CN112741809A - 益心舒颗粒的制备方法 - Google Patents
益心舒颗粒的制备方法 Download PDFInfo
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Abstract
本发明涉及医药技术领域,特别涉及一种益心舒颗粒的制备方法;该方法通过先将人参细粉与蔗糖、糊精和乙醇水溶液在高速匀浆机中分散,然后与清膏、稠膏在特定的5‑15kHz低频超声振动,不仅利于各组分的均匀分散,同时不会破坏浆料的粘合性,利于制粒。本发明提供的益心舒颗粒的制备方法制得的益心舒颗粒产品中活性成分尤其是微量有效成份(人参中的有效成分人参皂苷及丹参的有效成分丹酚酸B)的含量分布均匀,含量均匀度合格。
Description
技术领域
本发明涉及医药技术领域,特别涉及一种益心舒颗粒的制备方法。
背景技术
益心舒颗粒是由人参、麦冬、五味子、黄芪、丹参、川芎、山楂7味植物药组成,具有稳定斑块、改善微循环、保护心肌、增加心肌收缩力的功效,用于胸闷、胸痛、心慌、心悸、乏力、汗出等冠心病症候。因其不含有动物药、冰片等不适合长期服用的成分,因此适合长期口服。
现有的益心舒颗粒的制备方法是将五味子和丹参醇提物浓缩得到的清膏,麦冬、黄芪、川芎和山楂水提醇沉得到的提取液浓缩得到的稠膏,人参细粉与辅料混匀、制粒、干燥。该方法中是将人参生药粉直接入药,并与相对密度比较高、流动性差的稠膏混合,其有效成分均匀分布情况很差,实验证明:上述制备方法无法得到有效成分含量均匀度合格的颗粒剂。
而颗粒剂中有效成分含量均匀度不合格往往会导致不同批次、甚至同一批次、同一单剂量包装中有效成分含量的差异,为患者带来不良的后果。比如当重病的患者服用有效成分含量不达标的药物制剂时,很可能无法取得预期的疗效;其他患者如果长期服用有效成分含量差异较大的药物,也无法获得该药物正常的治疗效果。因此,确保益心舒颗粒产品中活性成分尤其是微量有效成份(人参中的有效成分人参皂苷及丹参的有效成分丹酚酸B)的均匀分布,对保障该产品临床用药安全有效具有重要意义。
发明内容
因此,本发明要解决的技术问题在于克服现有技术中益心舒颗粒的制备方法制得的益心舒颗粒剂中的微量有效成分含量均匀度不合格的缺陷,从而提供一种益心舒颗粒的制备方法。
为此,本发明提供了一种益心舒颗粒的制备方法,包括如下步骤:
浆料的制备:将人参粉碎成细粉,过筛,然后与蔗糖、糊精和乙醇水溶液于高速匀浆机中分散混合均匀后,得浆料;
清膏的制备:粉碎后的五味子和丹参经醇提、浓缩得清膏;
稠膏的制备:切片后的麦冬、黄芪、川芎和山楂经水提醇沉、浓缩得稠膏;
颗粒的制备:将清膏、稠膏和浆料超声混合均匀,制粒,干燥,即得益心舒颗粒;
其中,超声的频率为5-15kHz。
可选地,蔗糖、糊精和乙醇水溶液的质量体积比为(3-4)g:1g:4mL,乙醇水溶液的体积分数为63-75%。
可选地,人参粉碎后,过100目筛。
可选地,清膏的相对密度为1.12-1.15g/mL;稠膏的相对密度为1.30-1.36g/mL。
可选地,将五味子和丹参分别粉碎成粗粉和粗颗粒,加5-6倍量体积分数为85%乙醇浸泡30-50min后,回流提取二次,第一次2.5-3h,第二次1.5-2h,滤过,合并滤液,滤液减压浓缩得清膏。
粗粉指能全部通过二号筛,但混有能通过四号筛不超过40%的粉末。
粗颗粒是指2.5-10微米的颗粒。
