CN106309397A - 一种治疗小儿腹泻伤食泻组方半浸膏膜衣片及其制备方法 - Google Patents
一种治疗小儿腹泻伤食泻组方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腹泻伤食泻组方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:山楂25‑30、神曲6‑7、制半夏6‑7、莱菔子6‑7、陈皮13‑15、麦芽9‑10、茯苓5‑6、连翘10‑12、紫苏籽5‑6、蜂蜜25‑30、艾叶5‑6、杏仁5‑6、白扁豆5‑6。本发明的一种治疗小儿腹泻伤食泻组方半浸膏膜衣片针对小儿腹泻、伤食泻进行多方面调理,健脾、行气、燥湿化痰,具有较好的保健作用,且其适口性较好。
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腹泻伤食泻组方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,提供一种治疗小儿腹泻伤食泻组方半浸膏膜衣片。
本发明是通过以下技术方案实现的:
一种治疗小儿腹泻伤食泻组方半浸膏膜衣片,它是由下述组分及其重量份制成:
山楂25-30、神曲6-7、制半夏6-7、莱菔子6-7、陈皮13-15、麦芽9-10、茯苓5-6、连翘10-12、紫苏籽5-6、蜂蜜25-30、艾叶5-6、杏仁5-6、白扁豆5-6。
所述的一种治疗小儿腹泻伤食泻组方半浸膏膜衣片,是由下列步骤制成的:
1)、分别将制半夏、莱菔子、陈皮、麦芽、茯苓、连翘、紫苏籽、艾叶清洗干净,混合加入蜂蜜和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)、将山楂、神曲、杏仁、白扁豆混合磨粉,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:
本发明的一种治疗小儿腹泻伤食泻组方半浸膏膜衣片,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,通过表面改性技术把滑石粉、微粉硅胶以及甘松挥发油包覆在干的颗粒表面,从而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,并通过控制相对湿度,以有效防止颗粒吸湿而导致压片黏冲、薄膜衣片吸湿,导致衣膜变软等问题。
本发明的一种治疗小儿腹泻伤食泻组方半浸膏膜衣片,方中艾叶,味辛、苦、温,入肝、脾、肾经,散寒温,理气血;陈皮,味苦、辛、温,入脾、肝经,理气健脾,燥湿化痰,主治胸腹胀满、消化不良,配半夏更能加强燥湿化痰作用,配以麦芽化积消食;神曲,味辛、甘、温,入脾、胃经,行气消食,健脾开胃,与陈皮互为加强治疗伤食腹泻,配以山楂健胃消食、增强食欲;莱菔子,味甘、辛、平,入肺、脾经,降气定喘,化痰,消积,辅以紫苏籽强化理气;白扁豆,补脾胃,化暑湿,解毒,用于健脾,治慢性腹泻。本发明针对小儿腹泻、伤食泻进行多方面调理,健脾、行气、燥湿化痰,具有较好的保健作用,且其适口性较好。
具体实施方式
一种治疗小儿腹泻伤食泻组方半浸膏膜衣片,它是由下述组分及其重量份制成:
山楂25、神曲6、制半夏6、莱菔子6、陈皮13、麦芽9、茯苓5、连翘10、紫苏籽5、蜂蜜25、艾叶5、杏仁5、白扁豆5。
所述的一种治疗小儿腹泻伤食泻组方半浸膏膜衣片,是由下列步骤制成的:
1)、分别将制半夏、莱菔子、陈皮、麦芽、茯苓、连翘、紫苏籽、艾叶清洗干净,混合加入蜂蜜和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)、将山楂、神曲、杏仁、白扁豆混合磨粉,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)
1.一种治疗小儿腹泻伤食泻组方半浸膏膜衣片,其特征在于它是由下述组分及其重量份制成:
山楂25-30、神曲6-7、制半夏6-7、莱菔子6-7、陈皮13-15、麦芽9-10、茯苓5-6、连翘10-12、紫苏籽5-6、蜂蜜25-30、艾叶5-6、杏仁5-6、白扁豆5-6。
2.根据权利要求1所述的一种治疗小儿腹泻伤食泻组方半浸膏膜衣片,其特征在于是由下列步骤制成的:
1)、分别将制半夏、莱菔子、陈皮、麦芽、茯苓、连翘、紫苏籽、艾叶清洗干净,混合加入蜂蜜和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)、将山楂、神曲、杏仁、白扁豆混合磨粉,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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