CN116942773A - 一种中药组合物及无糖型颗粒的制备方法 - Google Patents
一种中药组合物及无糖型颗粒的制备方法 Download PDFInfo
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- CN116942773A CN116942773A CN202310703374.9A CN202310703374A CN116942773A CN 116942773 A CN116942773 A CN 116942773A CN 202310703374 A CN202310703374 A CN 202310703374A CN 116942773 A CN116942773 A CN 116942773A
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- Urology & Nephrology (AREA)
Abstract
本发明属于中药技术领域,特别是涉及一种中药组合物及无糖型颗粒的制备方法,中药组合物按重量份数计包括:党参100‑200份,黄芪100‑200份,当归100‑200份,紫河车3‑5份,淫羊藿3‑5份,菟丝子3‑5份,延龄草2‑4份,土茯苓2‑4份,甘草1‑3份,山楂1‑3份。与现有的参芪类药物相比,本发明在党参、黄芪、当归等主要成分的基础上,增加了紫河车、淫羊藿、菟丝子等中成药,大大弥补了现有如参芪颗粒等补益类药品在补肝肾、强紧固、祛风湿、益气养血等方面的不足,增强了药效;同时采用本发明的颗粒制备方法,大大降低了颗粒的蔗糖含量,解决了肥胖患者和禁糖患者的用药限制,满足不同患者用药需求,提高受众人群。
Description
技术领域
本发明属于中药技术领域,特别是涉及一种中药组合物及无糖型颗粒的制备方法。
背景技术
参芪颗粒是一种中成药,其主要成分包括人参、黄芪、当归等,在临床中的功效是补益中气,用于气虚所致体弱,四肢无力,特别适合治疗气血虚弱的患者,对于刚做完手术、身体瘦弱以及男性的性功能下降都适合等症状都可以通过参芪颗粒进行调养。
然而,现有的参芪颗粒针对肾亏、尿频患者的治疗效果差,并且产品中蔗糖含量占比高,约为55%,而近年来人群中肥胖患者和禁糖患者的流行趋势逐渐加重,含蔗糖的产品使肥胖患者和禁糖患者用药受到限制。
发明内容
有鉴于此,本发明的目的在于提供一种中药组合物及无糖型颗粒的制备方法,旨在解决现有补中益气药物存在的补肾阳效果差、因含糖量高存在用药限制的问题。
为达到上述目的,本发明提供了如下技术方案:
本发明提供一种中药组合物,按重量份数计包括:党参100-200份,黄芪100-200份,当归100-200份,紫河车3-5份,淫羊藿3-5份,菟丝子3-5份,延龄草2-4份,土茯苓2-4份,甘草1-3份,山楂1-3份。
在上述中药组合物中,紫河车始载于“本草拾遗”,为人出生时脱掉的胎盘,经过加工干燥而成。李时珍的《本草纲目》中记载:“儿孕胎中,脐系于母,胎系母脊,受母之荫,父精母血,相合而成。虽后天之形,实得先天之气,显然非他金石草木之类所比。其滋补之功极重,久服耳聪目明,须发乌黑,延年益寿”。
淫羊藿俗名仙灵脾,主治阴痿绝伤,茎中痛,利小便,益气力。
菟丝子是《中华草本》收录的草药,主治续绝伤,补不足,益气力。
在上述中药组合物中,党参、黄芪作为君药,具有补中益气、升阳举陷之功,当归、紫河车、淫羊藿和菟丝子作为臣药,具有增强君药之补中益气、升阳举陷之功,延龄草和土茯苓作为佐药既助君药补中益气,又具有清热解毒之功,甘草、山楂作为使药,具有健胃消食之功。
本发明的中药组合物在党参、黄芪、当归等主要成分的基础上,增加了紫河车、淫羊藿、菟丝子等中成药,大大弥补了现有如参芪颗粒等补益类药品在补肝肾、强筋骨、祛风湿、益气养血等方面的不足,增强了药效。
本发明还提供了一种无糖型颗粒的制备方法,包括以下步骤:
