CN106938001A - 清热解毒口服液及其制备工艺 - Google Patents
清热解毒口服液及其制备工艺 Download PDFInfo
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- CN106938001A CN106938001A CN201710222525.3A CN201710222525A CN106938001A CN 106938001 A CN106938001 A CN 106938001A CN 201710222525 A CN201710222525 A CN 201710222525A CN 106938001 A CN106938001 A CN 106938001A
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Abstract
本发明公开了一种清热解毒口服液及其制备工艺。本发明通过改进清热解毒口服液制备工艺的条件,用澄清剂代替传统方法中的醇沉过程,所使用的澄清剂为1%ZTC1+1澄清剂,用量为药液体积的2%,该方法使得各原料药材的利用率增高,所获得的提取物中黄芩苷、绿原酸、木樨草苷、毛蕊花糖苷、连翘苷等成分的含量有所提高,特别是黄芩苷和绿原酸的含量增高明显,说明本发明所述的方法既能够保证清热解毒口服液的澄清度和稳定性,也能够提高清热解毒口服液中各成分的含量,同时通过对多个成分的指标进行控制,使清热解毒口服液的品质得到保证。
Description
技术领域
本发明涉及中药制剂技术领域,特别涉及一种清热解毒口服液及其制备工艺。
背景技术
清热解毒口服液是由生石膏、金银花、玄参、生地黄、连翘、栀、甜地丁、黄芩、龙胆、板蓝根、知母、麦冬制备而成,具有清热解毒的功效,主要用于治疗流感,上呼吸道感染及各种发热疾病。
口服液是在汤剂、注射剂基础上发展起来的新剂型。口服液具有服用剂量小,质量稳定、吸收较快,服用方便等优点,适合工业化生产。口服液原料药的药材品种众多,成分来源复杂,其提取液可能含有较多的杂质或混合物。传统方法采用水提醇沉对中药制剂进行精制,但该方法在工业生产中消耗的醇量大,成本较高,生产周期长,同时醇沉后提取液中成分的损失严重。吸附澄清法是在中药提取液或提取浓缩液中加入一种吸附澄清剂,通过吸附的方式除去溶液中的粗颗粒,达到精制和提高制剂澄明度目的的一项高新技术。吸附澄清剂能有效减少成分的损失,提高澄清的效率,同时其操作简单,成本低,安全无毒。目前常用的天然澄清剂有甲壳素类、ZTC1+1系列、101果汁澄清剂等。
现有技术中清热解毒口服液的制备工艺多采用简单的水提醇沉,其提取物含杂质多,提取效率低,提取物中有效成分的含量偏低,因此制备工艺有待进一步改善。为解决这一问题,本发明通过改进制备工艺中的条件,用澄清剂代替传统方法中的醇沉过程,使得提取物的杂质含量降低,有效成分含量得到提高,并且通过不同的有效成分的含量来控制清热解毒口服液的质量,提升临床药效。
发明内容
本发明的目的在于提供一种清热解毒口服液的生产制备工艺,本发明还提供了上述工艺制备所得到提取物。
本发明提供了清热解毒口服液的生产制备工艺,所述的清热解毒口服液包含以下成分按重量份计:石膏670份、金银花134份、玄参107份、地黄80份、连翘67份、栀子67份、甜地丁67份、黄芩67份、龙胆67份、板蓝根67份、知母54份、麦冬54份;
所述的清热解毒口服液的生产制备工艺的具体步骤如下:
a.按照上述配方称取净药材,将药材投入提取罐内,加水进行煎煮两次,收集滤液并合并,送贮液罐贮备待浓缩;
