CN111035725B - 一种鱼用抗应激中药速溶粉及其制备方法 - Google Patents
一种鱼用抗应激中药速溶粉及其制备方法 Download PDFInfo
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- CN111035725B CN111035725B CN202010012344.XA CN202010012344A CN111035725B CN 111035725 B CN111035725 B CN 111035725B CN 202010012344 A CN202010012344 A CN 202010012344A CN 111035725 B CN111035725 B CN 111035725B
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- polyvinylpyrrolidone
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Abstract
本发明公开了一种对鱼类具有抗应激及镇静作用的中药速溶粉的组成及其制备方法。该中药速溶粉由芫花、山奈、丁香、没药、阿魏等中药组成,其制备包括称取粉碎、挥发油提取、药渣水提、称取辅料、制备酸源颗粒、制备碱源主药颗粒、制备速溶粉等工艺,具体为研磨后置挥发油提取器中,用水连续提取得淡黄色挥发油;药渣用超声萃取仪提取,所得提取液喷雾干燥制得药物粉末;将挥发油、药物粉末混合,加入辅料适量混匀,即为中药速溶粉。该中药速溶粉可以减少鱼体应激挣扎带来的危害,提高鱼类离水保活时间和存活率,具有镇静效果好、不残留、安全范围大、价格低廉的优点,在鱼用抗应激镇静剂的使用上具有重要的意义。
Description
技术领域
本发明涉及抗应激药,尤其涉及一种对鱼类具有抗应激及镇静作用的中药速溶粉及其制备方法。
背景技术
在鱼类的长途运输中,鱼类的应激或过度挣扎常常引起鱼类生病或死亡,从而造成很大的经济损失。应用具有抗应激及镇静作用的药物可以减少鱼体应激挣扎带来的危害,同时还能提高鱼类离水保活时间和存活率。
鱼用抗应激剂是一类可以降低鱼体内新陈代谢活动的药物。抗应激剂作用于鱼体后,首先抑制鱼脑的皮质进入触觉丧失期,再作用于基底神经节与小脑进入兴奋期,最后作用于脊髓进入麻醉期。合理使用抗应激剂能使鱼安静,降低鱼在运输条件下的应激反应,同时降低鱼的新陈代谢,从而提高其存活率。因此,抗应激药物在鱼用养殖中的应用广泛。
在现有的鱼用抗应激镇静药物中,化学类药物占主导。目前化学类鱼用抗应激镇静药物主要包括乙醚、MS-222、苯巴比妥、盐酸普鲁卡因和丁香酚等30种,但这些药物均存在以下不足:(1)对有些鱼类镇静效果不理想;(2)药物在鱼体内残留量大;(3)安全性能低;(4)休药期时间长;(5)价格昂贵等,同时这些化学类药物也会对水体以及生态环境造成一定的污染和危害。将鱼体进行冷冻或补充二氧化碳气体等无毒非化学镇静方法,价格高昂还可能对鱼体造成不可逆的损伤,很难被市场接受。因此,研发一种镇静效果好、不残留、安全范围大、价格低廉的鱼用抗应激镇静剂具有重要的生产意义。
发明内容
为了解决上述技术问题,本发明提供一种具有镇静效果好、药物残留少、安全范围大、价格低等优点的鱼用抗应激中药速溶粉及其制备方法。
为了实现本发明的目的,本发明提供了第一种技术方案:
一种鱼用抗应激中药速溶粉及其制备方法,以质量份计,该速溶粉由以下中药组成:芫花4~7份、山奈3~7份、丁香3~5份、没药3~5份、阿魏3~5份。
上述技术方案优选的,该中药速溶粉的中药组成中还包括以下一种或两种及以上的组分:艾叶3~5份、白芨2~4份、桂皮3~5份、冰片2~3份、小茴香2~3份、排草2~3份、香叶2~3份。
为了实现本发明的目的,本发明提供了第二种技术方案:
一种鱼用抗应激中药速溶粉及其制备方法,其制备方法包括以下步骤:
S1、称取粉碎;称取各组分的中药,若组分中不含有冰片,将中药各组分分别粉碎成粒径为10目~20目的粗粉,混合均匀得到混合中药粗粉;
若组分中含有冰片,将除冰片以外的其他中药分别粉碎成粒径为10目~20目的粗粉,混合均匀得到混合中药粗粉;冰片单独粉碎成粒径为10目~20目的冰片粗粉;
S2、挥发油提取;将上述混合中药粗粉置于挥发油提取器中,加入与混合中药粗粉总质量比为1:8~1:10的水,控制加热蒸气压力为0.13±0.02MPa,保证提取器内相对剧烈沸腾,保证油水分离器中的温度为85±5℃,提取时间为10~20h,制得中药挥发油并收集药渣;
S3、药渣水提;称取上述药渣总质量8~10倍量的水,将水作为溶剂,将上述药渣用超声萃取仪在1500~2000Hz、35~50℃条件下萃取15~30min,得到提取液,将所得提取液通过喷雾干燥制备成药物粉末备用;
S4、称取辅料;按质量比为1:1:2的比例,称取酒石酸、碳酸氢钠、乳糖,其中酒石酸与中药各组分总质量的比为2:1~5:1,将酒石酸、碳酸氢钠、乳糖分别粉碎后干燥至恒重,备用;
S5、制备酸源颗粒;称取1~3质量份的聚乙烯吡咯烷酮即PVP,将PVP与无水乙醇混合,制成5wt%PVP乙醇溶液;取干燥后的酒石酸,加入1~2倍的5wt%PVP乙醇溶液制粒,于45℃~65℃下干燥,制得酸源颗粒;
S6、制备碱源主药颗粒;将步骤S2制得的中药挥发油、步骤S3喷雾干燥制得的药物粉末、步骤S4干燥后的碳酸氢钠和乳糖充分混合均匀;
或者,将步骤S1制得的冰片粗粉、步骤S2制得的中药挥发油、步骤S3喷雾干燥制得的药物粉末、步骤S4干燥后的碳酸氢钠和乳糖充分混合均匀;
称取上述混合物总质量1~2倍质量份的5wt%PVP乙醇溶液,加入到混合物中制粒,于45℃~65℃下干燥,制得碱源主药颗粒;
S7、制备速溶粉;将制得的酸源颗粒或者酸源包衣颗粒与步骤S6制得的碱源主药颗粒均匀混合,粉碎,即得鱼用中药抗应激速溶粉。
上述技术方案优选的,所述酸源包衣颗粒的制备包括以下步骤:称取1~3质量份的聚乙二醇6000即PEG6000,加入纯水,制成5wt%PEG6000包衣剂;将步骤S5制备的酸源颗粒用5wt%PEG6000包衣,于45℃~60℃下干燥,制得酸源包衣颗粒。
上述技术方案优选的,在步骤S7之后增加了制片工艺,具体包括以下步骤:将制备的鱼用中药抗应激速溶粉放入压片机中压制成片,制得鱼用抗应激中药速溶片。
上述技术方案优选的,所述鱼用抗应激中药速溶片每片的质量为0.2~0.5g。
本发明相比现有技术的有益效果在于:
1)本发明基于各中药组分特殊的药用机理,在大量中药中将12种中药挑选出来进行组合,并设计特定的组合比例,使得芫花中的芫花素、丁香中的丁香酚、桂皮中的桂皮醇、没药中的木罗烯、阿魏中的阿魏酸、冰片中的右旋龙脑、排草中的灵香草精油等活性成分相互协同,发挥麻醉、消炎、镇静之作用;山奈中的山奈素、白芨中的白芨多糖、艾叶挥发油、小茴香挥发油、香叶中的香叶醇等中药成分含有特殊香味,对鱼类具有较强的吸引作用,同时可以抑菌消炎、保护黏膜、调节机体代谢,有助于提升鱼体在长时间镇静或麻醉过程中的存活率。
