著的疗效，且其质量稳定，渗油率低，适于大范围推广应用。
Description
技术领域
本发明属于中药技术领域，具体涉及妇炎康软胶囊及其制备方法。
背景技术
《中国药典》中记载了妇炎康片的处方：赤芍60g、土茯苓100g、醋三棱60g、炒川楝子60g、醋莪术60g、醋延胡索60g、炒芡实100g、当归100g、苦参60g、醋香附40g、黄柏60g、丹参100g和山药120g。中医用药讲究“君臣佐使”原则，而对于“君臣佐使”和药量的关系，后世医家作出了更为具体的阐释。金.张元素在《医学启源.用药各定分两》中指出“为君最多，臣次之，佐使又次之，药之于证，所主停者，则各等分也”。元.李杲对“君臣佐使”药味剂量的认识与张元素相同，认为药物的君臣佐使规定，还应受剂量的制约。一般来说，“君药分量最多，臣药次之，使药又次之，不可令臣过于君。君臣有序，相与宣摄，则可以御邪除病也”。因此，按照上述原则，妇炎康处方中应以山药为君药，土茯苓、炒芡实、当归、丹参为臣药，赤芍、醋三棱、炒川楝子、醋莪术、醋延胡索、苦参、黄柏为佐药，醋香附为使药。方中唯山药用量独重，意在体现该方滋补脾肾、扶正补虚的立意。该方经临床验证，对细菌性阴道炎具有显著的疗效，但对霉菌性阴道炎治疗效果不显著。
目前市场上的妇炎康制剂主要是云南白药集团股份有限公司生产的妇炎康片和深圳市佳泰药业股份有限公司生产的软胶囊。与片剂相比，软胶囊胶囊无需加入粘合剂，在胃肠道中崩解较片剂快，具有生物利用度高的优点，且中药提取成分稳定性较差，制成软胶囊剂有利于提高药物的稳定性。因此，目前市面上妇炎康软胶囊制剂占了主要的比重，如中国专利申请CN 1660146公开了一种妇炎康软胶囊，包括药液和囊壳，该药液包括药用主料和药用辅料；药用主料包括以下原料药：赤芍、川楝子、丹参、当归、莪术、黄柏、苦参、芡实、三棱、山药、土茯苓、香附及延胡索；该药用辅料包括植物油和助悬剂；该囊壳包括一定比例的明胶、甘油和水。如中国专利申请CN 1559573公开了一种妇炎康软胶囊，它由赤芍50-70、土茯苓80-120、三棱(醋灸)50-70、川栋子(炒)50-70、莪术(醋灸)50-70、延胡索(醋灸)50-70、芡实(炒)80-120、当归80-120、苦参50-70、香附(醋灸)30-50、黄柏50-70、丹参80-120、山药100-140制备而成。
虽然软胶囊与片剂相比能提高药物的稳定性，提高生物利用度，但其也存在一些问题，由于软胶囊一般均需加入油类物质，如甘油，导致中药提取物软胶囊在储存期内均会出现不同程度的胶丸渗油现象，软胶囊颗粒之间变得容易相互粘连，直接影响了产品的质量。而针对上述技术问题，目前尚未出现有效的解决方法。
因此，有必要提供一种治疗范围广，质量稳定，不易渗油妇炎康软胶囊。
发明内容
本发明旨在提供一种妇炎康软胶囊，该软胶囊克服了传统的软胶囊在储藏期间容易渗油，软胶囊颗粒间容易相互粘连的缺陷，其质量稳定，保质期长。
为了达到上述目的，本发明采用以下技术方案：妇炎康软胶囊，其由囊壳和内容物组成，所述内容物由中药提取物和辅料按1：(0.01～0.06)的重量比组成，所述中药提取物由以下重量的原料制备而成：当归80～120份、赤芍50～80份、醋炙莪术50～80份、苦参50～80份、丹参80～120份、炒川楝子50～80份、土茯苓80～120份、醋炙三棱50～80份、醋炙延胡索50～80份、炒芡实80～120份、醋炙香附30～60份、黄柏50～80份和山药80～120份。
