[關(guān)鍵詞]
[摘要]
結(jié)合當(dāng)前中藥注冊(cè)分類的修訂形勢(shì),對(duì)中藥新藥申報(bào)資料與天然藥物新藥技術(shù)要求進(jìn)行了思考。不同于化學(xué)藥新藥,中藥新藥復(fù)方制劑大多具有可供評(píng)價(jià)的人用經(jīng)驗(yàn),考慮如何應(yīng)用人用經(jīng)驗(yàn)的不同證據(jù)分級(jí),對(duì)申報(bào)資料進(jìn)行減免。醫(yī)療機(jī)構(gòu)中藥制劑具有較高證據(jù)級(jí)別的中藥臨床應(yīng)用經(jīng)驗(yàn),建議對(duì)醫(yī)療機(jī)構(gòu)中藥制劑的生產(chǎn)與使用情況進(jìn)行調(diào)研,促進(jìn)醫(yī)療機(jī)構(gòu)中藥制劑向中藥新藥轉(zhuǎn)化,為建立符合中藥特色的審評(píng)體系提供參考依據(jù)。另外,基于天然藥物與中藥的藥用物質(zhì)均為復(fù)雜混合物,建議天然藥物新藥的藥學(xué)和藥理毒理學(xué)要求與中藥新藥保持一致,天然藥物新藥的臨床要求參考化學(xué)藥新藥臨床技術(shù)要求。
[Key word]
[Abstract]
Combined with the revision of the current traditional Chinese medicine (TCM) registration classification, this paper has considered the new TCM application materials and the technical requirements of new natural medicines. Unlike chemical drugs, most of the new TCM compound preparations have experience for people to evaluate, considering how to apply different evidence classifications of human experience, and reduce the application materials. Medical institution TCM preparations have high clinical evidence of clinical application experience. It is recommended to investigate the situation of medical institution TCM preparations, promote the conversion of medical institution TCM preparations into new TCM, and provide reference for the establishment of a review system that conforms to the characteristics of TCM. In addition, based on the complex mixture of natural medicines and TCM, it is recommended that the pharmacy and pharmacological toxicological requirements of new natural medicines should be consistent with the new TCM. The clinical requirements of new natural medicines refer to the clinical technical requirements of new chemical drugs.
[中圖分類號(hào)]
R951
[基金項(xiàng)目]