S1-备料:按重量比例称取原料备用;
S2-制备浸膏:将原料用重量为药材重量8-10倍的水煎煮2-4次,每次煎煮1-3小时,将每次煎煮得到的煎液过滤后合并得到水提混合液,将水提混合液浓缩至60℃下相对密度为1.25-1.35,得到浸膏;
S3-制粒:将浸膏加入高温湿法混合制粒机中,再添加糊精和矫味剂作为辅料,其中,糊精的重量为浸膏重量的1.5-2倍,矫味剂的重量为浸膏重量的0.5%-1%,搅拌混匀后开始制粒,得到湿颗粒;
S4-干燥:将湿颗粒加入沸腾干燥机中进行干燥,当物料温度达到83℃时,停止加热;
S5-降温:将物料转至另一台沸腾干燥机中降温,物料温度降至50℃以下,出料;
S6-整粒:将干燥后的颗粒用旋振筛或振动筛进行整粒;
S7-总混:用对夹式料斗混合机进行总混;
S8-分装:按每袋5g进行分装。
糊精是淀粉在酸的作用下水解为单糖时产生的中间产物,由于糊精具有良好的吸水性,制粒后颗粒成型好,颗粒质量稳定,因此本发明选用糊精作为代替蔗糖的主要原料来进行制粒,得到的颗粒质量稳定,并且糖含量大大降低;再结合少量的矫味剂来调节颗粒的口感,使颗粒的口感与现有口感接近,大大降低了颗粒的蔗糖含量,解决了肥胖患者和禁糖患者的用药限制,满足不同患者用药需求,提高受众人群。
本发明的有益效果是:
1、本发明的中药组合物在党参、黄芪、当归等主要成分的基础上,增加了紫河车、淫羊藿、菟丝子等中成药,大大弥补了现有如参芪颗粒等补益类药品在补肝肾、强紧固、祛风湿、益气养血等方面的不足,增强了药效。
2、本发明大大降低了颗粒的蔗糖含量,解决了肥胖患者和禁糖患者的用药限制,满足不同患者用药需求,提高受众人群。
本发明的其他优点、目标和特征在某种程度上将在随后的说明书中进行阐述,并且在某种程度上,基于对下文的考察研究对本领域技术人员而言将是显而易见的,或者可以从本发明的实践中得到教导。本发明的目标和其他优点可以通过下面的说明书来实现和获得。
具体实施方式
以下通过特定的具体实例说明本发明的实施方式,本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用,本说明书中的各项细节也可以基于不同观点与应用,在没有背离本发明的精神下进行各种修饰或改变。需要说明的是,以下实施例中仅以示意方式说明本发明的基本构想,在不冲突的情况下,以下实施例及实施例中的特征可以相互组合。
本发明的中药组合物是一种补益类药物,主要用于补中益气、补肝肾、强筋骨、祛风湿、益气养血等,适用于气虚体弱、四肢无力、精神不振、手足冰冷、免疫力低下症状。
本发明的中药组合物按重量份数计包括:党参100-200份,黄芪100-200份,当归100-200份,紫河车3-5份,淫羊藿3-5份,菟丝子3-5份,延龄草2-4份,土茯苓2-4份,甘草1-3份,山楂1-3份。
本发明的中药组合物按上述处方可以直接煎煮后服用,也可以制成散剂、颗粒、胶囊、微丸等。
下面本发明提供一种具体颗粒的制备方法,步骤如下:
S1-备料:按上述重量比例分别称取药材备用;
S2-制备浸膏:将原料为药材总重量8-10倍的水煎煮3次,第一次煎煮2小时,第二、三次煎煮各1小时,将每次煎煮得到的煎液过滤后合并得到水提混合液,将水提混合液浓缩至60℃下相对密度为1.3,得到浸膏;
S3-制粒:将浸膏加入高温湿法混合制粒机中,再添加糊精和矫味剂作为辅料,其中,糊精的重量为浸膏重量的1.5-2倍,矫味剂采用纯度为5%的甜菊糖苷,矫味剂的重量为浸膏重量的0.5%-1%,搅拌混匀搅拌速度为100转/分钟,搅拌时间为30秒,然后用16目尼龙网开始制粒,得到湿颗粒;
S4-干燥:将湿颗粒加入沸腾干燥机中进行干燥,干燥机的进风温度为80-90℃,风机的频率为35-50Hz,加入时间不超过20分钟,当物料温度达到83℃时,停止加热;
S5-降温:将物料转至另一台沸腾干燥机中降温,物料温度降至50℃以下,出料;
S6-整粒:将干燥后的颗粒用旋振筛或振动筛进行整粒;
