CN111714568B - 一种妇炎消制剂的制备方法 - Google Patents
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Abstract
本发明公开了一种妇炎消制剂新的制备方法,是将大黄药材采用碱化后的乙醇进行回流提取,并将牡丹皮和苍术先提取挥发油后再煎煮或者将所有原料整体在水煎煮的同时提取挥发油。与现有技术相比,本发明中大黄素提取率更高,更保留了牡丹皮和苍术挥发性成分,使疗效更好。
Description
技术领域
本发明涉及一种妇炎消制剂的制备方法,属于医药技术领域。
背景技术
目前,妇科炎症是困扰众多女性患者的一大问题,如果不加以重视,不但会导致炎症的加重,还会引发一系列的并发症,让身体受到更大的伤害。现有技术中,也有很多治疗妇科炎症的药品,妇炎消胶囊也是其中的理想药物。妇炎消是根据苗族用药习惯和中医理论合理组方,以酢浆草、败酱草、天花粉、大黄、牡丹皮、苍术、乌药制成的纯中药制剂,具有清热解毒,行气化瘀,除湿止带。用于妇女生殖系统炎症,痛经带下。CN02134096.X已公开了妇炎消制备工艺,但在生产过程中一直存在有效成分 大黄素含量不稳定,时常影响产品疗效。
发明内容
针对以上问题,本发明的目的是提供一种既能提高大黄素含量又能提高产品疗效的妇炎消制剂的制备方法。
本发明是以如下技术方案实现的:一种妇炎消制剂的制备方法,所述妇炎消制剂由下述重量份的原料药制成:酢浆草300份、败酱草300份、天花粉250份、大黄300份、牡丹皮150份、苍术250份、乌药300 份;具体包括以下步骤:
将醇提后的大黄药渣与提取挥发油后的苍术、牡丹皮药渣,以及酢浆草、败酱草、天花粉、乌药,加6-10倍量水煎煮2-3次,每次1-3小时,合并煎液,滤过,滤液浓缩到相对密度为1.12-1.20的浸膏,备用;或将整体提取挥发油后的原料药药渣,加6-10倍量水煎煮2-3次,每次1-3小时,合并煎液,滤过,滤液浓缩到相对密度为1.12-1.20的浸膏,备用;
优选的,所述妇炎消制剂具体包括以下步骤:
优选的,所述妇炎消制剂具体包括以下步骤:
与现有技术相比,本发明的有益效果是:提供了一种妇炎消制剂新的提取、制备方法,能大幅度提高有效成分 大黄素的含量,还能有效保留丹皮酚和苍术油,提高产品疗效,操作简单,提取方便。
本发明所述的提取、制备方法,是在现有提取方法的基础上进行了改进而得的,具体的方法为:将大黄药材单独用碱化后的乙醇溶液回流提取,再与其他浸膏混合,同时将苍术和牡丹皮采用CO2超临界萃取法提取挥发油,或将所有原料药整体在进行水提时同时提取收集挥发油,并将挥发油用β环糊精进行包合。本发明一方面大幅度提高了大黄素的含量,另一方面提取收集了牡丹皮和苍术因水提工艺未收集而损失的大量的挥发油,增强了疗效。
为了对本发明的内容及有益效果进行阐述,本发明还进行了以下试验,旨在说明本发明,决不限制本发明的范围。
实验1:大黄提取方法选择:
以大黄素转移率为考察指标,按4因素3水平进行正交实验,实验结果分析见表1、表2。
具体方法为:分别称取2 kg大黄药材,按正交实验表因素水平进行实验,再将提取液合并、浓缩、干燥即得干膏粉,称重并测定大黄素含量。
表1因素水平表
表2 正交实验表
结果:从上表中可以看出,影响因素最大的是提取溶剂,用碱化后的75%乙醇溶液提取效果最好,直接用水提取的效果最差;其次是提取溶剂量,8倍量的提取溶剂提取效果比6倍量和10倍量的提取效果都好;而提取次数和提取时间显著性差异不大,在提取时间上,提取1小时、2小时和3小时差异很小,故确定提取时间为每次提取2小时,通过分析,得出最优组合为A3B2C2D2,即取大黄药材,加8倍量碱化后的75%乙醇(pH9-10)提取2次,每次2小时。