进一步地，所述中药提取物由以下重量的原料制备而成：当归100份、赤芍60份、醋炙莪术60份、苦参60份、丹参100份、炒川楝子60份、土茯苓120份、醋炙三棱60份、醋炙延胡索60份、炒芡实100份、醋炙香附40份、黄柏60份和山药120份。
进一步地，所述中药提取物由以下步骤制备得到：
S1、取醋炙莪术和山药粉碎成细粉，过筛，备用；取其余药材，加入药材重量5～10倍量的水煎煮1～3次，每次1～3h，合并煎煮液，过滤，滤液浓缩成稠膏，与上述细粉混匀，干燥，研成中药细粉，备用；
S2、将上述中药细粉置于正向直流电场中处理10～16s后，置于反向直流电场中处理3～8s，其中正向电流和反向电流的电压为10～25V，电流强度为8～10v/m。
进一步地，所述步骤S2中将上述中药细粉先置于正向直流电场中处理12s后，置于反向直流电场中处理6s，其中正向电流和反向电流的电压为10～20V，电流强度为8～10v/m。
进一步地，所述辅料包括豆油3～6份和大豆磷脂1～3份。
进一步地，所述囊壳由明胶、甘油和水按1：(0.2～0.6):1的重量比组成。
相应地，本发明还提供了一种制备上述的妇炎康软胶囊的方法，包括以下步骤：
A)中药提取物的制备：包括S1～S2步骤：
S1、取醋炙莪术和山药粉碎成细粉，过筛，备用；取其余药材，加入药材重量5～10倍量的水煎煮1～3次，每次1～3h，合并煎煮液，过滤，滤液浓缩成稠膏，与上述细粉混匀，干燥，研成中药细粉，备用；
S2、将上述中药细粉置于正向直流电场中处理10～16s后，置于反向直流电场中处理3～8s，其中正向电流和反向电流的电压为10～25V，电流强度为8～10v/m；
B)取上述制备得到的中药提取物，加入大豆油以及大豆磷脂，搅拌至全溶，研磨均匀，抽真空消去气泡，得药液，待用；取纯化水通入化胶罐内，加热至55～65℃后加入明胶、甘油，溶解，真空脱泡，继续搅拌至均匀，制成胶液；将上述药液移入滴制机中，制成软胶囊。
进一步地，所述步骤S2中将上述中药细粉先置于正向直流电场中处理12s后，置于反向直流电场中处理6s，其中正向电流和反向电流的电压为10～20V，电流强度为8～10v/m。
本发明提供了一种新配方，该方是在原有的配方的基础上经过药量增减变化得到的，主要变化为，增加了土茯苓的药量，由此处方的君药变为山药和土茯苓。而令人惊奇地是，这种改变意外地提高了妇炎康胶囊的疗效，并且同样适用于治疗霉菌性阴道炎，取得了意料不到的技术效果。而这一发现，是发明人在一次试验中偶然发现的。而经试验证明，采用本发明处方制备得到的软胶囊对细菌性阴道炎和霉菌性阴道炎均具有显著的疗效，明显优于原配方。
针对在背景技术提及的“软胶囊容易渗油”的问题，发明人经过对渗油的胶囊进行显微镜观察，发现渗油胶囊的囊壁的接缝处均存在较大的团聚颗粒，而在胶囊干燥收缩后以及在贮藏过程中，由此团聚颗粒造成的接缝处的空隙使药物中的油状物质缓慢渗出，而对不存在渗油现象的软胶囊进行观察，发现其接缝处无团聚颗粒。发明人对这一现象进一步分析，认为可能是由于中药颗粒粒径较大的原因。因此，发明人尝试将中药提取物的粒径控制在70μm以下，但制备得到的软胶囊仍然存在渗油的现象。发明人没有放弃，经过大量的试验以及资料调研，认为也许不是药材颗粒本身粒径大小的问题，可能是因为在贮藏过程中药粉颗粒之间因静电相互吸引，导致药粉颗粒团聚形成大颗粒，从而出现渗油的情形。因此，发明人经过大量的试验，终于得出一种有效解决软胶囊渗油的方法，即是将制备得到的中药细粉置于正向直流电场中处理10～16s后，置于反向直流电场中处理3～8s。经试验证明，将经过周期反向直流电流处理的中药细粉制成软胶囊，其在温度为25±2℃、相对湿度为60±10％的条件下放置24个月，渗油率为6.3～7.2％，软胶囊之间不存在相互粘连的情形，软胶囊质量稳定得到了有效的保障，而相反，没有经过该处理的软胶囊相同的条件下贮藏24个月后，渗油率高达27.8％。
