CN113413362A - 一种中药配方颗粒膏方标准化的制备方法及其应用 - Google Patents
一种中药配方颗粒膏方标准化的制备方法及其应用 Download PDFInfo
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- CN113413362A CN113413362A CN202110730744.9A CN202110730744A CN113413362A CN 113413362 A CN113413362 A CN 113413362A CN 202110730744 A CN202110730744 A CN 202110730744A CN 113413362 A CN113413362 A CN 113413362A
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Abstract
本发明提供一种中药配方颗粒膏方标准化的制备方法及其应用,属于中药标准化处理技术领域。本发明所述膏方为采用中药配方颗粒熬制膏方,滋阴类膏方采用阿胶为基质,补阳类膏方采用鹿角胶为基质,所述阿胶、鹿角胶也可以是阿胶、鹿角胶制成的配方颗粒,可缩短熬膏时间,避免烊化的繁琐工序。以中药配方颗粒制备膏方,通过筛选优化相关工艺条件,从而将制备过程标准化,经试验验证,其可应用于不同处方、不同剂量的中药配方颗粒膏方,同时能够有效缩短膏方制备时间,且避免人为因素造成的不同批次膏方的质量差异,因此具有良好的实际应用之价值。
Description
技术领域
本发明属于中药标准化处理技术领域,具体涉及一种中药配方颗粒膏方标准化的制备方法及其应用。
背景技术
公开该背景技术部分的信息仅仅旨在增加对本发明的总体背景的理解,而不必然被视为承认或以任何形式暗示该信息构成已经成为本领域一般技术人员所公知的现有技术。
“膏方”是以养生保健为主要目的所服用的中药膏剂,又称“膏滋”,是最古老的方剂剂型之一,是以复方中药煎熬,去渣滤清,取汁浓缩后,以胶或蜜等赋形剂调制而成的膏状内服制剂。膏方依据中医学整体观念,通过“辨证施治”和“因人、因时个体化治疗”广泛应用于内科、外科、妇科、儿科科疾病的治疗,还用于亚健康人群的养生保健。在预防和治疗内科疾病方面有着显著的临床效果。
传统膏方制作,药材来源与质量不同,在实际膏方制备过程中,不同批次之间制成量和质量差距较大;膏方制备过程需要浸泡、煎煮,对浸泡、煎煮时间及煎煮次数,尚无统一的要求,微小的差距可能影响药材成分煎出,影响治疗效果;收膏需要具备丰富的制膏经验,最终判定完全凭借个人经验判断,主观性强,没有量化标准。
发明内容
针对现有技术存在的问题,本发明提供一种中药配方颗粒膏方标准化的制备方法及其应用。本发明以中药配方颗粒制备膏方,通过筛选优化相关工艺条件,从而将制备过程标准化,经试验验证,其可应用于不同处方、不同剂量的中药配方颗粒膏方,因此具有良好的实际应用之价值。
具体的,本发明涉及以下技术方案:
本发明的第一个方面,提供一种中药配方颗粒膏方标准化的制备方法,所述制备方法包括调剂处方、复溶、熬膏和收膏;
其中,所述调剂处方具体包括:将所需中药配方颗粒按照处方量进行处方调剂配制;调剂处方中可使用中药配方颗粒调剂设备,而从提高调剂处方效率,减少人为因素产生的误差。
所述复溶具体方法为:加入清水,升温后加入调剂好的中药配方颗粒。
