CN109528955A - 具有健脾开胃和清暑化湿功效的黔曲配方颗粒的制备方法以及由该方法制备的黔曲配方颗粒 - Google Patents
具有健脾开胃和清暑化湿功效的黔曲配方颗粒的制备方法以及由该方法制备的黔曲配方颗粒 Download PDFInfo
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Abstract
本发明涉及中药配方颗粒技术领域,公开了一种具有健脾开胃和清暑化湿功效的黔曲配方颗粒的制备方法以及由该方法制备的黔曲配方颗粒。该方法包括:(1)取干燥的黔曲,研磨,加热水浸泡;(2)过滤,将得到的滤饼与乙醇水溶液混合;(3)超声提取2‑3次;(4)过滤,滤液减压浓缩;(5)将所述浓缩液与药学上可接受的辅料进行混合;(6)冷冻干燥,收集干膏粉,粉碎过80目筛,置于混合槽中混合;(7)将所得黔曲膏粉制粒,整粒。采用本发明所述的方法制备的黔曲配方颗粒具有较好的药效,而且颗粒尺寸均匀。
Description
技术领域
本发明涉及中药配方颗粒技术领域,具体涉及一种具有健脾开胃和清暑化湿功效的黔曲配方颗粒的制备方法以及由该方法制备的黔曲配方颗粒。
背景技术
中药配方颗粒是以传统中药饮片为原材料,经过现代加工工艺和制药技术对药材的全成分进行提取、分离、浓缩、干燥、制粒和包装等处理而得,无需煎煮,可供直接配方和冲服的颗粒剂。中药配方颗粒既保留了中药饮片的有效成分、主治和功效,又具有标准统一、疗效稳定、携带方便和易于调剂等饮片不具备的优点,用配方颗粒组成处方冲服,可作为中药汤剂和中成药的补充。
黔曲是由茯苓、陈皮等二十四味中药和酒曲通过固态发酵制备而成,具有健脾开胃、理气导滞、清暑化湿等特效。然而,目前还没有关于黔曲配方颗粒及其制备工艺的报道。
发明内容
本发明的目的是为了提供一种具有健脾开胃和清暑化湿功效的黔曲配方颗粒的制备方法以及由该方法制备的黔曲配方颗粒。
本发明提供了一种具有健脾开胃和清暑化湿功效的黔曲配方颗粒的制备方法,该方法包括以下步骤:
(1)取干燥的黔曲,研磨,加投料量2-5倍的热水浸泡,热水的温度为40-60℃,热水浸泡的时间为1-3小时;
(2)过滤,将得到的滤饼与10-15倍体积的乙醇水溶液混合,所述乙醇水溶液的浓度为20-40重量%;
(3)超声提取2-3次;
(4)过滤,滤液减压浓缩到相对密度为1.1-1.2的浓缩液;
(5)将所述浓缩液与药学上可接受的辅料进行混合;
(6)冷冻干燥,收集干膏粉,粉碎过80目筛,置于混合槽中混合;
(7)将所得黔曲膏粉制粒,颗粒依次用20目筛和50目筛整粒,得到黔曲配方颗粒。
本发明还提供了由上述方法制备的黔曲配方颗粒。
本发明的有益效果是:
(1)按照本发明所述的方法,可以将黔曲中的主要活性成分充分提取出来,可以有效去除无活性成分,提高了药物的稳定性、易储存、服用方便。
(2)按照本发明所述的方法制备的黔曲配方颗粒的颗粒成型较好,颗粒尺寸均匀。
(3)本发明所述的方法实施方便,容易实现工业化。
具体实施方式
以下对本发明的具体实施方式进行详细说明。应当理解的是,此处所描述的具体实施方式仅用于说明和解释本发明,并不用于限制本发明。
在本文中所披露的范围的端点和任何值都不限于该精确的范围或值,这些范围或值应当理解为包含接近这些范围或值的值。对于数值范围来说,各个范围的端点值之间、各个范围的端点值和单独的点值之间,以及单独的点值之间可以彼此组合而得到一个或多个新的数值范围,这些数值范围应被视为在本文中具体公开。
本发明所述的黔曲配方颗粒的制备方法包括以下步骤:
(1)取干燥的黔曲,研磨,加投料量2-5倍的热水浸泡,热水的温度为40-60℃,热水浸泡的时间为1-3小时;