本发明具有以下优点：
1)本发明提供了一种妇炎康软胶囊，其与传统的处方相比，扩大了治疗范围，且提高了治疗的疗效，与现有技术相比，具有显著的进步。
2)本发明提供了一种制备软胶囊的工艺，与传统的制备工艺相比，本发明制备得到的软胶囊质量稳定，不易渗油。
具体实施方式
以下通过实施例形式的具体实施方式，对本发明的上述内容作进一步的详细说明。但不应将此理解为本发明上述主题的范围仅限于以下实施例。
实施例1本发明妇炎康软胶囊的原料配方
配方1：当归100份、赤芍60份、醋炙莪术60份、苦参60份、丹参100份、炒川楝子60份、土茯苓120份、醋炙三棱60份、醋炙延胡索60份、炒芡实100份、醋炙香附40份、黄柏60份和山药120份。
配方2：当归80份、赤芍50份、醋炙莪术50份、苦参50份、丹参80份、炒川楝子50份、土茯苓80份、醋炙三棱50份、醋炙延胡索50份、炒芡实80份、醋炙香附30份、黄柏50份和山药80份。
配方3：当归120份、赤芍80份、醋炙莪术80份、苦参80份、丹参120份、炒川楝子80份、土茯苓20份、醋炙三棱80份、醋炙延胡索80份、炒芡实120份、醋炙香附60份、黄柏80份和山药120份。
对比配方1：当归100份、赤芍60份、醋炙莪术60份、苦参60份、丹参100份、炒川楝子60份、土茯苓100份、醋炙三棱60份、醋炙延胡索60份、炒芡实100份、醋炙香附40份、黄柏60份和山药120份。
实施例2本发明妇炎康软胶囊的制备
A)中药提取物的制备：包括S1～S2步骤：
S1、按配方1称取各味药材，取醋炙莪术和山药粉碎成细粉，过筛，备用；取其余药材，加入药材重量6倍量的水煎煮2次，每次2h，合并煎煮液，过滤，滤液浓缩成稠膏，与上述细粉混匀，干燥，研成中药细粉，备用；
S2、将上述中药细粉置于正向直流电场中处理12s后，置于反向直流电场中处理6s，其中正向电流和反向电流的电压为15V，电流强度为8v/m；
B)取上述制备得到的中药提取物，加入4份大豆油以及2份大豆磷脂，搅拌至全溶，研磨均匀，抽真空消去气泡，得药液，待用；取纯化水通入化胶罐内，加热至60℃后加入明胶、甘油，溶解，真空脱泡，继续搅拌至均匀，制成胶液；将上述药液移入滴制机中，制成0.5g/粒的软胶囊。
实施例3本发明妇炎康软胶囊的制备
实施例3与实施例2的区别在于，所述步骤S2中正向直流电场处理时间为10s，反向直流电场处理时间为3s，电压为20V，电流强度为10v/m，其余参数及操作如实施例2所示。
实施例4本发明妇炎康软胶囊的制备
实施例4与实施例2的区别在于，所述步骤S2中,正向直流电场处理时间为16s，反向直流电场处理时间为8s，电压为10V，电流强度为8v/m，其余参数及操作如实施例2所示。
对比例1本发明妇炎康软胶囊的制备
取实施例1中所述对比配方1各味药材，按照实施例2所述制备方法制备。
对比例2本发明妇炎康软胶囊的制备
对比例2与实施例2的区别在于，去掉S2步骤，其余参数及操作如实施例2所示。
对比例3本发明妇炎康软胶囊的制备
对比例3与实施例2的区别在于，去掉S2步骤中通入反向直流电场步骤，其余参数及操作如实施例2所示。
