CN104474007A - 一种兽用解热青蒿甘草颗粒和可溶性粉制剂及其制备方法 - Google Patents
一种兽用解热青蒿甘草颗粒和可溶性粉制剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种解热的中药制剂——青蒿甘草颗粒和可溶性粉剂及其制备方法，属兽药领域。该制剂将两味药材分别提取，采用多次水煮，喷雾或微波干燥，低温粉碎，得提取物，按比例混合，按照制剂学常规技术制成药物制剂。经功效试验、毒理试验及稳定性试验表明，具有功能显著、安全无毒、稳定性好、制备工艺完备成熟、生物利用度高等特点。用于治疗动物附红细胞体病、高热病、解暑热，疗效确切，治愈率达90.0%以上，副作用小，可制成多种剂型，如散剂、预混剂、可溶性粉剂、颗粒剂、口服液、注射液、粉针剂、片剂等。
Description
技术领域
本发明涉及一种以青蒿和甘草药材为原料制备用于解热的青蒿甘草颗粒剂及可溶性粉剂及其生产工艺，属兽药领域。
背景技术
当前，畜禽养殖饲料中添加化药或抗生素的现象极为普遍，滥用药物、不合理配伍等也使得畜禽养殖风险日益增加，导致出现免疫抑制、繁殖障碍、低出生成活率。人们寻求开发生产无公害、安全和绿色的添加剂用以替代抗生素等有负面效应的兽药和饲料添加剂已迫在眉睫。
青蒿为清热凉血退蒸之良药， 清透虚热，凉血除蒸，除蒸，截疟。用于暑邪发热，阴虚发热，夜热早凉，骨蒸劳热，疟疾寒热，湿热黄疸。该品苦寒清热，辛香透散，善使阴分伏热透达外散，为阴虚发热要药，此外兼有解暑，截疟之功。可治外感暑热，发热烦渴。刘鸿鸣等从青蒿的乙醇提取无中分离得到了两种香豆素类成分6-甲氧基-7-羟基香豆素（莨菪亭）和香豆素。药理研究表明东莨菪内酯有抗菌消炎、祛痰止咳的作用，对正常动物体温及大肠杆菌内毒素致热动物体温均有显著的降低作用，为青蒿中有效成分之一。
甘草在中国、印度和希腊的古代医药典籍中多有记载，至今已有几千年的使用历史，味甘，性平；能解百毒、补脏腑、泻诸火，兼补脾益气，缓急止痛；临床用于治疗呼吸系统、消化系统、免疫系统等多种疾病。由于甘草对多种疾病表现了良好的预防和治疗作用且毒副作用较小，近年来，对甘草潜在的多种药理活性的研究和挖掘一直是国内外药理界的研究热点。目前，多个试验结果表明甘草及其提取物具有抗炎、抗病毒、抗菌、保肝、抗癌、抗氧化、镇咳、免疫调解、降糖和抗血小板凝集等多种活性。
目前文献中提取青蒿的方法很多，多为有机溶剂法，溶剂多为乙醇和石油醚，低温减压浓缩。但是这些方法所提取的浸膏解热效果并不明显，普遍存在提取效率低，浸膏收率低、有效成分利用率低等问题。目前文献中对甘草的提取工艺研究也很多，刘玉红等以甘草酸和甘草苷转移率为评价指标，分别比较了氨醇提、醇提、水煎煮三种方法的优劣，氨醇的提取效果最佳，甘草酸和甘草苷的转移率为99.1%、97.2%，醇提与水提的效果略差。甘草酸可能以钾盐或钙盐或游离的形式存在，利用甘草酸为有机弱酸酸性条件下游离，吴伟康等分别比较了采用醇提酸沉和水提酸沉方法对甘草酸得率的影响，并优化了较好提取方法的最佳工艺。结果表明水提酸沉法得率较高，最佳工艺条件为加水回流2次（15倍，1.25 h；12倍，1 h）酸沉为pH 1。加水量≥24倍基本能提取完全。
