CN106377607A - 一种复方杨树花口服液及其制备方法 - Google Patents
一种复方杨树花口服液及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种复方杨树花口服液,包括以下重量份数的原料及辅料组成:原料:杨树花提取物40~80份、环丙沙星0.5~1.5 份、硫酸阿托品0.02~0.05 份、辅料:pH调节剂:EDTA‑2Na 0.005~0.02份、苯甲酸钠0.2~0.8份、甘油甲缩醛0.3~0.5 份、壳聚糖0.2~0.7份、明胶0.2~0.7份、醋酸溶液0.5~2份;其制备方法是:先制备杨树花提取物,然后制备絮凝沉淀剂,使用絮凝沉淀剂对杨树花提取物进行絮凝沉淀,然后融合环丙沙星、硫酸阿托品、EDTA‑2Na、苯甲酸钠、甘油甲缩醛,本发明有效减小大肠杆菌的耐药机率,对大肠杆菌病治疗见效快,能明显降低死亡率,提高治愈率;制备方法上,不用长时间静置处理,缩短了生产周期;节约了生产成本;有效成分最大程度的保留,提高了产品疗效;缩短了生产周期,降低了生产工人的劳动强度。
Description
技术领域
本发明属于兽药制剂技术领域,尤其涉及一种复方杨树花口服液及其制备方法。
背景技术
杨树花(别名梧树芒,杨树吊),为杨柳科植物毛白杨Populus Carr.、加拿大杨Populus canadensis Moench或同属数种植物的干燥雄花序。春季花开时采收,除去杂质,晒干。性味苦,寒。归肝、胆、大肠经。功能为清热解毒,化湿止泻。主治湿热下痢,幼畜泄泻。现代医学研究表明可直接抑杀病原体,对各种痢疾杆菌、大肠杆菌、肺炎双球菌、乙型链球菌、金黄色葡萄球菌和伤寒杆菌等均有一定的抑菌作用。提高机体的抵抗力,对抗免疫抑制剂,调节机体的免疫功能,有效缓解畜禽发病期间的各种应激反应,使动物胃肠肌及括约肌张力提高。
杨树花临床主要用于:
(一)痢疾,多由外感暑湿之邪,或食入霉烂草料,湿热郁结肠内,胃肠气血阻滞,肠道黏膜或肠壁脉络受损,化为脓血所致。证见精神短少,蜷腰卧地,食欲减少甚至废绝,反刍动物反刍减少或停止,鼻镜干燥;弓腰努责,泄粪不爽,里急后重,下痢稀糊,赤白相杂,或呈白色胶冻状,口色赤红,舌苔黄腻,脉数。
(二)肠炎,多由暑月炎天,劳役过重,乘饥而喂热料,或草料霉败,谷气料毒积于肠中,郁而化热,损伤脾胃,津液不能化生,则水反为湿,湿热下注而成。证见发热,精神沉郁,食欲减少或废绝,口渴多饮,有时轻微腹痛,蜷腰卧地,泄粪稀薄,黏腻腥臭,尿赤短,口色赤红,舌苔黄腻,口臭,脉象沉数。
杨树花通常可以直接煎煮内服,也可以制成散剂和片剂服用。在兽药方面,主要制剂有杨树花口服液及杨树花片,杨树花口服液收载于《兽药国家标准(中药、化药卷)第一册》,用于治疗家畜流感、仔猪白痢、肺炎及某些发热性疾患。
传统的杨树花口服液生产工艺是将中药材煎煮2次后,合并煎液浓缩至比重不低于1.02,静置24小时,取上清液灌装灭菌即得。在兽药领域,目前普遍仍采用水提醇沉(本产品使用静置除沉)的工艺,生产效能低下,产品质量不稳定,见效慢、治愈率低,该方法生产的杨树花口服液质量不稳定,经常在贮存运输过程中出现浑浊沉淀,影响产品使用。
