CN116726104B - 一种防治放射性口腔黏膜炎的中药组合物及其制备方法 - Google Patents
一种防治放射性口腔黏膜炎的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明涉及中药组合物，具体涉及一种防治放射性口腔黏膜炎的中药组合物及其制备方法，所述中药组合物，包括以下组分：岗梅根20‑25g、石膏10‑15g、熟地黄15‑20g、知母5‑10g、玄参10‑15g、川牛膝5‑10g、生甘草5‑10g。所述中药组合物的制备方法，包括下述步骤：按配方量称取岗梅根、石膏、熟地黄、知母、玄参、川牛膝和生甘草；称取的药物用水熬制成中药水剂；将中药水剂过滤后包装成袋。本发明的中药组合物可预防和治疗放射性口腔黏膜炎，而且刺激小、无依赖性，减轻患者疼痛，改善其生活质量。
Description
技术领域
本发明涉及中药及其制备方法，更具体地说，涉及一种用于防治放射性口腔黏膜炎的中药组合物。本发明还涉及该中药组的制备方法。
背景技术
头颈部肿瘤高发于华南、西南各省，是影响我国居民健康的十大恶性肿瘤之一。放射治疗是其首选治疗方法，5年生存率为80% 。但是放射治疗会不可避免地损伤正常组织和器官，引起各种放射性损伤。放射性口腔黏膜炎 (Radiotherapy-inducedoralmucositis，RTOM)是鼻咽癌患者放射治疗过程中最常见的不良反应，发生率为46%~78. 1%。RTOM不仅造成患者疼痛、进食困难和营养不良，而且造成口腔感染，部分患者甚至因此中断放射治疗，导致住院时间延长，影响患者的生活质量。
目前尚未有特效药用于治疗放射性口腔黏膜炎，治疗措施以供给营养、控制疼痛、预防继发感染为主，疗效欠佳。
发明内容
针对上述技术问题，本发明的第一个目的在于提供一种用于防治放射性口腔黏膜炎的中药组合物，该中药组合物可预防和治疗放射性口腔黏膜炎，而且刺激小、无依赖性，减轻患者疼痛，改善其生活质量。
本发明的第二个目的在于提供一种用于防治放射性口腔黏膜炎的中药组合物的制备方法，该方法制备的组合物疗效好，且方便保存和携带。
本发明第一个目的通过以下技术方案来实现：一种防治放射性口腔黏膜炎的中药组合物，包括以下组分：岗梅根20-25g、石膏10-15g 、熟地黄15-20g 、知母5-10g 、玄参10-15g 、川牛膝5-10g 、生甘草5-10g。
进一步地，所述的中药组合物包括以下组分：岗梅根22-25g、石膏12-15g 、熟地黄15-18g 、知母5-10g 、玄参10-15g 、川牛膝8-10g 、生甘草5-8g。
进一步地，所述的中药组合物包括以下组分：岗梅根24g、石膏15g 、熟地黄15g 、知母9g 、玄参12g 、川牛膝9g 、生甘草6g。
本发明的第二个目的通过以下技术方案来实现：上述中药组合物的制备方法，包括下述步骤：
(1)按配方量称取岗梅根、石膏、熟地黄、知母、玄参、川牛膝 和生甘草；
(2)将步骤(1)中称取的药物用水熬制成中药水剂；
(3)将中药水剂过滤后包装成袋。
进一步地，所述步骤(2)中，熬制的时间为10~15分钟。
与现有技术相比，本发明具有的有益效果为：
1.本发明的一种防治放射性口腔黏膜炎的中药组合物，可预防和治疗放射性口腔黏膜炎，而且刺激小、无依赖性，改善其生活质量。
2.本发明的中药组合物能够改善辐射的火毒之邪，对放疗导致的黏膜损伤起到防护作用。与放疗能够互相取长补短，***的同时，减少治疗带来的毒副作用，以提高患者免疫力，减轻患者放疗后的副反应与痛苦。
岗梅根为岭南道地药材，冬青科植物的根及茎；性味苦、甘、凉，归肺、脾、胃经。清热解毒，生津止渴，利口消肿，散瘀止痛为君药，针对鼻咽癌放疗后的病因病机特点起作用。石膏辛甘大寒以清泄胃火，熟地黄甘温以滋肾补阴，为臣药；二药合用，清火而滋水，虚实兼顾。知母助石膏清胃火；玄参助熟地黄滋肾阴，清虚火，共为佐药。牛膝引血热下行，兼补肝肾，为佐使药。本方能清能补，标本兼顾，以清为主，使胃热得清，肾阴得补，则诸证自愈。诸药合用，以达到治疗放射性口腔黏膜炎之目的。
3.本发明的中药组合物的制备方法，以适当时间进行熬煮，更有利于保留原料中的药物成分，制备的组合物方便携带和保存。
实施方式
下面结合具体实施方式，对本发明的技术方案作进一步的详细说明，但不构成对本发明的任何限制。
实施例1
称取岗梅根20g、石膏10g 、熟地黄15g 、知母10g 、玄参15g 、川牛膝10g 、生甘草10g，倒入锅中，文火熬制10分钟，熬成约200mL的中药水剂，再用50-80目筛网过滤去除滤渣，将水剂成袋装好，放于冰箱保存。
实施例2
岗梅根25g、石膏15g 、熟地黄18g 、知母5g 、玄参10g 、川牛膝8g 、生甘草5g。
制备方法与实施例1相同。
实施例3
岗梅根24g、石膏15g 、熟地黄15g 、知母9g 、玄参12g 、川牛膝9g 、生甘草6g。