将青蒿、甘草结合应用于清热解毒的兽药目前未见相关文献报道。
发明内容
本发明的目的之一在于提供一种能用于解热的青蒿、甘草复方兽药制剂，以无公害、天然成分的中药制剂替代抗生素；目的之二在于提供其制备方法，提高活性成分收率。
为达到上述目的,本发明采用水提方法，充分提取有效成分，经改进，青蒿采用弱酸条件煎煮提取，甘草直接在弱碱性条件下煎煮提取，具体采用如下技术方案:
本发明所述用于解热的天然药物复方兽药制剂, 选用青蒿和甘草为活性成分，青蒿和甘草质量比为1:1～0.1，经本发明所述工艺制备而成。
优选青蒿和甘草质量比为1:0.1。
本发明研究了青蒿:甘草质量比为5:5、6:4、7:3、8:2、9:1、10:1共6组 处方，结果发现这几组处方的复方制剂均具有解热作用，但由于偏重于青蒿清热作用,故本发明处方中以青蒿用量大于甘草用量为宜。
所述用于解热的天然药物复方兽药制剂的制备方法,包括以下步骤：
(1)青蒿提取物的制备
将青蒿粉碎成粗粉，置于带有搅拌的提取罐中，加8-12倍水，然后用磷酸盐缓冲液将PH值调至4.0～6.0，搅拌浸泡，然后加热搅拌使微沸蒸煮1-5小时，滤过，得第一次煎煮液。将上述药材渣加8-12倍水、PH值调至中性，加热搅拌使微沸蒸煮1-5小时，滤过，得第二次煎煮液，合并煎煮液，70~90℃减压浓缩，时间5-10小时，将浓缩液置于喷雾干燥塔，喷雾干燥得青蒿提取物，收率为26～30%。
作为优选，青蒿第一次提取时要在室温下边搅拌边浸泡4小时。
作为优选，青蒿提取物第一次煎煮pH值为5.0。
（2）甘草提取物的制备
将甘草饮片粉碎成粗粉，加8-12倍量水，每次用浓氨水调PH值至8.0-9.0，煎煮3次，每次2小时，过滤，滤液浓缩至适量，将浓缩液置于喷雾干燥塔，喷雾干燥得甘草提取物，收率为26～30%。
上述两步骤喷雾干燥的控制进风温度为180℃～190℃，出风温度为85℃～95℃。
（3）按质量比1:1～0.1称取上述青蒿提取物和甘草提取物，加入药学可接受的辅料，辅料和药物的比例为1:1～3，混合均匀，制成软材，过筛网制粒，通风干燥，过筛网整粒，干燥，得颗粒制剂。药学可接受的辅料可选PVPK30、糊精、蔗糖。
作为优选，颗粒制备中，青蒿甘草提取物混合物（10:1）、PVPK30、糊精、蔗糖重量比为1:0.05:0.5:0.25。
（4）按质量比1:1～0.1称取青蒿提取物和甘草提取物，混合均匀，得粉末制剂；或加入药学可接受的辅料，辅料和药物的比例为1:1～3，混合均匀，得粉末制剂。药学可接受的辅料可选无水葡萄糖、β-环糊精、矫味剂。
按重量比1:1～0.1称取青蒿提取物和甘草提取物，加入药学可接受的辅料，辅料和药物的比例为1:1～3，还可以制成散剂、片剂、口服液剂、胶囊剂、气雾剂、注射剂、膏剂、糖浆剂、涂膜剂、搽剂、贴剂、滴丸剂、栓剂等。
