CN109331159A - 一种治疗痛经的凝胶贴膏及其制备方法 - Google Patents
一种治疗痛经的凝胶贴膏及其制备方法 Download PDFInfo
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- CN109331159A CN109331159A CN201811358559.6A CN201811358559A CN109331159A CN 109331159 A CN109331159 A CN 109331159A CN 201811358559 A CN201811358559 A CN 201811358559A CN 109331159 A CN109331159 A CN 109331159A
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- dysmenorrhea
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Abstract
本发明属含有当归的药物制剂技术领域，具体涉及一种治疗痛经的凝胶贴膏。所述凝胶贴膏包括以下组分：卡波、聚丙烯酸钠、甘羟铝、高岭土、甘油、酒石酸和浸膏，所述浸膏的制备方法为：将当归、川芎、肉桂、小茴香、没药和干姜加入水，浸泡，水蒸气蒸馏提取，得到挥发油，药渣和提取液A，赤芍、元胡、蒲黄、五灵脂、官桂和药渣加入乙醇溶液，提取，回收提取液中的乙醇至无醇味，得到提取液B，将提取液B与提取液A合并浓缩，得初浸膏，再加入挥发油混合均匀，即得。
Description
技术领域
本发明属含有当归的药物制剂技术领域，具体涉及一种治疗痛经的凝胶贴膏及其制备方法。
背景技术
痛经是指在月经周期出现腹痛、腰酸、下腹坠胀等，部分患者疼痛剧烈时出现恶心，呕吐，甚至晕厥，严重者甚至影响工作和生活的病症，大多数患者经血呈黑褐色血块，下腹冷痛，舌淡黯，脉细涩，最早归属于“经行腹痛”范畴(“中西医结合治疗原发性痛经疗效观察”，杨海萍，现代医药卫生，2015年第31卷第17期，第2653-2655页，公开日2015年09月30日)。痛经可分为原发性痛经和继发性痛经两大类，原发性痛经是指生殖器官无器质性病变的痛经，占痛经90％以上，继发性痛经是指由于盆腔器质性病变引起的痛经(“河南省郏县城区843名初中女学生痛经的相关因素分析”，张晓芳，成都中医药大学，2009年，摘要，公开日2009年12月31日)。
据大型流行病学研究结果估计，超过女性人口一半的人患有痛经(“复方金玲四逆四物失效散治疗实验性原发性痛经的作用机制研究”，李倩等，中国中西医结合杂志，2016年第36卷第9期，第1087-1090页，公开日2016年09月30日)。据报道，痛经的发病率约为42％-90％，重度约占18％(“抗痛经中药研究”，高军卫，西安交通大学，2001年，摘要，公开日2001年12月31日)。
尽管痛经的发病率很高，然而，临床治疗效果却并不令人满意。目前，西医多应用非甾体类抗炎药、乙酸氨基酚、避孕药、口服避孕药、钙离子通道阻滞剂、前列腺素括抗剂等药物，缓解轻度不适，对于严重的痛经则应用可待因或其它强效止痛镇痛药。西药起效快捷，疗效尚可，但只能缓解症状，并不能彻底治愈，且存在一些毒副作用，易引起内分泌失调，长期服用还容易引起赖药性，使其在应用中受到一定限制。
中医认为，痛经的发病有情志所伤、起居不慎或六淫为害等不同病因，并与素体及经期、经期前后特殊的生理环境有关。“不通则痛”、“不荣则痛”是导致痛经发生的主要病因病机。中医药强调从整体观念出发治疗痛经，根据患者的证候特点，如气滞血瘀，寒凝瘀滞，冲任不足的本虚标实的发病特点，通过益气补血，温宫散寒，育肾养肝等疗法，从根本上使疾病得到缓解。痛经病程较长，需长期治疗与调养，而中药的副作用少，不会给患者带来身体上的不适或依赖性。因此中医药治疗痛经具有天然的优势，其应用将逐渐普遍。