S7-总混:用对夹式料斗混合机进行总混,混合机的转速为5转/分钟,混合时间为10分钟;
S8-分装:按每袋5g进行分装。
上述制备方法中,原料经过多次煎煮浓缩,完全提取了原料的功效,避免了药材的浪费;同时,在干燥过程中控制了干燥机的温度、风机频率和时间,避免了因长时间处于高温而影响药品功效;另外,制备过程中,干燥和降温采用两台不同的干燥机,第一步干燥达到要求后,直接输送到另一台干燥机降温,可以使整个生产线始终处于工作状态,提高生产的效率。
实施例1
一种中药组合物,按重量份数计包括:党参100份,黄芪100份,当归100份,紫河车3份,淫羊藿3份,菟丝子3份,延龄草2份,土茯苓2份,甘草1份,山楂1份。
一种颗粒的制备方法,步骤如下:
S1-备料:按上述重量比例分别称取药材备用;
S2-制备浸膏:将原料为药材总重量8倍的水煎煮3次,第一次煎煮2小时,第二、三次煎煮各1小时,将每次煎煮得到的煎液过滤后合并得到水提混合液,将水提混合液浓缩至60℃下相对密度为1.3,得到浸膏;
S3-制粒:将浸膏加入高温湿法混合制粒机中,再添加糊精和矫味剂作为辅料,其中,糊精的重量为浸膏重量的1.5倍,矫味剂的重量为浸膏重量的0.5%,搅拌混匀搅拌速度为100转/分钟,搅拌时间为30秒,然后用16目尼龙网开始制粒,得到湿颗粒;
S4-干燥:将湿颗粒加入沸腾干燥机中进行干燥,干燥机的进风温度为80-90℃,风机的频率为35-50Hz,加入时间不超过20分钟,当物料温度达到83℃时,停止加热;
S5-降温:将物料转至另一台沸腾干燥机中降温,物料温度降至50℃以下,出料;
S6-整粒:将干燥后的颗粒用旋振筛或振动筛进行整粒;
S7-总混:用对夹式料斗混合机进行总混,混合机的转速为5转/分钟,混合时间为10分钟;
S8-分装:按每袋5g进行分装。
实施例2
一种中药组合物,按重量份数计包括:党参150份,黄芪150份,当归150份,紫河车4份,淫羊藿4份,菟丝子4份,延龄草3份,土茯苓3份,甘草2份,山楂2份。
一种颗粒的制备方法,步骤如下:
S1-备料:按上述重量比例分别称取药材备用;
S2-制备浸膏:将原料为药材总重量9倍的水煎煮3次,第一次煎煮2小时,第二、三次煎煮各1小时,将每次煎煮得到的煎液过滤后合并得到水提混合液,将水提混合液浓缩至60℃下相对密度为1.3,得到浸膏;
S3-制粒:将浸膏加入高温湿法混合制粒机中,再添加糊精和矫味剂作为辅料,其中,糊精的重量为浸膏重量的1.8倍,矫味剂的重量为浸膏重量的0.8%,搅拌混匀搅拌速度为100转/分钟,搅拌时间为30秒,然后用16目尼龙网开始制粒,得到湿颗粒;
S4-干燥:将湿颗粒加入沸腾干燥机中进行干燥,干燥机的进风温度为80-90℃,风机的频率为35-50Hz,加入时间不超过20分钟,当物料温度达到83℃时,停止加热;
S5-降温:将物料转至另一台沸腾干燥机中降温,物料温度降至50℃以下,出料;
S6-整粒:将干燥后的颗粒用旋振筛或振动筛进行整粒;
S7-总混:用对夹式料斗混合机进行总混,混合机的转速为5转/分钟,混合时间为10分钟;
S8-分装:按每袋5g进行分装。
实施例3
一种中药组合物,按重量份数计包括:党参200份,黄芪200份,当归200份,紫河车5份,淫羊藿5份,菟丝子5份,延龄草4份,土茯苓4份,甘草3份,山楂3份。
一种颗粒的制备方法,步骤如下:
S1-备料:按上述重量比例分别称取药材备用;
S2-制备浸膏:将原料为药材总重量10倍的水煎煮3次,第一次煎煮2小时,第二、三次煎煮各1小时,将每次煎煮得到的煎液过滤后合并得到水提混合液,将水提混合液浓缩至60℃下相对密度为1.3,得到浸膏;
S3-制粒:将浸膏加入高温湿法混合制粒机中,再添加糊精和矫味剂作为辅料,其中,糊精的重量为浸膏重量的2倍,矫味剂的重量为浸膏重量的1%,搅拌混匀搅拌速度为100转/分钟,搅拌时间为30秒,然后用16目尼龙网开始制粒,得到湿颗粒;