本发明优点在于：1、采用酸法和碱法萃取方法，使青蒿和甘草中有效成分在水中最大化提取，采用喷雾干燥的方式，可以保证活性物质不降解，所得中药提取物不用粉碎。2、PVPK30、糊精、蔗糖、无水乙醇为辅料制得的颗粒色泽良好，迅速崩解融化，溶解度良好，吸湿率最低，休止角合适。3、本发明中药提取方法药效物质提取完全，有利于用单体成分控制制剂质量，体现中医治病综合成分作用的特点，并且符合药物经胃肠道转运过程，比常规提取方法更优，适合工业生产。4、溶媒为水，不用任何有机溶剂，减少了环境污染。
本发明制备的青蒿甘草制剂用于畜禽、水产养殖动物的暑邪发热，阴虚发热，夜热早凉，骨蒸劳热，疟疾寒热，湿热黄疸，对附红细胞引起的感染。经功效试验、毒理试验及稳定性试验表明，具有功能显著、安全无毒、稳定性好、生物利用度高等特点。治疗动物附红细胞体病、高热病、解暑热，疗效确切，治愈率达90.0%以上，副作用小。
具体实施方式
以下通过实施例，对本发明技术方案作进一步说明。
实施例1原料提取
(1)青蒿提取物的制备
将青蒿粉碎成粗粉，置于放入带有搅拌的提取罐中，加12倍水，然后用磷酸盐缓冲液将PH值调至5.0，搅拌浸泡，然后加热搅拌使微沸蒸煮4小时，滤过，得第一次煎煮液。将上述药材渣加10倍水、PH值调至中性，加热搅拌使微沸蒸煮4小时，滤过，得第二次煎煮液，合并煎煮液，80℃减压浓缩，时间5小时，将浓缩液置于喷雾干燥塔，喷雾干燥得青蒿提取物，收率为约26%。喷雾干燥的控制进风温度为180℃～190℃，出风温度为85℃～95℃。
（2）甘草提取物的制备
将甘草饮片粉碎成粗粉，加10倍量水，每次用浓氨水调PH值至8.0，煎煮3次，每次2小时，过滤，滤液浓缩至适量，将浓缩液置于喷雾干燥塔，喷雾干燥得甘草提取物，收率为约26%。喷雾干燥的控制进风温度为180℃～190℃，出风温度为85℃～95℃。
提取三批中试的结果如表1：
表1 三批样品中试试验技术数据表
青蒿提取物中有效成分提取对比见表2。
表2本工艺和普通工艺对比有效成分含量数据表
甘草提取物中有效成分提取对比见表3。
表3本工艺和普通工艺对比有效成分含量数据表
实施例2青蒿甘草颗粒制剂
按质量比10:1称取上述青蒿提取物和甘草提取物，混合，加糊精、蔗糖、PVPk30、无水乙醇制成12目青蒿甘草颗粒。青蒿甘草提取物混合物、PVPK30、糊精、蔗糖的重量比为1:0.05:0.5:0.25。
实施例3青蒿甘草颗粒制剂
按质量比为8:2称取上述青蒿提取物和甘草提取物，混合，加糊精、蔗糖、PVPk30、无水乙醇制成20目青蒿甘草颗粒。青蒿甘草提取物混合物、PVPK30、糊精、蔗糖重量比为1:0.05:0.5:0.25。
实施例4青蒿甘草颗粒制剂
按质量比为5:5称取上述青蒿提取物和甘草提取物，混合，加糊精、蔗糖、PVPk30、无水乙醇制成30目青蒿甘草颗粒。青蒿甘草提取物混合物、PVPK30、糊精、蔗糖重量比为1:0.05:0.5:0.25。
实施例5青蒿甘草颗粒制剂
按质量比为6:4称取上述青蒿提取物和甘草提取物，混合，加糊精、蔗糖、PVPk30、无水乙醇制成40目青蒿甘草颗粒。青蒿甘草提取物混合物、PVPK30、糊精、蔗糖重量比为1:0.05:0.25:0.5。
实施例6青蒿甘草可溶性粉制剂
按质量比为10:1称取上述青蒿提取物和甘草提取物，混合，制成青蒿甘草可溶性粉。
