中医外科外用药剂型的现状和剂型创新研究-中医外科学论文-中医学论文-医学论文

中医外科外用药剂型的现状和剂型创新研究-中医外科学论文-中医学论文-医学论文

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摘要：中医外科外用药剂型仍以传统的散剂、丹药、膏药、软膏等为主, 部分传统的剂型仍需现用现配, 具有用药灵活、疗效可靠的特点, 也存在着生物利用度低, 药物剂量不宜控制, 易污染衣物, 黏性小易脱落, 易干燥变硬等缺点, 不能满足临床需求。传统剂型的缺点和剂型研发的滞后制约了中医外科外用药的临床应用, 不能满足临床治疗需求, 剂型的创新就显得十分重要。本文阐述了中医外科外用中药剂型的现状, 对剂型创新进行了思考。

关键词：外用中药; 剂型; 中医外科; 新药; 载体;

Thinking the characteristics of the surgery of the external use of Chinese medicine formulations and dosage forms of innovation

ZHU Chao-jun HAN Wei L Jia-kang L Yuan-feng ZHANG Zhao-hui L Xiang

Department of Surgery of Traditional Chinese medicine, Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine Center for Drug Evaluation, China Food and Drug Administration School of Pharmacy, The Chinese University of Hong Kong Department of National Drug Clinical Trial Organization, Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine

Abstract：

The pharmaceutical dosage form of traditional Chinese medicine ( TCM) surgery are still based on traditional dispersants, dandruid, plaster and ointment. Some of the traditional pharmaceutical dosage form still need to be preparation when it is in need. External use

traditional Chinese medicine has the characteristics of drug use flexible, clinical effect is reliable. However, there also exist a lot of shortcomings, such as low bioavailability, drug dose should not be controlled, easily contaminated clothing, viscosity small easy to fall off, dry harden, can not meet the clinical needs. The shortcomings of traditional pharmaceutical dosage form and the lag of dosage forms have restricted the clinical application of external medicine of traditional Chinese medicine surgery. Formulation innovation is very important to meet the needs of clinical treatment. This paper expounds the present situation of traditional Chinese medicine dosage forms, and puts forward the necessity and preliminary thinking of the reform of traditional Chinese medicine dosage form.

Keyword：

external use traditional Chinese medicine; pharmaceutical dosage form; surgery of traditional Chinese medicine; new drugs; drug carriers;

药物剂型是药物用于临床的一定物质形式, 任何药物用于临床必需制成一定的剂型[1]。对于剂型的选择, 在《神农本草经》中有明确的记载:药有宜丸者、宜散者、宜水煮者、宜酒渍者、宜膏煎者, 亦有一物兼宜者亦有不可入汤酒者, 并随药性, 不得违越[2]。初步揭示了要根据药物的特点选择合理的制剂。在梁代陶弘景指出剂型亦兼参用所病之源以为其制耳, 提示药物的剂型要根据临床需要, 采取适当工艺加工制备而成。

外治之药即内治之药, 所异者, 法耳[3], 外用药与内服药起到同等的治疗作用。内服的中药新药在传统剂型的基础上, 开发了多种新剂型, 如合剂、乳剂、颗粒剂、胶囊剂、片剂、滴丸剂等。中医外科外用新药剂型仍以传统的散剂、丹药、膏剂等为主, 部分传统剂型需根据临床需要, 辨证选药后现用现配, 不能满足临床用药需求, 且依从性差, 制约了中医外科外用药的临床应用。本文从临床应用角度对中医外科外用新药剂型探讨如下。

1 中医外科传统剂型的特点

外用中药药物剂型有多种, 如散剂、硬膏、油膏、丹药、丸