CN107050265B - 一种兽用桑仁清肺口服液的制备方法 - Google Patents
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Abstract
本发明属于兽用中药口服液制备技术领域，具体公开一种兽用桑仁清肺口服液的制备方法。将药材原料依次历经粉碎、加水浸泡、酶解提取、煎煮、过滤、浓缩、定容灭菌，即得产品。本发明制备方法，效率高、能耗低、经济无污染且有效成分（黄芩苷、连翘苷）收率较传统工艺提升30%、40%，适合工业化生产，且本发明制备方法通过特殊工艺处理所得成品口服液无任何防腐剂添加，绿色无污染，省去了灭菌工序，减少了能耗，节约了生产成本和时间，且微生物检验符合《中国兽药典》标准要求，经过6个月加速验证后确认成品久储不变质。
Description
技术领域
本发明属于兽用中药口服液制备技术领域，具体涉及一种兽用桑仁清肺口服液的制备方法。
背景技术
桑仁清肺口服液是收录在《兽药国家标准汇编——兽药地方标准上升国家标准》第三册，（中国农业出版社，2012年7月第1版）中的一种畜禽用中药口服液，其处方为：桑白皮100g，知母80g，苦杏仁80g，前胡100g，石膏120g，连翘120g，枇杷叶60g，海浮石40g，甘草60g，橘红100g，黄芩140g；本品清肺，止咳，平喘，主治肺热咳喘，临床上主要用于鸡外感风热或感冒化热引起的肺热咳喘证。
目前，《兽药国家标准汇编——兽药地方标准上升国家标准》第三册对桑仁清肺口服液的制备方法为： 以制备1000ml药液为例，桑白皮100g，知母80g，苦杏仁80g，前胡100g，石膏120g，连翘120g，枇杷叶60g，海浮石40g，甘草60g，橘红100g，黄芩140g，以上11味，加水煎煮两次，合并煎液，滤过，滤液减压浓缩至相对密度为1.02（80℃），冷藏24小时，滤过，滤液加苯甲酸钠适量，加水至1000ml，搅匀，分装，灭菌即得。
中草药成分复杂，有活性成分，也有如蛋白质、果胶、淀粉、植物纤维等非活性成分，这些成分一方面影响植物细胞中活性成分的浸出，另一方面也影响中药液体制剂的澄清度。传统提取方法提取温度高，收率低，成本高，消耗大量溶剂，生产污染物排放多；根据酶具有催化效率高，作用专一性强和催化条件温和等特点，采用酶解提取可以较温和地将植物组织分解，加速有效成分的释放提取，可以较大幅度地提高有效成分的收率，同时可以提高生产效率，降低能耗，改善劳动条件，减少污染。
发明内容
本发明旨在提供一种生产效率高、能耗低、污染小、绿色不添加任何防腐剂的兽用桑仁清肺口服液的制备方法。
为实现上述目的，本发明采取的技术方案如下：
一种兽用桑仁清肺口服液的制备方法，每1000ml口服液，所采用的药材原料组成为：桑白皮100g、知母80g、苦杏仁80g、前胡100g、石膏120g、连翘120g、枇杷叶60g、海浮石40g、甘草60g、橘红100g、黄芩140g，其特别之处在于，1000ml口服液的制备方法包括如下步骤：
（1）将药材原料混合在一起粉碎/或者先各自粉碎后再混合在一起；
（2）取8-10倍步骤（1）所得药材原料粉总重量的水，升温至85-90℃，加入步骤（1）所得药材原料粉，浸泡10-20min；
（3）将步骤（2）所得药液降温至50-55℃，调节药液pH至5.0-5.5，加入生物酶，搅拌均匀，酶解1.5-2.0h，然后升温至85-90℃酶灭活处理5-10min；
（4）将步骤（3）所得酶解液煎煮两次，第一次煎煮1-1.5h，过滤，所得药渣加入6-8倍步骤（1）所得药材原料粉总重量的水，第二次煎煮0.5-1.0h，将两次煎煮液合并，经过离心得上清液；
（5）将步骤（4）所得上清液进行膜过滤；
（6）将步骤（5）所得过滤液减压浓缩至80℃相对密度为1.02-1.03；
