Current Situation, Existing Problems and Future Development of External Use of Traditional Chinese Medicine
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摘要: 中药外用因其疗效显著、使用方便、不良反应小等原因, 在国内外广受关注, 尤其在国际市场大放异彩, 但在快速发展的同时, 中药外用也存在部分关键性问题。笔者分析了中药外用制剂现状和中药外用的现代临床应用与研究进展, 指出中药外用理论有待完善、缺乏部分规范体系、临床数据分析总结和中药新型外用制剂临床应用等主要问题, 提出了建立指导中药外用的理论系统和规范体系、丰富现有外用中药的功效、组织专业人员对临床数据进行挖掘与归纳分析、加强中药外用平台建设等建议, 以期为中药外用剂型研发和临床安全用药提供参考。Abstract: The external use of traditional Chinese medicine has attracted wide attention at home and abroad because of its remarkable curative effect, convenient use and small adverse reactions, especially in the foreign market. However, with the rapid development, there are some key problems in the external use of traditional Chinese medicine. In this case, based on the analysis of the present situation of external use preparations of traditional Chinese medicine and the modern clinical application and research of external use of traditional Chinese medicine, the author puts forward three main problems existing in external use of traditional Chinese medicine: the theory of external use of traditional Chinese medicine needs to be improved, a lack of partial normative system, clinical data analysis and summary and clinical application of new topical preparations of traditional Chinese medicine. The possible solutions are put forward, that is, to establish a theoretical system and normative system to guide the external use of traditional Chinese medicine, enrich the efficacy of existing external use traditional Chinese medicine, organize professionals to mine, summarize and analyze clinical data, cultivate professionals and strengthen the construction of external use platform of traditional Chinese medicine, so as to provide reference for the research and development of traditional Chinese medicine dosage forms and clinical safe drug use.
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表 1 常用中药外用剂型比较
Table 1. Advantages and disadvantages of external preparations of traditional Chinese medicine
剂型 优点 缺点 代表制剂 汤剂[14] 药效发挥迅速; 制备简单; 应用灵活; 无刺激性。 携带困难; 制备难以形成流水线链条; 不宜长期存储。 蛇床子汤(《医宗金鉴》)、癣湿药水(《中国药典》) 散剂[15] 调配方便、灵活; 可随症增减给药量; 制备简单; 携带方便。 挥发性成分易损失; 剂量难以把握; 易吸潮; 质量难以控制。 二味拔毒散(《医宗金鉴》)、舒筋方(《大小诸证方论》)、云南白药(《中国药典》) 膏剂[16] 载药量高; 药效持久; 易于携带; 便于使用。 吸收显效时间较长; 易霉变, 不易保存。 乌麻膏(《千金翼方》)、黄连膏(《医宗金鉴》)、通络祛痛膏(《中国药典》) 膜剂[17] 精制度高; 药效持久; 工艺简单, 易于掌握; 适合穴位给药; 使用舒适。 载药量小; 部分药物难以吸收; 辅料与制备工艺研发处于发展阶段。 丹参膜、复方青黛散膜、疏痛安涂膜剂(《中国药典》) 栓剂[18] 吸收与起效较快; 局部用药部位药物浓度较高, 疗效更好; 对于口服给药困难患者, 腔道给药更为方便。 生产工艺较为复杂; 质量不够稳定; 给药次数较多。 双黄连栓、消糜栓、麝香痔疮栓(《中国药典》) 喷雾剂[19] 给药方便; 毒副作用小; 便于携带。 工艺提取不纯; 处方配比、质量评价标准不统一; 发展时间短。 复方丹参喷雾剂、鼻炎通喷雾剂(《中国药典》) 靶向制剂[20] 对皮肤损伤小; 促进药物经皮吸收; 对大分子药物具有促渗透作用; 可定位给药。 制剂长期有效性和安全性亟待进一步检验; 靶向制剂载药量普遍较小。 经皮外用靶向炎症部位的透明质酸修饰载姜黄素醇质体[21]、经皮外用靶向黑色素瘤B16细胞的党参总皂苷纳米乳[22] 
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表 2 中药临床外用现状
Table 2. Current situation of clinical external use of traditional Chinese medicine
科别 疾病类型 内科 高血压、痛风、股骨头坏死、甲状腺肿、肝内胆汁淤积症、偏头痛、肺结核并发肝硬化腹水、周围性面瘫、糖尿病肾病、糖尿病性周围神经病变、多囊肾 外科 慢性筋骨病损、轻型髌骨外侧支持带挤压综合征、腰肌劳损、糖尿病足、桡骨茎突狭窄性腱鞘炎、中老年Colles骨折、肩周炎、胫腓骨折术后患肢疼痛肿胀、关节强直、腰椎间盘突出症、退变性腰椎管狭窄、血栓性外痔、烧烫伤、急性软组织损伤、腱鞘炎、跟痛症、肩手综合征、切口脂肪液化、腰三横突综合征、臁疮、急性踝关节扭伤、膝骨性关节炎、类风湿性关节炎 妇科 妇科恶性肿瘤术后淋巴水肿、糖尿病所致的阴疮、慢性盆腔炎、乳腺增生病、外阴瘙痒、外阴白斑、霉菌性阴道炎、女性外阴营养不良、慢性宫颈炎、滴虫性阴道炎、宫颈糜烂、子宫内膜异位症 儿科 婴幼儿鹅口疮、儿童感冒、婴儿湿疹、异位性皮炎、婴幼儿腹泻、小儿鞘膜积液、儿童反复呼吸道感染、小儿流涎、小儿手足口病 皮肤科 银屑病、外阴硬化性苔癣、带状疱疹、白癜风、脂溢性脱发、痤疮、湿疹、荨麻疹、感染性创面及护场、多发性跖疣、黄褐斑、难愈性创面、肛周湿疹、激素依赖性皮炎、扁平疣、下肢慢性溃疡、有头疽、酒渣鼻 耳鼻喉科 过敏性鼻炎、先天性耳前瘘、慢性咽喉炎 其他 宫颈癌、高危型人乳头瘤病毒、尖锐湿疣、癌性疼痛、化疗药物周围神经毒性
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