实验2:挥发油提取方法选择:
以挥发油提取率为考察指标,考察不同提取方法对提取率的影响,结果见表3:
表3:不同提取方法提取挥发油对比表
方法 | 提取时间(h)) | 挥发油提取率 |
水蒸气蒸馏法 | 6 | 4.85% |
石油醚超声提取法 | 3 | 6.57% |
CO2超临界萃取法 | 4 | 9.34% |
结果:从表中可以看出,采用CO2超临界萃取法提取时挥发油提取率最高,提取时间也适中。在提取挥发油时可择优选择。而水蒸气蒸馏法虽然挥发油提取率较低,但其可以与水煎煮工艺同时进行,在大生产中比CO2超临界萃取法更能节能省时,也不失为一种有效的提取方法。
实验3:妇炎消制剂稳定性考察:
根据2015年版《中国药典》(四部)原料药物与制剂稳定性试验指导原则的相关规定进行加速稳定性试验,其试验结果见表4:
表4:妇炎消制剂加速稳定性试验检测结果
结果:从表中可以看出,一方面,本发明妇炎消制剂比市售妇炎胶囊大黄素含量高出近60%,另一方面,丹皮酚在原市售妇炎消胶囊中未能检出,而本发明中丹皮酚含量均在0.1mg/粒以上。同时上述产品经过加速性试验考察,结果均符合要求。
为了使本领域普通技术人员更好的理解本发明,本申请人进行了一系列动物实验研究,以证明本发明的效果:
一、抗炎作用试验:考察本发明妇炎消制剂对大鼠实验性子宫炎症的影响
取体重200-300g雌性Wistar大鼠60只,随机分为6组,各组动物在乙醚麻醉下,剪去大鼠腹毛,消毒后于腹正中切2cm长口,暴露子宫,在左侧子宫角上lcm处做一小切口,将一塑料管(管径2mm、长0.5mm,重2mg,用前消毒)置于子宫内缝合固定防止脱落,并将子宫切口及腹腔分层缝合好。术后2h各组分别灌胃给药,连续给药7天后处死动物,取出两侧子宫,用微量天平称重,左侧子宫在计算前应先减去2mg(塑料管重量)。计算肿胀率和抑制率。求出各组均值及标准差,并做t检验,比较组间差异的显著性。计算公式如下:
肿胀率E(%)=(vt- vn)/vn×100% (注:Vn、Vt分别代表未致炎和致炎子宫重量)
抑制率(%)=(Ec-En)/Ec×100% (注:En、Ec分别代表给药组和对照组的肿胀率)
实验结果见表5:
表5 本发明对子宫异物所致炎症肿胀的影响
组别 | 数量(只) | 剂量 | 肿胀率(%) | 抑制率(%) |
对照组 | 10 | — | 137.4±41.62 | —— |
抗妇炎胶囊 | 10 | 1.5g/kg | 64.1±32.54 | 53.3 |
市售妇炎消胶囊 | 10 | 1.5g/kg | 58.8±14.57 | 57.2 |
实施例1 | 10 | 1.5g/kg | 39.7±7.21 | 71.1 |
实施例2 | 10 | 1.5g/kg | 42.2±11.62 | 69.3 |
实施例3 | 10 | 1.5g/kg | 44.1±9.54 | 67.9 |
结果表明,本发明实施例制剂具有良好的抗炎作用,作用优于市售妇炎消胶囊。
二、镇痛作用试验:考察本发明妇炎消制剂对醋酸所致小鼠扭体反应的影响
取体重18~22g,痛阈在10~60s间的雌性昆明小鼠60只,随机分为6组,分别连续给药10天,于末次给药40分钟后,给小鼠腹腔注射0.6%醋酸溶液0.2ml/只,以小鼠扭体次数作为疼痛指标,记录注射致痛剂后15分钟内各小鼠扭体次数,按下式计算药物对扭体反应的抑制率评判药物镇痛效果:
抑制率%=(生理盐水组扭体均数-给药组扭体均数)/生理盐水组扭体均数×100%
