CN106975028A - 一种治疗痛风的中药制剂的制备方法 - Google Patents
一种治疗痛风的中药制剂的制备方法 Download PDFInfo
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- CN106975028A CN106975028A CN201710103932.2A CN201710103932A CN106975028A CN 106975028 A CN106975028 A CN 106975028A CN 201710103932 A CN201710103932 A CN 201710103932A CN 106975028 A CN106975028 A CN 106975028A
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Abstract
本发明公开了一种治疗痛风的中药制剂的制备方法,该制备方法通过调整辅料的种类以及用量,解决了临床应用上中药类压片糖果口感不良及其易吸湿受潮导致退色等质量不稳定问题,从而使产品稳定性更好。本发明方法简便,生产成本低,产品质量稳定,口感润滑、甜度适宜,患者容易接受。
Description
技术领域
本发明属于药品、保健食品、食品领域,涉及一种组合物制剂的制备方法,特别是涉及一种治疗痛风的中药制剂的制备方法。
背景技术
随着人们生活水平的提高,饮食结构的变化,糖、脂肪、蛋白质摄入量明显增加,痛风的发病率有逐年增高的趋势,除了侵犯骨和关节,还容易累及肾脏和心血管系统,高尿酸血症及原发性痛风与肥胖症、高脂血症、高血压病、糖尿病、动脉粥样硬化等疾病呈显著正相关。从临床实践来看,多数痛风病人不仅血尿酸值增高,而且血脂值也较高。在这种情况下,使用不良反应较少的保健食品、中药或中西药配合使用治疗痛风,有一定的优势,尤其是使用“药食同源”的原料制成的药品、保健品以及食品,更符合人们对疾病的治疗、日常保健的需求。
压片糖果其特点主要是通过口腔颊面粘膜吸收,具有吸收快、起效迅速等特点,在药学上可分为中药类和西药类。与西药类的化学制剂相比,中药类口服制剂常因口感不良以及易吸湿受潮导致质量问题在临床应用上受到极大制约,服用时与口腔接触时间更长的压片糖果尤为如此。而目前已有的中药类压片糖果往往存在易吸湿受潮导致退色等质量问题,同时由于添加大量的蔗糖来改善其口感,限制了糖尿病患者的使用。
发明内容
本发明针对现有中药类压片糖果口感不良、易吸湿受潮导致退色等质量不稳定以及为了改善其口感而使用大量蔗糖等问题,提供一种治疗痛风的中药制剂的制备方法,解决了临床应用上中药类压片糖果口感不良、易吸湿受潮导致退色等问题,从而使产品稳定性更好,患者更容易接受。本发明制剂简便,质量稳定,口感香甜滑口,不含蔗糖,可长期用于治疗痛风疾病,尤其适合伴随高血糖的患者使用,同时兼具提高机体免疫力的作用。
为解决上述技术问题,本发明是通过以下技术方案实现的:
一种治疗痛风的中药制剂的制备方法,包括如下步骤:
处方:药材提取清膏130-250份、玉米淀粉30-40份、麦芽糊精100-200份、微晶纤维素10-50份、甘露醇10-50份、甜味剂1-10份及占以上所述组分总重量0.5-1.0%的海藻糖;
制备方法:
(1)分别取:麦芽糊精、微晶纤维素、甘露醇,粉碎,过100目筛,备用;
(2)按配方量称取玉米淀粉、海藻糖,加水100份使溶解成淀粉海藻糖浆;
