CN110859915A - 一种止咳橘红颗粒及其制备方法 - Google Patents
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Abstract
本发明公开了一种止咳橘红颗粒,其按重量百分比计由以下组分组成:浸膏(以固体计)18%~25%,蔗糖35%~45%,环糊精18%~25%,糊精16%~22%,苹果酸0.3%~0.8%,三氯蔗糖0.05%~0.15%,所述浸膏由化橘红、陈皮、法半夏、茯苓、款冬花、甘草、瓜蒌皮、紫菀、麦冬、知母、桔梗、地黄、石膏、去皮炒苦杏仁、炒紫苏子制备而成。采用一定配比的蔗糖、环糊精、糊精、苹果酸及三氯蔗糖与中药材浸膏组合,遮蔽掩盖了浸膏本身令人不喜的味道,经试验验证,口感好,止咳,化痰效果良好,更适合工业化大生产。
Description
技术领域
本发明涉及一种止咳橘红颗粒及其制备方法。
背景技术
止咳橘红颗粒,可清肺,止咳,化痰。临床上用于痰热阻肺引起的咳嗽痰多,胸满气短,咽干喉痒。止咳橘红颗粒为纯天然植物药,选用正宗化州橘红,止咳化痰能力强,所应用的药材均性质温和,不良反应少,尤其适用于儿童患者。
目前市场上的止咳橘红颗粒有无糖和含糖的两种,尽管含糖的止咳橘红颗粒一定程度上改善了口感,但味道依然不尽如人意,病人尤其是儿童患者依从性一般。并且原止咳橘红颗粒的药材浸膏制备工艺复杂,大规模生产能耗高,效率低。
发明内容
本发明要解决的技术问题是提供一种口感好,制备方法简单的止咳橘红颗粒。
为解决上述技术问题,本发明公开了一种止咳橘红颗粒,其按重量百分比计由以下组分组成:浸膏以固体计18%~25%,蔗糖35%~45%,环糊精18%~25%,糊精16%~22%,苹果酸0.3%~0.8%,三氯蔗糖0.05%~0.15%,所述浸膏由化橘红、陈皮、法半夏、茯苓、款冬花、甘草、瓜蒌皮、紫菀、麦冬、知母、桔梗、地黄、石膏、去皮炒苦杏仁、炒紫苏子制备而成。
浸膏优选由如下重量比的化橘红2~4份、陈皮1~3份、法半夏1~2份、茯苓1~3份、款冬花0.5~1.5份、甘草0.5~1.5份、瓜蒌皮1~3份、紫菀1~2份、麦冬1~3份、知母0.5~1.5份、桔梗1~2份、地黄1~3份、石膏1~3份、去皮炒苦杏仁1~3份、炒紫苏子1~2份制备而成。
更优选由如下重量比的化橘红3份、陈皮2份、法半夏1.5份、茯苓2份、款冬花1份、甘草1份、瓜蒌皮2份、紫菀1.5份、麦冬2份、知母1份、桔梗1.5份、地黄2份、石膏2份、去皮炒苦杏仁2份、炒紫苏子1.5份制备而成。
采用一定配比的蔗糖、环糊精、糊精、苹果酸及三氯蔗糖与中药材浸膏组合,可遮蔽掩盖浸膏本身令人不喜的味道,带来良好的口感。
其优选配比为:浸膏20%,蔗糖39.4%,环糊精22%,糊精18%,苹果酸0.5%,三氯蔗糖0.1%。
其中所述浸膏可通过如下步骤制备:1)组分药材分别称量粗碎;2)石膏,水煎煮,滤过,滤液浓缩得浓缩液备用;3)其余十四味药材,水煎煮,滤过,滤液浓缩,加乙醇使含醇量达到55~65%,取醇沉后的上清液,滤过,滤液浓缩回收乙醇至无醇味;4)石膏浓缩液和收醇浓缩液合并,浓缩至相对密度1.1~1.3即得。
优选所述步骤2)中水煎煮为3次,第一次加10倍量水煎煮1.5小时,第二次、第三次分别加8倍量水煎煮1小时;所述步骤3)中水煎煮两次,第一次加8倍量水煎煮1小时,第二次加8倍量水煎煮1小时,滤过,滤液浓缩至相对密度1.03~1.07,加乙醇使含醇量达到60%,取醇沉24小时后的上清液,滤过,滤液浓缩回收乙醇至无醇味;4)石膏浓缩液和收醇浓缩液合并,浓缩至相对密度1.18~1.22即得。