目前，中医方面，临床用药主要以《医林改错》的少腹逐瘀汤、《金匮要略》的温经汤为基础，并结合具体证候进行加减。然而，以上少腹逐瘀汤和温经汤一般为水煎煮，得到的煎液为水溶性成分，往往因煎煮过程随意性大导致挥发油、有机酸、生物碱、黄酮类等药效成分提取不充分。
发明内容
有鉴于此，本发明的目的在于提供一种治疗痛经的凝胶贴膏，该贴膏挥发油、有机酸、生物碱、黄酮类等药效成分提取充分提取率高。
为实现上述目的，本发明的技术方案为：
治疗痛经的凝胶贴膏，包括以下组分：卡波(又名卡波姆)、丙烯酸钠(英文简称NP)、甘羟铝、高岭土、甘油、酒石酸和浸膏，所述浸膏的制备方法为：
将当归、川芎、肉桂、小茴香、没药和干姜加入水，浸泡，水蒸气蒸馏提取，得到挥发油，药渣和提取液A，赤芍、元胡、蒲黄、五灵脂、官桂和药渣加入乙醇溶液，提取，回收提取液中的乙醇至无醇味，得到提取液B，将提取液B与提取液A合并浓缩，得初浸膏，再加入挥发油混合均匀，即得。
发明人在研究过程中发现，包括以下组分：卡波(又名卡波姆)、丙烯酸钠(英文简称NP)、甘羟铝、高岭土、甘油、酒石酸和浸膏，所述浸膏的制备方法为：
将当归、川芎、肉桂、小茴香、没药和干姜加入水，浸泡，水蒸气蒸馏提取，得到挥发油，药渣和提取液A，赤芍、元胡、蒲黄、五灵脂、官桂和药渣加入乙醇溶液，提取，回收提取液中的乙醇至无醇味，得到提取液B，将提取液B与提取液A合并浓缩，得初浸膏，再加入挥发油混合均匀，即得；的凝胶贴膏挥发油、有机酸、生物碱、黄酮类等药效成分提取充分提取率高。
进一步，所述卡波为卡波940。
进一步，所述聚丙烯酸钠为聚丙烯酸钠700。
进一步，所述提取液A制备过程中，水的用量为当归、川芎、肉桂、小茴香、没药和干姜总质量的8-12倍，浸泡时间为20-40min，提取时间为5-7h。
进一步，所述提取液B制备过程中，乙醇溶液为体积分数为65％-755的乙醇溶液，乙醇溶液的用量为赤芍、元胡、蒲黄、五灵脂、官桂和药渣总质量的8-10倍，提取2次，每次1-2h。
进一步，所述浓缩的程度为浓缩至50℃下的相对密度为1.08-1.09。
进一步，以质量份计，配比关系为：卡波1.0-2.6份、聚丙烯酸钠1.6-3.5份、甘羟铝0.15-0.25份，高岭土0.5-1.5份、甘油12-16份、酒石酸0.12-0.16份，浸膏用量为卡波、聚丙烯酸钠、甘羟铝、高岭土、甘油和酒石酸总质量的10％-30％。
本发明的目的还在于保护所述治疗痛经的凝胶贴膏的制备方法，包括以下步骤：
A.向卡波中加水使充分溶胀作为A相；
B.聚丙烯酸钠、高岭土和甘羟铝用甘油分散均匀作为B相，酒石酸用水溶解作为C相；
C.将A相加入B相，搅拌均匀，加入C相、浸膏，搅拌均匀，涂布于无纺布上，烘干，即得。
本发明的有益效果在于：
本发明的凝胶贴膏挥发油、有机酸、生物碱、黄酮类等药效成分提取充分提取率高。
本发明的凝胶贴膏初黏力好，持黏力好，剥离强度高。
本发明的凝胶贴膏使用方便。
附图说明
图1为芍药苷色谱图；
图2为阿魏酸色谱图；
图3为异鼠李素-3-O-新橙皮苷色谱图；
图4为香蒲新苷色谱图；
图5为对照品溶液色谱图；
图6为供试品溶液色谱图；
图7为当归、川芎阴性样品溶液色谱图；
图8为赤芍阴性样品溶液色谱图；
图9为蒲黄阴性样品溶液色谱图；
图10为芍药苷线性关系图；
图11为阿魏酸线性关系图；
图12为异鼠李素-3-O-新橙皮苷线性关系图；
图13为香蒲新苷线性关系图。
具体实施方式
所举实施例是为了更好地对本发明的内容进行说明，但并不是本发明的内容仅限于所举实施例。所以熟悉本领域的技术人员根据上述发明内容对实施方案进行非本质的改进和调整，仍属于本发明的保护范围。
实施例1
浸膏，其具体制备步骤为：
A.将57.69g当归、38.46g川芎、19.23g官桂、0.385g小茴香、38.46g没药和3.846g干姜加入其总质量10倍的水，浸泡30min，水蒸气蒸馏提取6h，得到挥发油，药渣和提取液A；
B.将38.46g赤芍、19.23g元胡、57.69g蒲黄、38.64g五灵脂和步骤A所得药渣加入其总质量9倍的体积分数为70％的乙醇溶液，提取2次，每次1.5h，回收提取液中的乙醇至无醇味，得到提取液B，将提取液B与提取液A合并浓缩至50℃下的相对密度为1.08-1.09，得初浸膏，再加入挥发油混合均匀，即得。
