CN117298295A - 一种痛经贴及其制备方法 - Google Patents
一种痛经贴及其制备方法 Download PDFInfo
- Publication number
- CN117298295A CN117298295A CN202311542211.3A CN202311542211A CN117298295A CN 117298295 A CN117298295 A CN 117298295A CN 202311542211 A CN202311542211 A CN 202311542211A CN 117298295 A CN117298295 A CN 117298295A
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- Prior art keywords
- parts
- dysmenorrhea
- patch
- volatile oil
- common
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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Abstract
本发明公开了一种痛经贴及其制备方法,属于外用医药、保健用品的技术领域。所述痛经贴的有效成分包括挥发油环糊精包合物和药物浓缩液,所述挥发油环糊精包合物由β‑环糊精的空穴包嵌挥发油制备得到,所述挥发油由肉桂、炮姜、艾叶、川芎提取得到,所述药物浓缩液为原料经水提取浓缩后制备得到。本发明所述痛经贴能缓解原发性痛经症状,治愈效果良好。本发明采用亚临界提取与环糊精包合技术,充分提取中药中的挥发成分并保留在膏贴中,极大的保留了中药材挥发性成分,充分发挥其作用,达到更好的原发性痛经的治疗效果。并且,所述痛经贴还可与自发热包结合使用,在热敷的基础上使膏贴的效果更加明显。
Description
技术领域
本发明涉及外用医药、保健用品的技术领域,尤其涉及一种痛经贴及其制备方法。
背景技术
痛经是指行经前后或月经期出现下腹疼痛、坠胀,伴腰酸或其他不适。可分为原发性和继发性两大类,原发性痛经是指生殖器官无器质性病变的痛经,继发性痛经是指盆腔器质性疾病所引起的痛经。原发性痛经的发病率可能有30%左右。它主要是指女性在月经初潮1-2年之后出现了规律性的下腹部疼痛,疼痛主要是在来月经前的1-2天开始出现,来月经后的3-4天疼痛可以逐步的缓解。发生的具体原因就是体内的前列腺素释放而引起的。原发性痛经也可也可以分为轻、中、重度,轻度的原发性痛经可能对于身体的影响较小,而中重度的痛经会严重的影响到女性的生活和工作。对于这种痛经目前主要有中药和西药采取对症治疗,如西药采用非甾体抗炎药抑制前列腺素分泌的作用从而可以缓解痛经,中药采用口服、外敷,通过活血散瘀的方法治疗原发性痛经。
目前,针对女性痛经的治疗方法有多种、口服西药、中药、热敷和外用贴敷、艾灸与针灸。西药主要是非甾体药物抑制前列腺素的分泌、中医采用活血化瘀的方法。常用治疗痛经的西药药物有芬必得、去痛片以及吲哚美辛栓等但是均会引起不同程度的副反应,常用的中成药有丹莪妇康煎膏、益母草胶囊、田七痛经胶囊、经带宁、八珍益母胶囊等,但是现有的中成药往往会增加月经量,严重时造成内分泌紊乱。常见的治疗痛经的膏贴有暖宫贴、元胡止痛贴、散寒止痛贴等。但这些膏贴存在治愈率低等缺点。
因此,研究开发一种新型外用的、治愈率高、副作用小的痛经贴至关重要。
发明内容
有鉴于此,本发明要解决的技术问题在于提供一种痛经贴及其制备方法。所述痛经贴能缓解原发性痛经症状,治愈效果良好。
为达到以上目的,本发明采用的技术方案如下:
本发明提供了一种痛经贴,所述痛经贴的有效成分包括挥发油环糊精包合物和药物浓缩液。
所述挥发油环糊精包合物由β-环糊精的空穴包嵌挥发油制备得到。
所述挥发油由肉桂、炮姜、艾叶、川芎提取得到。