发明内容
本发明目的在于克服现有技术中存在的不足而提供的一种复方杨树花口服液及其制备方法。
本发明的目的是这样实现的:一种复方杨树花口服液,其特征在于:包括以下重量份数的原料及辅料组成:原料:杨树花提取物40~80份、环丙沙星0.5~1.5 份、硫酸阿托品0.02~0.05 份、辅料:pH调节剂:EDTA-2Na 0.005~0.02份、苯甲酸钠0.2~0.8份、甘油甲缩醛0.3~0.5 份、壳聚糖0.2~0.7份、明胶0.2~0.7份、醋酸溶液0.5~2份。
一种复方杨树花口服液,其特征在于:包括以下重量份数的原料及辅料组成:原料:杨树花提取物50~70份、环丙沙星0.7~1.2 份、硫酸阿托品0.025~0.045 份、辅料:pH调节剂:EDTA~2Na 0.009~0.015份、苯甲酸钠0.4~0.6份、甘油甲缩醛0.35~0.45 份、壳聚糖0.3~0.6份、明胶0.3~0.6份、醋酸溶液0.8~1.5份。
一种复方杨树花口服液,其特征在于:包括以下重量份数的原料及辅料组成:原料:杨树花提取物60份、环丙沙星1份、硫酸阿托品0.03份、辅料:pH调节剂:EDTA-2Na 0.01份、苯甲酸钠0.5份、甘油甲缩醛0.4 份、壳聚糖0.5份、明胶0.5份、醋酸溶液1份。
一种复方杨树花口服液的制备方法,其特征在于:具有以下步骤:
步骤1)、杨树花提取物的获得:取杨树花饮片80~100 份,加入600~800份的水,使水没过杨树饮片,浸泡4~6小时,然后利用蒸汽加热至沸腾,保持微沸状态煎煮1~3小时,然后进行过滤,获得的一次浓缩液;向过滤后的药渣中加水300~600份,利用蒸汽将药渣及水加热至沸腾,保持微沸状态煎煮1~3小时,然后进行过滤,获得的二次浓缩液;将一次浓缩液和二次浓缩液进行混合,然后对混合后的浓缩液进行浓缩,浓缩至50~100份,最后进行过滤,获得的上清液即为杨树花提取物;
步骤2)、制作絮凝沉淀剂:取上述所述份量的壳聚糖、明胶、醋酸溶液,将壳聚糖和明胶放入醋酸溶液中,搅拌后静置40~60小时,即可获得絮凝沉淀剂;
步骤3)、取步骤1)中获得的杨树花提取物加热至40~60摄氏度,然后加入步骤2)中获得的絮凝沉淀剂,在55~65摄氏度的环境下保温3~5个小时,杨树花提取物中的杂质与絮凝沉淀剂充分结合后,提取上清液,然后使用分离机将上清液进行分离,获得杨树花提取液;
步骤4)、取上述所述份量的环丙沙星、硫酸阿托品、EDTA-2Na、苯甲酸钠、甘油甲缩醛依次加入到步骤3)中所获得的杨树花提取液中,分别搅拌使溶液溶解完全,然后对混合液进行过滤,即可获得所述的复方杨树花口服液。
本发明的积极效果:在本发明中更好地去除杂质,保留有效成分,提高药液的澄清度及其稳定性,采用壳聚糖对杨树花原药提取液进行絮凝处理,以澄明度、检验、颜色和pH作为主要衡量指标,考察絮凝沉淀剂用量和絮凝温度对絮凝效果的影响,得到了适宜的絮凝工艺条件;且本发明采用中药与西药合用的复方制剂,杨树花、环丙沙星具有双重抗细菌的功效,硫酸阿托品能抑制肠道腺体的分泌,从而减少肠道内容物水分含量,而且有效减小大肠杆菌的耐药机率,对大肠杆菌病治疗见效快,有效并高效,能明显降低其死亡率,提高治愈率。