（7）向步骤（6）所得浓缩液中，加水定容至1000ml，灭菌，即得兽用桑仁清肺口服液。
较好地，步骤（3）中，所述生物酶为纤维素酶和果胶酶按质量比2∶1组成的复合酶，或为viscozyme L。
较好地，纤维素酶活度以20000U/g计，果胶酶活度以40000U/g计，1.0g≤纤维素酶和果胶酶组成的复合酶的添加量≤5.0g；viscozyme L活度以150FBG/g计，2.0g≤viscozyme L的添加量≤5.0g添加量。
较好地，步骤（4）中，离心时所用设备为管式高速离心机，转数为14000r/min，分离因数Kc为15000。
较好地，步骤（5）中，所述膜过滤为无机陶瓷膜过滤，孔径为0.05-0.5μm。
较好地，步骤（7）中，灭菌时控温在120±5℃。
有益效果：本发明制备方法，效率高、能耗低、经济无污染且有效成分（黄芩苷、连翘苷）收率较传统工艺提升30%、40%，适合工业化生产，且本发明制备方法通过特殊工艺处理所得成品口服液无任何防腐剂添加，绿色无污染，省去了灭菌工序，减少了能耗，节约了生产成本和时间，且微生物检验符合《中国兽药典》标准要求，经过6个月加速验证后确认成品久储不变质。
具体实施方式
以下结合具体实施例对本发明的技术方案作进一步详细说明，但本发明的保护范围并不局限于此。
实施例1
兽用桑仁清肺口服液的制备方法，以制备1000ml药液为例，所采用的药材原料组成为：桑白皮100g、知母80g、苦杏仁80g、前胡100g、石膏120g、连翘120g、枇杷叶60g、海浮石40g、甘草60g、橘红100g、黄芩140g，具体制备步骤如下：
（1）将药材原料混合在一起粉碎，过10目筛；
（2）取10倍步骤（1）所得药材原料粉总重量的纯化水，加热至90℃，加入步骤（1）所得药材原料粉，浸泡10min；
（3）将步骤（2）所得药液降温至50℃，利用5wt%稀柠檬酸水溶液调节药液pH至5.2，加入2.0g活度为20000U/g的纤维素酶和1.0g活度为40000U/g的果胶酶，搅拌均匀，酶解2h，然后加热升温至90℃酶灭活处理5min；
（4）将步骤（3）所得酶解液煎煮两次，第一次煎煮1.5h，过滤，所得药渣加入6倍步骤（1）所得药材原料粉总重量的纯化水，第二次煎煮0.5h，将两次煎煮液合并，经过高速管式离心机离心（转数为14000r/min，分离因数为15000）得上清液；
（5）将步骤（4）中所得上清液通过孔径为0.5μm的无机陶瓷膜进行过滤；
（6）将步骤（5）所得过滤液减压浓缩至相对密度为1.025(80℃)的浓缩液；
（7）向步骤（6）所得浓缩液中，加纯化水定容至1000ml，通过瞬时高温灭菌器（瞬时灭菌温度125℃）灌装于无菌玻璃瓶中即得兽用桑仁清肺口服液成品。
实施例2
兽用桑仁清肺口服液的制备方法，以制备1000ml药液为例，所采用的药材原料组成为：桑白皮100g、知母80g、苦杏仁80g、前胡100g、石膏120g、连翘120g、枇杷叶60g、海浮石40g、甘草60g、橘红100g、黄芩140g，具体制备步骤如下：
（1）先各自粉碎过10目筛后再混合在一起，；
（2）取9倍步骤（1）所得药材原料粉总重量的纯化水，加热至85℃，加入步骤（1）所得药材原料粉，浸泡15min；
（3）将步骤（2）所得药液降温至55℃，利用5wt%稀柠檬酸水溶液调节药液pH至5.0，加入3.5g活度为150FBG/g的生物酶viscozyme L，搅拌均匀，酶解1.5h，然后加热升温至85℃酶灭活处理6min；
（4）将步骤（3）所得酶解液煎煮两次，第一次煎煮1.0h，过滤，所得药渣加入8倍步骤（1）所得药材原料粉总重量的纯化水，第二次煎煮0.8h，将两次煎煮液合并，经过高速管式离心机离心（转数为14000r/min，分离因数为15000）得上清液；
（5）将步骤（4）中所得上清液通过孔径为0.25μm的无机陶瓷膜进行过滤；
