CN106309735B - 西洋参花粉口服液的制备方法 - Google Patents
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Abstract
本发明提供的是一种用于生产西洋参花粉口服液的制备方法。每1000ml口服液的原料组成为西洋参10～20g、枸杞子25～35g、蜂花粉90～110g、蜂蜜400～500g、枸橼酸钠5～7g、山梨酸钾0.5～1g。提取西洋参、枸杞子、蜂花粉，将西洋参提取物、枸杞子提取物、蜂蜜、枸橼酸钠、山梨酸钾混合，加水适量，搅拌至均匀，滤过，100℃煮沸30分钟，冷却后备用。取蜂花粉提取物，加水适量，搅拌至均匀，在室温下进行加压微滤，滤液加至上述煮沸后的混合液中，加水稀释至1000ml，搅匀，灌封，即得。新工艺不同程度的提高了各药材的提取率，显著提高指标成分的含量，有效改善口服液的稳定性，降低了生产成本。
Description
技术领域
本发明涉及医药技术领域，特别是涉及一种用于生产西洋参花粉口服液的制备方法。
背景技术
西洋参花粉口服液是由西洋参、枸杞子、蜂花粉等原料经一系列严格的生产工艺制备而成，具有防治心脑血管疾病，防癌抑癌和保肝，提高机体免疫力，调节内分泌***，抗衰老等显著功效。本品功能主治为益气养阴。适用于气阴两虚见有体虚乏力，心悸气短，食欲不振，易于疲劳，咽干口燥，五心烦热，头晕，便干。西洋参花粉口服液是国家批复的中药复方制剂，疗效明确，临床效果好，深受群众喜爱。但是由于早年生产工艺所限，导致药材有效成分提取不充分、生产成本高。
发明内容
本发明的目的正是针对上述现有技术中存在的不足之处而提供的一种用于生产西洋参花粉口服液的制备方法。
本发明的目的是通过以下方案来实现的：
本发明的西洋参花粉口服液中所用的三味药材分别提取，优化了各药材的提取工艺。特别是在其制备过程中西洋参在醇提后，药渣继续进行水提醇沉；蜂花粉进行醇提，离心机分离出的药渣继续进行水提，合并已回收乙醇的醇提液与水提液同时进行浓缩；配制过程中，蜂花粉提取物在室温下进行加压微滤，除去微生物及大分子物质的同时，保证有效成分不被破坏；并且通过大量的筛选试验，确定了各自的工艺参数。从试验结果看出，新工艺不同程度的提高了各药材的提取率，显著提高指标成分的含量，有效改善口服液的稳定性，降低了生产成本。
本发明的制备包括以下步骤：
a、每1000ml口服液的原料组成为西洋参10～20g、枸杞子25～35g、蜂花粉90～110g、蜂蜜400～500g、枸橼酸钠5～7g、山梨酸钾0.5～1g。
b、取西洋参粉碎成最粗粉，加65％乙醇浸泡30分钟后，加6倍量65％乙醇回流提取三次，提取时间分别为2小时、1小时、1小时，合并提取液，滤过，回收乙醇，浓缩至1:1体积，放冷备用。
c、取西洋参药渣与枸杞子加水温浸30分钟后，加8倍量水煎煮三次，每次1小时，合并提取液，滤过，滤液浓缩至1:1体积，放冷，搅拌下缓缓加入乙醇，使含醇量达70～80％，静置12小时，滤过，滤液回收乙醇，备用。
d、取蜂花粉加6倍量75％乙醇50～60℃保温提取3小时，经4000prm离心机分离30分钟，取上清液，残渣加6倍量75％乙醇,重复上述操作，合并上清液，低温减压回收乙醇。取醇提后的残渣加3倍量水50～60℃保温提取2小时，经4000prm离心机分离30分钟,取上清液，残渣加3倍量水，重复上述操作，合并上清液。合并已回收乙醇的醇提液与水提液，浓缩至1:1体积，备用。
e、按配方量将西洋参提取物、枸杞子提取物、蜂蜜、枸橼酸钠、山梨酸钾混合，加水适量，搅拌至均匀，滤过，100℃煮沸30分钟，冷却后备用。取蜂花粉提取物，加水适量，搅拌至均匀，在室温下进行加压微滤，滤液加至上述煮沸后的混合液中，加水稀释至1000ml，搅匀，灌封，即得。
