CN106421339A - 一种治疗小儿夜啼中药半浸膏膜衣片及其制备方法 - Google Patents
一种治疗小儿夜啼中药半浸膏膜衣片及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗小儿夜啼中药半浸膏膜衣片及其制备方法，它是由下述组分及其重量份制成：茯苓15‑17、甘草25‑30、白术15‑17、麦门冬15‑17、木香15‑17、酸枣仁25‑30、川芎10‑12、当归20‑23、五倍子25‑30、苹果醋25‑30、白芷20‑23、荆芥13‑15、丹皮13‑15、藕粉30‑35、蔗糖13‑15。本发明的一种治疗小儿夜啼中药半浸膏膜衣片，针对小儿夜啼进行多方位的调理，增强睡眠质量，宁心安神，健脾和胃，行气活血。
Description
技术领域
本发明涉及中药组方技术领域，尤其涉及一种治疗小儿夜啼中药半浸膏膜衣片及其制备方法。
背景技术
中药配方颗粒是由单味中药提取浓缩制成，临床用于代替饮片调配成汤剂，其科学、灵活、服用方便等优点已得到越来越广泛的认可。干法制粒具有效率高、制粒过程不受热、成品不易吸潮等特点，特别适合中药配方颗粒采用中药浸膏粉直接制粒、辅料用量少的特点。中药配方颗粒采用浸膏粉直接干法制粒，一次成型率普遍达到50%，通过二次制粒后，已大部分成为颗粒，生产效率高，但是，也有一部分品种浸膏粉黏性较差，往往一次不能成粒，需要反复挤压才行，生产效率低，而且制得的颗粒硬度大，溶化时间长。中药浸膏粉黏性大、吸湿性强，难以成型，不易制成颗粒，且制成的颗粒易吸湿及黏连，不稳定，为提高片剂质量，更好地发挥其疗效，拟将其改制成薄膜衣片。在《中药半浸膏薄膜衣片的成型工艺考察》中张源等将冠心平片的制粒工艺改用流化床制粒法，并对其制粒、压片及薄膜包衣工艺进行系统研究，为中药半浸膏薄膜衣片的大生产提供试验依据。压片总混时加滑石粉，可显著改善颗粒的流动性，满足压片的工艺要求。颗粒中水分在冲模对颗粒进行压缩时被挤压到颗粒的表面形成薄膜，形成的薄膜可起润滑作用改善压力的传递从而增加片剂的硬度。完全干燥的颗粒弹性大、塑性小，难以压成片，适量水分的存在能够增加脆碎粒子的塑性变形，减少弹性增强片剂硬度。但颗粒的含水量太高，在压片过程中既容易黏冲，同时会影响颗粒的流动性。中药浸膏及其制剂吸湿现象的解决是保证制剂质量稳定的关键。不同的品种成分不同，吸湿性也存在较大差异，这就要求药学工作者在生产实践中研究选择出最佳的生产工艺，同时控制生产车间的相对湿度和较好的防潮包装，这样中药浸膏及其制剂的吸湿问题定会迎刃而解。中药浸膏粉吸湿的可能性机制包括:药物中存在能与水分子中极性轻基形成氢键的极性基团，尤其是其中的活性经基；水分子与中药浸膏粉体之间通过分子间作用力相互吸引，水分子吸附在中药浸膏粉体表面；通过毛细管吸附作用，水分吸附和储存于粉体的孔隙中；由于中药浸膏粉中化学物质通常为无定型态，极易吸湿形成水合物，吸收水分后由无水晶型转变为水合晶型。
据报道，东方病毒清胶囊提取工艺制得的浸膏粉流动性差、吸潮性大。用微晶纤维素、淀粉及处方中黄芩细粉为辅料，分别与浸膏粉按不同比例混合，其中浸膏粉与淀粉为1:1的处方较大程度地改善了吸湿性，其临界相对湿度为60.5%，所以，要求生产车间的相对湿度控制在60% 以下，为生产控制车间湿度提供了理论依据。在40℃，相对湿度75% 的条件下，用不同辅料对吸潮性较强的中药浸膏制成冲剂后进行研究，通过测定吸湿百分率和临界相对湿度，结果表明：单独用乳糖作为辅料制成的冲剂，一旦吸湿则不能维持冲剂的颗粒状。虽然微晶纤维素的吸湿程度稍大于乳糖，但易制粒，吸湿后颗粒虽变软，却仍能维持颗粒状，故微晶纤维素对于吸湿的浸膏应是首选的辅料。