2)本发明在综合考虑各中药有效组分的基础上,设计速溶粉剂的制备方法,最大限度的保留了中药组分中的有效成分,并将各有效成分进行浓缩;加工过程中的辅料有助于增加药物有效成分在水体中溶解速率、扩散速度以及鱼体对药物的吸收效果。
3)药速溶粉效果明显。0.2g/L~0.3g/L浓度药剂对草鱼具有稳定的镇静作用,适用于鱼的长途运输、更换饲养环境等引起的应激反应,有效减少鱼应激造成的伤害。
4)该中药速溶粉安全范围高。最低致死量为最低有效剂量的10倍,半数致死浓度为6.8g/L,根据药物急性毒性判定标准应当判定为实际无毒(5001mg/L~10000mg/L),安全麻醉浓度范围内持续麻醉24h存活率为100%。
5)该中药速溶粉发挥作用快。添加速溶粉5min左右即可使鱼达到有效安静状态。实际使用时可根据水温、水体pH、水体含氧量、鱼种类等不同影响因素而适量加减用药量,均可达到良好镇静效果。
6)该中药速溶粉成本低廉。相比目前市场流行的MS-222(渔夫宝)、丁香油水门汀等化学镇静药物成本价要低30%左右。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白,以下结合实施例,对本发明进行进一步详细说明,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。
实施例1
1、药物组成:芫花7份、山奈7份、丁香5份、没药5份、阿魏5份。
2、制备方法
S1、粉碎;按照以上质量份分别称取各组分中药:芫花7份、山奈7份、丁香5份、没药5份、阿魏5份,分别粉碎成粒径为10目的粗粉,混合均匀;
S2、挥发油提取;将上述混合中药粗粉置于挥发油提取器中,加入与混合中药粗粉总质量比为10的水,控制加热蒸气压力为0.13MPa,保证提取器内相对剧烈沸腾,保证油水分离器中的温度为85℃,提取时间为20h,制得中药挥发油并收集药渣;
S3、药渣水提;称取上述药渣总质量10倍量的水,将水作为溶剂,将上述药渣用超声萃取仪在1500Hz、50℃条件下萃取30min,得到提取液,将所得提取液通过喷雾干燥制备成药物粉末备用;
S4、称取辅料;按质量比为1:1:2的比例,称取酒石酸、碳酸氢钠、乳糖,其中酒石酸与中药各组分总质量的比为2︰1,将酒石酸、碳酸氢钠、乳糖分别粉碎后干燥至恒重,备用;
S5、制备酸源颗粒;称取2质量份的聚乙烯吡咯烷酮即PVP,将PVP与无水乙醇混合,制成5wt%PVP乙醇溶液;取干燥后的酒石酸,加入1.5倍的5wt%PVP乙醇溶液制粒,于45℃下干燥,制得酸源颗粒;
S6、制备碱源主药颗粒;将步骤S2制得的中药挥发油、步骤S3喷雾干燥制得的药物粉末、步骤S4干燥后的碳酸氢钠和乳糖充分混合均匀,称取上述混合物总质量1倍质量份的5wt%PVP乙醇溶液,加入到混合物中制粒,于45℃下干燥,制得碱源主药颗粒;
S7、制备速溶粉;将步骤S6制得的酸源颗粒与步骤S7制得的碱源主药颗粒均匀混合,粉碎,即得鱼用中药抗应激速溶粉1。
实施例2
1、药物组成:芫花4份、山奈3份、丁香3份、没药3份、阿魏3份、艾叶3份、白芨2份、冰片2份。
2、制备方法
S1、粉碎;按照以下质量份分别称取各组分中药:芫花4份、山奈3份、丁香3份、没药3份、阿魏3份、艾叶3份、白芨2份、冰片2份,将除冰片以外的其他中药分别粉碎成粒径为10目的粗粉后混匀,将冰片单独粉碎成粒径为10目的冰片粗粉;