所述熬膏具体方法为:待上述颗粒完全溶解后,设置保温温度、熬膏温度、熬膏时间,使药液浓缩逐渐变为稠厚的清膏。
所述收膏具体方法为:加入蜂蜜与矫味剂,密闭熬煮得稠膏即为中药配方颗粒膏方。
本发明的第二个方面,提供上述中药配方颗粒膏方标准化的制备方法在制备膏方中的应用。
以上一个或多个技术方案的有益技术效果:
上述技术方案提供一种中药配方颗粒膏方标准化的制备方法,所述膏方为采用中药配方颗粒熬制膏方,滋阴类膏方采用阿胶为基质,补阳类膏方采用鹿角胶为基质,所述阿胶、鹿角胶也可以是阿胶、鹿角胶制成的配方颗粒,可缩短熬膏时间,避免烊化的繁琐工序。所述制备方法采用标准化的制备流程和专用膏方设备,大大缩短膏方的制备时间,且熬膏、收膏终点可控,最大程度的避免人为因素造成的不同批次膏方的质量差异,在此基础上,上述技术方案进一步对配方颗粒复溶加水量、复溶方式、加水的温度、熬膏温度、熬膏时间、蜂蜜用量、矫味剂用量等进行优化,从而得到中药配方颗粒膏方标准化的制备方法,因此具有良好的实际应用之价值。
具体实施方式
应该指出,以下详细说明都是例示性的,旨在对本申请提供进一步的说明。除非另有指明,本文使用的所有技术和科学术语具有与本申请所属技术领域的普通技术人员通常理解的相同含义。
需要注意的是,这里所使用的术语仅是为了描述具体实施方式,而非意图限制根据本申请的示例性实施方式。如在这里所使用的,除非上下文另外明确指出,否则单数形式也意图包括复数形式,此外,还应当理解的是,当在本说明书中使用术语“包含”和/或“包括”时,其指明存在特征、步骤、操作、器件、组件和/或它们的组合。
结合具体实例对本发明作进一步的说明,以下实例仅是为了解释本发明,并不对其内容进行限定。如果实施例中未注明的实验具体条件,通常按照常规条件,或按照销售公司所推荐的条件;实施例中所用的材料、试剂等,如无特殊说明,均可通过商业途径购买得到。
如前所述,传统膏方制作,药材来源与质量不同,在实际膏方制备过程中,不同批次之间制成量和质量差距较大;膏方制备过程需要浸泡、煎煮,对浸泡、煎煮时间及煎煮次数,尚无统一的要求,微小的差距可能影响药材成分煎出,影响治疗效果;收膏需要具备丰富的制膏经验,最终判定完全凭借个人经验判断,主观性强,没有量化标准。这些都严重制约了膏方的大规模推广。
而采用中药配方颗粒制备膏方,优势有以下三点:
(1)质量可控,中药配方颗粒原料稳定可控,与饮片相比,中药配方颗粒经过工厂工业化生产、检验,原料固定产地,诸多质控指标把控完全,确保不同批次的制备工艺、煎出率及质量稳定。
(2)操作简便效率高,传统饮片制备膏方,操作繁复,需经历浸、煎、榨、化、滤、熬及收等共七道工序,至少需要2天时间;应用中药配方颗粒制备膏方仅需复溶、熬膏及收膏三个过程,仅需40-60分钟,大大缩短膏方的制备时间。
(3)标准化流程,中药配方颗粒制备膏方,采用标准化的制备流程和专用膏方设备,最大程度的避免人为因素造成的不同批次膏方的质量差异,保证临床疗效的一致性。
有鉴于此,本发明的一个具体实施方式中,提供一种中药配方颗粒膏方标准化的制备方法,所述膏方制备方法包括调剂处方、复溶、熬膏和收膏;
其中,所述调剂处方具体包括:将所需中药配方颗粒按照处方量进行处方调剂配制;调剂处方中可使用中药配方颗粒调剂设备,而从提高调剂处方效率,减少人为因素产生的误差。
所述中药配方颗粒膏方是采用不同处方的配方颗粒制备膏方,可以包括滋阴类膏方和补阳类膏方;