（6）将步骤（5）所得过滤液减压浓缩至相对密度为1.026(80℃)的浓缩液；
（7）向步骤（6）所得浓缩液中，加纯化水定容至1000ml，通过瞬时高温灭菌器（瞬时灭菌温度115℃）灌装于无菌玻璃瓶中即得兽用桑仁清肺口服液成品。
对照例1
与实施例1的不同之处在于：步骤（3）中，加入的生物酶为2.0g半纤维素酶和1.0g其它酶（果胶酶、淀粉酶、木瓜蛋白酶、木聚糖酶中的一种）的复配，酶活分别为：半纤维素酶20000U/g、果胶酶40000U/g、淀粉酶20000U/g、木瓜蛋白酶15000U/g、木聚糖酶15000U/g。
对照例2
与实施例1的不同之处在于：步骤（3）中，酶解条件为：药液温度为50℃，药液pH为5.2，加入1.0g活度为20000U/g的纤维素酶和0.5g活度为40000U/g的果胶酶，搅拌均匀，酶解1.0h。
效果例
为进一步检验按照本发明制备方法制备的桑仁清肺口服液的药效，发明人按照《兽药国家标准汇编——兽药地方标准上升国家标准》第三册记载的检验标准对现有方法、实施例1、对照例1、对照例2所得口服液进行检验对比，对比实验结果见表1。其中，现有方法为按照《兽药国家标准汇编——兽药地方标准上升国家标准》第三册中桑仁清肺口服液的制备方法。
由表1可以看出：现有方法、本发明制备方法、对照方法所制作的桑仁清肺口服液均符合标准要求，且本发明与现有方法、对照方法相比，所得药液澄清度更好，按本发明所提供制备方法所得药液薄层鉴别斑点较现有方法、对照方法斑点更明显、清晰，且有效成分相对现有方法黄芩苷含量提高33%，连翘苷含量提高40%。
将实施例1、实施例2所得口服液，进一步参照《兽药研究技术指导原则汇编》（化学工业出版社，2012年3月第一版）中兽用中药、天然药物稳定性试验技术指导原则，在温度（40±2）℃、相对湿度75%±5%的条件下放置6个月，经过加速验证后确认成品久储不变质。
Claims (4)
1.一种兽用桑仁清肺口服液的制备方法，每1000ml口服液，所采用的药材原料组成为：桑白皮100g、知母80g、苦杏仁80g、前胡100g、石膏120g、连翘120g、枇杷叶60g、海浮石40g、甘草60g、橘红100g、黄芩140g，其特征在于，1000ml口服液的制备方法包括如下步骤：
（1）将药材原料混合在一起粉碎/或者先各自粉碎后再混合在一起；
（2）取8-10倍步骤（1）所得药材原料粉总重量的水，升温至85-90℃，加入步骤（1）所得药材原料粉，浸泡10-20min；
（3）将步骤（2）所得药液降温至50-55℃，调节药液pH至5.0-5.5，加入生物酶，搅拌均匀，酶解1.5-2.0h，然后升温至85-90℃酶灭活处理5-10min；其中，所述生物酶为2.0g活度为20000U/g的纤维素酶和1.0g活度为40000U/g的果胶酶；
（4）将步骤（3）所得酶解液煎煮两次，第一次煎煮1-1.5h，过滤，所得药渣加入6-8倍步骤（1）所得药材原料粉总重量的水，第二次煎煮0.5-1.0h，将两次煎煮液合并，经过离心得上清液；
（5）将步骤（4）所得上清液进行膜过滤；
（6）将步骤（5）所得过滤液减压浓缩至80℃相对密度为1.02-1.03；
（7）向步骤（6）所得浓缩液中，加水定容至1000ml，灭菌，即得兽用桑仁清肺口服液。
2.如权利要求1所述的制备方法，其特征在于：步骤（4）中，离心时所用设备为管式高速离心机，转数为14000r/min，分离因数Kc为15000。
3.如权利要求1所述的制备方法，其特征在于：步骤（5）中，所述膜过滤为无机陶瓷膜过滤，孔径为0.05-0.5μm。
4.如权利要求1所述的制备方法，其特征在于：步骤（7）中，灭菌时控温在120±5℃。
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