b.将药液用负压吸入蒸发器内加热进行浓缩,浓缩至药材质量与煎煮后药液体积的比为1:1~1:1.5,浓缩后加入澄清剂,搅拌25~40分钟,静置4~8小时,过滤,收集滤液,将滤液进行浓缩;
c.将适量的纯化水加入至浓配罐中煮沸,将浓缩后的滤液加入至浓配罐中,充分搅拌后,再加入辅料,煮沸30分钟,开启冷却水使药液冷却至70℃以下开始粗滤,将冷却后的药液进行过滤至稀配灌,将稀配灌中的药液充分搅拌,再依次加入甜菊素和苯甲酸钠充分溶解,定容调节药液pH,搅拌后经检验合格,即得提取物;
进一步,所述步骤a中两次煎煮方法为加入提取药材重量的4~5倍量饮用水加热至40℃~55℃保温1小时,第一次煎煮,待沸腾后,加金银花和黄芩,煎煮1小时,120目过滤,收集滤液;第二次加药材重量的3~4倍量饮用水煎煮30~40分钟,120目过滤,收集滤液;
进一步,所述步骤b中加热浓缩条件为:真空度控制在一效-0.02~0.04MPa、二效-0.06~0.08MPa;温度控制在一效80~90℃、二效60~75℃,蒸汽压力0.05~0.07MPa;
进一步,所述步骤b中加入的澄清剂选自1%ZTC1+1澄清剂、壳聚糖、101果汁澄清剂,澄清剂的用量为药液体积的1%-4%;
进一步,所述步骤b中加入的澄清剂为1%ZTC1+1,其中A组分用量为药液体积的2%,B组分用量为药液体积的4%;
进一步,所述步骤b中收集的滤液经过浓缩在80℃测时相对密度为1.10~1.22,其中每毫升滤液含黄芩苷≥5mg;
进一步,所述步骤c中加入的辅料为活性炭5份、甜菊素10~15份、苯甲酸钠3~8份;
进一步,所述步骤c中用氢氧化钠调节药液的PH值,使药液的PH值为5.4~6.0。
本发明还提供了上述制备工艺所得到的提取物,所述的提取物中如下成分的含量分别为:黄芩苷4%~6%、绿原酸1.8~2.8%、木樨草苷0.08~0.15%、毛蕊花糖苷0.02~0.06%、连翘苷0.17~0.24%、哈巴苷和哈巴俄苷的总量0.45~0.60%。
本发明通过改进清热解毒口服液制备工艺的条件,用澄清剂代替传统方法中的醇沉过程,使得药物的利用率增高,所获得的提取物中黄芩苷、绿原酸、木樨草苷、毛蕊花糖苷、连翘苷等成分的含量提高,特别是黄芩苷和绿原酸的含量增高明显,同时通过对清热解毒口服液中的多个成分的指标进行控制,使清热解毒口服液的质量和品质得到保证。
具体实施方式
以下通过具体的实施方式对本发明所述的内容进行更加详细的说明。本发明所述的实施例不代表将发明的范围限定于实施例,本发明所保护的范围以权利要求书记载的范围为准。
实施例1
称取石膏871g、金银花174.2g、玄参139.1g、地黄104g、连翘87.1g、栀子87.1g、甜地丁87.1g、黄芩87.1g、龙胆87.1g、板蓝根87.1g、知母70.2g、麦冬70.2g;
a.按照上述配方称取净药材,将药材投入提取罐内,加水进行煎煮两次,加入提取药材重量的4~5倍量饮用水加热至40℃~55℃保温1小时,第一次煎煮,待沸腾后,加金银花和黄芩,煎煮1小时,120目过滤,收集滤液;第二次加药材重量的3~4倍量饮用水煎煮30~40分钟,120目过滤,收集滤液,送贮液罐贮备待浓缩;
b.将药液用负压吸入蒸发器内加热进行浓缩,浓缩条件为:真空度控制在一效-0.02~0.04MPa、二效-0.06~0.08MPa;温度控制在一效80~90℃、二效60~75℃,蒸汽压力0.05~0.07MPa,浓缩至药材质量与煎煮后药液体积的比为1:1.5;浓缩后加入1%ZTC 1+1(先加1%浓度的组分B,用量为药液体积的4%,搅拌30分钟,再加入1%浓度的组分A,用量为药液体积的2%,搅拌30分钟),静置4~8小时,过滤,收集滤液,将滤液进行浓缩,经过浓缩后在80℃测时相对密度为1.10~1.22,其中每毫升滤液含黄芩苷≥5mg;