制备方法与实施例1相同。
应用例
为考查本发明中药组合物的功效，选取2021年1月 - 2022年3月放射治疗的鼻咽癌放疗患者20例，按照放疗开始的时间顺序分为奇数组和偶数组，奇数组为对照组，共10例患者，偶数组为实验组共10例患者。两组患者均采用常规根治性放疗。对照组按传统方法护理，使用维生素B12漱口，每日6次。实验组使用实施例3制得的中药组合物进行漱口，含漱时将少量溶液含入口内，紧闭嘴唇，上下牙稍微张开，使液体通过牙间隙区，轻轻加压，然后鼓动两颊及唇部，使溶液能在口腔内充分的接触口腔黏膜表面，同时运动舌，使漱口水能自由地接触口腔的各个部位反复冲洗数次。然后把头仰起漱15s左右，然后吐出。含漱时间；每日6次 (早午晚餐前后) ，每次持续3-5分钟，每次30-40mL。
放疗后开始使用，每周观察两组发生放射性口腔黏膜的程度。干预前，两组性别、年龄，用药方案、剂量、周期有可比性。干预后结果显示，实验组效果明显优于对照组。具体如表1所示（数据为放疗后第三周做出的统计）：
备注：按照世界卫生组织（WHO）标准将放射性口腔黏膜炎分为5级。0级：黏膜正常无变化；1级：黏膜有充血现象，伴轻微疼痛感，不影响进食；2级：黏膜呈片状炎症，伴炎性血清分泌物，中度疼痛，可进半流质饮食；3级：黏膜呈融合性纤维片状，明显严重，伴有重度疼痛，只能进流质饮食；4级：黏膜有出血、溃疡及坏死表现，进食困难。
表1 对照组与实验组疗效比较
| 分级 组别 | 0级放射性口腔黏膜炎 | 1级放射性口腔黏膜炎 | 2级放射性口腔黏膜炎 | 3级放射性口腔黏膜炎 | 4级放射性口腔黏膜炎 |
| 对照组（n=10） | 0 | 0 | 4 | 6 | 0 |
| 实验组（n=10） | 1 | 3 | 6 | 0 | 0 |
可见，本发明所制备的中药组合物能起到预防口腔黏膜炎的作用，也能够很大程度地促进口腔的愈合或者减小，大部分患者在治疗过程中能够正常进食，小部分患者可以进半流食。
另外，在放疗期间每周对患者进行口腔黏膜炎分级、疼痛评分、口腔情况评价标准评估（OAG），放疗后三个月内每周随访一次，口腔黏膜炎分级、疼痛评分、口腔情况评价标准、口腔黏膜愈合时间。
与对照组相比，实验组患者开始出现口腔黏膜炎时间延后，平均发病时间为14.80±0.84天，而对照组平均发病时间为12.40+ 1.82天，P＜0.05；实验组患者口腔OAG评分(12.20±2.28) 要显著低于对照组 (17.20± 1.30) ，P＜0.01，本发明的中药组合物能一定程度上减轻患者口腔黏膜炎严重程度；且实验组患者平均口腔黏膜炎恢复到1级以下时间 (38.80±2. 17) 要远短于对照组患者 (45.60± 1.94) ，P＜0.01 。
由此可见，使用本申请的中药组合物含漱能使患者放射性口腔黏膜炎的发生率降低，延缓患者放疗后口腔黏膜炎出现时间，并加快创面愈合速度，还能提高患者的生活质量。。
Claims (5)
1.一种防治放射性口腔黏膜炎的含漱中药组合物，其特征在于，由以下组分制成：岗梅根20-25g、石膏10-15g 、熟地黄15-20g 、知母5-10g 、玄参10-15g 、川牛膝5-10g 、生甘草5-10g。
2.根据权利要求1所述的一种防治放射性口腔黏膜炎的含漱中药组合物，其特征在于，由以下组分制成：岗梅根22-25g、石膏12-15g 、熟地黄15-18g 、知母5-10g 、玄参10-15g 、川牛膝8-10g 、生甘草5-8g。
3.根据权利要求1或2所述的一种防治放射性口腔黏膜炎的含漱中药组合物，其特征在于，由以下组分制成：岗梅根24g、石膏15g 、熟地黄15g 、知母9g 、玄参12g 、川牛膝9g 、生甘草6g。
4.权利要求1-3任一项所述的一种防治放射性口腔黏膜炎的含漱中药组合物的制备方法，其特征在于，包括下述步骤：
(1)按配方量称取岗梅根、石膏、熟地黄、知母、玄参、川牛膝 和生甘草；
(2)将步骤(1)中称取的药物用水熬制成中药水剂；
(3)将中药水剂过滤后包装成袋。
5.根据权利要求4所述的用于防治放射性口腔黏膜炎的含漱中药组合物的制备方法，其特征在于，所述步骤(2)中，熬制的时间为10~15分钟。
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| CN104800369A (zh) * | 2015-04-15 | 2015-07-29 | 苏州市天灵中药饮片有限公司 | 一种治疗口腔溃疡的中药水剂及其制备方法 |
| CN105213807A (zh) * | 2015-10-30 | 2016-01-06 | 王栩 | 用于治疗阴虚火旺型复发性口腔溃疡的药物 |
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