可选地,麦冬、黄芪、川芎和山楂分别切片,加6-8倍量水浸泡1-1.5h,煎煮二次,第一次2-3h,第二次1-2h,滤过,合并滤液,滤液浓缩至相对密度为1.20-1.30g/mL的清膏,加入1-1.5倍量的体积分数为85%乙醇,充分搅拌后静置过夜,滤过,浓缩得稠膏。
本发明还提供了上述的益心舒颗粒的制备方法制得的益心舒颗粒。
可选地,所述的益心舒颗粒包括如下重量份的原料:人参150-200份、麦冬150-200份、黄芪150-200份、五味子100-150份、丹参150-200份、川芎80-120份、山楂120-180份、蔗糖360-560份、糊精100-140份。
与现有技术相比,本发明的优点:
1.本发明提供的益心舒颗粒的制备方法,通过将粉碎后的人参与蔗糖、糊精和乙醇水溶液在高速匀浆机中分散混合,可将人参细粉均匀分散在浆料中;通过将清膏、稠膏和浆料在低频超声振动5-15kHz下混合,利于流动性较差的清膏和稠膏中各活性组分以及浆料中的人参细粉及辅料分散均匀,防止在更低的超声频率下,各组分不能分散均匀,均质化程度地;更大的超声频率下,组分中稠膏具有粘性,导致各组分尤其是颗粒出现团簇。
本发明提供的益心舒颗粒的制备方法,通过先将人参细粉与蔗糖、糊精和乙醇水溶液在高速匀浆机中分散,然后与清膏、稠膏在特定的5-15kHz低频超声振动,不仅利于各组分的均匀分散,同时不会破坏浆料的粘合性,利于制粒。本发明提供的益心舒颗粒的制备方法制得的益心舒颗粒产品中活性成分尤其是微量有效成份(人参中的有效成分人参皂苷及丹参的有效成分丹酚酸B)的含量分布均匀,含量均匀度合格;且每袋益心舒颗粒产品含人参以人参皂苷Rgl(C42H72O14)和人参皂苷Re(C48H82O18)的总量计,不少于1.20mg;以人参皂苷Rb1(C54H92O23)计,不少于0.90mg;每袋益心舒颗粒产品含丹参以丹酚B(C36H30O16)计,不少于3.0mg,且符合2015版中国药典中颗粒剂下有关的各规定(通则0104)。
2.本发明提供的益心舒颗粒的制备方法,通过限定蔗糖、糊精和乙醇水溶液的质量体积比为(3-4)g:1g:4mL,乙醇水溶液的体积分数为63-75%,可进一步提高人参细粉在浆料中的均匀分散性,提高益心舒颗粒中人参的含量均匀性;同时保持浆料的粘性,利于后期制粒。
3.本发明提供的益心舒颗粒,通过限定各原料的重量份数,可快速释放,快速起效,同时满足吞咽功能障碍的病人用药,极大地满足国内临床的用药需要。且符合2015版中国药典中颗粒剂下有关的各规定(通则0104)。
具体实施方式
实施例1
本实施例提供一种益心舒颗粒,其制备方法如下:
浆料的制备:将人参粉碎成细粉,过100目筛,然后称取粉碎过筛后的人参细粉150kg与蔗糖450kg、糊精130kg和体积分数为70%的乙醇水溶液520L于高速匀浆机中分散混合均匀后,得浆料;
清膏的制备:五味子和丹参分别粉碎成粗粉和粗颗粒,然后称取粉碎后的五味子100kg,丹参150kg,然后加5倍量体积分数为85%乙醇浸泡50min后,回流提取二次,第一次2.5h,第二次1.5h,滤过,合并滤液,滤液减压浓缩至相对密度为1.12g/mL(60℃)的清膏;