试验例一、妇炎康软胶囊渗油现象试验
取实施例2～4以及对比例2～3制备得到的妇炎康软胶囊各1000粒，在温度为25±2℃、相对湿度为60±10％的条件下放置24个月，用显微镜观察各组样品，统计各组软胶囊渗油数量，计算渗油率，统计结果如下表1所示。
| 组别 | 总数(粒) | 渗油胶囊数量(粒) | 渗油率(％) |
| 实施例2 | 1000 | 63 | 6.3％ |
| 实施例3 | 1000 | 72 | 7.2％ |
| 实施例4 | 1000 | 68 | 6.8％ |
| 对比例2 | 1000 | 278 | 27.8％ |
| 对比例3 | 1000 | 169 | 16.9％ |
由表1可知，1000粒本发明实施例2～4制备得到的软胶囊在温度为25±2℃、相对湿度为60±10％的条件下放置24个月，仅仅有63～72粒胶囊存在渗油现象，渗油率为6.3～7.2％。其中以实施例2制备得到的软胶囊渗油率最小，为本发明最佳实施例。
而对比例2与本发明实施例2相比，不经过周期正反向电场处理，制备得到的软胶囊，在相同的环境下贮藏24个月后，1000粒中有278粒出现了渗油现象，渗油率高达27.8％；对比例3与实施例2相比，去掉了反向电场处理，制备得到的软胶囊，在在相同的环境下贮藏24个月后，1000粒中有169粒出现了渗油现象，渗油率高达16.9％。这说明，通入周期正反向电流处理有利于降低软胶囊在贮藏期间出现的渗油的现象。
试验例二、细菌性阴道炎动物试验
1.材料与方法
1.1药物 本发明实施例2和对比例1制备得到的妇炎康软胶囊临床拟用量为50.5g.d-1(与生药量计算)。
1.2动物 清洁级NIH小鼠30只，雌性，体重18～22g。
1.3试验菌株 临床菌株：金黄色葡萄球菌(109cfu.mL-1)、大肠埃希菌(109cfu.mL-1)，由湖南中医药大学微生物实验室提供，将上述两种致病菌等体积混合成造模菌并制备成造模液。
1.4试验方法30只雌性小鼠皮下注射2mg.mL-1苯二甲酸雌二醇注射液0.05mL，连续3次，每隔2d一次。于第6d将20μL造模液注入海绵中，将海绵塞于小鼠阴道内，于接种后的第4d用灭菌后的棉签采阴道分泌物接种于2种选择培养基上培养24～48h，结果显示沙门志贺氏菌属琼脂培养基上有大肠埃希菌菌落生长，高盐甘露醇琼脂培养基上有大量金黄色葡球菌菌落生长，说明小鼠细菌性阴道炎造模成功。将上述造模成功的30只小鼠随机分成3组，分别为模型对照组、实施例2组、对比例1组，每组10只。每天用相应的药液灌胃，连续10d，每天1次。
2结果
2.1治疗前后阴道分泌物细菌学检测
表2治疗后阴道分泌物涂片有无菌落生长的平板数
2.2治疗前后阴道清洁度的变化和疗效
治愈：阴道外观正常，清洁度Ⅰ级，无杂菌生长，病例检查无炎性细胞浸润。
好转：阴道外观正常，清洁度Ⅱ级，无或每平皿1～2个致病菌落，病例检查大致正常。
治愈率(％)＝痊愈的动物数/各组总动物数×100％
有效率(％)＝(痊愈+好转动物数)/各组总动物数×100％
表3治疗前后阴道清洁度的变化和疗效
注：Ⅰ、Ⅱ级清洁度表示正常，Ⅲ级表示有炎症，Ⅳ级表示有严重炎症。
由表2～3可知，经本发明实施例2处方药液灌胃后，治愈率高达90％，有效率达到100％，具有显著地抑杀致病菌的作用。而与实施例2组相比，对比例1组处方为药典记载的传统处方，其对两种致病菌德尔抑杀作用有所下降。
试验例二、霉菌性阴道炎动物试验
1.材料与方法
1.1药物：本发明实施例2以及对比例1制备得到的妇炎康软胶囊。