S2、挥发油提取;将上述混合中药粗粉置于挥发油提取器中,加入与混合中药粗粉总质量比为1:8的水,控制加热蒸气压力为0.13MPa,保证提取器内相对剧烈沸腾,保证油水分离器中的温度为85℃,提取时间为10h,制得中药挥发油并收集药渣;
S3、药渣水提;称取上述药渣总质量8倍量的水,将水作为溶剂,将上述药渣用超声萃取仪在2000Hz、35℃条件下萃取15min,得到提取液,将所得提取液通过喷雾干燥制备成药物粉末备用;
S4、称取辅料;按质量比为1:1:2的比例,称取酒石酸、碳酸氢钠、乳糖,其中酒石酸与中药各组分总质量的比为2︰1,将酒石酸、碳酸氢钠、乳糖分别粉碎后干燥至恒重,备用;
S5、制备酸源颗粒;称取3质量份的聚乙烯吡咯烷酮即PVP,将PVP与无水乙醇混合,制成5wt%PVP乙醇溶液;取干燥后的酒石酸,加入2倍的5wt%PVP乙醇溶液制粒,于65℃下干燥,制得酸源颗粒;
S6、制备酸源包衣颗粒;称取2质量份的聚乙二醇6000即PEG6000,加入纯水,制成5wt%PEG6000包衣剂;将步骤S5制备的酸源颗粒用5wt%PEG6000包衣,于65℃下干燥,得酸源包衣颗粒;
S7、制备碱源主药颗粒;将步骤S1制得的冰片粗粉、步骤S2制得的中药挥发油、步骤S3喷雾干燥制得的药物粉末、步骤S4干燥后的碳酸氢钠和乳糖充分混合均匀,称取上述混合物总质量2倍质量份的5wt%PVP乙醇溶液,加入到混合物中制粒,于60℃下干燥,制得碱源主药颗粒;
S8、制备速溶粉;将步骤S6制得的酸源包衣颗粒与步骤S7制得的碱源主药颗粒均匀混合,粉碎,即得鱼用中药抗应激速溶粉2。
实施例3
1、药物组成:芫花5份、山奈5份、丁香4份、没药4份、阿魏4份、艾叶3份、桂皮4份、冰片3份、排草3份。
2、制备方法
S1、粉碎;按照以下质量份分别称取各组分中药:芫花5份、山奈5份、丁香4份、没药4份、阿魏4份、艾叶3份、桂皮4份、冰片3份、排草3份,将除冰片以外的其他中药分别粉碎成粒径为20目的粗粉后混匀;将冰片单独粉碎成粒径为20目的冰片粗粉;
S2、挥发油提取;将上述混合中药粗粉置于挥发油提取器中,加入与混合中药粗粉总质量比为1:9的水,控制加热蒸气压力为0.15MPa,保证提取器内相对剧烈沸腾,保证油水分离器中的温度为88℃,提取时间为15h,制得中药挥发油并收集药渣;
S3、药渣水提;称取上述药渣总质量10倍量的水,将水作为溶剂,将上述药渣用超声萃取仪在1800Hz、45℃条件下萃取20min,得到提取液,将所得提取液通过喷雾干燥制备成药物粉末备用;
S4、称取辅料;按质量比为1:1:2的比例,称取酒石酸、碳酸氢钠、乳糖,其中酒石酸与中药各组分总质量的比为3︰1,将酒石酸、碳酸氢钠、乳糖分别粉碎后干燥至恒重,备用;
S5、制备酸源颗粒;称取3质量份的聚乙烯吡咯烷酮即PVP,将PVP与无水乙醇混合,制成5wt%PVP乙醇溶液;取干燥后的酒石酸,加入2倍的5wt%PVP乙醇溶液制粒,于50℃下干燥,制得酸源颗粒;
S6、制备酸源包衣颗粒;称取3质量份的聚乙二醇6000即PEG6000,加入纯水,制成5wt%PEG6000包衣剂;将步骤S5制备的酸源颗粒用5wt%PEG6000包衣,于50℃下干燥,得酸源包衣颗粒;
S7、制备碱源主药颗粒;将步骤S1制得的冰片粗粉、步骤S2制得的中药挥发油、步骤S3喷雾干燥制得的药物粉末、步骤S4干燥后的碳酸氢钠和乳糖充分混合均匀,称取上述混合物总质量2倍质量份的5wt%PVP乙醇溶液,加入到混合物中制粒,于50℃下干燥,制得碱源主药颗粒;