稠膏的制备:麦冬、黄芪、川芎和山楂分别切片,并取切片后的麦冬160kg、黄芪200kg、川芎120kg、山楂150kg,然后加7倍量水浸泡1.2h,90℃煎煮二次,第一次2h,第二次2h,滤过,合并滤液,滤液浓缩至相对密度为1.20g/mL(60℃)的清膏,加入1.2倍量的体积分数为85%乙醇,充分搅拌后静置过夜,滤过,滤液回收乙醇并浓缩至相对密度为1.30g/mL(80℃)稠膏;
颗粒的制备:将上述的清膏、稠膏和浆料在10kHz的频率下超声混合均匀,制粒,干燥,即得益心舒颗粒。所得益心舒颗粒为黄棕色,分装为每袋4g。
实施例2
本实施例提供一种益心舒颗粒,其制备方法如下:
浆料的制备:将人参粉碎成细粉,过100目筛,然后称取粉碎过筛后的人参细粉200kg与蔗糖560kg、糊精140kg和体积分数为63%的乙醇水溶液560L于高速匀浆机中分散混合均匀后,得浆料;
清膏的制备:五味子和丹参分别粉碎成粗粉和粗颗粒,然后称取粉碎后的五味子150kg,丹参180kg,然后加6倍量体积分数为85%乙醇浸泡30min后,回流提取二次,第一次3h,第二次1.5h,滤过,合并滤液,滤液减压浓缩至相对密度为1.15g/mL(60℃)的清膏;
稠膏的制备:麦冬、黄芪、川芎和山楂分别切片,并取切片后的麦冬150kg、黄芪150kg、川芎100kg、山楂180kg,然后加8倍量水浸泡1.5h,85℃煎煮二次,第一次3h,第二次1.5h,滤过,合并滤液,滤液浓缩至相对密度为1.30g/mL(60℃)的清膏,加入1倍量的体积分数为85%乙醇,充分搅拌后静置过夜,滤过,滤液回收乙醇并浓缩至相对密度为1.36g/mL(80℃)稠膏;
颗粒的制备:将上述的清膏、稠膏和浆料在15kHz的频率下超声混合均匀,制粒,干燥,即得益心舒颗粒。所得益心舒颗粒为黄棕色,分装为每袋4g。
实施例3
本实施例提供一种益心舒颗粒,其制备方法如下:
浆料的制备:将人参粉碎成细粉,过100目筛,然后称取粉碎过筛后的人参细粉180kg与蔗糖360kg、糊精120kg和体积分数为63%的乙醇水溶液480L于高速匀浆机中分散混合均匀后,得浆料;
清膏的制备:五味子和丹参分别粉碎成粗粉和粗颗粒,然后称取粉碎后的五味子130kg,丹参200kg,然后加5倍量体积分数为85%乙醇浸泡40min后,回流提取二次,第一次2.5h,第二次2h,滤过,合并滤液,滤液减压浓缩至相对密度为1.13g/mL(60℃)的清膏;
稠膏的制备:麦冬、黄芪、川芎和山楂分别切片,并取切片后的麦冬200kg、黄芪180kg、川芎80kg、山楂120kg,然后加6倍量水浸泡1h,90℃煎煮二次,第一次2.5h,第二次2h,滤过,合并滤液,滤液浓缩至相对密度为1.20g/mL(60℃)的清膏,加入1.5倍量的体积分数为85%乙醇,充分搅拌后静置过夜,滤过,滤液回收乙醇并浓缩至相对密度为1.33g/mL(80℃)稠膏;
颗粒的制备:将上述的清膏、稠膏和浆料在5kHz的频率下超声混合均匀,制粒,干燥,即得益心舒颗粒。所得益心舒颗粒为黄棕色,分装为每袋4g。
实施例4
本实施例提供一种益心舒颗粒,其制备方法如下:
浆料的制备:将人参粉碎成细粉,过100目筛,然后称取粉碎过筛后的人参细粉150kg与蔗糖450kg、糊精100kg和体积分数为70%的乙醇水溶液400L于高速匀浆机中分散混合均匀后,得浆料;
清膏的制备:五味子和丹参分别粉碎成粗粉和粗颗粒,然后称取粉碎后的五味子100kg,丹参150kg,然后加5倍量体积分数为85%乙醇浸泡50min后,回流提取二次,第一次2.5h,第二次1.5h,滤过,合并滤液,滤液减压浓缩至相对密度为1.12g/mL(60℃)的清膏;
