CN110585296A - 治疗慢性鼻-鼻窦炎的中药滴鼻剂及其制备方法 - Google Patents
治疗慢性鼻-鼻窦炎的中药滴鼻剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗慢性鼻‑鼻窦炎的中药滴鼻剂及其制备方法，中药滴鼻剂包括辛夷、白芷、鱼腥草、丝瓜络、皂角刺、鹅不食草、川芎、麻黄、黄芩、薄荷脑和乳香；制备方法为将辛夷、白芷、鱼腥草、丝瓜络、皂角刺、鹅不食草、川芎、麻黄、黄芩一起浸泡在麻油中，再于文火中加热，待药材炸成黄褐色时捞出，静置，过滤，将薄荷脑和乳香共研，加入液体石蜡，搅匀，过滤后与前步麻油混合均匀即得。本发明滴鼻剂纯中药配制，组份科学、合理配伍，具有疏风清热、利水消肿、芳香通窍、活血止痛之功效；制备方法简单，副作用小，价格便宜，疗效显著，临床治愈率达89%。
Description
技术领域
本发明属于中药制剂领域，具体涉及一种治疗慢性鼻-鼻窦炎的中药滴鼻剂及其制备方法。
背景技术
慢性鼻-鼻窦炎是一种较为常见的临床疾病，临床治疗效果不尽如人意。在中医学领域，该病应归属为“头风”、“鼻渊”等范畴。在《素问·气厥论》中就有关于该病的相关记载，其中有“胆移热于脑”的说法。慢性鼻窦炎多发于青少年群体，并且近年来患病人数明显增多，患者发病后会有明显的头痛、闭塞、流涕等症状，且患者易反复发作，不易完全治愈，患者病情进展严重时可能出现精神不佳、记忆力衰退等严重后果，给患者的正常生活造成严重的影响。传统西医治疗中一般采用抗生素、糖皮质激素等方式，严重者施手术治疗，但是治疗效果并不显著。中医治疗慢性鼻-鼻窦炎方法多样，疗效确切且副作用少，但多是口服制剂，因此，发明一种治疗慢性鼻-鼻窦炎的中药外用势在必行。
发明内容
本发明是为了克服现有技术中存在药物副作用大，服用不方便的缺点而提出的，其目的是提供一种治疗慢性鼻-鼻窦炎的中药滴鼻剂及其制备方法。
本发明的技术方案是：
一种治疗慢性鼻-鼻窦炎的中药滴鼻剂，所述中药滴鼻剂包含的组分和各组分的质量份数为：
辛夷 25 ~30份；
白芷 25~30份；
鱼腥草 15~20份；
丝瓜络 18~25份；
皂角刺 10~15份；
鹅不食草 18~25份；
川芎 10~15份；
麻黄 8~12份；
黄芩 10~15份；
薄荷脑 3~6份；
乳香 6~8份。
一种治疗慢性鼻-鼻窦炎的中药滴鼻剂的制备方法，包括以下步骤：
（ⅰ）将辛夷、白芷、鱼腥草、丝瓜络、皂角刺、鹅不食草、川芎、麻黄和黄芩一起浸泡在650~750ml麻油中48小时，再于文火中加热，待药材炸成黄褐色时捞出，静置，过滤后保留麻油；
（ⅱ）将薄荷脑和乳香一起研磨，使之液化，加入液体石蜡500~600mL，搅匀，过滤，得到混液；
（ⅲ）将步骤（ⅰ）所得麻油和步骤（ⅱ）所得混液混合均匀，即得治疗慢性鼻-鼻窦炎的中药滴鼻剂。
本发明的有益效果是：
本发明提供了一种治疗慢性鼻-鼻窦炎的中药滴鼻剂及其制备方法，滴鼻剂纯中药配制，组份科学、合理配伍，具有疏风清热、利水消肿、芳香通窍、活血止痛之功效；制备方法简单，副作用小，价格便宜，疗效显著，临床治愈率达89%。
具体实施方式
下面结合实施例对本发明治疗慢性鼻-鼻窦炎的中药滴鼻剂及其制备方法进行详细说明：