实施例7青蒿甘草可溶性粉制剂
按质量比为8:2称取上述青蒿提取物和甘草提取物，混合，制成青蒿甘草可溶性粉。
实施例8青蒿甘草可溶性粉制剂
按质量比为6:4称取上述青蒿提取物和甘草提取物混合，制成青蒿甘草可溶性粉。
实施例9青蒿甘草可溶性粉制剂
按质量比为5:5称取上述青蒿提取物和甘草提取物混合，制成青蒿甘草可溶性粉。
实施例10青蒿甘草可溶性粉制剂
按质量比为10:1称取上述青蒿提取物和甘草提取物，混合，加入药学可接受的辅料：无水葡萄糖、β-环糊精、矫味剂制成青蒿甘草可溶性粉。
实施例11青蒿甘草可溶性粉制剂
按质量比为10:5称取上述青蒿提取物和甘草提取物，混合，加入药学可接受的辅料：无水葡萄糖、β-环糊精、矫味剂制成青蒿甘草可溶性粉。
应用例1
用本工艺生产的药物针对某养猪场筛选出200头仔猪，这些猪表现为混合感染引起的长期发热，久治不愈，白细胞低下，给猪用本发明颗粒制剂拌料使用，依据精神状态、食欲、粪便状态及发病情况、死亡淘汰情况等作为临床症状，经过3天用该颗粒拌料治疗，体重增加明显，所有病态症状消失，对比前后的临床症状表明，有效率为100%，显效率为98%。
应用例2
通过血清学检测、直接镜检、细菌分离、单抗酶联免疫试验RT-PCR等实验室方法判断一批发热症状的病猪，用其他药不见减轻症状。结果显示：分离及检测到C型链球菌、附红细胞体、猪瘟病毒阳性、猪繁殖与呼吸障碍综合征病毒阳性、猪伪狂犬病毒阳性、流感病毒阳性、并且大部分样品检测到2种或2种以上的病原微生物，说明混合感染较严重。本发明的治疗猪病混合感染的青蒿甘草颗粒剂与猪饲料的混饲预防量：2000克本发明的颗粒剂拌1吨饲料进行饲喂。本发明的治疗颗粒与猪饲料的混饲治疗量：500克的青蒿甘草颗粒剂拌200市斤料连喂3日，在此期间自由饮水，若不吃不喝每头家畜可按每公斤体重0.5克(本发明的青蒿甘草颗粒剂)灌服。对病重和妊娠母猪，在治疗的同时，可给予补充VB1、VC，可有效提高治愈率。猪发热病的疗效评估：临床针对性应用于猪发热病实验观察400例，其中240例均为混合感染；单纯性流行性感冒70例；猪伪狂犬病毒感染30例；附红细胞体感染60例；总有效率达97.75%，治愈率可达91.3%，详见表4。
表4 青蒿甘草颗粒剂用于治疗由于感染引起发热的效果表
应用例3
选取兽医临床判定为禽流感（精神沉郁，饲料消耗量减少，消瘦；母鸡的就巢性增强，产蛋量下降；轻度直至严重的呼吸道症状，包括咳嗽、打喷嚏和大量流泪；头部和脸部水肿，神经紊乱和腹泻）的病鸡。将青蒿甘草可溶性粉按剂量为1g/kg/天（病鸡体重按2g/kg/天计）添加至饲料或饮水中，供病鸡自由采食或饮用，连续给药3 天。结果见表5。从表5 可以看出，本发明的药物组合物对鸡流感有良好的治疗效果，3天总治愈率为90.35%，治疗效果显著，使用后迅速控制病情。
Claims (7)
1.一种兽用解热青蒿甘草中药制剂，其特征在于，采用如下方法制备而成：
(1)青蒿提取物的制备