为改善丹参冲剂的吸湿性，分别考察单一辅料(分别为可溶性淀粉、蔗糖、糊精、乳糖）和两种辅料(分别为乳糖和可溶性淀粉、乳糖和蔗糖、乳糖和糊精、 乳糖和羧甲基淀粉钠、乳糖和甘露醇）对其吸湿性的影响。结果表明，单一辅料的吸湿程度顺序为乳糖、蔗糖、可溶性淀粉、糊精，乳糖最不易吸湿；两种辅料的吸湿程度顺序为乳糖与甘露醇、乳糖与蔗糖、乳糖与可溶性淀粉、乳糖与糊精、乳糖与羧甲基淀粉钠，乳糖与甘露醇最不易吸湿。消炎胶囊内容物用淀粉和PVP作为辅料，不仅可使吸湿率降低27.3%，且辅料用量也符合要求。肝炎宁胶囊为全浸膏制剂，易吸潮。制备干浸膏后，粉碎，加入液体石蜡，混匀，在相对湿度45% 容器内考察吸湿率。结果表明，液体石蜡的用量为2% 较适宜，加入了液体石蜡达到了降低吸湿的效果。 用西番莲的40％乙醇提取浸膏进行喷雾干燥时，加入硅胶(Aerosil200） 作为干燥剂辅助剂，具有一定的防吸湿作用，且不影响药物活性。
发明内容
本发明目的就是为了弥补已有技术的缺陷，提供一种治疗小儿夜啼中药半浸膏膜衣片。
本发明是通过以下技术方案实现的：
一种治疗小儿夜啼中药半浸膏膜衣片，它是由下述组分及其重量份制成：
茯苓15-17、甘草25-30、白术15-17、麦门冬15-17、木香15-17、酸枣仁25-30、川芎10-12、当归20-23、五倍子25-30、苹果醋25-30、白芷20-23、荆芥13-15、丹皮13-15、藕粉30-35、蔗糖13-15。
所述的一种治疗小儿夜啼中药半浸膏膜衣片，是由下列步骤制成的：
1）、分别将甘草、白术、麦门冬、木香、川芎、当归、五倍子、白芷、荆芥、丹皮清洗干净，混合加入苹果醋和30-35倍量水，浸泡30-35分钟，加热煮沸，转文火熬煮1.5-2.5小时，过滤收集提取液，注入同样水再次提取，合并两次提取液，然后加热浓缩；
2）、将茯苓、酸枣仁、藕粉、蔗糖混合磨粉，与步骤1所得提取物放入料筒内，启动程序，使物料在料筒内呈沸腾状态，设定调节进风温度85-90℃，雾化压力0.10-0.12MPa，物料温度51-53℃，风机流量120-140 M3•h－1，供液泵转速15-20r•min－1，待物料温度至51-53℃，开始喷黏合浆液，控制颗粒长大程度，直到获得大小均匀圆整、适合压片要求的颗粒为止；
3）、将步骤2所得湿颗粒于热风循环干燥箱内，于60-65℃干燥25-30分钟，出料，过14-20目筛，冷却至室温；
4）、将步骤3所得物混合加入质量分数1.5-1.7%的微粉硅胶、1.5-2%甘松挥发油、1.5-1.7%滑石粉混合均匀，再加入1.9-2.0倍量60-75%乙醇为湿润剂，在相对湿度50-60%的环境下，调节压力为0.45-0.50MPa，进行压片，每片质量控制在12.5-13g，制得浸膏片；
5）、将步骤4所得浸膏片进行浓度为5-5.5%的HPMC薄膜包衣，分装，密封保存。
本发明的优点是：
本法明的一种治疗小儿夜啼中药半浸膏膜衣片，压片总混时加滑石粉，可显著改善颗粒的流动性；颗粒中水分在冲模对颗粒进行压缩时被挤压到颗粒的表面形成薄膜，形成的薄膜可起润滑作用改善压力的传递，从而增加片剂的硬度；表面改性技术降低中药提取物的吸湿性，改善中药提取物不良嗅味，提高中药挥发油的稳定性，降低中药有效部位的黏膜刺激性等；半浸膏的形态处于干粉与流动液体之间，一方面增强可塑性和粘附性，使方便制粒、压片，另一方面增强药物稳定性。
本方中酸枣仁，味甘，平，入心、脾、肝经，宁心安神，敛汗生津，治疗失眠，适用于血虚而致的心烦，不眠，配以茯苓补益气血；川芎，辛，温，归肝、胆、心包经，有活血祛瘀、行气止痛的作用，与当归合用增强活血、行瘀、止痛之效；白术，味甘、苦、微温，入脾、胃经，补中益气，健脾和胃，燥湿利水，配当归、川穹治疗脾胃虚寒泄泻，配以木香健胃消食，止泻除满，增进食欲；五倍子，味酸，平，除痰饮咳嗽，生津止渴，解热，敛肺止血化痰；丹皮，味苦、辛、寒，入心、肝、肾经，清热凉血，活血散瘀。针对小儿夜啼进行多方位的调理，增强睡眠质量，宁心安神，健脾和胃，行气活血。