本发明中所述的各中药材，均指符合中国药典及其他国家标准要求的中药材原料。
本发明在原有西洋参花粉口服液配方的基础上，优化了生产工艺，得到了性能更好的产品。西洋参提高免疫力、抗感染、抗肿瘤、抗疲劳、降血糖、预防心脑血管疾病，枸杞子改善免疫调节、抗衰老、抗肿瘤、抗疲劳、抗辐射损伤、提高呼吸道抗病能力，蜂花粉抗肿瘤、抗炎、增强免疫力、降胆固醇。西洋参花粉口服液将三者完美的结合起来，在治疗领域具有显著优势，成为益气养阴类药品中的佼佼者。
本发明具有以下优点:
在其制备过程中西洋参在醇提后，药渣继续进行水提醇沉；蜂花粉进行醇提，离心机分离出的药渣继续进行水提，合并已回收乙醇的醇提液与水提液同时进行浓缩；配制过程中，蜂花粉提取物在室温下进行加压微滤，除去微生物及大分子物质的同时，保证有效成分不被破坏。新工艺不同程度的提高了各药材的提取率，显著提高指标成分的含量，有效改善口服液的稳定性，降低了生产成本。
具体实施方式
下面举例对本发明做更详细地描述：
实施例1
(1)配方
(2)制备工艺
取西洋参粉碎成最粗粉，加65％乙醇浸泡30分钟后，加6倍量65％乙醇回流提取三次，提取时间分别为2小时、1小时、1小时，合并提取液，滤过，回收乙醇，浓缩至1:1体积，放冷备用。
取西洋参药渣与枸杞子加水温浸30分钟后，加8倍量水煎煮三次，每次1小时，合并提取液，滤过，滤液浓缩至1:1体积，放冷，搅拌下缓缓加入乙醇，使含醇量达70％，静置12小时，滤过，滤液回收乙醇，备用。
取蜂花粉加6倍量75％乙醇55℃保温提取3小时，经4000prm离心机分离30分钟，取上清液，残渣加6倍量75％乙醇,重复上述操作，合并上清液，低温减压回收乙醇。取醇提后的残渣加3倍量水55℃保温提取2小时，经4000prm离心机分离30分钟,取上清液，残渣加3倍量水，重复上述操作，合并上清液。合并已回收乙醇的醇提液与水提液，浓缩至1:1体积，备用。
按配方量将西洋参提取物、枸杞子提取物、蜂蜜、枸橼酸钠、山梨酸钾混合，加水适量，搅拌至均匀，滤过，100℃煮沸30分钟，冷却后备用。取蜂花粉提取物，加水适量，搅拌至均匀，在室温下进行加压微滤，滤液加至上述煮沸后的混合液中，加水稀释至1000ml，搅匀，灌封，即得。
实施例2
(1)配方
(2)制备工艺
取西洋参粉碎成最粗粉，加65％乙醇浸泡30分钟后，加6倍量65％乙醇回流提取三次，提取时间分别为2小时、1小时、1小时，合并提取液，滤过，回收乙醇，浓缩至1:1体积，放冷备用。
取西洋参药渣与枸杞子加水温浸30分钟后，加8倍量水煎煮三次，每次1小时，合并提取液，滤过，滤液浓缩至1:1体积，放冷，搅拌下缓缓加入乙醇，使含醇量达75％，静置12小时，滤过，滤液回收乙醇，备用。
取蜂花粉加6倍量75％乙醇56℃保温提取3小时，经4000prm离心机分离30分钟，取上清液，残渣加6倍量75％乙醇,重复上述操作，合并上清液，低温减压回收乙醇。取醇提后的残渣加3倍量水56℃保温提取2小时，经4000prm离心机分离30分钟,取上清液，残渣加3倍量水，重复上述操作，合并上清液。合并已回收乙醇的醇提液与水提液，浓缩至1:1体积，备用。
按配方量将西洋参提取物、枸杞子提取物、蜂蜜、枸橼酸钠、山梨酸钾混合，加水适量，搅拌至均匀，滤过，100℃煮沸30分钟，冷却后备用。取蜂花粉提取物，加水适量，搅拌至均匀，在室温下进行加压微滤，滤液加至上述煮沸后的混合液中，加水稀释至1000ml，搅匀，灌封，即得。
实施例3
(1)配方
(2)制备工艺
取西洋参粉碎成最粗粉，加65％乙醇浸泡30分钟后，加6倍量65％乙醇回流提取三次，提取时间分别为2小时、1小时、1小时，合并提取液，滤过，回收乙醇，浓缩至1:1体积，放冷备用。