其中,滋阴类膏方采用阿胶做基质,补阳类膏方采用鹿角胶做基质,所述阿胶、鹿角胶可以为阿胶、鹿角胶做成的配方颗粒;
所述阿胶配方颗粒制备方法为:取阿胶饮片,烊化,制成颗粒,即得。阿胶配方颗粒1g相当于2g原药材。
所述鹿角胶配方颗粒制备方法为:取鹿角胶饮片,烊化,制成颗粒,即得。鹿角胶配方颗粒1g相当于1.5g原药材。
所述复溶具体方法为:加入清水,升温后加入调剂好的中药配方颗粒。
所述熬膏具体方法为:待上述颗粒完全溶解后,设置保温温度、熬膏温度、熬膏时间,使药液浓缩逐渐变为稠厚的清膏。
所述收膏具体方法为:加入蜂蜜与矫味剂,密闭熬煮得稠膏即为中药配方颗粒膏方。
本发明的一个或多个具体实施方式中,所述复溶中,加入的水量为颗粒总重量的0.8-1.5倍,优选为1.3倍;复溶时间控制控制为5-15分钟,优选为10分钟。
本发明的一个或多个具体实施方式中,复溶方式具体为中药配方颗粒加入水中,复溶的温度为50℃-55℃。通过采用将调剂好的配方颗粒加入到热水中搅拌溶解的方式,更有利于配方颗粒溶解,提高制备效率。
本发明的一个或多个具体实施方式中,所述熬膏中,熬膏温度控制为70-90℃,优选为80℃,所述熬膏时间控制为17-68min,优选为34min;
本发明的一个或多个具体实施方式中,熬出清膏应用阿贝折光仪测定折光率应为1.45-1.49,应用密度计测得相对密度为1.34-1.38。
本发明的一个或多个具体实施方式中,所述收膏过程中,控制加入的蜂蜜量为配方颗粒质量的15-25%,优选为20%,通过优化蜂蜜加入量,从而提高膏方品质。
本发明的一个或多个具体实施方式中,所述矫味剂包括但不限于柠檬酸、D-酒石酸或L苹果酸;进一步优选为柠檬酸;
控制加入柠檬酸的量为配方颗粒质量的0~1.2%,优选为1%,从而提高膏方口感。
本发明的一个或多个具体实施方式中,收膏温度控制为40-60℃,优选为50℃;收膏时间控制为3-10分钟,优选为5分钟;
本发明的一个或多个具体实施方式中,熬出稠膏应用阿贝折光仪测定折光率应为1.45-1.49,应用密度计测得相对密度为1.34-1.38,固含量为70%-75%。
本发明的一个或多个具体实施方式中,提供上述中药配方颗粒膏方标准化的制备方法在制备膏方中的应用。
其中,所述膏方包括但不限于滋养肝肾配方颗粒膏方、平心复脉配方颗粒膏方、温补肾阳配方颗粒膏方和强身健体中药配方颗粒膏方。
以下通过实施例对本发明做进一步解释说明,但不构成对本发明的限制。应理解这些实施例仅用于说明本发明而不用于限制本发明的范围。
实施例1(滋养肝肾配方颗粒膏方)
采用配方颗粒熬制膏方,需对配方颗粒复溶加水量、复溶方式、加水的温度、熬膏温度、熬膏时间、阿胶用量、蜂蜜用量、柠檬酸用量等参数进行实验研究及验证。
1、处方:
2、试验方法:
2.1、复溶方式研究
平均称取两份滋养肝肾膏方配方颗粒,其中一份将称量好的配方颗粒缓缓倒入热水中,搅拌溶解,另一份是将热水缓缓倒入颗粒中,搅拌溶解,观察溶解情况并记录时间,结果见表1-1
表1-1 配方颗粒加水方式考察
加水方式 | 复溶时间(min) | 现象 |
颗粒加到热水中 | 10 | 颗粒全部溶解 |
热水倒入颗粒中 | 大于20 | 颗粒成球,不易溶解 |
结论:复溶方式为调剂好的配方颗粒加入到热水中搅拌溶解。
2.2、复溶加水温度考察:
平均称取3份滋养肝肾膏方配方颗粒,分别将称量好的配方颗粒缓缓倒入30-40℃温水、50-60℃热水、80-90℃热水中,搅拌溶解,观察溶解情况并记录时间,结果见表1-2。