(3)按配方量称取步骤(1)项下各辅料,以等量递增法混合均匀,得混合粉;
(4)取步骤(3)项下的混合粉,按配方量加入药材提取清膏和步骤(3)项下的淀粉海藻糖浆制软材,过筛制粒,干燥,控制水分在2%以内,过筛整粒,得颗粒;
(5)按配方量称取甜味剂,与步骤(5)项下颗粒混合均匀,压片,即得。
以上所述治疗痛风的中药制剂的制备方法,所述处方进一步优选为:药材提取清膏150-200份、玉米淀粉30-40份、麦芽糊精150-200份、微晶纤维素10-30份、甘露醇10-30份、甜味剂3-8份及占以上所述组分总重量0.5-0.8%的海藻糖。
以上所述治疗痛风的中药制剂的制备方法,所述处方最佳优选为:药材提取清膏180份、玉米淀粉30份、麦芽糊精150份、微晶纤维素30份、甘露醇30份、甜味剂5份及占以上所述组分总重量0.7%的海藻糖。
以上所述治疗痛风的中药制剂的制备方法,所述药材提取清膏的制备方法优选为:按以下重量份称取:葛根100-200份、仙草80-150份、蝮蛇10-30份、山楂80-150份、木瓜80-150份、火麻仁80-150份、栀子80-150份、茯苓50-100份、螺旋藻50-100份、薏苡仁50-100份,加6-8倍量水,煎煮提取2次,每次1-2小时,煎液过滤,合并滤液,加1-2倍量乙醇,混匀,静置过夜,滤过,滤液回收乙醇至无醇味并浓缩至相对密度在60℃时为1.25.-1.28的清膏。
以上所述治疗痛风的中药制剂的制备方法,所述药材提取清膏的制备方法最佳优选为:按以下重量份称取:葛根150份、仙草100份、蝮蛇20份、山楂100份、木瓜100份、火麻仁100份、栀子100份、茯苓80份、螺旋藻80份、薏苡仁80份,加水煎煮提取2次,每次1小时,第一次加8倍量的水,第二次加6倍量的水,煎液过滤,合并滤液,加1.5倍量乙醇,混匀,静置过夜,滤过,滤液回收乙醇至无醇味并浓缩至相对密度在60℃时为1.26的清膏。
以上所述治疗痛风的中药制剂的制备方法,所述甜味剂优选为低聚果糖或乳糖与甜菊糖、阿司巴甜、纽甜、罗汉果甜苷、阿力甜中的一种组合,最佳优选为低聚果糖与阿司巴甜。
进一步的,步骤(4)项下所述过筛步骤所用的筛网优选为20-40目,最佳优选为30目;步骤(5)项下所述干燥步骤温度优选为60-70℃。
本发明的有益效果是:
1.本发明克服现有中药类压片糖果口感不良及其易吸湿受潮导致退色等质量不稳定问题,使产品稳定性更好,疗效更确切,适用于痛风患者长期服用,无副作用。
2.本发明制剂简便,颗粒流动性好,压片不粘冲,所制得的片剂表面光滑,不易吸湿受潮,口感香甜滑口,质量稳定,携带方便,尤其适用于老年人和不能吞咽固体制剂的患者,生物利用度高,使用更安全有效。
3.本发明不含蔗糖,适合糖尿病患者服用,还可以补充人体所需的营养、提高免疫力,提高痛风患者的生活质量。
具体实施方式
虽然本说明书通过特别指出并清楚要求保护本发明的权利要求书作出结论,但应该相信下列说明将更好地理解本发明。
如本文所用,单词“优选”及变体是指在特定环境下能够提供特定有益效果的本发明的实施方案。然而,其它的实施方案在相同或其它的环境下也可以是优选的。此外,一个或多个优选实施方案的详述并不表示其它实施方案是无用的,并且不旨在从本发明的范畴排除其它的实施方案。
一、制剂条件筛选
1.粘合剂选择
粘合剂能使粉粒润湿,呈现粘性,以利于制备颗粒,压成片剂。本发明对比了干法压片、湿法制粒再压片,干法压片采用普通压片机效果不好,对设备要求高,故本发明采用湿法制粒再压片。试验中对比了5%羟丙甲纤维素水溶液、20%麦芽糊精、30%淀粉浆、85%乙醇做粘合剂,结果见表1。