取西洋参药渣与枸杞子加水温浸30分钟后，加8倍量水煎煮三次，每次1小时，合并提取液，滤过，滤液浓缩至1:1体积，放冷，搅拌下缓缓加入乙醇，使含醇量达80％，静置12小时，滤过，滤液回收乙醇，备用。
取蜂花粉加6倍量75％乙醇57℃保温提取3小时，经4000prm离心机分离30分钟，取上清液，残渣加6倍量75％乙醇,重复上述操作，合并上清液，低温减压回收乙醇。取醇提后的残渣加3倍量水57℃保温提取2小时，经4000prm离心机分离30分钟,取上清液，残渣加3倍量水，重复上述操作，合并上清液。合并已回收乙醇的醇提液与水提液，浓缩至1:1体积，备用。
按配方量将西洋参提取物、枸杞子提取物、蜂蜜、枸橼酸钠、山梨酸钾混合，加水适量，搅拌至均匀，滤过，100℃煮沸30分钟，冷却后备用。取蜂花粉提取物，加水适量，搅拌至均匀，在室温下进行加压微滤，滤液加至上述煮沸后的混合液中，加水稀释至1000ml，搅匀，灌封，即得。
按照现有技术工艺与实施例2所述的制备方法，取同批同量药材各制备三批样品。用现有技术工艺制备的样品，批号为20140414、20140415、20140416，用实施例2所述方法制备的样品，批号为20140417、20140418、20140419。用国家药品标准规定的方法对相关指标进行测定，稳定性考察24个月后重新测定上述指标，结果见下表：
结论
上述考察结果表明，采用新工艺制备的西洋参花粉口服液与现有工艺制备的西洋参花粉口服液相比，人参总皂苷含量获得显著提高，并且稳定性良好。制备过程中西洋参在醇提后，药渣继续进行水提醇沉；蜂花粉进行醇提，离心机分离出的药渣继续进行水提，合并已回收乙醇的醇提液与水提液同时进行浓缩；蜂花粉提取物在室温下进行加压微滤，除去微生物及大分子物质以及各药材提取工艺的优化确实提高了药材的提取率，提高了药品质量，降低了生产成本。是对现有西洋参花粉口服液制备方法创造性的改进，开拓了制备口服液的新途径，有效改善原有技术中的不足。
Claims (1)
1.一种用于生产西洋参花粉口服液的制备方法，其特征在于：所述制备方法包括以下步骤：
a、每1000mL口服液的原料组成为西洋参10～20g、枸杞子25～35g、蜂花粉90～110g、蜂蜜400～500g、枸橼酸钠5～7g、山梨酸钾0.5～1g；
b、取西洋参粉碎成最粗粉，加65％乙醇浸泡30分钟后，加6倍量65％乙醇回流提取三次，提取时间分别为2小时、1小时、1小时，合并提取液，滤过，回收乙醇，浓缩至1:1体积，放冷备用；
c、取西洋参药渣与枸杞子加水温浸30分钟后，加8倍量水煎煮三次，每次1小时，合并提取液，滤过，滤液浓缩至1:1体积，放冷，搅拌下缓缓加入乙醇，使含醇量达70～80％，静置12小时，滤过，滤液回收乙醇，备用；
d、取蜂花粉加6倍量75％乙醇50～60℃保温提取3小时，经4000prm离心机分离30分钟，取上清液，残渣加6倍量75％乙醇,重复上述操作，合并上清液，低温减压回收乙醇，取醇提后的残渣加3倍量水50～60℃保温提取2小时，经4000prm离心机分离30分钟,取上清液，残渣加3倍量水，重复上述操作，合并上清液，合并已回收乙醇的醇提液与水提液，浓缩至1:1体积，备用；
e、按配方量将西洋参提取物、枸杞子提取物、蜂蜜、枸橼酸钠、山梨酸钾混合，加水适量，搅拌至均匀，滤过，100℃煮沸30分钟，冷却后备用，取蜂花粉提取物，加水适量，搅拌至均匀，在室温下进行加压微滤，滤液加至上述煮沸后的混合液中，加水稀释至1000ml，搅匀，灌封，即得。
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