表1-2 配方颗粒加水温度考察
加水温度 | 复溶时间(min) | 现象 |
30-40℃ | 大于20 | 不易溶解 |
50-60℃ | 10 | 颗粒全部溶解 |
80-90℃ | 大于20 | 颗粒成球,不易溶解 |
结论:取调剂好的配方颗粒加入到热水50-60℃中搅拌溶解。
2.3、加水量考察:
平均称取4份滋养肝肾膏方配方颗粒,分别加入0.8、1.0、1.3、1.5倍水考察颗粒溶解度,确定加水量,结果见表1-3。
表1-3 配方颗粒复溶加水量
加水量(颗粒倍数) | 复溶时间(min) | 现象 |
0.8 | 10 | 大量颗粒未溶解 |
1.0 | 10 | 少量颗粒未溶解 |
1.3 | 10 | 颗粒全部溶解 |
1.5 | 10 | 颗粒全部溶解,加水量过多 |
结论:取调剂好的配方颗粒缓缓倒入1.3倍量热水(50-60℃)中搅拌溶解。
2.4、熬膏温度考察:
平均称取两份滋养肝肾膏方配方颗粒,分别考察不同熬膏温度熬膏情况,最终确定最佳熬膏温度。结果见表1-4
表1-4 熬膏温度考察
结论:熬膏温度控制在80±5℃。
2.5、熬膏时间考察:
取不同量的颗粒,按前面确定的条件熬膏,熬至膏滴在吸水纸不散、“滴水成珠”状态时,测定相对密度与折光率,并分别记录达物理参数一致时所需熬膏时间,最终确定熬膏时间。结果见表1-5
表1-5 熬膏时间考察
颗粒量 | 熬膏时间(min) | 折光率 | 相对密度 |
250 | 17 | 1.4858 | 1.37 |
500 | 34 | 1.4833 | 1.37 |
1000 | 68 | 1.4809 | 1.37 |
结论:熬制时间为34min/500g。
2.6阿胶加入量考察:
取阿胶,烊化,成稠膏。
平均称取3份滋养肝肾方配方颗粒,在熬制收膏时分别加入配方颗粒2%、4%、6%阿胶,搅拌熬制后,评价该三个膏滋性状口感,结果见表1-6。
表1-6 阿胶量考察
颗粒量 | 阿胶量% | 膏滋性状 | 膏滋口感 |
500 | 2 | 膏滋不够丝滑光亮 | 口感不顺滑 |
500 | 5 | 膏滋丝滑光亮 | 口感顺滑,不黏腻 |
500 | 8 | 膏滋丝滑光亮 | 口感顺滑但很黏腻 |
结论:阿胶加入量为处方配方颗粒的5%。
2.7、蜂蜜加入量的确定:
平均称取3份滋养肝肾膏方配方颗粒,在熬制收膏时分别加入配方颗粒15%、20%、25%蜂蜜,搅拌熬制后,评价该三个膏滋口感,结果见表1-6
表1-6 添加不同量蜂蜜口感情况
结论:熬膏加入蜂蜜量为配方颗粒的20%。
2.8、柠檬酸加入量考察:
平均称取4份滋养肝肾膏方配方颗粒,在熬制收膏时加入20%蜂蜜后,再分别加入配方颗粒0%、0.6%、1%、1.2%的柠檬酸,搅拌熬制后,评价该4个膏滋口感情况,结果见表1-7
表1-7 添加不同柠檬酸口感情况
柠檬酸量(颗粒量的百分比) | 口感 |
0 | 苦、涩等中药特有异味浓重,与蜂蜜的甜不融洽 |
0.6% | 苦、涩味略有缓和 |
1% | 酸甜适宜,接受度大大提高 |
1.2% | 偏酸 |
结论:熬膏加入柠檬酸量为配方颗粒的1%。
3、膏方标准化工艺流程