具体实施方式
实施例1:一种复方杨树花口服液,其特征在于:包括以下重量份数的原料及辅料组成:原料:杨树花提取物60克、环丙沙星1克、硫酸阿托品0.03克、辅料:pH调节剂:EDTA-2Na 0.01克、苯甲酸钠0.5克、甘油甲缩醛0.4 克、壳聚糖0.5克、明胶0.5克、醋酸溶液1克。
一种复方杨树花口服液的制备方法,其特征在于:具有以下步骤:
步骤1)、杨树花提取物的获得:取杨树花100克,加入700ml的水,使水没过杨树饮片,浸泡4小时,然后利用蒸汽加热至沸腾,保持微沸状态煎煮2小时,然后进行过滤,获得的一次浓缩液;向过滤后的药渣中加水500ml,利用蒸汽将药渣及水加热至沸腾,保持微沸状态煎煮2小时,然后使用板框过滤器进行过滤,获得的二次浓缩液;将一次浓缩液和二次浓缩液进行混合,然后对混合后的浓缩液进行浓缩,浓缩至100ml,最后使用板框过滤器进行过滤,获得的上清液即为杨树花提取物;
步骤2)、制作絮凝沉淀剂:取上述所述份量的壳聚糖、明胶、醋酸溶液,将壳聚糖和明胶放入醋酸溶液中,搅拌后静置50小时,即可获得絮凝沉淀剂;
步骤3)、取步骤1)中获得的杨树花提取物加热至50摄氏度,然后加入步骤2)中获得的絮凝沉淀剂,在60摄氏度的环境下保温4个小时,杨树花提取物中的杂质与絮凝沉淀剂充分结合后,提取上清液,然后使用碟式分离机将上清液进行分离,获得杨树花提取液;
步骤4)、取上述所述份量的环丙沙星、硫酸阿托品、EDTA-2Na、苯甲酸钠、甘油甲缩醛依次加入到步骤3)中所获得的杨树花提取液中,分别搅拌使溶液溶解完全,调节溶液pH值5.0~7.0,再用纯化水定容至100 mL,使用板框过滤器进行过滤;经检验合格后,灌装、密封、灭菌,即得复方杨树花口服液。
在复方杨树花口服液的制备方法上,不用长时间静置处理,缩短了生产周期;不用静置处理,节约了部分生产成本(冷库库贮藏等);产品稳定性提高,提升产品品质;有效成分最大程度的保留,提高了产品疗效;缩短了生产周期,降低了生产工人的劳动强度。
实验:絮凝沉淀剂最佳方法的考察:
絮凝剂的添加比例,按照6%、8%、10%三组添加比例,絮凝沉淀的温度,选取40℃、50℃、60℃三组不同比例的温度,试验方案设计:
分别取杨树花提取液50 mL,按照以上试验方案分组,搅拌状态下加入絮凝沉淀剂,保温4 h,在此过程中,杂质与沉淀剂已充分结合,并沉淀置烧杯底部,过滤,对上清液分别比较(参考《中国兽药典》2010年版二部的检验方法)检验,主要考察指标为澄明度、颜色、性状、PH及冷藏放置后的澄明度。
试验结果:
试验结果表明,向杨树花提取液中加入8%的絮凝沉淀剂,所得到的澄清提取液质量最佳。将五组澄明度合格的澄清液分别在4℃条件下冷藏放置24 h,第1组、第4组出现轻微浑浊,其余三组未出现浑浊,通过以上结果我们可以看到,随着温度上升,絮凝沉淀效果增强,同时随着絮凝沉淀剂添加比例增加,澄清效果增强,但是同时含量有下降趋势。使用8%的絮凝沉淀剂用量,在60℃保温措施能够获得最佳的效果。
产品使用报告1:
驻马店牧康养殖有限公司现存栏育肥猪3000头,父母代母猪300头,2015年04月06日发生仔猪白痢,此病又称迟发性大肠杆菌病,症状表现为病猪大便稀薄,呈灰白色或灰黄色,有腥臭,后期排便失禁,日渐瘦弱而死,或成为侏儒猪。导致猪的生产性能下降,淘汰数量增多,最终影响公司的经济效益。而目前治疗此类疾病的药物主要集中使用西药抗菌药,临床使用此类药物易导致大肠杆菌的耐压性产生,会逐渐增加临床治疗成本及治愈率的下降。
临床治疗最终选择本发明所提供的复发杨树花口服液,每头猪10ml,连续使用5天,从第3天起,整群症状得到控制,饮食量开始增加,未发生死亡,至用药结束,病情得到控制,整群采食量及生产情况回复正常。本发明在对仔猪白痢的治疗上具有很好的治疗效果,同时又一定程度上杜绝了大肠杆菌耐药性的产生。
产品使用报告2:
新乡市牧野禽业有限公司现有商品蛋鸡10万只,2015年03月份,鸡厂内的鸡出现精神萎靡不振、采食减少或不食、离群呆立或蹲伏不起、冠呈青紫色、眼虹膜呈灰白色、视力减退或失明、羽毛松乱、肛门周围羽毛沾有粪便、绿色或黄白色稀粪,个别症状严重的出现蹲伏、不能站、不愿动或跛行、关节肿大、肝肿大、肠道粘膜出血和溃疡、心包发炎、腹腔积水等症状,有零星死亡。经病原分离鉴定结合临床症状,判定为大肠杆菌感染。
临床治疗选用本发明连续使用5天,第3天开始鸡群精神状态基本正常,无死亡,5天后,恢复到正常状态,采食量正常。本发明在对大肠杆菌病的治疗上具有很好的治疗效果,在大肠杆菌普遍耐药的情况下,对本发明还具有很高的敏感性,临床应用有很大的前景。
以下实施例中复方杨树花口服液的制备方法与实施例1相同,不再赘述。
实施例2:一种复方杨树花口服液,其特征在于:包括以下重量份数的原料及辅料组成:原料:杨树花提取物40克、环丙沙星0.5克、硫酸阿托品0.03克、辅料:pH调节剂:EDTA-2Na 0.005克、苯甲酸钠0.2克、甘油甲缩醛0.3 克、壳聚糖0.2克、明胶0.2克、醋酸溶液0.5克。
实施例3:一种复方杨树花口服液,其特征在于:包括以下重量份数的原料及辅料组成:原料:杨树花提取物80克、环丙沙星1.5克、硫酸阿托品0.05克、辅料:pH调节剂:EDTA-2Na 0.02克、苯甲酸钠0.8克、甘油甲缩醛0.5 克、壳聚糖0.7克、明胶0.7克、醋酸溶液2克。
实施例4:一种复方杨树花口服液,其特征在于:包括以下重量份数的原料及辅料组成:原料:杨树花提取物600克、环丙沙星10克、硫酸阿托品0.3克、辅料:pH调节剂:EDTA-2Na 0.1克、苯甲酸钠5克、甘油甲缩醛4 克、壳聚糖5克、明胶5克、醋酸溶液10克。
实施例5:一种复方杨树花口服液,其特征在于:包括以下重量份数的原料及辅料组成:原料:杨树花提取物400克、环丙沙星5克、硫酸阿托品0.3克、辅料:pH调节剂:EDTA-2Na 0.05克、苯甲酸钠2克、甘油甲缩醛3 克、壳聚糖2克、明胶2克、醋酸溶液5克。
实施例6:一种复方杨树花口服液,其特征在于:包括以下重量份数的原料及辅料组成:原料:杨树花提取物800克、环丙沙星15克、硫酸阿托品0.5克、辅料:pH调节剂:EDTA-2Na 0.2克、苯甲酸钠8克、甘油甲缩醛5 克、壳聚糖7克、明胶7克、醋酸溶液20克。