所述药物浓缩液为原料经水提取浓缩后制备得到。
所述药物浓缩液的原料包括肉桂、炮姜、艾叶、川芎提取出挥发油后剩余的中药残渣以及五灵脂、蒲黄、当归、赤芍、醋香附、木香、川乌、三棱、醋元胡、川楝子和小茴香。
本发明优选的,所述痛经贴的有效成分的原料,按重量份计,包括以下组分:
1~18份五灵脂、1~18份蒲黄、1~18份当归、1~18份赤芍、1~18份醋香附、1~9份木香、1~9份川乌、1~18份三棱、1~18份醋元胡、1~18份川楝子、1~5份小茴香、1~18份肉桂、1~5份炮姜、1~36份艾叶、1~18份川芎、1~30份β-环糊精。
更优选的,所述痛经贴的有效成分的原料,按重量份计,包括以下组分:
3~15份五灵脂、3~15份蒲黄、3~15份当归、3~15份赤芍、3~15份醋香附、2~7份木香、2~7份川乌、3~15份三棱、3~15份醋元胡、3~15份川楝子、2~3份小茴香、3~15份肉桂、2~3份炮姜、6~30份艾叶、3~15份川芎、10~20份β-环糊精。
进一步优选的,所述痛经贴的有效成分的原料,按重量份计,包括以下组分:
10份五灵脂、10份蒲黄、10份当归、10份赤芍、10份醋香附、5份木香、5份川乌、10份三棱、10份醋元胡、10份川楝子、2.6份小茴香、10份肉桂、2.5份炮姜、20份艾叶、10份川芎、15份β-环糊精。
本发明优选的,所述痛经贴添加以下组分以实现有效成分成型:
0.05~10份聚丙烯酸钠、0.001~10份羧甲基纤维素钠、0.01~1.5份甘羟铝、0.01~0.08份柠檬酸、0.1~1份甘油。
更优选的,所述痛经贴添加以下组分以实现有效成分成型:
0.2~8份聚丙烯酸钠、0.05~8份羧甲基纤维素钠、0.012~1.0份甘羟铝、0.02~0.06份柠檬酸、0.2~0.8份甘油。
进一步优选的,所述痛经贴添加以下组分以实现有效成分成型:
0.3份聚丙烯酸钠、0.3份羧甲基纤维素钠、0.09份甘羟铝、0.04份柠檬酸、0.5份甘油。
本发明还提供了一种痛经贴的有效成分原液的制备方法,包括以下步骤:
1)称取肉桂、艾叶、川芎、炮姜,粉碎后,采用亚临界提取得到挥发油和中药残渣;
2)将步骤1)得到的挥发油与β-环糊精加热混合,然后降温,得到挥发油环糊精包合物;
3)称取五灵脂、蒲黄、当归、赤芍、醋香附、木香、川乌、三棱、醋元胡、川楝子、小茴香,粉碎后与水、步骤1)所述的中药残渣混合,然后煎煮1~2次,合并煎煮液,将所述的煎煮液浓缩,得到药物浓缩液;
4)将步骤2)得到的挥发油环糊精包合物、步骤3)得到的药物浓缩液与水混合,得到痛经贴的有效成分原液。
上述制备方法采用亚临界挥发油提取技术和挥发油环糊精包合技术相结合,最大限度的提取了挥发油并保留了挥发油在膏贴中的含量,实现了中药有效成分的利用最大化。
本发明优选的,所述痛经贴的有效成分原液经过定型得到痛经贴。
所述定型具体为:
将聚丙烯酸钠、甘油与甘羟铝混合,得到A液;
将羧甲基纤维素钠、步骤2)得到的挥发油环糊精包合物、步骤3)得到的药物浓缩液与水混合,得到B液;
将A液与B液混合,加入柠檬酸,得到中药膏液;
将中药膏液涂覆于棉托表面得到痛经贴。
本发明优选的,所述步骤1)中的亚临界提取采用的溶剂选自1,1,1,2-四氟乙烷。
优选的,所述1,1,1,2-四氟乙烷(R134a)和挥发油提取原料的质量比为(10~15):1;更优选为12:1。
优选的,所述亚临界提取的压力为6~12Mpa;更优选为8~10Mpa。在本发明的一些具体实施例中,优选为9Mpa。
优选的,所述亚临界提取的温度为15℃~30℃;更优选为18℃~25℃。在本发明的一些具体实施例中,优选为20℃或25℃。
优选的,所述亚临界提取的时间为1~3h;更优选为1.5h。
本发明优选的,所述步骤2)中的挥发油与β-环糊精的质量比为1:(8~20);更优选为1:(9~15);进一步优选为1:10或1:15。