c.将适量的纯化水加入至浓配罐中煮沸,将清热解毒口服液浸膏加入至浓配罐中,充分搅拌后,再加入辅料活性炭6.5g,煮沸30分钟,开启冷却水使药液冷却至70℃以下开始粗滤,将冷却后的药液进行过滤至稀配灌,将稀配灌中的药液充分搅拌,再依次加入甜菊素16.9g、苯甲酸钠6.5g充分溶解,定容用氢氧化钠调节药液的PH值,使药液的PH值为5.4~6.0,即得提取物。
实施例2
称取石膏871g、金银花174.2g、玄参139.1g、地黄104g、连翘87.1g、栀子87.1g、甜地丁87.1g、黄芩87.1g、龙胆87.1g、板蓝根87.1g、知母70.2g、麦冬70.2g;
a.按照上述配方称取净药材,将药材投入提取罐内,加水进行煎煮两次,加入提取药材重量的4~5倍量饮用水加热至40℃~55℃保温1小时,第一次煎煮,待沸腾后,加金银花和黄芩,煎煮1小时,120目过滤,收集滤液;第二次加药材重量的3~4倍量饮用水煎煮30~40分钟,120目过滤,收集滤液,送贮液罐贮备待浓缩;
b.将药液用负压吸入蒸发器内加热进行浓缩,浓缩条件为:真空度控制在一效-0.02~0.04MPa、二效-0.06~0.08MPa;温度控制在一效80~90℃、二效60~75℃,蒸汽压力0.05~0.07MPa,浓缩至药材质量与煎煮后药液体积的比为1:1.5;浓缩后加入1%ZTC1+1(先加1%浓度的组分B,用量为药液体积的2%,搅拌30分钟,再加入1%浓度的组分A,用量为药液体积的1%,搅拌30分钟),静置4~8小时,过滤,收集滤液,将滤液进行浓缩,经过浓缩后在80℃测时相对密度为1.10~1.22,其中每毫升滤液含黄芩苷≥5mg;
c.将适量的纯化水加入至浓配罐中煮沸,将清热解毒口服液浸膏加入至浓配罐中,充分搅拌后,再加入辅料活性炭6.5g,煮沸30分钟,开启冷却水使药液冷却至70℃以下开始粗滤,将冷却后的药液进行过滤至稀配灌,将稀配灌中的药液充分搅拌,再依次加入甜菊素16.9g、苯甲酸钠6.5g充分溶解,定容用氢氧化钠调节药液的PH值,使药液的PH值为5.4~6.0,即得提取物。
实施例3
称取石膏871g、金银花174.2g、玄参139.1g、地黄104g、连翘87.1g、栀子87.1g、甜地丁87.1g、黄芩87.1g、龙胆87.1g、板蓝根87.1g、知母70.2g、麦冬70.2g;
a.按照上述配方称取净药材,将药材投入提取罐内,加水进行煎煮两次,加入提取药材重量的4~5倍量饮用水加热至40℃~55℃保温1小时,第一次煎煮,待沸腾后,加金银花和黄芩,煎煮1小时,120目过滤,收集滤液;第二次加药材重量的3~4倍量饮用水煎煮30~40分钟,120目过滤,收集滤液,送贮液罐贮备待浓缩;
b.将药液用负压吸入蒸发器内加热进行浓缩,浓缩条件为:真空度控制在一效-0.02~0.04MPa、二效-0.06~0.08MPa;温度控制在一效80~90℃、二效60~75℃,蒸汽压力0.05~0.07MPa,浓缩至药材质量与煎煮后药液体积的比为1:1.5;浓缩后加入1%ZTC1+1(先加1%浓度的组分B,用量为药液体积的6%,搅拌30分钟,再加入1%浓度的组分A,用量为药液体积的3%,搅拌30分钟),静置4~8小时,过滤,收集滤液,将滤液进行浓缩,经过浓缩后在80℃测时相对密度为1.10~1.22,其中每毫升滤液含黄芩苷≥5mg;
c.将适量的纯化水加入至浓配罐中煮沸,将清热解毒口服液浸膏加入至浓配罐中,充分搅拌后,再加入辅料活性炭6.5g,煮沸30分钟,开启冷却水使药液冷却至70℃以下开始粗滤,将冷却后的药液进行过滤至稀配灌,将稀配灌中的药液充分搅拌,再依次加入甜菊素16.9g、苯甲酸钠6.5g充分溶解,定容用氢氧化钠调节药液的PH值,使药液的PH值为5.4~6.0,即得提取物。