与现有的浸膏制备方法相比,上述浸膏的制备方法工艺较为简单,流程可控性好,生产能耗低,效率高。
所述浸膏也可通过如下步骤制备:1)组分药材分别称量粗碎;2)石膏置热回流提取浓缩系统中,水煎煮,滤过,滤液浓缩得浓缩液备用;3)其余十四味药材,通过乙醇水溶液作为夹带剂的超临界CO2流体萃取,萃取液回收乙醇至无醇味;4)石膏浓缩液和收醇浓缩液合并,浓缩至相对密度1.18~1.22即得。
优选所述步骤3)中所述乙醇水溶液中乙醇含量为60%,添加量占CO2摩尔流量百分比为6%,萃取温度为55℃,萃取压力为16MPa,萃取时间为2小时。
通过乙醇水溶液作为夹带剂的超临界CO2流体萃取药材中有效成分的方法萃取浸膏,提取效率高,所需时间短,可控性好,药效好。
本发明所公开的止咳橘红颗粒,可通过如下步骤制备:1)蔗糖、环糊精过筛,备用;2)取浸膏加入乙醇,搅拌均匀,备用;3)浸膏溶液倒入蔗糖、环糊精、糊精、苹果酸和三氯蔗糖中制粒;4)制得的颗粒干燥、整粒,混合即得。
本发明所公开的止咳橘红颗粒,经试验验证,口感好,止咳,化痰效果良好,更适合工业化大生产。
具体实施方式
以下通过具体实施例再对本发明的上述内容作进一步的详细说明。但不应将此理解为本发明上述主题的范围仅局限于以下的实施例。在不脱离本发明上述技术思想的情况下,根据本领域普通技术知识和惯用手段做出的各种替换或变更,均应包括在本发明的范围内。
实施例1
(制备2000g颗粒)
浸膏处方:
浸膏制备方法:
1)组分药材分别称量粗碎;
2)石膏加水进行煎煮,第一次加10倍量饮用水煎煮1小时,第二次加8倍量饮用水煎煮1小时,滤过,滤液备用。
3)化橘红、陈皮、款冬花、苦杏仁四味,加4倍量水,进行水蒸汽蒸馏,收集蒸馏液;蒸馏器内药液滤过,滤液加乙醇使含醇量达到60%,搅匀,静置,滤过,滤液备用;
4)其余法半夏等十味与上述药渣混匀,用60%乙醇作溶剂,浸渍24小时后进行渗漉,收集漉液。
5)取醇沉24小时后的上清液,滤过,滤液与渗漉液合并,回收乙醇至无醇味。
6)浓缩液与石膏水煎液、蒸馏液合并浓缩至相对密度1.35-1.38g/cm3(50℃),收膏(以固体计)402g。
颗粒处方:
浸膏(含固量) | 402g | 蔗糖 | 760g |
环糊精 | 500g | 糊精 | 320g |
苹果酸 | 15g | 三氯蔗糖 | 3g |
颗粒制备方法:
1)蔗糖、环糊精过筛,备用;
2)取浸膏加入适当乙醇,搅拌均匀,备用;
3)将蔗糖、环糊精、糊精、苹果酸和三氯蔗糖加入混合制粒机内干混均匀,加入浸膏溶液混合制软材;
4)软材通过摇摆制粒机制粒;
5)制得的颗粒干燥、整粒,混合即得。
实施例2(变更后工艺)
(制备2000g颗粒)
浸膏处方:
化橘红 | 232g | 陈皮 | 154g | 法半夏 | 116g |
茯苓 | 154g | 款冬花 | 77g | 甘草 | 77g |
瓜蒌皮 | 154g | 紫菀 | 116g | 麦冬 | 154g |
知母 | 77g | 桔梗 | 116g | 地黄 | 154g |
石膏 | 154g | 去皮炒苦杏仁 | 154g | 炒紫苏子 | 116g |
浸膏制备方法:
1)组分药材分别称量粗碎;
2)石膏,水煎煮3次,第一次加10倍量水煎煮1小时,第二次、第三次加8倍量水煎煮1小时,滤过,滤液浓缩得浓缩液备用;
3)其余十四味药材,水煎煎煮两次,第一次加8倍量水煎煮2小时,第二次加8倍量水煎煮2小时,滤过,滤液浓缩至相对密度约1.05,加乙醇使含醇量达到60%,取醇沉24小时后的上清液,滤过,滤液浓缩回收乙醇至无醇味;