优选的,所述步骤2)中加热的温度选自50℃~80℃。在本发明的一些具体实施例中,优选为65℃。
优选的,所述步骤2)中的降温具体为降低温度至-5℃~0℃。在本发明的一些具体实施例中,优选为降低温度至-2℃。
本发明优选的,所述步骤3)中煎煮的温度为100℃。
优选的,所述煎煮的时间为1.5~2h/次;更优选为1.75h/次。
优选的,所述煎煮的溶剂选自水。
所述水和步骤3)中的中药残渣的质量比优选为(4~6):1;更优选为5:1。
上述制备方法中,所述的煎煮液的浓缩优选采用减压浓缩。
所述减压浓缩时的压力优选为-0.06MPa。
所述减压浓缩时的温度优选为60℃~80℃。
经减压浓缩后,得到在相对密度为1.350~1.380(20℃下测定)的痛经贴的药物浓缩液。
然后,将上述制备得到的挥发油环糊精包合物、药物浓缩液与水混合,得到痛经贴的有效成分原液。
最后,将所述痛经贴的有效成分原液经过上述定型得到痛经贴。
与现有技术相比,本发明提供的痛经贴的有效成分包括挥发油环糊精包合物和药物浓缩液,所述挥发油环糊精包合物由β-环糊精的空穴包嵌挥发油制备得到,所述挥发油由肉桂、炮姜、艾叶、川芎提取得到,所述药物浓缩液为原料经水提取浓缩后制备得到。所述药物浓缩液的原料包括肉桂、炮姜、艾叶、川芎提取出挥发油后剩余的中药残渣以及五灵脂、蒲黄、当归、赤芍、醋香附、木香、川乌、三棱、醋元胡、川楝子和小茴香。本发明所述痛经贴能缓解原发性痛经症状,治愈效果良好。本发明采用亚临界提取与环糊精包合技术,充分提取中药中的挥发成分并保留在膏贴中,极大的保留了中药材挥发性成分,充分发挥其作用,达到更好的原发性痛经的治疗效果。并且,所述痛经贴还可与自发热包结合使用,在热敷的基础上使膏贴的效果更加明显。
附图说明
图1为实施例1制备痛经贴的流程图。
具体实施方式
为了进一步说明本发明,下面结合实施例对本发明提供的一种痛经贴及其制备方法进行详细描述。
实施例1
(1)挥发油的提取
称取肉桂100g、炮姜25g、艾叶200g、川芎100g,粉碎成40目细粉,加入亚临界提取装置中,加入5100g的R134a,加压至9Mpa,温度为25℃,保持1.5小时后,泄压至常压,过滤后,回收R134a,得到挥发油10g和中药残渣。
(2)挥发油环糊精包合物的制备
10g挥发油与150g环糊精在500mL水中加热搅拌至65℃,保持1小时后,降温,降温至-2℃以下4小时,抽滤,得挥发油环糊精包合物。
(3)浓缩液的提取
称取五灵脂100g、蒲黄100g、当归100g、赤芍100g、醋香附100g、木香50g、川乌50g、三棱100g、醋元胡100g、川楝子100g、小茴香26g,粉碎为40目,然后与步骤(1)得到的中药残渣和水混合在100℃下煎煮1.75h,过滤,收集滤液,滤渣再加水100℃下煎煮1.5h,合并煎煮液,将所述的煎煮液在80℃,-0.06MPa压力下进行减压浓缩得到相对密度为1.380(20℃)的药物浓缩液。
(4)痛经贴中药膏液的制备
将3g聚丙烯酸钠、5g甘油与0.9g甘羟铝混合,得到A液;将3g羧甲基纤维素钠、步骤(2)得到的挥发油环糊精包合物、步骤(3)得到的浓缩液和水搅拌均匀,得到B液;将A液与B液搅拌均匀,加入0.4g柠檬酸,过胶体磨即得中药膏液。
(5)成品的制备
将中药膏液灌装至铝塑袋中,每袋灌装为1.5g,与带有防渗圈的医用胶布棉托一起包装。
对比例1
(1)挥发油的提取
称取肉桂100g、炮姜25g、艾叶200g、川芎100g,粉碎成40目细粉,水蒸气蒸馏得到挥发油和中药残渣;其中水蒸气蒸馏的时间为(1.5h),得到挥发油8.5g。
(2)挥发油环糊精包合物的制备
8.5g挥发油与127.5g的β-环糊精在500mL水中加热搅拌至65℃,保持1小时后,降温,降温至-2℃以下4小时,抽滤,得挥发油环糊精包合物。
(3)浓缩液的提取