表1粘合剂考察结果表
序号 | 粘合剂 | 制粒情况 | 颗粒外观 |
1 | 5%羟丙甲纤维素水溶液 | 成团,制粒易结块 | 颗粒硬 |
2 | 20%麦芽糊精 | 少量成团,制粒易结块 | 颗粒较硬 |
3 | 30%淀粉浆 | 成团,制粒不结块 | 颗粒松紧合适 |
4 | 80%乙醇 | 不成团,制粒不结块 | 颗粒松 |
从表1中的试验结果可知:本发明使用30%淀粉浆制粒情况效果较好,故本发明粘合剂选择蔗糖溶液。为进一步优化淀粉溶液浓度,本发明继续优化淀粉溶液浓度,试验结果见表2。
表2淀粉溶液浓度考察结果表
序号 | 湿润剂 | 制粒情况 | 颗粒外观 |
1 | 20%淀粉溶液 | 不成团,制粒困难 | 颗粒松 |
2 | 30%淀粉溶液 | 成团,制粒不结块 | 颗粒松紧合适 |
3 | 40%淀粉溶液 | 成团,制粒不结块 | 颗粒松紧合适 |
4 | 50%淀粉溶液 | 成团,制粒结块 | 颗粒紧 |
从表2中的试验结果可知:本发明使用30%-40%淀粉溶液制粒情况效果较好,浓度低太松,浓度高太紧,均影响制粒,故本发明粘合剂选择30%-40%淀粉溶液。
2.稀释剂的选择
易吸湿受潮是中药类口服固体制剂尤其是压片糖果普遍存在的问题,因此在稀释剂的种类和用量的筛选时要尽量能降低其吸潮性。基于生产成本的考虑,本发明试验中对比了麦芽糊精、微晶纤维素与甘露醇、山梨醇、木糖醇组合使用时的压片情况、片剂硬度、口感,并将分别用上述稀释剂制成的样品,分别用聚乙烯瓶装好,置稳定性加速试验箱内试验:温度:40±2℃,相对湿度:75±5%,加速试验3个月,试验结果见表3。
表3稀释剂试验结果表
从表3中的试验结果可知:麦芽糊精、微晶纤维素与甘露醇、山梨醇或木糖醇组合用作稀释剂时,压片情况均良好,片剂硬度适中,口感均较好,但加速试验发现,麦芽糊精、微晶纤维素与山梨醇或木糖醇组合使用为稀释剂制成的样品,水分含量变化大,不符合规定,故本发明选用麦芽糊精、微晶纤维素、甘露醇为稀释剂。
3.甜味剂的选择
只有具有良好口感的压片糖果才易被人们接受,因此,较于普通片剂来说,压片糖果的口感较为重要,而此往往通过甜味剂的选择来实现。本发明试验中对比了海藻糖、低聚果糖、乳糖、葡萄糖、甜菊糖、阿司巴甜、罗汉果甜苷、纽甜、阿力甜等甜味剂的使用,以口感、外观性状、水分含量为考察指标,并将分别用上述甜味剂制成的样品,分别用聚乙烯瓶装好,置稳定性加速试验箱内试验:温度:40±2℃,相对湿度:75±5%,加速试验3个月,结果见表4。
表4甜味剂试验结果表
表4的试验结果表明:海藻糖与低聚果糖或乳糖组合,再配以阿司巴甜组合使用时,口感均较好,加速试验3个月外观性状、水份变化均不大,说明海藻糖能使本发明产品稳定性更好,故本发明选用海藻糖、低聚果糖、乳糖、阿司巴甜为甜味剂。为此,进一步考察海藻糖的加入量并将所得样品进行加速试验,试验方法同表4,结果详见表5。
表5海藻糖的加入量试验结果表
从表5中的试验结果可知:加入0.2-0.4%海藻糖后压片糖果的外观性状、水分含量变化均较大;而含0.5-1.5%海藻糖的压片糖果的外面性状、水分含量在3个月的加速时间内变化小,质量稳定,出于生产成本的考虑,本发明控制海藻糖的加入量为0.5-1.0%。
本发明还进一步对比了海藻糖、低聚果糖与阿司巴甜、甜菊糖、纽甜、罗汉果甜苷、阿力甜中的一种组合使用时的口感,结果口感均较好,其中以海藻糖、低聚果糖与阿司巴甜组合为甜味剂时口感最佳,故本发明选用海藻糖与低聚果糖、乳糖中的一种组合,再配以阿司巴甜、甜菊糖、纽甜、罗汉果甜苷、阿力甜中的一种为甜味剂。