(2)过滤,将得到的滤饼与10-15倍体积的乙醇水溶液混合,所述乙醇水溶液的浓度为20-40重量%;
(3)超声提取2-3次;
(4)过滤,滤液减压浓缩到相对密度为1.1-1.2的浓缩液;
(5)将所述浓缩液与药学上可接受的辅料进行混合;
(6)冷冻干燥,收集干膏粉,粉碎过80目筛,置于混合槽中混合;
(7)将所得黔曲膏粉制粒,颗粒依次用20目筛和50目筛整粒,得到黔曲配方颗粒。
在本发明所述的方法中,在热水浸泡过程中,以体积计,热水的投料量为黔曲药材的2-5倍,具体地,例如可以为2倍、2.5倍、3倍、3.5倍、4 倍或5倍。
在本发明所述的方法中,以体积计,所述乙醇水溶液的投料量为黔曲药材的10-15倍,具体地,例如可以为10倍、11倍、12倍、13倍、14倍或15倍。在本发明所述的方法中,使黔曲与所述乙醇水溶液按照这样的体积比进行投料,可以充分提取出所述黔曲药材中的主要活性成分。
在本发明所述的方法中,所述乙醇水溶液的浓度可以为20-40重量%,具体地,例如可以为20重量%、25重量%、30重量%、35重量%或40重量%。在优选情况下,所述乙醇水溶液的浓度为25-35重量%。
在本发明所述的方法中,优选地,超声提取过程中采用的超声波频率为 50-125kHz,每次提取时间为30-60分钟。在本发明所述的方法中,使黔曲在所述乙醇水溶液中超声提取的时间和频率在上述范围之内,可以充分提取出黔曲中的主要活性成分,并且可以防止活性成分发生变性,使得制备的黔曲配方颗粒具有较好的药效。
在本发明所述的方法中,两次过滤均可以采用本领域常规的滤网过滤。在具体的实施方式中,两次过滤所用的滤网均可以是网孔尺寸为200目的不锈钢丝网。
在本发明所述的方法中,优选地,所述辅料为可溶性淀粉、淀粉、乳糖、蔗糖和糊精中的至少一种。进一步优选地,所述辅料为淀粉、乳糖和糊精的混合。当所述辅料为淀粉、乳糖和糊精的混合时,三者的混合重量比例优选为1:0.01-0.5:0.1-2。
在本发明所述的方法中,所述辅料的加料量使得黔曲配方颗粒的规格为每1-3克相当于黔曲药材5-15克。
在本发明所述的方法中,所述制粒的方法可以为使所述黔曲膏粉过筛进行制粒。
在本发明所述的方法中,通过使制粒后得到的颗粒依次用20目筛和50 目筛整粒,可以获得颗粒尺寸均匀的黔曲配方颗粒。
本发明还提供了由上述方法制备的黔曲配方颗粒。
优选地,所述黔曲配方颗粒的规格为每1-3克相当于黔曲药材5-15克,具体地,每1克所述黔曲配方颗粒相当于黔曲生药材5克,每2克所述黔曲配方颗粒相当于黔曲生药材10克,每3克所述黔曲配方颗粒相当于黔曲生药材15克。
以下将通过实施例对本发明进行详细描述。
实施例1
(1)取1kg干燥的黔曲,研磨成粉,加投料量3倍的热水(50℃)浸泡2小时,用200目的不锈钢丝网过滤,将所得滤饼与投料量13倍的乙醇水溶液(浓度为30%)混合,在90kHz的超声波频率下超声提取3次,每次提取45分钟,用200目的不锈钢丝网过滤,滤液减压浓缩到相对密度为1.15 的浓缩液;
(2)在浓缩液中加入100g淀粉、乳糖和糊精的混合物(三者重量比为 1:0.25:1)进行混合,冷冻干燥,收集干膏粉,粉碎过80目筛,置混合槽混合;
(3)取黔曲膏粉,过筛制粒,颗粒依次用20目筛和50目筛整粒,得黔曲配方颗粒样品A1。
实施例2
(1)取1kg干燥的黔曲,研磨成粉,加投料量4倍的热水(40℃)浸泡3小时,用200目的不锈钢丝网过滤,将所得滤饼与投料量13倍的乙醇水溶液(浓度为35%)混合,在90kHz的超声波频率下超声提取3次,每次提取45分钟,用200目的不锈钢丝网过滤,滤液减压浓缩到相对密度为1.16 的浓缩液;