称取五灵脂100g、蒲黄100g、当归100g、赤芍100g、醋香附100g、木香50g、川乌50g、三棱100g、醋元胡100g、川楝子100g、小茴香26g,粉碎为40目,然后与中药残渣和水混合在100℃下煎煮1.75h,过滤,收集滤液,滤渣再加水100℃下煎煮1.5h,合并煎煮液,将所述的煎煮液在80℃,-0.06MPa压力下进行减压浓缩得到相对密度为1.380(20℃)的药物浓缩液。
(4)痛经贴中药膏液的制备
将3g聚丙烯酸钠、5g甘油与0.9g甘羟铝混合,得到A液;将3g羧甲基纤维素钠、步骤(2)得到的挥发油环糊精包合物、步骤(3)得到的浓缩液和水搅拌均匀,得到B液;将A液与B液搅拌均匀,加入0.4g柠檬酸,过胶体磨即得中药膏液
(5)成品的制备
将中药膏液灌装至铝塑袋中,每袋灌装为1.5g,与带有防渗圈的医用胶布棉托一起包装。
对比例2
(1)挥发油的提取
称取肉桂100g、炮姜25g、艾叶200g、川芎100g,粉碎成40目细粉,加入亚临界提取装置中,加入500g的R134a,加压至9Mpa,保持1.5小时后,泄压至常压,过滤后,回收R134a,得到挥发油10g和中药残渣。
(2)浓缩液的提取
称取五灵脂100g、蒲黄100g、当归100g、赤芍100g、醋香附100g、木香50g、川乌50g、三棱100g、醋元胡100g、川楝子100g、小茴香26g,粉碎为40目,然后与步骤(1)得到的中药残渣和水混合在100℃下煎煮1.75h,过滤,收集滤液,滤渣再加水100℃下煎煮1.5h,合并煎煮液,将所述的煎煮液在80℃,-0.06MPa压力下进行减压浓缩得到相对密度为1.380(20℃)的药物浓缩液。
(3)痛经贴中药膏液的制备
将3g聚丙烯酸钠、5g甘油与0.9g甘羟铝混合,得到A液;将3g羧甲基纤维素钠、步骤(1)得到的10g挥发油、步骤(2)得到的浓缩液和水搅拌均匀,得到B液;将A液与B液搅拌均匀,加入0.4g柠檬酸,过胶体磨即得中药膏液。
(4)成品的制备
将中药膏液灌装至铝塑袋中,每袋灌装为1.5g,与带有防渗圈的医用胶布棉托一起包装。
对比例3
购买普通市售温经止痛膏,主要成分:香附、当归、丹参、吴茱萸、肉桂、木香、川芎、细辛、蒲黄、白芍、延胡索、冰片。
临床应用验证例
为了验证本发明对缓解痛经的疗效,采用实施例和对比例进行疗效比较的方法进行验证。
具体方法如下:选择到门诊进行就诊的原发性痛经患者150人,按时间、年龄随机进行分组,分为五组,每组30人。分别采用实施例1和对比例1、2制备的痛经贴样品和对比例3购买的市售产品,贴于气海穴。一天一贴。与月经临来前三天开始贴敷,连续贴敷三个生理周期,观察原发性痛经变化情况。观察指标:痊愈,临床症状完全消失;有效,临床症状明显改善,其中重度疼痛改善为轻度或中度疼痛,中度疼痛改善为轻度疼痛均为有效;无效,临床症状无改善。
治疗总有效率为痊愈率与有效率之和。
各实施例和对比例的相关情况见表1(痛经级别)和表2(年龄),治疗后情况(使用效果)见表3。
表1痛经级别统计表
组别 | 例数 | 轻度 | 中度 | 重度 |
实施例1 | 30 | 5 | 13 | 12 |
对比例1 | 30 | 8 | 20 | 2 |
对比例2 | 30 | 3 | 22 | 5 |
对比例3 | 30 | 9 | 18 | 3 |
表2年龄统计表
组别 | 例数 | 14岁~18岁 | 18岁~25岁 | 25岁以上 |
实施例1 | 30 | 16 | 12 | 2 |
对比例1 | 30 | 14 | 13 | 3 |
对比例2 | 30 | 17 | 9 | 4 |
对比例3 | 30 | 9 | 15 | 6 |
表3使用效果统计表
注:总有效率(%)=(痊愈例+有效例)/总测试例
表1、2、3表明,本发明选用随机分组的原发性痛经患者对本发明所述的痛经贴进行性能测试。由表3可知,实施例1制备得到的痛经帖痊愈率最高、总有效率最高,具有治疗效果好、方便实用等优点。