药效成分检测
(1)对照品溶液的制备
分别精密称取阿魏酸、芍药苷、异鼠李素-3-O-新橙皮苷、香蒲新苷对照品适量，用甲醇分别制成浓度为198.7、141.8、127.8、99.2μg/mL的混合对照品溶液。用甲醇稀释至系列浓度的混合对照品溶液，备用。
(2)供试品溶液的制备
从实施例1制得的浸膏中吸取5ml蒸干，加5ml体积分数为70％的甲醇溶液使溶解，转移至10ml容量瓶，定容，摇匀，用孔径为0.22μm的滤膜滤过，即得。
(3)阴性溶液的制备
按处方比列称取除当归、川芎以外的其他药材，按照制备工艺路线及供试品溶液的制备方法进行制备，作为阴性对照溶液。
按处方比列称取除赤芍以外的其他药材，按照制备工艺路线及供试品溶液的制备方法进行制备，作为赤芍阴性对照溶液。
按处方比列称取除蒲黄以外的其他药材，按照制备工艺路线及供试品溶液的制备方法进行制备，作为蒲黄阴性对照溶液。
(4)色谱条件
色谱柱：Ulimate XB-C18(250mm×4.6mm，5μm)
流动相：甲醇-0.05％磷酸水溶液(质量分数)
梯度洗脱：0-20min，30％-45％甲醇(体积分数)
流速：1.0mL/min
检测波长235nm
柱温40℃
进样量：10ul。
(5)专属性考察
精密吸取对照品溶液，供试品溶液，当归、川芎阴性样品溶液，赤芍阴性样品溶液、蒲黄阴性样品溶液各10ul，按照以上色谱条件，进样分析，结果如图1-9所示；其中，图1为芍药苷色谱图；图2为阿魏酸色谱图；图3为异鼠李素-3-O-新橙皮苷色谱图；图4为香蒲新苷色谱图；图5为对照品溶液色谱图；图6为供试品溶液色谱图；图7为当归、川芎阴性样品溶液色谱图；图8为赤芍阴性样品溶液色谱图；图9为蒲黄阴性样品溶液色谱图。
由图1-9可知，采用以上方法检测芍药苷、阿魏酸、异鼠李素-3-O-新橙皮苷和香蒲新苷，专属性好，能够用于芍药苷、阿魏酸、异鼠李素-3-O-新橙皮苷和香蒲新苷的含量测定。
(6)线性考察
取一系列不同质量浓度的混合对照品溶液，按照上述色谱条件进样分析，测定相应的峰面积。以对照品的浓度(μg/mL)为横坐标(x)，峰面积为纵坐标(y)，绘制标准曲线，计算线性回归方程，芍药苷的线性回归方程为：y＝29592x-13619(r＝0.999 8，线性范围：85.05-283.51μg/mL)；阿魏酸的线性回归方程为：y＝70561x+246694(r＝0.999 8，线性范围：119.22-437.12μg/mL)；异鼠李素-3-O-新橙皮苷的线性回归方程为：y＝28745x-51540(r＝0.999 7，线性范围：59.50-218.16μg/mL)；香蒲新苷的线性回归方程为：y＝22083x-36737(r＝0.999 5，线性范围：76.65-281.05μg/mL)。然后，根据图6的峰面积和以上线性回归方程，得出供试品溶液中芍药苷含量为281.19mg/g，阿魏酸含量为30.55mg/g异鼠李素-3-O-新橙皮苷含量为18.96mg/g，香蒲新苷含量为38.46mg/g。
(7)出膏率测定
精密移取供试品溶液10mL，转至蒸发皿中(恒重)，水浴蒸干溶剂，置于烘箱中(105℃)鼓风干燥化1-2天，取出，置于干燥器中冷却30分钟，称重，按照公式出膏率＝浸膏重量/药物投料量×100％计算出膏率，得出出膏率为26.8％。由此证明，本发明的方法出膏率高。
实施例2
治疗痛经的凝胶贴膏，其采用以下原料及工艺制备而得：
A.向2.6g卡波姆940中加入15g纯化水，放置过夜，使充分溶胀，作为A相；
B.将2.42g聚丙烯酸钠700、0.96g高岭土和0.25g甘羟铝用16g甘油分散均匀作为B相，0.16g酒石酸用1g水溶解作为C相；
C.将A相加入B相，搅拌均匀，加入C相和8g实施例1制得的浸膏，水浴锅(60℃)搅拌均匀，然后立即涂布于无纺布上，于30℃烘箱中放置12h，即得。
实施例3
性能测试