(2)在浓缩液中加入100g淀粉、乳糖和糊精的混合物(三者重量比为 1:0.25:1)进行混合,冷冻干燥,收集干膏粉,粉碎过80目筛,置混合槽混合;
(3)取黔曲膏粉,过筛制粒,颗粒依次用20目筛和50目筛整粒,得黔曲配方颗粒样品A2。
实施例3
(1)取1kg干燥的黔曲,研磨成粉,加投料量4倍的热水(50℃)浸泡3小时,用200目的不锈钢丝网过滤,将所得滤饼与投料量14倍的乙醇水溶液(浓度为25%)混合,在90kHz的超声波频率下超声提取3次,每次提取45分钟,用200目的不锈钢丝网过滤,滤液减压浓缩到相对密度为1.12 的浓缩液;
(2)在浓缩液中加入100g淀粉、乳糖和糊精的混合物(三者重量比为 1:0.25:1)进行混合,冷冻干燥,收集干膏粉,粉碎过80目筛,置混合槽混合;
(3)取黔曲膏粉,过筛制粒,颗粒依次用20目筛和50目筛整粒,得黔曲配方颗粒样品A3。
实施例4
(1)取1kg干燥的黔曲药材,粉碎至60目,加投料量2倍的热水(60℃) 浸泡3小时,用200目的不锈钢丝网过滤,将所得滤饼与投料量15倍的乙醇水溶液(浓度为25%)混合,在125kHz的超声波频率下超声提取2次,每次提取60分钟,用200目的不锈钢丝网过滤,滤液减压浓缩到相对密度为1.10的浓缩液;
(2)在浓缩液中加入80g淀粉、乳糖和糊精的混合物(三者重量比为1: 0.25:1)进行混合,冷冻干燥,收集干膏粉,粉碎过80目筛,置混合槽混合;
(3)取黔曲膏粉,过筛制粒,颗粒依次用20目筛和50目筛整粒,得黔曲配方颗粒样品A4。
实施例5
(1)取1kg干燥的黔曲药材,粉碎至100目,加投料量4倍的热水(50℃) 浸泡3小时,用200目的不锈钢丝网过滤,将所得滤饼与投料量12倍的乙醇水溶液(浓度为35%)混合,在125kHz的超声波频率下超声提取2次,每次提取60分钟,用200目的不锈钢丝网过滤,滤液减压浓缩到相对密度为1.12的浓缩液;
(2)在浓缩液中加入80g淀粉、乳糖和糊精的混合物(三者重量比为1:0.25:1)进行混合,冷冻干燥,收集干膏粉,粉碎过80目筛,置混合槽混合;
(3)取黔曲膏粉,过筛制粒,颗粒依次用20目筛和50目筛整粒,得黔曲配方颗粒样品A5。
实施例6
(1)取1kg干燥的黔曲药材,粉碎至80目,加投料量4倍的热水(50℃) 浸泡3小时,用200目的不锈钢丝网过滤,将所得滤饼与投料量14倍的乙醇水溶液(浓度为30%)混合,在125kHz的超声波频率下超声提取2次,每次提取60分钟,用200目的不锈钢丝网过滤,滤液减压浓缩到相对密度为1.15的浓缩液;
(2)在浓缩液中加入80g淀粉、乳糖和糊精的混合物(三者重量比为1: 0.25:1)进行混合,冷冻干燥,收集干膏粉,粉碎过80目筛,置混合槽混合;
(3)取黔曲膏粉,过筛制粒,颗粒依次用20目筛和50目筛整粒,得黔曲配方颗粒样品A6。
实施例7
(1)取1kg干燥的黔曲药材,粉碎至100目,加投料量5倍的热水(40℃) 浸泡1小时,用200目的不锈钢丝网过滤,将所得滤饼与投料量10倍的乙醇水溶液(浓度为35%)混合,在50kHz的超声波频率下超声提取3次,每次提取30分钟,用200目的不锈钢丝网过滤,滤液减压浓缩到相对密度为 1.20的浓缩液;
(2)在浓缩液中加入50g淀粉、乳糖和糊精的混合物(三者重量比为1: 0.25:1)进行混合,冷冻干燥,收集干膏粉,粉碎过80目筛,置混合槽混合;
(3)取黔曲膏粉,过筛制粒,颗粒依次用20目筛和50目筛整粒,得黔曲配方颗粒样品A7。
实施例8
(1)取1kg干燥的黔曲药材,粉碎至80目,加投料量4倍的热水(45℃) 浸泡3小时,用200目的不锈钢丝网过滤,将所得滤饼与投料量12倍的乙醇水溶液(浓度为40%)混合,在50kHz的超声波频率下超声提取3次,每次提取30分钟,用200目的不锈钢丝网过滤,滤液减压浓缩到相对密度为 1.16的浓缩液;