S4-干燥:将湿颗粒加入沸腾干燥机中进行干燥,干燥机的进风温度为80-90℃,风机的频率为35-50Hz,加入时间不超过20分钟,当物料温度达到83℃时,停止加热;
S5-降温:将物料转至另一台沸腾干燥机中降温,物料温度降至50℃以下,出料;
S6-整粒:将干燥后的颗粒用旋振筛或振动筛进行整粒;
S7-总混:用对夹式料斗混合机进行总混,混合机的转速为5转/分钟,混合时间为10分钟;
S8-分装:按每袋5g进行分装。
临床试验
随机抽取A、B、C、D四组患者,每组50名,患者年龄在50-60岁的患者,男女各25名,患者具有气虚体弱、四肢无力、手足不温、易困、容易感冒、肾亏、尿频等症状,分别用补中益气丸、和上述实施例得到的颗粒制剂,每日3次,每次一袋,连续服用30日,得到结果如下:
治愈:患者精力充沛,免疫力明显提高;
有效:气虚体弱、四肢无力、手足冰冷、容易感冒、尿频等症状得到控制和改善,免疫力提高;
无效:气虚体弱、四肢无力、手足冰冷、容易感冒、抵抗力差、肾亏、尿频依然存在。
从上述B、C、D组服用实施例1、实施例2和实施例3得到的治疗效果不难看出,相比A组服用现有补中益气丸的患者而言,服用本发明的颗粒制剂有效率明显提高。
特殊患者
张X,年龄35岁,男,患有过敏性鼻炎,气虚体弱,免疫功能差,容易感冒,同时还伴有头晕、耳鸣、尿频、尿不禁、性功能差等症状,在连续服用本产品30日后,精力得到明显改善,夜间起夜次数减少,夫妻生活次数增加。
最后说明的是,以上实施例仅用以说明本发明的技术方案而非限制,尽管参照较佳实施例对本发明进行了详细说明,本领域的普通技术人员应当理解,可以对本发明的技术方案进行修改或者等同替换,而不脱离本技术方案的宗旨和范围,其均应涵盖在本发明的权利要求范围当中。
Claims (7)
1.一种中药组合物,其特征在于,按重量份数计包括:党参100-200份,黄芪100-200份,当归100-200份,紫河车3-5份,淫羊藿3-5份,菟丝子3-5份,延龄草2-4份,土茯苓2-4份,甘草1-3份,山楂1-3份。
2.一种如权利要求1所述中药组合物的无糖型颗粒的制备方法,其特征在于,包括以下步骤:
S1-备料:按重量比例称取原料备用;
S2-制备浸膏:将原料用重量为药材重量8-10倍的水煎煮2-4次,每次煎煮1-3小时,将每次煎煮得到的煎液过滤后合并得到水提混合液,将水提混合液浓缩至60℃下相对密度为1.25-1.35,得到浸膏;
S3-制粒:将浸膏加入高温湿法混合制粒机中,再添加糊精和矫味剂作为辅料,其中,糊精的重量为浸膏重量的1.5-2倍,矫味剂的重量为浸膏重量的0.5%-1%,搅拌混匀后开始制粒,得到湿颗粒;
S4-干燥:将湿颗粒加入沸腾干燥机中进行干燥,当物料温度达到83℃时,停止加热;
S5-降温:将物料转至另一台沸腾干燥机中降温,物料温度降至50℃以下,出料;
S6-整粒:将干燥后的颗粒用旋振筛或振动筛进行整粒;
S7-总混:用对夹式料斗混合机进行总混;
S8-分装:按每袋5g进行分装。
3.根据权利要求2所述的无糖型颗粒的制备方法,其特征在于,在步骤S2中,将原料加水煎煮3次,第一次煎煮2小时,第二、三次煎煮各1小时。
4.根据权利要求2所述的无糖型颗粒的制备方法,其特征在于,在步骤S3中,矫味剂为纯度为5%的甜菊糖苷。
5.根据权利要求2所述的无糖型颗粒的制备方法,其特征在于,在步骤S3中,在步骤S3搅拌混匀过程中,搅拌速度为80-150转/分钟,搅拌时间为20-60秒,制粒机采用16目尼龙网。
6.根据权利要求2所述的无糖型颗粒的制备方法,其特征在于,在步骤S4中,干燥机的进风温度为80-90℃,风机的频率为35-50Hz,加入时间不超过20分钟。
7.根据权利要求2所述的无糖型颗粒的制备方法,其特征在于,在步骤S7中,混合机的转速为5转/分钟,混合时间为10分钟。
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