Abstract The standardization and readability of drug labels and package leaflets are important to clinical pharmaceutical practice, international drug business as a technical rampart, competition ability of homemade drug in international market, improvement of pharmaceutical research, and promoting our medical administration system. It is a long and important work to improve the standardization and readability of drug labels and package leaflets in our country. Aim to improve the standardization and readability of drug labels and package leaflets in our country, through describing the status quo and evolvement on the standardization and readability of drug labels and package leaflets in the world, and comparing research among different periods, terrains, and countries. Objective to describe the change in time serial and the status que about the standardization and readability of drug labels and package leaflets in mainland of China, to describe the status que on the standardization and readability of drug labels and package leaflets in Macau, and put forward some strategies for improving the standardization and readability of drug labels and package leaflets in the mainland of China and Macau. Method to analyze the status que on the standardization and readability of drug labels and package leaflets in the mainland of China and Macau qualitatively through reference summary from CNKI, Sciencedirect and other databases, key person visiting to pharmaceutical administration officers, and world case research. The change in time serial and the status que about the standardization and readability of drug labels and package leaflets in the mainland of China and Macau were described quantitatively, and the compare on the standardization of drug labels and package leaflets between the mainland of China to Macau was also done, through comparing the probability of item labeling and item labeling summation by chi-square test. Then the strategies for improving the standardization of drug labels and package leaflets in the mainland of China and Macau were brought forward. Result: (1) There is distinct difference on the probability of item labeling summation in package leaflets of Chinese traditional medicine between former to now as standardization action, and Rx to OTC. The probability of item labeling summation in standardization action is higher than before, and the probability of item labeling summation in Rx is higher than in OTC. There is distinct difference on the probability of item labeling summation in package leaflets of western medicine between former to now as standardization action, and domestic medicine to foreign medicine. There is no difference on the probability of item labeling summation in package leaflets of western medicine between Rx to OTC. The probability of item labeling summation in standardization action is higher than before, and the probability of item labeling summation in domestic medicine is higher than in joint-stock made medicine, but lower than in import medicine. There is distinct difference on the probability of item labeling summation in package leaflets between Chinese traditional medicine to western medicine, and Rx of Chinese traditional medicine to Rx of western medicine. There is no difference on the probability of item labeling summation in package leaflets between OTC of Chinese traditional medicines to OTC of western medicine. The probability of item labeling summation in package leaflets of Chinese traditional medicine and Rx of Chinese traditional medicine is higher than of western medicine and Rx of western medicine. (2) There is distinct difference on the probability of item labeling summation in package leaflets between Chinese traditional medicines to western medicine, and Rx to OTC in Macau. The probability of item labeling summation in package leaflets of Chinese traditional medicine and Rx is higher than of western medicine and OTC respectively in Macau. There