4)石膏浓缩液和收醇浓缩液合并,浓缩至相对密度约1.35,称重,得浸膏(以固体计)360g。颗粒处方:
浸膏(含固量) | 360g | 蔗糖 | 900g |
环糊精 | 360g | 糊精 | 373g |
苹果酸 | 6g | 三氯蔗糖 | 1g |
颗粒制备方法:
1)蔗糖、环糊精过筛,备用;
2)取浸膏加入适量乙醇,搅拌均匀,备用;
3)将蔗糖、环糊精、糊精、三氯蔗糖及苹果酸加入混合制粒机内干混均匀,加入浸膏溶液混合制软材;
4)软材通过摇摆制粒机制粒;
5)制得的颗粒干燥、整粒,混合即得。
实施例3
(制备2000g颗粒)
浸膏处方:
化橘红 | 232g | 陈皮 | 154g | 法半夏 | 116g |
茯苓 | 154g | 款冬花 | 77g | 甘草 | 77g |
瓜蒌皮 | 154g | 紫菀 | 116g | 麦冬 | 154g |
知母 | 77g | 桔梗 | 116g | 地黄 | 154g |
石膏 | 154g | 去皮炒苦杏仁 | 154g | 炒紫苏子 | 116g |
浸膏制备方法:
1)组分药材分别称量粗碎;
2)石膏,水煎煮3次,第一次加10倍量水煎煮1.5小时,第二次、第三次分别加8倍量水煎煮1小时,滤过,滤液浓缩得浓缩液备用;
3)其余十四味药材,水煎煎煮两次,第一次加8倍量水煎煮1小时,第二次加8倍量水煎煮1小时,滤过,滤液浓缩至相对密度约1.05,加乙醇使含醇量达到60%,取醇沉24小时后的上清液,滤过,滤液浓缩回收乙醇至无醇味;
4)石膏浓缩液和收醇浓缩液合并,浓缩至相对密度约1.34,称重,得浸膏(以固体计)430g。颗粒处方:
浸膏(含固量) | 430g | 蔗糖 | 700g |
环糊精 | 412g | 糊精 | 440g |
苹果酸 | 16g | 三氯蔗糖 | 2g |
颗粒制备方法:
1)蔗糖、环糊精过筛,备用;
2)取浸膏加入乙醇,搅拌均匀,备用;
3)将蔗糖、环糊精、糊精、苹果酸和三氯蔗糖加入混合制粒机内干混均匀,加入浸膏溶液混合制软材;
4)软材通过摇摆制粒机制粒;
5)制得的颗粒干燥、整粒,混合即得。
实施例4
(制备2000g颗粒)
浸膏处方:
化橘红 | 232g | 陈皮 | 154g | 法半夏 | 116g |
茯苓 | 154g | 款冬花 | 77g | 甘草 | 77g |
瓜蒌皮 | 154g | 紫菀 | 116g | 麦冬 | 154g |
知母 | 77g | 桔梗 | 116g | 地黄 | 154g |
石膏 | 154g | 去皮炒苦杏仁 | 154g | 炒紫苏子 | 116g |
浸膏制备方法:
1)组分药材分别称量粗碎;
2)石膏置热回流提取浓缩系统中,水煎煮3次,第一次加10倍量水煎煮1.5小时,第二次、第三次分别加8倍量水煎煮1小时,滤过,滤液浓缩得浓缩液备用;
3)其余十四味药材,通过摩尔流量百分比为5%的65%乙醇水溶液作为夹带剂的超临界CO2流体萃取,萃取温度为50℃,萃取压力为17MPa,萃取时间为1.5小时,萃取液回收乙醇至无醇味;
4)石膏浓缩液和收醇浓缩液合并,浓缩至相对密度1.33,得浸膏(以固体计)380g。
颗粒处方:
颗粒制备方法:
1)蔗糖、环糊精过筛,备用;
2)取浸膏加入乙醇,搅拌均匀,备用;
3)将蔗糖、环糊精、糊精、苹果酸和三氯蔗糖加入混合制粒机内干混均匀,加入浸膏溶液混合制软材;
4)软材通过摇摆制粒机制粒;
5)制得的颗粒干燥、整粒,混合即得。
实施例5
(制备2000g颗粒)
浸膏处方:
化橘红 | 232g | 陈皮 | 154g | 法半夏 | 116g |
茯苓 | 154g | 款冬花 | 77g | 甘草 | 77g |
瓜蒌皮 | 154g | 紫菀 | 116g | 麦冬 | 154g |
知母 | 77g | 桔梗 | 116g | 地黄 | 154g |
石膏 | 154g | 去皮炒苦杏仁 | 154g | 炒紫苏子 | 116g |
浸膏制备方法:
1)组分药材分别称量粗碎;
2)石膏置热回流提取浓缩系统中,水煎煮3次,第一次加10倍量水煎煮1.5小时,第二次、第三次分别加8倍量水煎煮1小时,滤过,滤液浓缩得浓缩液备用;
3)其余十四味药材,通过摩尔流量百分比为6%的60%乙醇水溶液作为夹带剂的超临界CO2流体萃取,萃取温度为55℃,萃取压力为16MPa,萃取时间为2小时,萃取液回收乙醇至无醇味;
4)石膏浓缩液和收醇浓缩液合并,浓缩至相对密度1.32,得浸膏(以固体计)401g。
颗粒处方:
浸膏(含固量) | 401g | 蔗糖 | 787g |
环糊精 | 440g | 糊精 | 360g |
苹果酸 | 10g | 三氯蔗糖 | 2g |
颗粒制备方法:
1)蔗糖、环糊精过筛,备用;
2)取浸膏加入乙醇,搅拌均匀,备用;
3)将蔗糖、环糊精、糊精、苹果酸和三氯蔗糖加入混合制粒机内干混均匀,加入浸膏溶液混合制软材;
4)软材通过摇摆制粒机制粒;
5)制得的颗粒干燥、整粒,混合即得。
本发明以上实施例所制备的止咳橘红颗粒的试验测试结果如下:
1)以上实施例所得到的止咳橘红颗粒均为棕黄色颗粒。
2)实施例所制备的止咳橘红颗粒的口感评价:健康志愿者300名,随机分成6组,50人/组,分别给予参比制剂【市售止咳橘红颗粒(含糖)康芝药业股份有限公司】和实施例1~5所制备得样品(1袋,用50ml开水溶解,冷却至60℃,一次饮用完毕),做口味评分(0~10分),统计均值。结果显示实施例制得的样品口感优于参比制剂,具体结果见表1。
表1
3)实施例所制备的止咳橘红颗粒的止咳疗效验证:昆明小鼠140只,雌雄各半,随机分为对照组,参比制剂组【市售止咳橘红颗粒(含糖,康芝药业股份有限公司)加蒸馏水配置成0.12g/ml溶液】及实施例1~5组(加蒸馏水配置成0.12g/ml溶液),以灌胃方式给药,各组按0.06g/10g体重灌胃给药(对照组给予等量蒸馏水),每日1次,连续3日,于末次给药后1h,将小鼠置于2L的密闭罩内,恒定压力用雾化器喷雾浓氨水15S,记录小鼠咳嗽潜伏期(从喷雾开始到小鼠出现第一次咳嗽的时间为潜伏期)和5min内咳嗽次数,统计均值。结果显示实施例制得的止咳橘红颗粒止咳效果良好,等于或优于参比制剂。具体结果见下表2
表2
潜伏期(sec) | 5min内咳嗽数 | |
对照组 | 15.6 | 22 |
参比制剂组 | 49.3 | 8 |
实施例1 | 51.4 | 10 |
实施例2 | 53.4 | 7 |
实施例3 | 56.1 | 8 |
实施例4 | 58,2 | 6 |
实施例5 | 61.2 | 6 |
4)实施例所制备的止咳橘红颗粒的祛痰疗效验证:昆明小鼠140只,雌雄各半,随机分为对照组,参比制剂组【市售止咳橘红颗粒(含糖,康芝药业股份有限公司)加蒸馏水配置成0.12g/ml溶液】及实施例1~5组(加蒸馏水配置成0.12g/ml溶液),以灌胃方式给药,各组按0.06g/10g体重灌胃给药(对照组给予等量蒸馏水),每日1次,连续3日,于末次给药后各组动物腹腔注射酚红0.1mL(5mg)/10g体重,注射酚红0.5h处死动物,剥离气管周围组织,剪下自甲状软骨下至气管分支处的一段气管,放人盛有2mL生理盐水的试管中,再加0.1mL氢氧化钠,用分光光度计,波长546nm测OD值。并根据酚红的标准曲线计算酚红含量,记录结果并进行统计学处理。结果显示实施例制得的止咳橘红颗粒祛痰效果良好,等于或优于参比制剂。具体结果见下表3