稠膏的制备:麦冬、黄芪、川芎和山楂分别切片,并取切片后的麦冬160kg、黄芪200kg、川芎120kg、山楂150kg,然后加7倍量水浸泡1.2h,90℃煎煮二次,第一次2h,第二次2h,滤过,合并滤液,滤液浓缩至相对密度为1.20g/mL(60℃)的清膏,加入1.2倍量的体积分数为85%乙醇,充分搅拌后静置过夜,滤过,滤液回收乙醇并浓缩至相对密度为1.30g/mL(80℃)稠膏;
颗粒的制备:将上述的清膏、稠膏和浆料在10kHz的频率下超声混合均匀,制粒,干燥,即得益心舒颗粒。所得益心舒颗粒为黄棕色,分装为每袋4g。
实施例5
本实施例提供一种益心舒颗粒,其制备方法如下:
浆料的制备:将人参粉碎成细粉,过100目筛,然后称取粉碎过筛后的人参细粉150kg与蔗糖360kg、糊精130kg和体积分数为70%的乙醇水溶液520L于高速匀浆机中分散混合均匀后,得浆料;
清膏的制备:五味子和丹参分别粉碎成粗粉和粗颗粒,然后称取粉碎后的五味子100kg,丹参150kg,然后加5倍量体积分数为85%乙醇浸泡50min后,回流提取二次,第一次2.5h,第二次1.5h,滤过,合并滤液,滤液减压浓缩至相对密度为1.12g/mL(60℃)的清膏;
稠膏的制备:麦冬、黄芪、川芎和山楂分别切片,并取切片后的麦冬160kg、黄芪200kg、川芎120kg、山楂150kg,然后加7倍量水浸泡1.2h,90℃煎煮二次,第一次2h,第二次2h,滤过,合并滤液,滤液浓缩至相对密度为1.20g/mL(60℃)的清膏,加入1.2倍量的体积分数为85%乙醇,充分搅拌后静置过夜,滤过,滤液回收乙醇并浓缩至相对密度为1.30g/mL(80℃)稠膏;
颗粒的制备:将上述的清膏、稠膏和浆料在10kHz的频率下超声混合均匀,制粒,干燥,即得益心舒颗粒。所得益心舒颗粒为黄棕色,分装为每袋4g。
对比例1
本对比例提供一种益心舒颗粒,其制备方法如下:
浆料的制备:将人参粉碎成细粉,过100目筛,然后称取粉碎过筛后的人参细粉150kg与蔗糖450kg、糊精130kg和体积分数为70%的乙醇水溶液520L于高速匀浆机中分散混合均匀后,得浆料;
清膏的制备:五味子和丹参分别粉碎成粗粉和粗颗粒,然后称取粉碎后的五味子100kg,丹参150kg,然后加5倍量体积分数为85%乙醇浸泡50min后,回流提取二次,第一次2.5h,第二次1.5h,滤过,合并滤液,滤液减压浓缩至相对密度为1.12g/mL(60℃)的清膏;
稠膏的制备:麦冬、黄芪、川芎和山楂分别切片,并取切片后的麦冬160kg、黄芪200kg、川芎120kg、山楂150kg,然后加7倍量水浸泡1.2h,90℃煎煮二次,第一次2h,第二次2h,滤过,合并滤液,滤液浓缩至相对密度为1.20g/mL(60℃)的清膏,加入1.2倍量的体积分数为85%乙醇,充分搅拌后静置过夜,滤过,滤液回收乙醇并浓缩至相对密度为1.30g/mL(80℃)稠膏;
颗粒的制备:将上述的清膏、稠膏和浆料在20kHz的频率下超声混合均匀,制粒,干燥,即得益心舒颗粒。所得益心舒颗粒为棕色,分装为每袋4g。
对比例2
本对比例提供一种益心舒颗粒,其制备方法如下:
浆料的制备:将人参粉碎成细粉,过100目筛,然后称取粉碎过筛后的人参细粉150kg与蔗糖450kg、糊精130kg和体积分数为70%的乙醇水溶液520L于高速匀浆机中分散混合均匀后,得浆料;