S8、制备速溶粉;将步骤S6制得的酸源包衣颗粒与步骤S7制得的碱源主药颗粒均匀混合,粉碎,即得鱼用中药抗应激速溶粉。
S9、制备速溶片;将步骤S8制备的鱼用中药抗应激速溶粉经过压片机压片,制得鱼用中药抗应激速溶片3。
实施例4
对不同浓度的药物对鱼的镇静效果和存活率进行研究,以及相同浓度的药物、不同的作用时间下对鱼的镇静效果和存活率进行研究,研究方法和结果如下。
研究对象:平均体长8~10cm的草鱼鱼苗,在水温26℃、水体pH 6.5、自然曝气24h以上的水体环境下适应性饲养7d。
供试品:上述3个实施例分别制备的鱼用抗应激速溶粉1、鱼用抗应激速溶粉2和鱼用抗应激速溶片3。
1、药物不同浓度对草鱼镇静效果研究。
取草鱼180尾,随机分成18组,每组10尾。用水溶解速溶粉1,分别得到浓度分别为0.1、0.15、0.2、0.25、0.3以及0.35g/L的药液;用水溶解速溶粉2,分别得到浓度分别为0.1、0.15、0.2、0.25、0.3以及0.35g/L的药液;用水溶解速溶片3,分别得到浓度分别为0.1、0.15、0.2、0.25、0.3以及0.35g/L的药液;将18组鱼分别放入上述药物浓度的水体中,记录鱼的行为特征,测定并记录其进入镇静状态的时间和放回清水中后的苏醒时间,结果如下:
由上表结果可以得出,0.2g/L~0.3g/L浓度药剂对草鱼具有较好的镇静作用,镇静诱导时间随药液浓度提升而减少,苏醒时间随药液浓度提升而增加。在药物的镇静作用下,草鱼长时间处于水池底部,游动量大大减少,打捞或者外部疼痛刺激反应迟钝,呼吸和鳃动正常,放入清水中不久即可苏醒恢复正常。
2、药物不同浸泡时间对草鱼存活率的影响研究。
取150尾草鱼,分成15组,每组10尾;用水溶解速溶粉1、速溶粉2和速溶片3,分别制得0.3g/L的药物水溶液;将15组鱼分别放入三种药物水溶液中浸泡3、6、12、24和48h,取出,置于清水中,记录各组鱼镇静后的苏醒时间及苏醒率,结果如下:
由上表结果可以得出,草鱼持续药剂浸泡48h内存活率为100%且无任何不良反应,镇静作用后的苏醒时间随药液浸泡时间的增加而增加。
3、安全性考察。对镇静试验结束后的草鱼进行连续96h的观察,发现鱼并未出现死亡以及其他不良反应,表明该中药抗应激速溶粉对鱼不仅有良好的镇静作用,而且对鱼体安全无毒。
以上内容仅仅是对本发明所做的举例和说明,本发明不受上述实施例的限制,该领域的技术人员根据上述发明的内容做出一些非本质性的调整和改进,都属于本专利的保护范围。
Claims (5)
1.一种鱼用抗应激中药速溶粉的制备方法,其特征在于,以质量份计,该速溶粉由以下中药组分组成:芫花4~7份、山奈3~7份、丁香3~5份、没药3~5份、阿魏3~5份,其制备方法包括以下步骤:
S1、称取粉碎:称取各组分的中药,将中药各组分分别粉碎成粒径为10目~20目的粗粉,混合均匀得到混合中药粗粉;
S2、挥发油提取:将上述混合中药粗粉置于挥发油提取器中,加入与混合中药粗粉总质量比为1:8~1:10的水,控制加热蒸气压力为0.13±0.02MPa,保证提取器内剧烈沸腾,保证油水分离器中的温度为85±5℃,提取时间为10~20h,制得中药挥发油并收集药渣;
S3、药渣水提:称取上述药渣总质量8~10倍量的水,将水作为溶剂,将上述药渣用超声萃取仪在1500~2000Hz、35~50℃条件下萃取15~30min,得到提取液,将所得提取液通过喷雾干燥制备成药物粉末备用;