二、治疗痛风的中药制剂的制备方法
实施例1
治疗痛风的中药制剂的制备方法,包括如下步骤:
处方:药材提取清膏180kg、玉米淀粉30kg、麦芽糊精150kg、微晶纤维素30kg、甘露醇30kg、低聚果糖4.5kg、阿司巴甜0.5kg及占以上所述组分总重量0.7%的海藻糖2.954kg;
制备方法:
(1)按以下重量份称取:葛根150kg、仙草100kg、蝮蛇20kg、山楂100kg、木瓜100kg、火麻仁100kg、栀子100kg、茯苓80kg、螺旋藻80kg、薏苡仁80kg,加水煎煮提取2次,每次1小时,第一次加8倍量的水,第二次加6倍量的水,煎液过滤,合并滤液,加1.5倍量乙醇,混匀,静置过夜,滤过,滤液回收乙醇至无醇味并浓缩至相对密度在60℃时为1.26的清膏;
(2)分别取:麦芽糊精、微晶纤维素、甘露醇,粉碎,过100目筛,备用;
(3)按配方量称取玉米淀粉、海藻糖,加水100升使溶解成淀粉海藻糖浆;
(4)按配方量称取步骤(2)项下各辅料,以等量递增法混合均匀,得混合粉;
(5)取步骤(4)项下的混合粉,按配方量加入步骤(1)项下的药材提取清膏和步骤(3)项下的淀粉海藻糖浆制软材,过30目筛制粒,65℃干燥,控制水分在2%以内,过筛30目整粒,得颗粒;
(6)按配方量称取低聚果糖、阿司巴甜,与步骤(5)项下颗粒混合均匀,压片,即得。
实施例2
治疗痛风的中药制剂的制备方法,包括如下步骤:
处方:药材提取清膏130kg、玉米淀粉30kg、麦芽糊精100kg、微晶纤维素10kg、甘露醇10kg、乳糖0.5kg、甜菊糖0.5kg及占以上所述组分总重量0.5%的海藻糖1.405kg;
制备方法:
(1)按以下重量份称取:葛根100kg、仙草80kg、蝮蛇10kg、山楂80kg、木瓜80kg、火麻仁80kg、栀子80kg、茯苓50kg、螺旋藻50kg、薏苡仁80kg,分别加6倍量的水煎煮提取2次,第一次2小时,第二次1小时,煎液过滤,合并滤液,加1倍量乙醇,混匀,静置过夜,滤过,滤液回收乙醇至无醇味并浓缩至相对密度在60℃时为1.25的清膏;
(2)分别取:麦芽糊精、微晶纤维素、甘露醇,粉碎,过100目筛,备用;
(3)按配方量称取玉米淀粉、海藻糖,加水100升使溶解成淀粉海藻糖浆;
(4)按配方量称取步骤(2)项下各辅料,以等量递增法混合均匀,得混合粉;
(5)取步骤(4)项下的混合粉,按配方量加入步骤(1)项下的药材提取清膏和步骤(3)项下的淀粉海藻糖浆制软材,过40目筛制粒,70℃干燥,控制水分在2%以内,过筛40目整粒,得颗粒;
(6)按配方量称取低聚果糖、阿司巴甜,与步骤(5)项下颗粒混合均匀,压片,即得。
实施例3
治疗痛风的中药制剂的制备方法,包括如下步骤:
处方:药材提取清膏250kg、玉米淀粉40kg、麦芽糊精200kg、微晶纤维素50kg、甘露醇50kg、低聚果糖9.5kg、罗汉果甜苷1kg及占以上所述组分总重量1.0%的海藻糖6kg;
制备方法:
(1)按以下重量份称取:葛根200kg、仙草150kg、蝮蛇30kg、山楂150kg、木瓜150kg、火麻仁150kg、栀子150kg、茯苓100kg、螺旋藻100kg、薏苡仁100kg,分别加8倍量的水煎煮提取2次,每次2小时,煎液过滤,合并滤液,加2倍量乙醇,混匀,静置过夜,滤过,滤液回收乙醇至无醇味并浓缩至相对密度在60℃时为1.28的清膏;