具体实施方式
一种治疗小儿夜啼中药半浸膏膜衣片，它是由下述组分及其重量份制成：
茯苓15、甘草25、白术15、麦门冬15、木香15、酸枣仁25、川芎10、当归20、五倍子25、苹果醋25、白芷20、荆芥13、丹皮13、藕粉30、蔗糖13。
所述的一种治疗小儿夜啼中药半浸膏膜衣片，是由下列步骤制成的：
1）、分别将甘草、白术、麦门冬、木香、川芎、当归、五倍子、白芷、荆芥、丹皮清洗干净，混合加入苹果醋和30倍量水，浸泡30分钟，加热煮沸，转文火熬煮1.5小时，过滤收集提取液，注入同样水再次提取，合并两次提取液，然后加热浓缩；
2）、将茯苓、酸枣仁、藕粉、蔗糖混合磨粉，与步骤1所得提取物放入料筒内，启动程序，使物料在料筒内呈沸腾状态，设定调节进风温度85℃，雾化压力0.10MPa，物料温度51℃，风机流量120 M3•h－1，供液泵转速15r•min－1，待物料温度至51℃，开始喷黏合浆液，控制颗粒长大程度，直到获得大小均匀圆整、适合压片要求的颗粒为止；
3）、将步骤2所得湿颗粒于热风循环干燥箱内，于60℃干燥25分钟，出料，过14目筛，冷却至室温；
4）、将步骤3所得物混合加入质量分数1.5%的微粉硅胶、1.5%甘松挥发油、1.5%滑石粉混合均匀，再加入1.9倍量60%乙醇为湿润剂，在相对湿度50%的环境下，调节压力为0.45MPa，进行压片，每片质量控制在12.5g，制得浸膏片；
5）、将步骤4所得浸膏片进行浓度为5%的HPMC薄膜包衣，分装，密封保存。
Claims (2)
1.一种治疗小儿夜啼中药半浸膏膜衣片，其特征在于它是由下述组分及其重量份制成：
茯苓15-17、甘草25-30、白术15-17、麦门冬15-17、木香15-17、酸枣仁25-30、川芎10-12、当归20-23、五倍子25-30、苹果醋25-30、白芷20-23、荆芥13-15、丹皮13-15、藕粉30-35、蔗糖13-15。
2.根据权利要求1所述的一种治疗小儿夜啼中药半浸膏膜衣片，其特征在于是由下列步骤制成的：
1）、分别将甘草、白术、麦门冬、木香、川芎、当归、五倍子、白芷、荆芥、丹皮清洗干净，混合加入苹果醋和30-35倍量水，浸泡30-35分钟，加热煮沸，转文火熬煮1.5-2.5小时，过滤收集提取液，注入同样水再次提取，合并两次提取液，然后加热浓缩；
2）、将茯苓、酸枣仁、藕粉、蔗糖混合磨粉，与步骤1所得提取物放入料筒内，启动程序，使物料在料筒内呈沸腾状态，设定调节进风温度85-90℃，雾化压力0.10-0.12MPa，物料温度51-53℃，风机流量120-140 M3•h－1，供液泵转速15-20r•min－1，待物料温度至51-53℃，开始喷黏合浆液，控制颗粒长大程度，直到获得大小均匀圆整、适合压片要求的颗粒为止；
3）、将步骤2所得湿颗粒于热风循环干燥箱内，于60-65℃干燥25-30分钟，出料，过14-20目筛，冷却至室温；
4）、将步骤3所得物混合加入质量分数1.5-1.7%的微粉硅胶、1.5-2%甘松挥发油、1.5-1.7%滑石粉混合均匀，再加入1.9-2.0倍量60-75%乙醇为湿润剂，在相对湿度50-60%的环境下，调节压力为0.45-0.50MPa，进行压片，每片质量控制在12.5-13g，制得浸膏片；
5）、将步骤4所得浸膏片进行浓度为5-5.5%的HPMC薄膜包衣，分装，密封保存。
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