1.2菌株：白色念珠菌，由中国医学科学院皮肤病防治研究所提供，为临床分离菌株。
1.3动物：日本大耳白家兔，雌性，体重2～2.5kg。
1.4试验方法：取日本大耳家兔40只，先用接种针，再用接种环分别在阴道口内2～4cm处用“连续划线法”接种白色念珠菌，连续两天。于第二天接种后第三天作阴道涂片检查，结果白色念珠菌镜检呈阳性，证明造模成功。将上述造模成功的家兔分为4组，分别为模型组、实施例2组以及对比例1组，模型组和空白对照组(不感染不处理)给予温生理盐水冲洗，连续7天，其余各组每天用相应的药液灌胃，连续10d，每天1次，末次给药后次日，用2ml灭菌生理盐水灌洗阴道，取洗液于选择性鉴定培养基，分别培养24h，计算菌落数(结果以给药前后家兔阴道菌落计数差表示)。
2.结果
表4治疗前后阴道内白色念珠菌菌落计数
注：与用药前相比，*P＜0.05，**P＜0.01。
由表4可知，本发明实施例2对白色念珠菌具有显著的抑杀作用，证明其对霉菌性阴道炎具有显著的疗效，用药前后差异显著，具有统计学意义。而从对比例1的试验结果可以看出，传统的处方对白色念珠菌引起的霉菌性阴道炎疗效不明显，用药前后差异不明显。这说明，本发明提供的改进后的处方更适用于制备妇炎康软胶囊。
上述实施例仅例示性说明本发明的原理及其功效，而非用于限制本发明。任何熟悉此技术的人士皆可在不违背本发明的精神及范畴下，对上述实施例进行修饰或改变。因此，举凡所属技术领域中具有通常知识者在未脱离本发明所揭示的精神与技术思想下所完成的一切等效修饰或改变，仍应由本发明的权利要求所涵盖。
Claims (4)
1.妇炎康软胶囊，其特征在于，其由囊壳和内容物组成，所述内容物由中药提取物和辅料按1：(0.01～0.06)的重量比组成，所述中药提取物由以下重量的原料制备而成：当归100份、赤芍60份、醋炙莪术60份、苦参60份、丹参100份、炒川楝子60份、土茯苓120份、醋炙三棱60份、醋炙延胡索60份、炒芡实100份、醋炙香附40份、黄柏60份和山药120份；
所述的妇炎康软胶囊的方法，其特征在于，包括以下步骤：
A)中药提取物的制备：包括S1～S2步骤：
S1、取醋炙莪术和山药粉碎成细粉，过筛，备用；取其余药材，加入药材重量5～10倍量的水煎煮1～3次，每次1～3h，合并煎煮液，过滤，滤液浓缩成稠膏，与上述细粉混匀，干燥，研成中药细粉，备用；
S2、将上述中药细粉置于正向直流电场中处理10～16s后，置于反向直流电场中处理3～8s，其中正向电流和反向电流的电压为10～25V，电流强度为8～10v/m；
B)取上述制备得到的中药提取物，加入大豆油以及大豆磷脂，搅拌至全溶，研磨均匀，抽真空消去气泡，得药液，待用；取纯化水通入化胶罐内，加热至55～65℃后加入明胶、甘油，溶解，真空脱泡，继续搅拌至均匀，制成胶液；将上述药液移入滴制机中，制成软胶囊。
2.如权利要求1所述的妇炎康软胶囊，其特征在于，所述步骤S2中将上述中药细粉先置于正向直流电场中处理12s后，置于反向直流电场中处理6s，其中正向电流和反向电流的电压为10～20V，电流强度为8～10v/m。
3.如权利要求1所述的妇炎康软胶囊，其特征在于，所述辅料包括豆油3～6份和大豆磷脂1～3份。
4.如权利要求1所述的妇炎康软胶囊，其特征在于，所述囊壳由明胶、甘油和水按1：(0.2～0.6):1的重量比组成。
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