Jia Wei, Gao Wen-yuan, Wang Tao, Liu Yun-bin, Xue Jing, Xiao Pei-gen
College of Pharmaceutical Science and Technology, Tianjin University, Tianjin 300072, China.
Zhongguo Zhong Yao Za Zhi. 2003 Jan;28(1):7-11.
The TCM (traditional Chinese medicine) transdermal plaster (also known as "cataplasma") are flexible adhesive patches used for treatment of pain, resulted from arthritis, sprain and bruise, tendovaginitis, lumbar spine protrude, neuralgia, hyperosteogeny ache, abdominal discomfort and metastatic cancer, etc. Since the 1980's, investigators in China have used this modern patch delivery system for herbal drugs and obtained satisfactory results especially from the treatment of various types of pain associated with bone diseases, abdominal discomfort, and tumors, etc. The production of TCM cataplasma was successfully scaled up in early 90's and the commercial product line for an antirheumatic agent was first established in Shanghai by Leiyunshang Group. Thus far, a number of products in the form of TCM cataplasma became commercially available in the market, and clinical investigations with these products indicated that topically applicable herbal preparations, especially in the form of cataplasma, are preferred formulations with respect to the treatment comfort of the patient. Compared to the traditional preparations which utilize rubber and rosin as adhesives, cataplasma is advantageous in that the lipophilic and hydrophilic ingredients of the herbal extracts are solubilized and then "gellified" with the organic polymers, and that the drug matrix containing up to 40%-70% of water serves as a "drug reservoir" that will sustain the quick and continuous release of herbal ingredients over several days across the skin. While there are conventional remedies for palliation of pain and discomfort associated with bone diseases or cancers, administration of oral medicinal herbs combined with topical agents such as TCM cataplasma may significantly alleviate the symptoms and improve their quality of life. This article provides a review on three aspects, which include the process development, characteristics and developmental status of TCM cataplasma, and future development of such a technology.
中药透皮贴剂(又称“膏药”)是一种用于治疗因关节炎、扭伤和挫伤、腱鞘炎、腰椎间盘突出、神经痛、骨质增生疼痛、腹部不适及转移性癌症等引起疼痛的柔性粘贴片。自20世纪80年代以来,中国的研究人员已将这种现代贴剂给药系统用于草药,并取得了令人满意的效果,尤其是在治疗与骨病、腹部不适及肿瘤等相关的各类疼痛方面。20世纪90年代初,中药膏药的生产成功实现了规模化,上海雷允上集团率先建立了抗风湿药物的商业化生产线。迄今为止,多种中药膏药产品已投放市场,对这些产品的临床研究表明,局部应用的草药制剂,尤其是膏药形式,在患者治疗舒适度方面是首选剂型。与以橡胶和松香为黏合剂的传统制剂相比,膏药的优势在于草药提取物的亲脂性和亲水性成分可被溶解,然后与有机聚合物“胶凝”,且含水量高达40%-70%的药物基质可作为“药物储存库”,在数天内持续使草药成分快速且持续地透过皮肤释放。虽然有缓解与骨病或癌症相关疼痛和不适的传统疗法,但口服草药与中药膏药等局部用药联合使用可能会显著减轻症状并改善患者生活质量。本文从三个方面进行综述,包括中药膏药的工艺开发、特点和发展现状以及该技术的未来发展。