(2)分别取:麦芽糊精、微晶纤维素、甘露醇,粉碎,过100目筛,备用;
(3)按配方量称取玉米淀粉、海藻糖,加水100升使溶解成淀粉海藻糖浆;
(4)按配方量称取步骤(2)项下各辅料,以等量递增法混合均匀,得混合粉;
(5)取步骤(4)项下的混合粉,按配方量加入步骤(1)项下的药材提取清膏和步骤(3)项下的淀粉海藻糖浆制软材,过20目筛制粒,60℃干燥,控制水分在2%以内,过筛20目整粒,得颗粒;
(6)按配方量称取低聚果糖、罗汉果甜苷,与步骤(5)项下颗粒混合均匀,压片,即得。
实施例4
治疗痛风的中药制剂的制备方法,包括如下步骤:
处方:药材提取清膏200kg、玉米淀粉35kg、麦芽糊精180kg、微晶纤维素40kg、甘露醇40kg、低聚果糖7kg、纽甜1kg及占以上所述组分总重量0.8%的海藻糖4.024kg;
制备方法:
(1)按以下重量份称取:葛根180kg、仙草120kg、蝮蛇25kg、山楂120kg、木瓜120kg、火麻仁120kg、栀子120kg、茯苓70kg、螺旋藻70kg、薏苡仁70kg,加水煎煮提取2次,每次1小时,第一次加8倍量的水,第二次加6倍量的水,煎液过滤,合并滤液,加1.5倍量乙醇,混匀,静置过夜,滤过,滤液回收乙醇至无醇味并浓缩至相对密度在60℃时为1.27的清膏;
(2)分别取:麦芽糊精、微晶纤维素、甘露醇,粉碎,过100目筛,备用;
(3)按配方量称取玉米淀粉、海藻糖,加水100升使溶解成淀粉海藻糖浆;
(4)按配方量称取步骤(2)项下各辅料,以等量递增法混合均匀,得混合粉;
(5)取步骤(4)项下的混合粉,按配方量加入步骤(1)项下的药材提取清膏和步骤(3)项下的淀粉海藻糖浆制软材,过30目筛制粒,62℃干燥,控制水分在2%以内,过筛30目整粒,得颗粒;
(6)按配方量称取低聚果糖、纽甜,与步骤(5)项下颗粒混合均匀,压片,即得。
实施例5
治疗痛风的中药制剂的制备方法,包括如下步骤:
处方:药材提取清膏150kg、玉米淀粉30kg、麦芽糊精130kg、微晶纤维素20kg、甘露醇20kg、低聚果糖2.5kg、阿力甜0.5kg及占以上所述组分总重量0.6%的海藻糖2.118kg;
制备方法:
(1)按以下重量份称取:葛根120kg、仙草90kg、蝮蛇15kg、山楂90kg、木瓜90kg、火麻仁90kg、栀子90kg、茯苓60kg、螺旋藻60kg、薏苡仁60kg,加水煎煮提取2次,每次1小时,第一次加8倍量的水,第二次加6倍量的水,煎液过滤,合并滤液,加1.5倍量乙醇,混匀,静置过夜,滤过,滤液回收乙醇至无醇味并浓缩至相对密度在60℃时为1.26的清膏;
(2)分别取:麦芽糊精、微晶纤维素、甘露醇,粉碎,过100目筛,备用;
(3)按配方量称取玉米淀粉、海藻糖,加水100升使溶解成淀粉海藻糖浆;
(4)按配方量称取步骤(2)项下各辅料,以等量递增法混合均匀,得混合粉;
(5)取步骤(4)项下的混合粉,按配方量加入步骤(1)项下的药材提取清膏和步骤(3)项下的淀粉海藻糖浆制软材,过30目筛制粒,68℃干燥,控制水分在2%以内,过筛30目整粒,得颗粒;
(6)按配方量称取低聚果糖、阿力甜,与步骤(5)项下颗粒混合均匀,压片,即得。
三、稳定性试验
将上述实施例1-5样品分别用聚乙烯瓶装好,置稳定性加速试验箱内试验:温度:40±2℃,相对湿度:75±5%,加速试验3个月,结果实施例1-5样品的外观性状、口感、水分等稳定性重点考察指标与0时样品测定结果比较,均无明显变化,说明本发明实施例1-5样品质量较为稳定,可满足贮存、运输、使用的稳定性要求。试验结果见表6。