实施例1
一种治疗慢性鼻-鼻窦炎的中药滴鼻剂的制备方法，称取辛夷25g、白芷25g、鱼腥草15g、丝瓜络18g、皂角刺10g、鹅不食草18g、川芎10g、麻黄8g和黄芩10g，一起浸泡在650mL麻油中48小时，再用文火中加热，待药材炸成黄褐色时捞出，静置，过滤，保留含有药材萃取物的麻油；称取薄荷脑3g和乳香6g共研，使之液化，加入液体石蜡500ml，搅匀，过滤后与上步所得麻油混合均匀，即得中药滴鼻剂。
实施例2
一种治疗慢性鼻-鼻窦炎的中药滴鼻剂的制备方法，称取辛夷28g、白芷28g、鱼腥草18g、丝瓜络22g、皂角刺12g、鹅不食草22g、川芎12g、麻黄10g和黄芩12g，一起浸泡在700ml麻油中48小时，再用文火中加热，待药材炸成黄褐色时捞出，静置，过滤，保留含有药材萃取物的麻油；称取薄荷脑4.5g和乳香7g共研，使之液化，加入液体石蜡550ml，搅匀，过滤后与上步所得麻油混合均匀，即得中药滴鼻剂。
实施例3
一种治疗慢性鼻-鼻窦炎的中药滴鼻剂的制备方法，称取辛夷30g、白芷30g、鱼腥草20g、丝瓜络25g、皂角刺15g、鹅不食草25g、川芎15g、麻黄12g和黄芩15g，一起浸泡在750ml麻油中48小时，再用文火中加热，待药材炸成黄褐色时捞出，静置，过滤，保留含有药材萃取物的麻油；称取薄荷脑6g和乳香8g共研，使之液化，加入液体石蜡600ml，搅匀，过滤后与上步所得麻油混合均匀，即得中药滴鼻剂。
将实施例1所得的中药滴鼻剂进行临产实验验证。
一、实验对象
将实施例1所得的中药滴鼻剂应用于确诊为慢性鼻鼻窦炎的102例患者，上述患者参照《慢性鼻鼻窦炎诊断和治疗指南》（2012年，昆明）诊断、病例选择标准。病人按确诊顺序奇偶数被分为两组，治疗组57例，其中男28例，女29例；平均年龄（33.8±5.1）岁；对照组55例，其中男27例，女28例；平均年龄（33.6±4.9）岁。
二、治疗方案
对照组：口服抗生素（头孢克肟颗粒，商品名：世福素，广州白云山医药集团股份有限公司白云山制药总厂，50mg/袋，国药准字H10940128，按说明书和体质量用药）1周。
桉柠薇肠溶软胶囊：商品名：切诺；规格：0.3g；批准文号：国药准字；H20052401，生产企业：北京九和药业有限公司
治疗组：在对照组的基础上，给予本发明中药滴鼻剂，每日三次，7d为一个疗程。使用方法：仰卧在床上，头垂下床沿，尽量后仰，鼻孔与天花板成垂直，每侧鼻孔2滴，滴完后，轻轻捏鼻翼，使其药液涂匀于鼻粘膜，静躺1min，即可起身。
三、临床观标指标
症状体征量化计分标准（参考2002版《中药新药临床研究指导原则》制定。
（１）主症及次症为鼻涕（鼻腔分泌物）、鼻塞、头痛或头昏、嗅觉减退等症状的改变。
（２）体征：鼻甲肿胀程度；鼻内镜检查或鼻窦CT改变。
其中主症及体征评分记为0分、2分、4分或者6分，次症评分记为0分、1分、2分或者3分。
（3）慢性鼻-鼻窦炎主观病情的评估：使用症状视觉模拟量表（visual analoguescale,VAS），将病情程度按视觉模拟量表进行量化，从最轻度的０分，到最难忍受的10分进行评分。
根据患者的病情严重度判定：轻度0~3分；中度＞3~7分；重度＞7~10分。VAS是患者对病情严重度的主观评价指标。