实施例7:一种复方杨树花口服液,其特征在于:包括以下重量份数的原料及辅料组成:原料:杨树花提取物4000克、环丙沙星50克、硫酸阿托品3克、辅料:pH调节剂:EDTA-2Na 0.5克、苯甲酸钠20克、甘油甲缩醛30 克、壳聚糖20克、明胶20克、醋酸溶液50克。
实施例8:一种复方杨树花口服液,其特征在于:包括以下重量份数的原料及辅料组成:原料:杨树花提取物8000克、环丙沙星150克、硫酸阿托品5克、辅料:pH调节剂:EDTA-2Na 2克、苯甲酸钠80克、甘油甲缩醛50 克、壳聚糖70克、明胶70克、醋酸溶液200克。
Claims (4)
1.一种复方杨树花口服液,其特征在于:包括以下重量份数的原料及辅料组成:原料:杨树花提取物40~80份、环丙沙星0.5~1.5 份、硫酸阿托品0.02~0.05 份、辅料:pH调节剂:EDTA-2Na 0.005~0.02份、苯甲酸钠0.2~0.8份、甘油甲缩醛0.3~0.5 份、壳聚糖0.2~0.7份、明胶0.2~0.7份、醋酸溶液0.5~2份。
2.一种复方杨树花口服液,其特征在于:包括以下重量份数的原料及辅料组成:原料:杨树花提取物50~70份、环丙沙星0.7~1.2 份、硫酸阿托品0.025~0.045 份、辅料:pH调节剂:EDTA-2Na 0.009~0.015份、苯甲酸钠0.4~0.6份、甘油甲缩醛0.35~0.45 份、壳聚糖0.3~0.6份、明胶0.3~0.6份、醋酸溶液0.8~1.5份。
3.一种复方杨树花口服液,其特征在于:包括以下重量份数的原料及辅料组成:原料:杨树花提取物60份、环丙沙星1份、硫酸阿托品0.03份、辅料:pH调节剂:EDTA-2Na 0.01份、苯甲酸钠0.5份、甘油甲缩醛0.4 份、壳聚糖0.5份、明胶0.5份、醋酸溶液1份。
4.一种复方杨树花口服液的制备方法,其特征在于:具有以下步骤:
步骤1)、杨树花提取物的获得:取杨树花80~100 份,加入600~800份的水,使水没过杨树饮片,浸泡4~6小时,然后利用蒸汽加热至沸腾,保持微沸状态煎煮1~3小时,然后进行过滤,获得的一次浓缩液;向过滤后的药渣中加水300~600份,利用蒸汽将药渣及水加热至沸腾,保持微沸状态煎煮1~3小时,然后进行过滤,获得的二次浓缩液;将一次浓缩液和二次浓缩液进行混合,然后对混合后的浓缩液进行浓缩,浓缩至50~100份,最后进行过滤,获得的上清液即为杨树花提取物;
步骤2)、制作絮凝沉淀剂:取上述所述份量的壳聚糖、明胶、醋酸溶液,将壳聚糖和明胶放入醋酸溶液中,搅拌后静置40~60小时,即可获得絮凝沉淀剂;
步骤3)、取步骤1)中获得的杨树花提取物加热至40~60摄氏度,然后加入步骤2)中获得的絮凝沉淀剂,在55~65摄氏度的环境下保温3~5个小时,杨树花提取物中的杂质与絮凝沉淀剂充分结合后,提取上清液,然后使用分离机将上清液进行分离,获得杨树花提取液;
步骤4)、取上述所述份量的环丙沙星、硫酸阿托品、EDTA-2Na、苯甲酸钠、甘油甲缩醛依次加入到步骤3)中所获得的杨树花提取液中,分别搅拌使溶液溶解完全,然后对混合液进行过滤,即可获得所述的复方杨树花口服液。
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