在膏方机锅中,加入颗粒总重量1.3倍量的清水,将保温温度与熬膏温度设置为55℃,时间设置为10min,开始加热搅拌,当温度达到50℃以上时,缓缓加入调剂好的中药配方颗粒;复溶10min结束,将熬膏温度设置为85℃,设置时间(34分钟/500g颗粒),使药液浓缩逐渐变为稠厚的清膏;加入阿胶(25g阿胶/500g颗粒或50g阿胶配方颗粒/500g颗粒),蜂蜜(100g蜂蜜/500g颗粒)与柠檬酸(5g柠檬酸/500g颗粒),盖上盖子,避免在膏体表面形成一层膜,继续85℃加热搅拌熬煮,熬膏时间(5min/500g颗粒)得膏滋,(此时应用阿贝折光仪测定折光率,应为1.45-1.49;相对密度为1.34-1.38;固含量为70%-75%。
实施例2(平心复脉配方颗粒膏方)
1.1调剂处方:
应用中药配方颗粒调剂设备按照一个处方量进行处方调剂配制,共617g颗粒。
1.2复溶:
在膏方机锅中,加入颗粒总重量1.3倍量的清水(802g),将保温温度与熬膏温度设置为55℃,时间设置为10min,开始加热搅拌,当温度达到50℃以上时,缓缓加入调剂好的中药配方颗粒617g。
1.3熬膏:
颗粒完全溶解后,将保温温度与熬膏温度设置为85℃,设置时间42分钟,使药液浓缩逐渐变为稠厚的清膏。(此时应用阿贝折光仪测定折光率,为1.471;密度计测得相对密度为1.37)。
1.4收膏:
加入30.85g的阿胶烊化后的阿胶稠膏、蜂蜜123g与柠檬酸6.2g,盖上盖子,避免在膏体表面形成一层膜。继续85℃加热搅拌熬煮,熬膏时间6min得膏,(此时应用阿贝折光仪测定折光率为1.48;相对密度为1.37;固含量为73%)。
实施例3(温补肾阳配方颗粒膏方)
处方及处方量:
1.1调剂处方:
应用中药配方颗粒调剂设备按照一个处方量进行处方调剂配制,共565g颗粒。
1.2复溶:
在膏方机锅中,加入颗粒总重量1.3倍量的清水(735g),将保温温度与熬膏温度设置为55℃,时间设置为10min,开始加热搅拌,当温度达到50℃以上时,缓缓加入调剂好的中药配方颗粒565g。
1.3熬膏:
颗粒完全溶解后,将保温温度与熬膏温度设置为85℃,设置时间38分钟,使药液浓缩逐渐变为稠厚的清膏。(此时应用阿贝折光仪测定折光率,为1.46;密度计测得相对密度为1.36)。
1.4鹿角胶加入量考察:
取鹿角胶,烊化,成稠膏。
平均称取3份温补肾阳方配方颗粒,在熬制收膏时分别加入配方颗粒1%、3%、6%鹿角胶,搅拌熬制后,评价该三个膏滋性状口感,结果见表1-6。
表1-8 鹿角胶量考察
颗粒量 | 鹿角胶量% | 膏滋性状 | 膏滋口感 |
565 | 1 | 膏滋不够丝滑光亮 | 口感不顺滑 |
565 | 3 | 膏滋丝滑光亮 | 口感顺滑,不黏腻 |
565 | 6 | 膏滋丝滑光亮 | 口感顺滑但很黏腻 |
结论:鹿角胶加入量为处方配方颗粒的3%。
1.4收膏:
加入17g的鹿角胶烊化后的鹿角胶稠膏、蜂蜜113g与柠檬酸5.6g,盖上盖子,避免在膏体表面形成一层膜。继续85℃加热搅拌熬煮,熬膏时间6min得膏,(此时应用阿贝折光仪测定折光率为1.47;相对密度为1.36;固含量为72%)。
实施例4(强身健体中药配方颗粒膏方)
处方及处方量:
1.1调剂处方:
应用中药配方颗粒调剂设备按照一个处方量进行处方调剂配制,共606g颗粒。
1.2复溶:
在膏方机锅中,加入颗粒总重量1.3倍量的清水(788g),将保温温度与熬膏温度设置为55℃,时间设置为10min,开始加热搅拌,当温度达到50℃以上时,缓缓加入调剂好的中药配方颗粒606g。
1.3熬膏:
颗粒完全溶解后,将保温温度与熬膏温度设置为85℃,设置时间41分钟,使药液浓缩逐渐变为稠厚的清膏。(此时应用阿贝折光仪测定折光率,为1.48;密度计测得相对密度为1.38)。
1.4收膏:
加入18.18g鹿角胶烊化的稠膏、蜂蜜121g与柠檬酸6.1g,盖上盖子,避免在膏体表面形成一层膜。继续85℃加热搅拌熬煮,熬膏时间6min得膏,(此时应用阿贝折光仪测定折光率为1.48;相对密度为1.37;固含量为72%)。
最后应说明的是:以上所述仅为本发明的优选实施例而已,并不用于限制本发明,尽管参照前述实施例对本发明进行了详细的说明,对于本领域的技术人员来说,其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分技术特征进行等同替换。凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (10)
1.一种中药配方颗粒膏方标准化的制备方法,其特征在于,所述制备方法包括调剂处方、复溶、熬膏和收膏;
其中,所述调剂处方具体包括:将所需中药配方颗粒按照处方量进行处方调剂配制;
所述复溶具体方法为:加入清水,升温后加入调剂好的中药配方颗粒;
所述熬膏具体方法为:待上述颗粒完全溶解后,设置保温温度、熬膏温度、熬膏时间,使药液浓缩逐渐变为稠厚的清膏;
所述收膏具体方法为:加入蜂蜜与矫味剂,密闭熬煮得稠膏即为中药配方颗粒膏方。
2.如权利要求1所述的制备方法,其特征在于,所述复溶中,加入的水量为颗粒总重量的0.8-1.5倍,优选为1.3倍;复溶时间控制控制为5-15分钟,优选为10分钟。
3.如权利要求1所述的制备方法,其特征在于,复溶方式具体为中药配方颗粒加入水中,复溶的温度为50℃-55℃。
4.如权利要求1所述的制备方法,其特征在于,所述熬膏中,熬膏温度控制为70-90℃,优选为80℃,所述熬膏时间控制为17-68min,优选为34min。
5.如权利要求1所述的制备方法,其特征在于,熬出清膏应用阿贝折光仪测定折光率应为1.45-1.49,应用密度计测得相对密度为1.34-1.38。
6.如权利要求1所述的制备方法,其特征在于,所述收膏过程中,控制加入的蜂蜜量为配方颗粒质量的15-25%,优选为20%;
所述矫味剂包括柠檬酸、D-酒石酸或L苹果酸;进一步优选为柠檬酸;
控制加入柠檬酸的量为配方颗粒质量的0~1.2%,优选为1%。
7.如权利要求1所述的制备方法,其特征在于,收膏温度控制为40-60℃,优选为50℃;收膏时间控制为3-10分钟,优选为5分钟。
8.如权利要求1所述的制备方法,其特征在于,熬出稠膏应用阿贝折光仪测定折光率应为1.45-1.49,应用密度计测得相对密度为1.34-1.38,固含量为70%-75%。
9.如权利要求1所述的制备方法,其特征在于,所述中药配方颗粒膏方包括滋阴类膏方和补阳类膏方;
其中,滋阴类膏方采用阿胶做基质,补阳类膏方采用鹿角胶做基质,所述阿胶、鹿角胶为阿胶、鹿角胶做成的配方颗粒;
所述阿胶配方颗粒制备方法为:取阿胶饮片,烊化,制成颗粒,即得;
所述鹿角胶配方颗粒制备方法为:取鹿角胶饮片,烊化,制成颗粒,即得。
10.权利要求1-9任一项所述中药配方颗粒膏方标准化的制备方法在制备膏方中的应用;
优选的,所述膏方包括滋养肝肾配方颗粒膏方、平心复脉配方颗粒膏方、温补肾阳配方颗粒膏方和强身健体中药配方颗粒膏方。
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