S4、称取辅料:称取质量比为1:1:2的酒石酸、碳酸氢钠、乳糖,其中酒石酸与中药各组分总质量的比为2:1~5:1,将酒石酸、碳酸氢钠、乳糖分别粉碎后干燥至恒重,备用;
S5、制备酸源颗粒或酸源包衣颗粒:称取1~3质量份的聚乙烯吡咯烷酮,将聚乙烯吡咯烷酮与无水乙醇混合,制成聚乙烯吡咯烷酮浓度为5wt% 聚乙烯吡咯烷酮-乙醇溶液;取干燥后的酒石酸,加入1~2倍的5wt% 聚乙烯吡咯烷酮-乙醇溶液制粒,于45℃~65℃下干燥,制得酸源颗粒;
或者,称取1~3质量份的聚乙烯吡咯烷酮,将聚乙烯吡咯烷酮与无水乙醇混合,制成聚乙烯吡咯烷酮浓度为5wt% 聚乙烯吡咯烷酮-乙醇溶液;取干燥后的酒石酸,加入1~2倍的5wt% 聚乙烯吡咯烷酮-乙醇溶液制粒,于45℃~65℃下干燥,制得酸源颗粒;称取1~3质量份的聚乙二醇6000,加入纯水,制成5wt% 聚乙二醇6000包衣剂;将酸源颗粒用5wt% 聚乙二醇6000包衣剂包衣,于45℃~60℃下干燥,制得酸源包衣颗粒;
S6、制备碱源主药颗粒:将步骤S2制得的中药挥发油、步骤S3喷雾干燥制得的药物粉末、步骤S4干燥后的碳酸氢钠和乳糖充分混合均匀,得到混合物;
称取上述混合物总质量1~2倍质量份的5wt% 聚乙烯吡咯烷酮-乙醇溶液,加入到混合物中制粒,于45℃~65℃下干燥,制得碱源主药颗粒;
S7、制备速溶粉:将制得的酸源颗粒或者酸源包衣颗粒与步骤S6制得的碱源主药颗粒均匀混合,粉碎,即得鱼用中药抗应激速溶粉。
2.一种鱼用抗应激中药速溶粉的制备方法,其特征在于,以质量份计,该速溶粉由以下中药组分组成:芫花4份、山奈3份、丁香3份、没药3份、阿魏3份、艾叶3份、白芨2份、冰片2份,其制备方法包括以下步骤:
S1、称取粉碎:称取各组分的中药,将除冰片以外的其他中药分别粉碎成粒径为10目~20目的粗粉,混合均匀得到混合中药粗粉;冰片单独粉碎成粒径为10目~20目的冰片粗粉;
S2、挥发油提取:将上述混合中药粗粉置于挥发油提取器中,加入与混合中药粗粉总质量比为1:8~1:10的水,控制加热蒸气压力为0.13±0.02MPa,保证提取器内剧烈沸腾,保证油水分离器中的温度为85±5℃,提取时间为10~20h,制得中药挥发油并收集药渣;
S3、药渣水提:称取上述药渣总质量8~10倍量的水,将水作为溶剂,将上述药渣用超声萃取仪在1500~2000Hz、35~50℃条件下萃取15~30min,得到提取液,将所得提取液通过喷雾干燥制备成药物粉末备用;
S4、称取辅料:称取质量比为1:1:2的酒石酸、碳酸氢钠、乳糖,其中酒石酸与中药各组分总质量的比为2:1~5:1,将酒石酸、碳酸氢钠、乳糖分别粉碎后干燥至恒重,备用;
S5、制备酸源颗粒或酸源包衣颗粒:称取1~3质量份的聚乙烯吡咯烷酮,将聚乙烯吡咯烷酮与无水乙醇混合,制成聚乙烯吡咯烷酮浓度为5wt% 聚乙烯吡咯烷酮-乙醇溶液;取干燥后的酒石酸,加入1~2倍的5wt% 聚乙烯吡咯烷酮-乙醇溶液制粒,于45℃~65℃下干燥,制得酸源颗粒;
或者,称取1~3质量份的聚乙烯吡咯烷酮,将聚乙烯吡咯烷酮与无水乙醇混合,制成聚乙烯吡咯烷酮浓度为5wt% 聚乙烯吡咯烷酮-乙醇溶液;取干燥后的酒石酸,加入1~2倍的5wt% 聚乙烯吡咯烷酮-乙醇溶液制粒,于45℃~65℃下干燥,制得酸源颗粒;称取1~3质量份的聚乙二醇6000,加入纯水,制成5wt% 聚乙二醇6000包衣剂;将酸源颗粒用5wt% 聚乙二醇6000包衣剂包衣,于45℃~60℃下干燥,制得酸源包衣颗粒;