四、疗效评价标准
参照《中医耳鼻咽喉科常见病诊疗指南》（2012年）和《中药新药临床研宄指导原则》制定：
疗效指数Ｎ=［（治疗前积分-治疗后积分）/治疗前积分）］*100%。
临床治愈：治疗后鼻涕（鼻腔分泌物）鼻塞、头痛或头昏、嗅觉减退不显，鼻甲无明显肿胀，疗效指数Ｎ≥90%；
显效：治疗后鼻涕（鼻腔分泌物）、鼻塞、头痛或头昏、嗅觉减退症状明显改善，鼻甲肿胀程度明显减轻，疗效指数66.67%≤Ｎ＜90%；
有效：治疗后鼻涕（鼻腔分泌物）、鼻塞、头痛或头昏、嗅觉减退症状较前有所改善，鼻甲肿胀程度较前有所减轻，疗效指数33.33%≤Ｎ＜66.67%；
无效：治疗后鼻涕（鼻腔分泌物）、鼻塞、头痛或头昏、嗅觉减退症状及鼻甲肿胀程度无明显改变，疗效指数Ｎ＜33.33%。
五、数据统计方法
统计分析采用SPSS24.0。计数资料用卡方检验；组内和组间比较采用ｔ检验；以P＜0.05有统计学意义，P＞0.05无统计学意义。
六、实验结果
结果显示，治疗组显效率为38.60%，总有效率达到92.98%，疗效显著，具体见表1。
表1两组临床疗效比较
| 组别 | 例数 | 显效 | 有效 | 弱效 | 无效 | 显效率（%） | 总有效率（%） |
| 对照组 | 55 | 11 | 18 | 9 | 17 | 21.28 | 69.09 |
| 治疗组 | 57 | 22 | 23 | 8 | 4 | 36.73 | 92.98 |
本发明提供了一种治疗慢性鼻-鼻窦炎的中药滴鼻剂及其制备方法，滴鼻剂纯中药配制，组份科学、合理配伍，具有疏风清热、利水消肿、芳香通窍、活血止痛之功效；制备方法简单，副作用小，价格便宜，疗效显著，临床治愈率达89%。
Claims (2)
1.一种治疗慢性鼻-鼻窦炎的中药滴鼻剂，其特征在于：所述中药滴鼻剂包含的组分和各组分的质量份数为：
辛夷 25 ~30份；
白芷 25~30份；
鱼腥草 15~20份；
丝瓜络 18~25份；
皂角刺 10~15份；
鹅不食草 18~25份；
川芎 10~15份；
麻黄 8~12份；
黄芩 10~15份；
薄荷脑 3~6份；
乳香 6~8份。
2.根据权利要求1所述的治疗慢性鼻-鼻窦炎的中药滴鼻剂的制备方法，其特征在于：包括以下步骤：
（ⅰ）将辛夷、白芷、鱼腥草、丝瓜络、皂角刺、鹅不食草、川芎、麻黄和黄芩一起浸泡在650~750ml麻油中48小时，再于文火中加热，待药材炸成黄褐色时捞出，静置，过滤后保留麻油；
（ⅱ）将薄荷脑和乳香一起研磨，使之液化，加入液体石蜡500~600mL，搅匀，过滤，得到混液；
（ⅲ）将步骤（ⅰ）所得麻油和步骤（ⅱ）所得混液混合均匀，即得治疗慢性鼻-鼻窦炎的中药滴鼻剂。
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| 李春生等: "《家庭妙方治疗百病》", 31 December 1997, 中国青年出版社 * |
| 赵建平等: "通鼻滴剂的制备和临床应用", 《中国医院药学杂志》 * |
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