对实施例2制得的凝胶贴膏进行外观性状、初黏力、持黏力和剥离强度测试，同时，按照公式综合评价＝外观性状分数×0.4+初黏力分数×0.2+持黏力分数×0.2+剥离强度×0.2测定实施例2制得的凝胶贴膏的综合评价，结果如表2所示；
其中，外观性状按照表1所示标准进行评定；
初黏力的检测方法为：取凝胶贴膏，揭去防黏层，固定于初黏力测试仪上，倾斜角调整为30°。将一定重量规格(10号)的钢球，自斜面顶端自由滚下，测定钢球被膏体黏住时所滚动的距离，记录读数，重复测量3次，取平均值。以实际测得的最小距离为100分，其余按(最小值/测得值)×100计算初黏力得分；
持黏力的检测方法为：取凝胶贴膏(6cm×4cm)，粘贴于试验板表面，垂直放置，沿凝胶贴膏的下端悬挂一200g的砝码，记录5min内下滑距离，重复测量3次，取平均值。以实际测得的最小距离为100分，其余按(最小值/测得值)×100计算持黏力得分；
剥离强度的检测方法为：取凝胶贴膏(6cm×4cm)，粘贴于试验板表面，垂直放置，沿凝胶贴膏的上端悬挂一200g的砝码，记录膏体脱落所需时间，重复测量3次，取平均值。以实际测得时间的最小值为100分，其余按(最小值/测得值)×100计算得分。
表1外观性状评分标准
备注：将上述6个外观性状评价指标得分相加，指定测最大值为100分，其余得分与之相比较(测得值/最大值×100)即外观性状得分。
表2贴膏性能测试结果
由表2可知，实施例2的贴膏的各项指标均较优，综合评分最高。其中，贴膏初黏力测试中钢球移动距离为6cm，持黏力下滑距离为2min，剥离强度测试脱落所需时间为1min。由此证明，本发明的凝胶贴膏初黏力好，持黏力好，剥离强度高。
此外，应当理解，虽然本说明书按照实施方式加以描述，但并非每个实施方式仅包含一个独立的技术方案，说明书的这种叙述方式仅仅是为清楚起见，本领域技术人员应当将说明书作为一个整体，各实施例中的技术方案也可以经适当组合，形成本领域技术人员可以理解的其他实施方式。
Claims (8)
1.治疗痛经的凝胶贴膏，其特征在于，包括以下组分：卡波、聚丙烯酸钠、甘羟铝、高岭土、甘油、酒石酸和浸膏，所述浸膏的制备方法为：
将当归、川芎、官桂、小茴香、没药和干姜加入水，浸泡，水蒸气蒸馏提取，得到挥发油，药渣和提取液A，赤芍、元胡、蒲黄、五灵脂和药渣加入乙醇溶液，提取，回收提取液中的乙醇至无醇味，得到提取液B，将提取液B与提取液A合并浓缩，得初浸膏，再加入挥发油混合均匀，即得。
2.根据权利要求1所述治疗痛经的凝胶贴膏，其特征在于，所述卡波为卡波940。
3.根据权利要求1或2所述治疗痛经的凝胶贴膏，其特征在于，所述聚丙烯酸钠为聚丙烯酸钠700。
4.根据权利要求1、2或3所述治疗痛经的凝胶贴膏，其特征在于，所述提取液A制备过程中，水的用量为当归、川芎、官桂、小茴香、没药和干姜总质量的8-12倍，浸泡时间为20-40min，提取时间为5-7h。
5.根据权利要求1、2、3或4所述治疗痛经的凝胶贴膏，其特征在于，所述提取液B制备过程中，乙醇溶液为体积分数为65％-755的乙醇溶液，乙醇溶液的用量为赤芍、元胡、蒲黄、五灵脂和药渣总质量的8-10倍，提取2次，每次1-2h。
6.根据权利要求1、2、3、4或5所述治疗痛经的凝胶贴膏，其特征在于，所述浓缩的程度为浓缩至50℃下的相对密度为1.08-1.09。
7.根据权利要求1、2、3、4、5或6所述治疗痛经的凝胶贴膏，其特征在于，以质量份计，配比关系为：卡波1.0-2.6份、聚丙烯酸钠1.6-3.5份、甘羟铝0.15-0.25份，高岭土0.5-1.5份、甘油12-16份、酒石酸0.12-0.16份，浸膏用量为卡波、聚丙烯酸钠、甘羟铝、高岭土、甘油和酒石酸总质量的10％-30％。
8.权利要求1-7所述治疗痛经的凝胶贴膏的制备方法，其特征在于，包括以下步骤：
A.向卡波中加水使充分溶胀作为A相；
B.聚丙烯酸钠、高岭土和甘羟铝用甘油分散均匀作为B相，酒石酸用水溶解作为C相；
C.将A相加入B相，搅拌均匀，加入C相、浸膏，搅拌均匀，涂布于无纺布上，烘干，即得。
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