清膏的制备:五味子和丹参分别粉碎成粗粉和粗颗粒,然后称取粉碎后的五味子100kg,丹参150k,然后加5倍量体积分数为85%乙醇浸泡50min后,回流提取二次,第一次2.5h,第二次1.5h,滤过,合并滤液,滤液减压浓缩至相对密度为1.12g/mL(60℃)的清膏;
稠膏的制备:麦冬、黄芪、川芎和山楂分别切片,并取切片后的麦冬160kg、黄芪200kg、川芎120kg、山楂150kg,然后加7倍量水浸泡1.2h,90℃煎煮二次,第一次2h,第二次2h,滤过,合并滤液,滤液浓缩至相对密度为1.20g/mL(60℃)的清膏,加入1.2倍量的体积分数为85%乙醇,充分搅拌后静置过夜,滤过,滤液回收乙醇并浓缩至相对密度为1.30g/mL(80℃)稠膏;
颗粒的制备:将上述的清膏、稠膏和浆料在3kHz的频率下超声混合均匀,制粒,干燥,即得益心舒颗粒。所得益心舒颗粒为棕色,分装为每袋4g。
对比例3
本对比例提供一种益心舒颗粒,其制备方法如下:
浆料的制备:将人参粉碎成细粉,过100目筛,然后称取粉碎过筛后的人参细粉150kg与蔗糖450kg、糊精130kg和体积分数为70%的乙醇水溶液520L搅拌混合均匀后,得浆料;
清膏的制备:五味子和丹参分别粉碎成粗粉和粗颗粒,然后称取粉碎后的五味子100kg,丹参150kg,然后加5倍量体积分数为85%乙醇浸泡50min后,回流提取二次,第一次2.5h,第二次1.5h,滤过,合并滤液,滤液减压浓缩至相对密度为1.12g/mL(60℃)的清膏;
稠膏的制备:麦冬、黄芪、川芎和山楂分别切片,并取切片后的麦冬160kg、黄芪200kg、川芎120kg、山楂150kg,然后加7倍量水浸泡1.2h,90℃煎煮二次,第一次2h,第二次2h,滤过,合并滤液,滤液浓缩至相对密度为1.20g/mL(60℃)的清膏,加入1.2倍量的体积分数为85%乙醇,充分搅拌后静置过夜,滤过,滤液回收乙醇并浓缩至相对密度为1.30g/mL(80℃)稠膏;
颗粒的制备:将上述的清膏、稠膏和浆料在10kHz的频率下超声混合均匀,制粒,干燥,即得益心舒颗粒。所得益心舒颗粒为棕色,分装为每袋4g。。
对比例4
本对比例提供一种益心舒颗粒,其制备方法如下:
将人参粉碎成细粉,过100目筛,然后称取粉碎过筛后的人参细粉150kg,备用;
清膏的制备:五味子和丹参分别粉碎成粗粉和粗颗粒,然后称取粉碎后的五味子100kg,丹参150kg,然后加5倍量体积分数为85%乙醇浸泡50min后,回流提取二次,第一次2.5h,第二次1.5h,滤过,合并滤液,滤液减压浓缩至相对密度为1.12g/mL(60℃)的清膏;
稠膏的制备:麦冬、黄芪、川芎和山楂分别切片,并取切片后的麦冬160kg、黄芪200kg、川芎120kg、山楂150kg,然后加7倍量水浸泡1.2h,90℃煎煮二次,第一次2h,第二次2h,滤过,合并滤液,滤液浓缩至相对密度为1.20g/mL(60℃)的清膏,加入1.2倍量的体积分数为85%乙醇,充分搅拌后静置过夜,滤过,滤液回收乙醇并浓缩至相对密度为1.30g/mL(80℃)稠膏;
颗粒的制备:将上述的清膏、稠膏、人参细粉、450kg蔗糖和130kg糊精在10kHz的频率下超声混合均匀,制粒,干燥,即得益心舒颗粒。所得益心舒颗粒为棕色,分装为每袋4g。
实验例
