CN106266551A - 一种治疗慢性鼻窦炎组方半浸膏膜衣片及其制备方法 - Google Patents

一种治疗慢性鼻窦炎组方半浸膏膜衣片及其制备方法 Download PDF

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CN106266551A
CN106266551A CN201610897091.2A CN201610897091A CN106266551A CN 106266551 A CN106266551 A CN 106266551A CN 201610897091 A CN201610897091 A CN 201610897091A CN 106266551 A CN106266551 A CN 106266551A
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radix
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chronic sinusitis
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赵元英
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Bozhou City Poly Pharmaceutical Sales Co Ltd
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Abstract

本发明公开了一种治疗慢性鼻窦炎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：麦门冬15‑17、礞石15‑17、知母13‑15、黄芩13‑15、栀子13‑15、辛夷10‑12、枇杷叶10‑12、桔根15‑17、野菊花13‑15、藿香叶10‑12、三七13‑15、米酒23‑25、荆芥籽5‑6、枣仁10‑12。本发明的一种治疗慢性鼻窦炎组方半浸膏膜衣片，所含有效成分具有清肝热、抗炎消肿、利尿解毒等功效，对于慢性鼻窦炎，具有标本兼治的功效。

Description

一种治疗慢性鼻窦炎组方半浸膏膜衣片及其制备方法
技术领域
本发明涉及中药组方技术领域，尤其涉及一种治疗慢性鼻窦炎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，提供一种治疗慢性鼻窦炎组方半浸膏膜衣片。
本发明是通过以下技术方案实现的：
一种治疗慢性鼻窦炎组方半浸膏膜衣片，它是由下述组分及其重量份制成：
麦门冬15-17、礞石15-17、知母13-15、黄芩13-15、栀子13-15、辛夷10-12、枇杷叶10-12、桔根15-17、野菊花13-15、藿香叶10-12、三七13-15、米酒23-25、荆芥籽5-6、枣仁10-12。
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）、分别将麦门冬、黄芩、栀子、辛夷、枇杷叶、桔根、野菊花、藿香叶、三七、荆芥籽清洗干净，混合加入米酒和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）、将知母、礞石、枣仁混合磨粉，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：
本发明的一种治疗慢性鼻窦炎组方半浸膏膜衣片，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，而HPMC薄膜包衣进一步达到抗吸湿、塑性的作用，HPMC具有优良的成膜性、以及广泛的耐酶性、分散性，透明性高，无热量，对皮肤、黏膜接触无刺激。
本发明的一种治疗慢性鼻窦炎组方半浸膏膜衣片，方中黄芩，苦寒，入肺、脾、胆、大小肠径，主治肺热咳嗽，血热妄行，湿热下痢，配以麦门冬、枣仁治疗肺热咳嗽，与藿香叶、荆芥籽同用，化湿脾、理气和胃；栀子，苦寒，入心、肝、肺、胃经，清热降火，除烦利尿，凉血解毒，搭以黄芪托毒，减少毒素吸收；野菊花，甘、苦、微寒，入肺、肝经，疏风除热，清肝明目，与黄岑搭配，清热降压，有助于消除头痛、失眠等症状，与栀子共施清肝热之功；三七，甘、微苦、温，入肝、胃经，止血化瘀、消肿止血。
具体实施方式
一种治疗慢性鼻窦炎组方半浸膏膜衣片，它是由下述组分及其重量份制成：
麦门冬15、礞石15、知母13、黄芩13、栀子13、辛夷10、枇杷叶10、桔根15、野菊花13、藿香叶10、三七13、米酒23、荆芥籽5、枣仁10。
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）、分别将麦门冬、黄芩、栀子、辛夷、枇杷叶、桔根、野菊花、藿香叶、三七、荆芥籽清洗干净，混合加入米酒和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）、将知母、礞石、枣仁混合磨粉，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)

1.一种治疗慢性鼻窦炎组方半浸膏膜衣片，其特征在于它是由下述组分及其重量份制成：
麦门冬15-17、礞石15-17、知母13-15、黄芩13-15、栀子13-15、辛夷10-12、枇杷叶10-12、桔根15-17、野菊花13-15、藿香叶10-12、三七13-15、米酒23-25、荆芥籽5-6、枣仁10-12。
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）、分别将麦门冬、黄芩、栀子、辛夷、枇杷叶、桔根、野菊花、藿香叶、三七、荆芥籽清洗干净，混合加入米酒和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）、将知母、礞石、枣仁混合磨粉，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。
CN201610897091.2A 2016-10-14 2016-10-14 一种治疗慢性鼻窦炎组方半浸膏膜衣片及其制备方法 Pending CN106266551A (zh)

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101112509A (zh) * 2007-08-17 2008-01-30 仲鹏 一种内服治疗慢性鼻窦炎的中药组合物

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101112509A (zh) * 2007-08-17 2008-01-30 仲鹏 一种内服治疗慢性鼻窦炎的中药组合物

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张源，等: "中药半浸膏薄膜衣片的成型工艺考察", 《中国实验方剂学杂志》 *

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