表6治疗痛风的中药制剂稳定性试验结果表
。
Claims (10)
1.一种治疗痛风的中药制剂的制备方法,其特征在于,包括如下步骤:
处方:药材提取清膏130-250份、玉米淀粉30-40份、麦芽糊精100-200份、微晶纤维素10-50份、甘露醇10-50份、甜味剂1-10份及占以上所述组分总重量0.5-1.0%的海藻糖;
制备方法:
(1)分别取:麦芽糊精、微晶纤维素、甘露醇,粉碎,过100目筛,备用;
(2)按配方量称取玉米淀粉、海藻糖,加水100份使溶解成淀粉海藻糖浆;
(3)按配方量称取步骤(1)项下各辅料,以等量递增法混合均匀,得混合粉;
(4)取步骤(3)项下的混合粉,按配方量加入药材提取清膏和步骤(3)项下的淀粉海藻糖浆制软材,过筛制粒,干燥,控制水分在2%以内,过筛整粒,得颗粒;
(5)按配方量称取甜味剂,与步骤(5)项下颗粒混合均匀,压片,即得。
2.根据权利要求1所述治疗痛风的中药制剂的制备方法,其特征在于,所述处方为:药材提取清膏150-200份、玉米淀粉30-40份、麦芽糊精150-200份、微晶纤维素10-30份、甘露醇10-30份、甜味剂3-8份及占以上所述组分总重量0.5-0.8%的海藻糖。
3.根据权利要求1所述治疗痛风的中药制剂的制备方法,其特征在于,所述处方为:药材提取清膏180份、玉米淀粉30份、麦芽糊精150份、微晶纤维素30份、甘露醇30份、甜味剂5份及占以上所述组分总重量0.7%的海藻糖。
4.根据权利要求1-3中任一所述治疗痛风的中药制剂的制备方法,其特征在于,所述药材提取清膏的制备方法为:按以下重量份称取:葛根100-200份、仙草80-150份、蝮蛇10-30份、山楂80-150份、木瓜80-150份、火麻仁80-150份、栀子80-150份、茯苓50-100份、螺旋藻50-100份、薏苡仁50-100份,加6-8倍量水,煎煮提取2次,每次1-2小时,煎液过滤,合并滤液,加1-2倍量乙醇,混匀,静置过夜,滤过,滤液回收乙醇至无醇味并浓缩至相对密度在60℃时为1.25.-1.28的清膏。
5.根据权利要求1-3中任一所述治疗痛风的中药制剂的制备方法,其特征在于,所述药材提取清膏的制备方法为:按以下重量份称取:葛根150份、仙草100份、蝮蛇20份、山楂100份、木瓜100份、火麻仁100份、栀子100份、茯苓80份、螺旋藻80份、薏苡仁80份,加水煎煮提取2次,每次1小时,第一次加8倍量的水,第二次加6倍量的水,煎液过滤,合并滤液,加1.5倍量乙醇,混匀,静置过夜,滤过,滤液回收乙醇至无醇味并浓缩至相对密度在60℃时为1.26的清膏。
6.根据权利要求1-3中任一所述治疗痛风的中药制剂的制备方法,其特征在于,所述甜味剂为低聚果糖或乳糖与甜菊糖、阿司巴甜、纽甜、罗汉果甜苷、阿力甜中的一种组合。
7.根据权利要求1-3中任一所述治疗痛风的中药制剂的制备方法,其特征在于,所述甜味剂为低聚果糖与阿司巴甜。
8.根据权利要求1所述治疗痛风的中药制剂的制备方法,其特征在于,步骤(4)项下所述过筛步骤所用的筛网为20-40目。
9.根据权利要求1所述治疗痛风的中药制剂的制备方法,其特征在于,步骤(4)项下所述过筛步骤所用的筛网为30目。
10.根据权利要求1所述治疗痛风的中药制剂的制备方法,其特征在于,步骤(4)项下所述干燥步骤温度为60-70℃。
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