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分散片在我国研制开发已有20年,至今尚未见分散片的溶出度和生物利用度高于同类药品普通制剂的报道;造成此现象的根本原因在于分散片在生产过程中仅将原料药做常规微粉化处理。美国与日本等发达国家从未将分散片作为1种新剂型,更未像我国这样大量审批数量众多的分散片剂型。综述分散片的名称及其存在的缺陷和国外审批情况等,并一一作了分析。为减轻医保和患者的经济负担,建议国家药典委员会和药品监管行政部门及时修正此种行政审批分散片剂型的现象。
Dispersed tablets in our research and development has been 20 years, has yet to see dispersible tablets dissolution and bioavailability higher than the generic preparations of similar drugs reported; the root cause of this phenomenon is that the dispersible tablets in the production process will only do raw material medicine Conventional micronization. Developed countries such as the United States and Japan have never regarded dispersible tablets as a new type of formulation, nor have they approve a large number of dispersible tablet dosage forms like ours. Summarized the name of dispersible tablets and its defects and foreign approval, etc., and analyzed one by one. In order to reduce the financial burden on medical insurance and patients, it is suggested that the State Pharmacopoeia Commission and the administrative department of pharmaceutical supervision promptly amend such administrative approval of scattered tablets.