实施例4
称取石膏871g、金银花174.2g、玄参139.1g、地黄104g、连翘87.1g、栀子87.1g、甜地丁87.1g、黄芩87.1g、龙胆87.1g、板蓝根87.1g、知母70.2g、麦冬70.2g;
a.按照上述配方称取净药材,将药材投入提取罐内,加水进行煎煮两次,加入提取药材重量的4~5倍量饮用水加热至40℃~55℃保温1小时,第一次煎煮,待沸腾后,加金银花和黄芩,煎煮1小时,120目过滤,收集滤液;第二次加药材重量的3~4倍量饮用水煎煮30~40分钟,120目过滤,收集滤液,送贮液罐贮备待浓缩;
b.将药液用负压吸入蒸发器内加热进行浓缩,浓缩条件为:真空度控制在一效-0.02~0.04MPa、二效-0.06~0.08MPa,浓缩至药材质量与煎煮后药液体积的比为1:1.5;温度控制在一效80~90℃、二效60~75℃,蒸汽压力0.05~0.07MPa;浓缩后加入1%壳聚糖,用量为药液体积的2%,搅拌30分钟,静置4~8小时,过滤,收集滤液,将滤液进行浓缩,经过浓缩后在80℃测时相对密度为1.10~1.22,其中每毫升滤液含黄芩苷≥5mg;
c.将适量的纯化水加入至浓配罐中煮沸,将清热解毒口服液浸膏加入至浓配罐中,充分搅拌后,再加入辅料活性炭6.5g,煮沸30分钟,开启冷却水使药液冷却至70℃以下开始粗滤,将冷却后的药液进行过滤至稀配灌,将稀配灌中的药液充分搅拌,再依次加入甜菊素16.9g、苯甲酸钠6.5g充分溶解,定容用氢氧化钠调节药液的PH值,使药液的PH值为5.4~6.0,即得提取物。
实施例5
称取石膏871g、金银花174.2g、玄参139.1g、地黄104g、连翘87.1g、栀子87.1g、甜地丁87.1g、黄芩87.1g、龙胆87.1g、板蓝根87.1g、知母70.2g、麦冬70.2g;
a.按照上述配方称取净药材,将药材投入提取罐内,加水进行煎煮两次,加入提取药材重量的4~5倍量饮用水加热至40℃~55℃保温1小时,第一次煎煮,待沸腾后,加金银花和黄芩,煎煮1小时,120目过滤,收集滤液;第二次加药材重量的3~4倍量饮用水煎煮30~40分钟,120目过滤,收集滤液,送贮液罐贮备待浓缩;
b.将药液用负压吸入蒸发器内加热进行浓缩,浓缩条件为:真空度控制在一效-0.02~0.04MPa、二效-0.06~0.08MPa,浓缩至药材质量与煎煮后药液体积的比为1:1.5;温度控制在一效80~90℃、二效60~75℃,蒸汽压力0.05~0.07MPa;浓缩后加入1%101果汁澄清剂,用量为药液体积的2%,搅拌30分钟,静置4~8小时,过滤,收集滤液,将滤液进行浓缩,经过浓缩后在80℃测时相对密度为1.10~1.22,其中每毫升滤液含黄芩苷≥5mg;
c.将适量的纯化水加入至浓配罐中煮沸,将清热解毒口服液浸膏加入至浓配罐中,充分搅拌后,再加入辅料活性炭6.5g,煮沸30分钟,开启冷却水使药液冷却至70℃以下开始粗滤,将冷却后的药液进行过滤至稀配灌,将稀配灌中的药液充分搅拌,再依次加入甜菊素16.9g、苯甲酸钠6.5g充分溶解,定容用氢氧化钠调节药液的PH值,使药液的PH值为5.4~6.0,即得提取物。
取实施例1~实施例5所得提取物加入澄清剂搅拌均匀后,通过观察并记录其澄清的速度,其结果见表1;
取实施例1~实施例5所得提取物观察其澄明度,其结果见表2;
取实施例1~实施例5所得提取物进行稳定性观察,其结果见表3;
