中药配方颗粒国际组织标准的研究与制定

中药配方颗粒以其使用方便、安全有效、质量可控，且保持了饮片组方灵活、加减随机的特点与优势，在国内外具有广阔的市场前景，但由于缺乏统一的质量标准，影响了产品的国际推广。本研究根据中药配方颗粒生产和发展的实际需求，选取300 味常用中药品种，从品名、来源、性状、鉴别、检查、含量测定、功能与主治、用法与用量、注意、规格、贮藏、有效期等方面，对其生产工艺和质量标准进行规范，以我为主率先研制中药配方颗粒国际组织标准，以保证中药配方颗粒在国际市场上健康有序地发展。

Progress in the International Organization Standard for Chinese Herbal Granules

Chinese herbal granules are convenient for use, safe and effective, with controllable quality, while maintaining the characteristic and advantage of Chinese herbal pieces. To gain broader domestic and international markets, the international promotion is critical, and thus a unified quality specification is urgently needed. According to the production and development of Chinese herbal granules, this work set up a standard for the production craft and quality specification of 300 kinds of commonly used Chinese herbal granules. The items covered include the name, origin, character, distinction, inspection, content determination, function and indication, usage and dosage, attention, specification, storage, aspect and term of validity. The establishment of the international organization standard for Chinese herbal granules, under the guidance by WFCMS, may be helpful to the healthy and orderly development of the international market for Chinese herbal granules.