实验结果见表6:
表6 本发明对醋酸所致小鼠扭体反应的影响
组别 | 数量(只) | 剂量 | 扭体次数 | 抑制率(%) |
生理盐水组 | 10 | — | 32 | — |
抗妇炎胶囊 | 10 | 1.5g/kg | 25 | 21.8% |
市售妇炎消胶囊 | 10 | 1.5g/kg | 20 | 37.5% |
实施例1 | 10 | 1.5g/kg | 12 | 62.5% |
实施例2 | 10 | 1.5g/kg | 14 | 56.2% |
实施例3 | 10 | 1.5g/kg | 16 | 50% |
结果表明,本发明实施例制剂具有良好的镇痛作用,作用优于市售妇炎消胶囊。
三、抑菌作用试验:
取妇炎消制剂药粉,分别加入蒸馏水煎煮2次,每次30分钟,合并两次煎煮滤液,制成水煎液,制成的药物浓度为0.5g/ml,并消毒、灭菌后备用。
取无菌试管若干支,用相应的液体培养基稀释药液,每管1ml,其最终浓度分别为100、50、25、12.5、6.25、3.125mg/ml;同时设药物对照及菌珠对照。每管加入0.1ml10-3稀释的新鲜菌液,置37℃培养箱内培养18小时后观察有无细菌生长,如果药物颜色深或不透明,无法判定有无细胞生长时,可把可疑的管再移种到平皿培养基上,培养18小时后观察有无细菌生长。细菌不生长的最高药物稀释度为该药的最低抑菌浓度。实验结果见表7:
表7 本发明妇炎消制剂的抑菌作用结果表
-表示无菌生长;+,++,+++表示有菌生长
结果表明,本发明的实施例制剂具有很好的抑菌效果,而且作用明显优于市售妇炎消胶囊。
具体实施方式
实施例1:
处方:酢浆草300g、败酱草300g、天花粉250 g、大黄300g、牡丹皮150g、苍术250g、乌药300 g;
制备工艺:
取苍术、牡丹皮粉碎成粗粉,投入超临界萃取釜中,采用CO2超临界萃取法提取挥发油,调节萃取釜温度为42℃,压力为18MPa, CO2流量为3L/h,萃取时间为4小时,萃取结束后收集挥发油备用,药渣备用;
实施例2:
处方:酢浆草300g、败酱草300g、天花粉250 g、大黄300g、牡丹皮150g、苍术250g、乌药300 g;
制备工艺:
实施例3:
处方:酢浆草300g、败酱草300g、天花粉250 g、大黄300g、牡丹皮150g、苍术250g、乌药300 g;
制备工艺:
Claims (5)
1.一种妇炎消制剂的制备方法,其特征在于,所述妇炎消制剂由下述重量份的原料药制成:酢浆草300份、败酱草300份、天花粉250 份、大黄300份、牡丹皮150份、苍术250份、乌药300 份,具体包括以下步骤:
将醇提后的大黄药渣与提取挥发油后的苍术、牡丹皮药渣,以及酢浆草、败酱草、天花粉、乌药,加6-10倍量水煎煮2-3次,每次1-3小时,合并煎液,滤过,滤液浓缩到相对密度为1.12-1.20的浸膏,备用;或将整体提取挥发油后的原料药药渣,加6-10倍量水煎煮2-3次,每次1-3小时,合并煎液,滤过,滤液浓缩到相对密度为1.12-1.20的浸膏,备用;
2.根据权利要求1所述的制备方法,其特征在于,所述提取挥发油的方法为水蒸气蒸馏法、超声提取法或者超临界萃取法。
3.根据权利要求1所述的制备方法,其特征在于,所述剂型为胶囊剂、片剂、颗粒剂、丸剂、栓剂。
4.根据权利要求1-3任一项所述的制备方法,其特征在于,所述步骤如下:
5.根据权利要求1-3任一项所述的制备方法,其特征在于,所述步骤如下:
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