取实施例1~实施例5所得提取物中的黄芩苷、绿原酸、木樨草苷、毛蕊花糖苷、连翘苷以及哈巴苷和哈巴俄苷的总量的含量,分别按照《中国药典》2015年版收载的药材黄芩、金银花、地黄、连翘、玄参项目的含量测定方法进行测定,测定结果见表4。
表1各样品中澄清剂的澄清速度
样品 | 实施例1 | 实施例2 | 实施例3 | 实施例4 | 实施例5 |
澄清所用时间(h) | 5.2 | 5.5 | 5.8 | 6.8 | 7.3 |
表2各样品的澄明度观察结果
样品 | 实施例1 | 实施例2 | 实施例3 | 实施例4 | 实施例5 |
溶液情况 | 澄清 | 澄清 | 澄清 | 少量颗粒状沉淀 | 少量颗粒状沉淀 |
沉降情况 | 沉淀完全 | 沉淀完全 | 沉淀完全 | 沉淀不完全 | 沉淀不完全 |
表3各样品的稳定性观察结果
表4各样品中成分含量测定结果
由表1~表4的结果,可见实施例1所选用的澄清剂及其用量比例最佳,其澄清所用时间短,澄清效果以及稳定性较好;实施例1所得提取物的各成分的含量较实施例2~实施例5所得提取的成分含量高,因此本发明所述的制备工艺中所使用的澄清剂为1%ZTC1+1澄清剂,用量为药液体积的2%所获得的提取物的质量较好。
对比实施例
对比实施例1
称取石膏670g、金银花134g、玄参107g、地黄80g、连翘67g、栀子67g、甜地丁67g、黄芩67g、龙胆67g、板蓝根67g、知母54g、麦冬54g;
(1)称取金银花134g,用70%的乙醇1200ml进行回流提取两次,每次提取1小时,过滤,滤液回收乙醇至相对密度1.30,余下的药渣及提取液备用;
(2)取石膏、玄参、生地黄、连翘、栀子、甜地丁、龙胆、板蓝根、知母、麦冬加温水浸泡1小时,加热至沸腾后加入金银花回流提取后的药渣和黄芩煎煮两次,第一次煎煮1小时,第二次煎煮40分钟,过滤,收集并合并滤液,加热浓缩至相对密度为1.25,加入5g活性炭,加热30分钟;
(3)加0.3g苯甲酸钠于煎液中,搅拌使其溶解,再加入300ml单糖浆,加热煮沸后过滤,放冷,再加入金银花回流提取液,搅拌使其溶解,加水至1000ml,混匀,即得提取物。
对比实施例2
称取石膏670g、金银花134g、玄参107g、地黄80g、连翘67g、栀子67g、甜地丁67g、黄芩67g、龙胆67g、板蓝根67g、知母54g、麦冬54g;
以上十二味,除了金银花、黄芩我,其余石膏等药材先加水温浸1小时,煎煮(待煮沸后,再加入金银花和黄芩)二次,第一次1小时,第二次40分钟,滤过,合并滤液,滤液浓缩至相对密度约1.17(80℃),加入乙醇使含醇量达65%~70%,冷藏48小时,滤过,滤液回收乙醇,加矫味剂适量,加入活性炭5g,加热30分钟,滤过,加水至1000ml,滤过,灌封,灭菌,即得。
按照《中国药典》2015年版收载的药材黄芩、金银花、地黄、连翘、玄参项目的含量测定方法,分别测定对比实施例1和对比实施例2所得提取物中的黄芩苷、绿原酸、木樨草苷、毛蕊花糖苷、连翘苷以及哈巴苷和哈巴俄苷的总量的含量,结果见表5。
表5各对比实施例中成分含量测定结果
由表4和表5的测定结果,可见实施例1~实施例5所得提取物各成分的含量与对比实施例1、对比实施例2相比较有所提高,特别是黄芩苷和绿原酸的含量增高明显;本发明所述的优选方法所得到的提取物中黄芩苷和绿原酸的含量分别为5.8%、2.8%,与对比实施例所得到的提取物相比较,黄芩苷提高了44.83%~48.28%,绿原酸提高了39.28%~46.43%,说明本发明所述的方法能够提高清热解毒口服液中各成分的含量,同时控制多个成分的含量指标,确保清热解毒口服液的质量。
本发明的有益效果