将各实施例和对比例制得的益心舒颗粒按照2015版中国药典一部益心舒颗粒项下的鉴别的方法及含量测定方法分别对益心舒颗粒中的人参、黄芪、丹参、五味子和麦冬等有效成分进行TLC鉴别、人参和丹参的含量进行HPLC测定;TLC鉴别的结果显示益心舒颗粒中均含有人参、黄芪、丹参、五味子和麦冬等有效成分;人参和丹参的含量测试结果如下表所示;
表1人参含量测试结果
表2人参含量测试结果
表3丹参含量测试结果
由上表中的数据可知,本发明提供的益心舒颗粒的制备方法制得的益心舒颗粒产品中活性成分尤其是微量有效成份(人参中的有效成分人参皂苷及丹参的有效成分丹酚酸B)的含量分布均匀,含量均匀度合格;且每袋益心舒颗粒产品含人参以人参皂苷Rgl(C42H72O14)和人参皂苷Re(C48H82O18)的总量计,不少于1.20mg;以人参皂苷Rb1(C54H92O23)计,不少于0.90mg;每袋益心舒颗粒产品含丹参以丹酚B(C36H30O16)计,不少于3.0mg,且符合2015版中国药典中益心舒颗粒项下的相关规定。
显然,所描述的实施例仅仅是本发明的一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
Claims (8)
1.一种益心舒颗粒的制备方法,其特征在于,包括如下步骤:
浆料的制备:将人参粉碎成细粉,过筛,然后与蔗糖、糊精和乙醇水溶液于高速匀浆机中分散混合均匀后,得浆料;
清膏的制备:粉碎后的五味子和丹参经醇提、浓缩得清膏;
稠膏的制备:切片后的麦冬、黄芪、川芎和山楂经水提醇沉、浓缩得稠膏;
颗粒的制备:将清膏、稠膏和浆料超声混合均匀,制粒,干燥,即得益心舒颗粒;
其中,超声的频率为5-15kHz。
2.根据权利要求1所述的益心舒颗粒的制备方法,其特征在于,蔗糖、糊精和乙醇水溶液的质量体积比为3-4g:1g:4mL,乙醇水溶液的体积分数为63-75%。
3.根据权利要求1或2所述的益心舒颗粒的制备方法,其特征在于,人参粉碎后,过100目筛。
4.根据权利要求1-3任一项所述的益心舒颗粒的制备方法,其特征在于,
清膏的相对密度为1.12-1.15g/mL;稠膏的相对密度为1.30-1.36g/mL。
5.根据权利要求1-4任一项所述的益心舒颗粒的制备方法,其特征在于,将五味子和丹参分别粉碎成粗粉和粗颗粒,加5-6倍量体积分数为85%乙醇浸泡30-50min后,回流提取二次,第一次2.5-3h,第二次1.5-2h,滤过,合并滤液,滤液减压浓缩得清膏。
6.根据权利要求1-5任一项所述的益心舒颗粒的制备方法,其特征在于,
麦冬、黄芪、川芎和山楂分别切片,加6-8倍量水浸泡1-1.5h,煎煮二次,第一次2-3h,第二次1-2h,滤过,合并滤液,滤液浓缩至相对密度为1.20-1.30g/mL的清膏,加入1-1.5倍量的体积分数为85%乙醇,搅拌后静置过夜,滤过,浓缩得稠膏。
7.权利要求1-6任一项所述的益心舒颗粒的制备方法制得的益心舒颗粒。
8.根据权利要求7所述的益心舒颗粒,其特征在于,包括如下重量份的原料:人参150-200份、麦冬150-200份、黄芪150-200份、五味子100-150份、丹参150-200份、川芎80-120份、山楂120-180份、蔗糖360-560份、糊精100-140份。
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