(2)在浓缩液中加入50g淀粉、乳糖和糊精的混合物(三者重量比为1: 0.25:1)进行混合,冷冻干燥,收集干膏粉,粉碎过80目筛,置混合槽混合;
(3)取黔曲膏粉,过筛制粒,颗粒依次用20目筛和50目筛整粒,得黔曲配方颗粒样品A8。
实施例9
(1)取1kg干燥的黔曲药材,粉碎至50目,加投料量5倍的热水(55℃) 浸泡3小时,用200目的不锈钢丝网过滤,将所得滤饼与投料量14倍的乙醇水溶液(浓度为30%)混合,在50kHz的超声波频率下超声提取3次,每次提取30分钟,用200目的不锈钢丝网过滤,滤液减压浓缩到相对密度为 1.18的浓缩液;
(2)在浓缩液中加入50g淀粉、乳糖和糊精的混合物(三者重量比为1: 0.25:1)进行混合,冷冻干燥,收集干膏粉,粉碎过80目筛,置混合槽混合;
(3)取黔曲膏粉,过筛制粒,颗粒依次用20目筛和50目筛整粒,得黔曲配方颗粒样品A9。
对比例1
按照实施例1的方法制备黔曲配方颗粒,所不同的是,步骤(3)中制粒后的颗粒不经过20目筛和50目筛整粒,从而制得黔曲配方颗粒样品D1。
测试例
采用粒度分布仪检测上述实施例和对比例制备的黔曲配方颗粒样品的粒径分布情况,并分析计算粒径为0.25-0.35mm范围内的粒径的颗粒数百分比U0.25-0.35。
结果如下表1所示。
表1
实施例编号 | U<sub>0.25-0.35</sub> |
实施例1 | 93% |
实施例2 | 91% |
实施例3 | 94% |
实施例4 | 92% |
实施例5 | 90% |
实施例6 | 89% |
实施例7 | 94% |
实施例8 | 89% |
实施例9 | 91% |
对比例1 | 25% |
通过表1的结果可以看出,采用本发明所述的方法制备的黔曲配方颗粒颗粒尺寸均匀。
以上详细描述了本发明的优选实施方式,但是,本发明并不限于此。在本发明的技术构思范围内,可以对本发明的技术方案进行多种简单变型,包括各个技术特征以任何其它的合适方式进行组合,这些简单变型和组合同样应当视为本发明所公开的内容,均属于本发明的保护范围。
Claims (6)
1.一种具有健脾开胃和清暑化湿功效的黔曲配方颗粒的制备方法,其特征在于,该方法包括以下步骤:
(1)取干燥的黔曲,研磨,加投料量2-5倍的热水浸泡,热水的温度为40-60℃,热水浸泡的时间为1-3小时;
(2)过滤,将得到的滤饼与10-15倍体积的乙醇水溶液混合,所述乙醇水溶液的浓度为20-40重量%;
(3)超声提取2-3次;
(4)过滤,滤液减压浓缩到相对密度为1.1-1.2的浓缩液;
(5)将所述浓缩液与药学上可接受的辅料进行混合;
(6)冷冻干燥,收集干膏粉,粉碎过80目筛,置于混合槽中混合;
(7)将所得黔曲膏粉制粒,颗粒依次用20目筛和50目筛整粒,得到黔曲配方颗粒。
2.根据权利要求1所述的方法,其特征在于,在步骤(1)中,超声提取过程中采用的超声波频率为50-125kHz,每次提取时间为30-60分钟。
3.根据权利要求1所述的方法,其特征在于,所述辅料为可溶性淀粉、淀粉、乳糖、蔗糖和糊精中的至少一种。
4.根据权利要求3所述的方法,其特征在于,所述辅料为淀粉、乳糖和糊精的混合物,且淀粉、乳糖和糊精的重量比为1:0.01-0.5:0.1-2。
5.由权利要求1-4中任意一项所述的方法制备的黔曲配方颗粒。
6.根据权利要求5所述的黔曲配方颗粒,其特征在于,所述黔曲配方颗粒的规格为每1-3克相当于黔曲药材5-15克。
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