表3
Claims (9)
1.一种止咳橘红颗粒,其特征在于,按重量百分比计由以下组分组成:浸膏以固体计18%~25%,蔗糖35%~45%,环糊精18%~25%,糊精16%~22%,苹果酸0.3%~0.8%,三氯蔗糖0.05%~0.15%,所述浸膏由化橘红、陈皮、法半夏、茯苓、款冬花、甘草、瓜蒌皮、紫菀、麦冬、知母、桔梗、地黄、石膏、去皮炒苦杏仁、炒紫苏子制备而成。
2.如权利要求1所述的止咳橘红颗粒,其特征在于,按重量百分比计由以下组分组成:浸膏以固体计20%,蔗糖39.4%,环糊精22%,糊精18%,苹果酸0.5%,三氯蔗糖0.1%。
3.如权利要求1所述的止咳橘红颗粒,其特征在于:所述浸膏由如下重量比的化橘红2~4份、陈皮1~3份、法半夏1~2份、茯苓1~3份、款冬花0.5~1.5份、甘草0.5~1.5份、瓜蒌皮1~3份、紫菀1~2份、麦冬1~3份、知母0.5~1.5份、桔梗1~2份、地黄1~3份、石膏1~3份、去皮炒苦杏仁1~3份、炒紫苏子1~2份制备而成。
4.如权利要求3所述的止咳橘红颗粒,其特征在于:所述浸膏由如下重量比的化橘红3份、陈皮2份、法半夏1.5份、茯苓2份、款冬花1份、甘草1份、瓜蒌皮2份、紫菀1.5份、麦冬2份、知母1份、桔梗1.5份、地黄2份、石膏2份、去皮炒苦杏仁2份、炒紫苏子1.5份制备而成。
5.如权利要求1所述的止咳橘红颗粒,其特征在于,所述浸膏通过如下步骤制备:1)组分药材分别称量粗碎;2)石膏,水煎煮,滤过,滤液浓缩得浓缩液备用;3)其余十四味药材,水煎煮,滤过,滤液浓缩,加乙醇使含醇量达到55~65%,取醇沉后的上清液,滤过,滤液浓缩回收乙醇至无醇味;4)石膏浓缩液和收醇浓缩液合并,浓缩至相对密度1.1~1.3即得。
6.如权利要求5所述的止咳橘红颗粒,其特征在于,所述步骤2)中水煎煮为3次,第一次加10倍量水煎煮1.5小时,第二次、第三次分别加8倍量水煎煮1小时;所述步骤3)中水煎煮两次,第一次加8倍量水煎煮1小时,第二次加8倍量水煎煮1小时,滤过,滤液浓缩至相对密度1.03~1.07,加乙醇使含醇量达到60%,取醇沉24小时后的上清液,滤过,滤液浓缩回收乙醇至无醇味;4)石膏浓缩液和收醇浓缩液合并,浓缩至相对密度1.18~1.22即得。
7.如权利要求1所述的止咳橘红颗粒,其特征在于,所述浸膏通过如下步骤制备:1)组分药材分别称量粗碎;2)石膏置热回流提取浓缩系统中,水煎煮,滤过,滤液浓缩得浓缩液备用;3)其余十四味药材,通过乙醇水溶液作为夹带剂的超临界CO2流体萃取,萃取液回收乙醇至无醇味;4)石膏浓缩液和收醇浓缩液合并,浓缩至相对密度1.18~1.22即得。
8.如权利要求7所述的止咳橘红颗粒,其特征在于,所述步骤3)中所述乙醇水溶液中乙醇含量为60%,添加量占CO2摩尔流量百分比为6%,萃取温度为55℃,萃取压力为16MPa,萃取时间为2小时。
9.如权利要求1-8任一项所述的止咳橘红颗粒的制备方法,其特征在于,包括如下步骤:1)蔗糖、环糊精过筛,备用;2)取浸膏加入苹果酸和三氯蔗糖,搅拌均匀,备用;3)浸膏溶液倒入蔗糖、环糊精和糊精中制粒;4)制得的颗粒干燥、整粒,混合即得。
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