is no difference in un-tangent label, and there is no difference in tangent label between Rx to OTC. There is distinct difference on the probability of item labeling summation in tangent label between OTC of western medicine to OTC of Chinese traditional medicine. The probability of item labeling summation in tangent label of OTC of western medicine is higher than of Chinese traditional medicine. (3) There is distinct difference on the probability of item labeling summation in package leaflets among domestic medicine, foreign medicine in the mainland of China, and foreign medicine in Macau. There is no difference in Chinese traditional OTC medicine un-tangent label between in the mainland of China to in Macau. Conclusion: (1) The standardization of drug labels and package leaflets obviously heightened along with standardization action. But there are still some problems especial the convert phenomenon between Rx to ОТС. (2) The standardization level of domestic drug labels and package leaflets is higher than that of joint-stock medicine, but is lower than that of medicine from advanced pharmaceutical country. (3) There is a gap on the readability of drug labels and package leaflets between the domestic drugs to foreign drugs. One of main reasons is short of academic research. (4) The standardization and readability of drug labels and package leaflets are not satisfied in Macau. Strategy: The government should consummate the law system on drug labels and package leaflets according to the situation of our country, promote the pharmaceutical research base on the short of drug labels and package leaflets, and are a good steward on medicine administration. The obstruction of civilization background and language should be resolved by better translation. The different edition of drug labels and package leaflets, popularization and specialization, should be designed. The special edition of drug labels and package leaflets should be prepared for special people, for example blind people. The drug labels and package leaflets should be easier obtained by internet and traditional medium. The public research should be done on drug labels and package leaflets. All of above will be benefit to the improvement of the standardization and readability on drug labels and package leaflets. Keywords: Label, Package Leaflet, Drug, Standardization, Readability

中文摘要 藥品標籤、說明書的規範性與可讀性關乎指導廣大國民和醫藥工作者安全合理用藥;關乎到我國藥品超越國際醫藥商業重要技術壁壘,實現國際化;關乎到我國藥品在國際化市場的競爭力;關乎到指導進一步的藥學科研;關乎到如何改進完善我國的醫藥管理體系。紮實的提高我國藥品標籤、說明書的規範性和可讀性是長期而重要的問題。 本文旨在描述世界藥品標籤、說明書規範性與可讀性的變化與現狀,進行不同時期、地域和國別間的比較研究,為提高我國藥品標籤、說明書的規範性與可讀性提出策略建議。目的:縱向描述我國大陸藥品標籤、說明書規範性和可讀性的變化與現狀; 橫斷面描述澳門藥品標籤、說明書規範性與可讀性現狀;比較大陸藥品與澳門抽樣進口藥品標籤、說明書規範性;提出進一步提高我國大陸和澳門藥品標籤、說明書規範性與可讀性的策略建議。方法:通過 CNKI 和 Sciencedirect 等資料庫文獻調研綜述大陸和國外已有研究資料,結合大陸藥事管理者關鍵人物訪談和國內外案例研究,定性分析我國大陸和澳門藥品標籤、說明書規範性和可讀性變化與現狀。採取計算藥品標籤、說明書項目標注率,並比較藥品標籤、說明書項目總體標注率,採取行列表卡方檢驗法,定量研究大陸藥品標籤、說明書規範性變化和現狀,大陸與澳門各類藥品間藥品標籤、說明書規範性比較。從而定量研究分析大陸和澳門藥品標籤、說明書規範性問題,提出進一步改進的策略建議。 結果:(1)我國大陸中藥說明書項目總體標注率,規範前與規範中存在顯著差異,處方藥與非處方藥存在顯著差異,規範中高於規範前,處方藥高於OTC。大陸西藥說明書項目總體標注率, 規範前與規範中存在顯著性差異,處方藥與非處方藥間向不能說存在顯著性差異, 規範中國產藥與涉外藥說明書項目總體標注率存在顯著性差異,規範中高於規範前,國產藥項目總體標注率高於合資藥品,低於進口藥品。規範中,藥品說明書項目總體標注率,中藥與西藥總體存在顯著性差異,中西處方藥間存在顯著性差異, OTC 間無顯著性差異。中藥總體和處方藥說明書項目總體標注率分別高於西藥總體和西藥處方藥。(2) 澳門藥品說明書項目總體標注率,西藥與中藥,處方藥與OTC間存在顯著性差異,西藥高於中藥,處方藥高於OTC。中標籤項目總體標注率,中、西藥,處方藥與OTC間均無顯著性差異。內標籤項目總體標注率,Rx與OTC間無顯著性差異,西藥OTC高於中藥OTC。(3) 藥品說明書項目總體標注率,國產西藥、中藥、Rx、OTC,以及大陸涉外西藥與澳門調研的國外產中西藥間均存在極顯著性差異,國產中西藥和涉外藥均高於澳門調研國外產藥品。大陸中藥OTC與澳門中藥OTC藥品中標籤項目總體標注率無顯著性差異。結論:(1)隨著大陸藥品標籤、說明書規範行動,我國大陸藥品標籤、說明書規範性明顯提高,然而部分問題 依然存在,尤其是處方藥與非處方藥品標籤、說明書規範性“倒置”現象,須改進。 (2)大陸藥品標籤、說明書整體規範性高於合資藥品,低於發達制藥強國水平。(3) 大陸藥品標籤、說明書在可讀性方面與國外有相當差距,首要是理論研究不足。(4) 澳門藥品標籤、說明書的規範性與可讀性不令人滿意。策略:為了進一步提高我國 大陸和澳門藥品標籤、說明書規範性,政府應結合國情,進一步完善藥品標籤、說明書法律法規體系。同時針對藥品標籤、說明書某些標注薄弱環節,加強藥學研究, 紮紮實實不越位不缺位的做好監管工作。而筆者認為克服文化背景的障礙,掃清語 言障礙;嘗試設計專業和通俗化不同版本的藥品標籤、說明書;注意對如盲人人群等各種特殊人群的藥品標籤、說明書的建立;利用互聯網和傳統傳媒增加藥品標籤、 說明書的國際可及性;開展藥品標籤、說明書可讀性人群試驗研究,對於切實提高我國大陸和澳門藥品標籤、說明書可讀性是很必要的。 關鍵字:標籤、說明書、藥品、規範性、可讀性