S6、制备碱源主药颗粒:将步骤S1制得的冰片粗粉、步骤S2制得的中药挥发油、步骤S3喷雾干燥制得的药物粉末、步骤S4干燥后的碳酸氢钠和乳糖充分混合均匀,得到混合物;
称取上述混合物总质量1~2倍质量份的5wt% 聚乙烯吡咯烷酮-乙醇溶液,加入到混合物中制粒,于45℃~65℃下干燥,制得碱源主药颗粒;
S7、制备速溶粉:将制得的酸源颗粒或者酸源包衣颗粒与步骤S6制得的碱源主药颗粒均匀混合,粉碎,即得鱼用中药抗应激速溶粉。
3.一种鱼用抗应激中药速溶粉的制备方法,其特征在于,以质量份计,该速溶粉由以下中药组分组成:芫花5份、山奈5份、丁香4份、没药4份、阿魏4份、艾叶3份、桂皮4份、冰片3份、排草3份,其制备方法包括以下步骤:
S1、称取粉碎:称取各组分的中药,将除冰片以外的其他中药分别粉碎成粒径为10目~20目的粗粉,混合均匀得到混合中药粗粉;冰片单独粉碎成粒径为10目~20目的冰片粗粉;
S2、挥发油提取:将上述混合中药粗粉置于挥发油提取器中,加入与混合中药粗粉总质量比为1:8~1:10的水,控制加热蒸气压力为0.13±0.02MPa,保证提取器内剧烈沸腾,保证油水分离器中的温度为85±5℃,提取时间为10~20h,制得中药挥发油并收集药渣;
S3、药渣水提:称取上述药渣总质量8~10倍量的水,将水作为溶剂,将上述药渣用超声萃取仪在1500~2000Hz、35~50℃条件下萃取15~30min,得到提取液,将所得提取液通过喷雾干燥制备成药物粉末备用;
S4、称取辅料:称取质量比为1:1:2的酒石酸、碳酸氢钠、乳糖,其中酒石酸与中药各组分总质量的比为2:1~5:1,将酒石酸、碳酸氢钠、乳糖分别粉碎后干燥至恒重,备用;
S5、制备酸源颗粒或酸源包衣颗粒:称取1~3质量份的聚乙烯吡咯烷酮,将聚乙烯吡咯烷酮与无水乙醇混合,制成聚乙烯吡咯烷酮浓度为5wt% 聚乙烯吡咯烷酮-乙醇溶液;取干燥后的酒石酸,加入1~2倍的5wt% 聚乙烯吡咯烷酮-乙醇溶液制粒,于45℃~65℃下干燥,制得酸源颗粒;
或者,称取1~3质量份的聚乙烯吡咯烷酮,将聚乙烯吡咯烷酮与无水乙醇混合,制成聚乙烯吡咯烷酮浓度为5wt% 聚乙烯吡咯烷酮-乙醇溶液;取干燥后的酒石酸,加入1~2倍的5wt% 聚乙烯吡咯烷酮-乙醇溶液制粒,于45℃~65℃下干燥,制得酸源颗粒;称取1~3质量份的聚乙二醇6000,加入纯水,制成5wt% 聚乙二醇6000包衣剂;将酸源颗粒用5wt% 聚乙二醇6000包衣剂包衣,于45℃~60℃下干燥,制得酸源包衣颗粒;
S6、制备碱源主药颗粒:将步骤S1制得的冰片粗粉、步骤S2制得的中药挥发油、步骤S3喷雾干燥制得的药物粉末、步骤S4干燥后的碳酸氢钠和乳糖充分混合均匀,得到混合物;
称取上述混合物总质量1~2倍质量份的5wt% 聚乙烯吡咯烷酮-乙醇溶液,加入到混合物中制粒,于45℃~65℃下干燥,制得碱源主药颗粒;
S7、制备速溶粉:将制得的酸源颗粒或者酸源包衣颗粒与步骤S6制得的碱源主药颗粒均匀混合,粉碎,即得鱼用中药抗应激速溶粉。
4.根据权利要求1或2或3所述的一种鱼用抗应激中药速溶粉的制备方法,其特征在于,在步骤S7之后增加了制片工艺,具体包括以下步骤:将制备的鱼用中药抗应激速溶粉放入压片机中压制成片,制得鱼用抗应激中药速溶片。
5.根据权利要求4所述的一种鱼用抗应激中药速溶粉的制备方法,其特征在于,所述鱼用抗应激中药速溶片每片的质量为0.2~0.5g。
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