本发明通过改进清热解毒口服液制备工艺的条件,用澄清剂代替传统方法中的醇沉过程,所使用的澄清剂为1%ZTC1+1澄清剂,用量为药液体积的2%,通过本发明所述的方法使得各原料药材的利用率增高,所获得的提取物中黄芩苷、绿原酸、木樨草苷、毛蕊花糖苷、连翘苷等成分的含量有所提高,特别是黄芩苷和绿原酸的含量增高明显,本发明所述的优选方法所得到的提取物中黄芩苷和绿原酸的含量分别为5.8%、2.8%,与对比实施例相比,黄芩苷提高了44.83%~48.28%,绿原酸提高了39.28%~46.43%,说明本发明所述的方法既能够保证清热解毒口服液的澄清度和稳定性,也能够提高清热解毒口服液中各成分的含量,同时通过对多个成分的指标进行控制,使清热解毒口服液的品质得到保证。
Claims (9)
1.清热解毒口服液及其制备工艺,其特征在于,所述的清热解毒口服液包含以下成分按重量份计:石膏670份、金银花134份、玄参107份、地黄80份、连翘67份、栀子67份、甜地丁67份、黄芩67份、龙胆67份、板蓝根67份、知母54份、麦冬54份;
所述的清热解毒口服液是通过如下步骤实现的:
a.按照上述配方称取净药材,将药材投入提取罐内,加水进行煎煮两次,收集滤液并合并,送贮液罐贮备待浓缩;
b.将药液用负压吸入蒸发器内加热进行浓缩,浓缩至药材质量与煎煮后药液体积的比为1:1~1:1.5,浓缩后加入澄清剂,搅拌25~40分钟,静置4~8小时,过滤,收集滤液;
c.将适量的纯化水加入至浓配罐中煮沸,将浓缩后的滤液加入至浓配罐中,充分搅拌后,再加入辅料,煮沸30分钟,开启冷却水使药液冷却至70℃以下开始粗滤,将冷却后的药液进行过滤至稀配灌,将稀配灌中的药液充分搅拌,再依次加入甜菊素和苯甲酸钠充分溶解,定容调节药液pH,搅拌后经检验合格,即得提取物。
2.根据权利要求1所述的清热解毒口服液及其制备工艺,其特征在于,所述步骤a中,加入提取药材重量的4~5倍量饮用水加热至40℃~55℃保温1小时,第一次煎煮,待沸腾后,加金银花和黄芩,煎煮1小时,120目过滤,收集滤液;第二次加药材重量的3~4倍量饮用水煎煮30~40分钟,120目过滤,收集滤液。
3.根据权利要求1所述的清热解毒口服液及其制备工艺,其特征在于,所述步骤b中加热浓缩条件为:真空度控制在一效-0.02~0.04MPa、二效-0.06~0.08MPa;温度控制在一效80~90℃、二效60~75℃,蒸汽压力0.05~0.07MPa。
4.根据权利要求1所述的清热解毒口服液及其制备工艺,其特征在于,所述步骤b中加入的澄清剂选自1%ZTC1+1澄清剂、壳聚糖、101果汁澄清剂,澄清剂的用量为药液体积的1%-4%。
5.根据权利要求1所述的清热解毒口服液及其制备工艺,其特征在于,所述步骤b中加入的澄清剂为1%ZTC1+1,其中A组分用量为药液体积的2%,B组分用量为药液体积的4%。
6.根据权利要求1所述的清热解毒口服液及其制备工艺,其特征在于,所述步骤b中收集的滤液经过浓缩后在80℃测时相对密度为1.10~1.22,其中每毫升滤液含黄芩苷≥5mg。
7.根据权利要求1所述的清热解毒口服液及其制备工艺,其特征在于,所述步骤c中加入的辅料为活性炭5份、甜菊素10~15份、苯甲酸钠3~8份。
8.根据权利要求1所述的清热解毒口服液及其制备工艺,其特征在于,所述步骤c中用氢氧化钠调节药液的PH值,使药液的PH值为5.4~6.0。
9.根据权利要求1~8任意一项所述的提取物,其特征在于,所述的提取物中如下成分的含量分别为:黄芩苷4%~6%、绿原酸1.8~2.8%、木樨草苷0.08~0.15%、毛蕊花糖苷0.02~0.06%、连翘苷0.17~0.24%、哈巴苷和哈巴俄苷的总量0.45~0.60%。
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