将青蒿粉碎成粗粉，置于带有搅拌的提取罐中，加8-12倍水，然后用磷酸盐缓冲液将PH值调至4.0～6.0，搅拌浸泡，然后加热搅拌使微沸蒸煮1-5小时，滤过，得第一次煎煮液；将上述药材渣加8-12倍水、PH值调至中性，加热搅拌使微沸蒸煮1-5小时，滤过，得第二次煎煮液，合并煎煮液，70~90℃减压浓缩，时间5-10小时，将浓缩液置于喷雾干燥塔，喷雾干燥得青蒿提取物；
（2）甘草提取物的制备
将甘草饮片粉碎成粗粉，加8-12倍量水，每次用浓氨水调PH值至8.0-9.0，煎煮3次，每次2小时，过滤，滤液浓缩至适量，将浓缩液置于喷雾干燥塔，喷雾干燥得甘草提取物；
（3）按质量比1:1～0.1称取上述青蒿提取物和甘草提取物，加入药学可接受的辅料，辅料和药物的比例为1:1～3，混合均匀，制成软材，过筛网制粒，通风干燥，过筛网整粒，干燥，得颗粒制剂；
（4）按质量比1:1～0.1称取上述青蒿提取物和甘草提取物，混合均匀，得粉末制剂；或加入药学可接受的辅料，辅料和药物的比例为1:1～3，混合均匀，得粉末制剂。
2.如权利要求1所述的兽用解热青蒿甘草中药制剂，其特征在于，按质量比1:0.1称取青蒿提取物和甘草提取物。
3.如权利要求1所述的兽用解热青蒿甘草中药制剂，其特征在于，青蒿第一次提取时在室温下边搅拌边浸泡4小时；青蒿提取物第一次煎煮pH值为5.0。
4.如权利要求1所述的兽用解热青蒿甘草中药制剂，其特征在于，颗粒制备中，药学可接受的辅料选PVPK30、糊精和蔗糖；青蒿甘草提取物、PVPK30、糊精、蔗糖的重量比为1:0.05:0.5:0.25。
5.如权利要求1所述的兽用解热青蒿甘草中药制剂，其特征在于，将其制成散剂、片剂、口服液剂、胶囊剂、气雾剂、注射剂、膏剂、糖浆剂、涂膜剂、搽剂、贴剂、滴丸剂或栓剂。
6.制备如权利要求1所述的兽用解热青蒿甘草中药制剂，其特征在于，采用如下方法制备：
(1)青蒿提取物的制备
将青蒿粉碎成粗粉，置于带有搅拌的提取罐中，加8-12倍水，然后用磷酸盐缓冲液将PH值调至4.0～6.0，搅拌浸泡，然后加热搅拌使微沸蒸煮1-5小时，滤过，得第一次煎煮液；将上述药材渣加8-12倍水、PH值调至中性，加热搅拌使微沸蒸煮1-5小时，滤过，得第二次煎煮液，合并煎煮液，70~90℃减压浓缩，时间5-10小时，将浓缩液置于喷雾干燥塔，喷雾干燥得青蒿提取物；
（2）甘草提取物的制备
将甘草饮片粉碎成粗粉，加8-12倍量水，每次用浓氨水调PH值至8.0-9.0，煎煮3次，每次2小时，过滤，滤液浓缩至适量，将浓缩液置于喷雾干燥塔，喷雾干燥得甘草提取物；
（3）按质量比1:1～0.1称取上述青蒿提取物和甘草提取物，加入药学可接受的辅料，辅料和药物的比例为1:1～3，混合均匀，制成软材，过筛网制粒，通风干燥，过筛网整粒，干燥，得颗粒制剂；
（4）按质量比1:1～0.1称取上述青蒿提取物和甘草提取物，混合均匀，得粉末制剂；或加入药学可接受的辅料，辅料和药物的比例为1:1～3，混合均匀，得粉末制剂。
7.如权利要求6所述的兽用解热青蒿甘草中药制的制备方法，其特征在于，所述步骤（1）、（2）喷雾干燥的控制进风温度为180℃～190℃，出风温度为85℃～95℃。
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