以上实施例的说明只是用于帮助理解本发明的方法及其核心思想。应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以对本发明进行若干改进和修饰,这些改进和修饰也落入本发明权利要求的保护范围内。
Claims (10)
1.一种痛经贴,其特征在于,所述痛经贴的有效成分包括挥发油环糊精包合物和药物浓缩液;
所述挥发油环糊精包合物由β-环糊精的空穴包嵌挥发油制备得到;
所述挥发油由肉桂、炮姜、艾叶、川芎提取得到;
所述药物浓缩液为原料经水提取浓缩后制备得到;
所述药物浓缩液的原料包括肉桂、炮姜、艾叶、川芎提取出挥发油后剩余的中药残渣以及五灵脂、蒲黄、当归、赤芍、醋香附、木香、川乌、三棱、醋元胡、川楝子和小茴香。
2.根据权利要求1所述的痛经贴,其特征在于,所述痛经贴的有效成分的原料,按重量份计,包括以下组分:
1~18份五灵脂、1~18份蒲黄、1~18份当归、1~18份赤芍、1~18份醋香附、1~9份木香、1~9份川乌、1~18份三棱、1~18份醋元胡、1~18份川楝子、1~5份小茴香、1~18份肉桂、1~5份炮姜、1~36份艾叶、1~18份川芎、1~30份β-环糊精。
3.根据权利要求1所述的痛经贴,其特征在于,所述痛经贴的有效成分的原料,按重量份计,包括以下组分:
3~15份五灵脂、3~15份蒲黄、3~15份当归、3~15份赤芍、3~15份醋香附、2~7份木香、2~7份川乌、3~15份三棱、3~15份醋元胡、3~15份川楝子、2~3份小茴香、3~15份肉桂、2~3份炮姜、6~30份艾叶、3~15份川芎、10~20份β-环糊精。
4.根据权利要求1所述的痛经贴,其特征在于,所述痛经贴的有效成分的原料,按重量份计,包括以下组分:
10份五灵脂、10份蒲黄、10份当归、10份赤芍、10份醋香附、5份木香、5份川乌、10份三棱、10份醋元胡、10份川楝子、2.6份小茴香、10份肉桂、2.5份炮姜、20份艾叶、10份川芎、15份β-环糊精。
5.根据权利要求1所述的痛经贴,其特征在于,所述痛经贴添加以下组分以实现有效成分成型:
0.05~10份聚丙烯酸钠、0.001~10份羧甲基纤维素钠、0.01~1.5份甘羟铝、0.01~0.08份柠檬酸、0.1~1份甘油。
6.根据权利要求1所述的痛经贴,其特征在于,所述痛经贴添加以下组分以实现有效成分成型:
0.2~8份聚丙烯酸钠、0.05~8份羧甲基纤维素钠、0.012~1.0份甘羟铝、0.02~0.06份柠檬酸、0.2~0.8份甘油。
7.一种痛经贴的有效成分原液的制备方法,其特征在于,包括以下步骤:
1)称取肉桂、艾叶、川芎、炮姜,粉碎后,采用亚临界提取得到挥发油和中药残渣;
2)将步骤1)得到的挥发油与β-环糊精加热混合,然后降温,得到挥发油环糊精包合物;
3)称取五灵脂、蒲黄、当归、赤芍、醋香附、木香、川乌、三棱、醋元胡、川楝子、小茴香,粉碎后与水、步骤1)所述的中药残渣混合,然后煎煮1~2次,合并煎煮液,将所述的煎煮液浓缩,得到药物浓缩液;
4)将步骤2)得到的挥发油环糊精包合物、步骤3)得到的药物浓缩液与水混合,得到痛经贴的有效成分原液。
8.根据权利要求7所述的制备方法,其特征在于,所述痛经贴的有效成分原液经过定型得到痛经贴;
所述定型具体为:
将聚丙烯酸钠、甘油与甘羟铝混合,得到A液;
将羧甲基纤维素钠、步骤2)得到的挥发油环糊精包合物、步骤3)得到的药物浓缩液与水混合,得到B液;
将A液与B液混合,加入柠檬酸,得到中药膏液;
将中药膏液涂覆于棉托表面得到痛经贴。
9.根据权利要求7所述的制备方法,其特征在于,所述步骤1)中的亚临界提取采用的溶剂选自1,1,1,2-四氟乙烷。
10.根据权利要求7所述的制备方法,其特征在于,所述步骤1)中亚临界提取的压力为6~12Mpa;
所述亚临界提取的温度为15℃~30℃;
所述亚临界提取的时间为1~3h。
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