聚乙烯吡咯烷酮（聚维酮，PVP）广泛用作片剂的辅料，常作为粘合剂，崩解剂、包衣薄膜材料，此外在混悬剂中也常用作助悬剂。PVP依其分子量和粘度有多种规格，如K15（平均分子量10000），K25、K30（平均分子量25000～40000），K60（平均分子量160000），K90（平均分子量360000）等。该辅料早已收载于BP，USP和CP。
近年来，由于改剂型的品种增多，对有些微溶于水、难溶于水或在水溶液中较易析晶的药物，申办人愈来愈多的在处方中使用PVP，对有些口服制剂起到较好的效果。但是近期，有些申办人静脉注射剂的处方中加入PVP以达到增溶、稳定，防止药物结晶析出的目的。并在使用依据中提供了相应的文献（主要是早期作为血浆代用品）和1972年的美国专利（专利号3674859）。但均无法提供目前国内外上市产品的证据。
我们在检索中发现，美国FDA于1978年颁布通告，将用于静脉注射剂中使用或含有PVP的产品全部召回。理由是静脉注射剂中的PVP妨碍凝血过程，在输血或配血中影响血型的鉴定，存在不安全的隐患。
对此我们的建议是：在注射剂中禁用PVP；对已申报品种中使用的，建议修改和调整处方。
在此我们也请申办人注意，在处方设计筛选中，应认真、全面的进行文献调研，尽量避免此类问题的出现。
附美国FDA的决定。
SUMMARY: The Food and Drug Administration (FDA) is proposing to amend its
regulations to include a list of drug products that may not be used for
pharmacy compounding pursuant to the exemptions under section 503A of the
Federal Food, Drug, and Cosmetic Act (the act) because they have had their
approval withdrawn or were removed from the market because the drug product or
its components have been found to be unsafe or not effective. The list has been
compiled under the new statutory requirements of the Food and Drug
Administration Modernization Act of 1997 (Modernization Act).Povidone: All
intravenous drug products containing povidone.Povidone, marketed as
Polyvinylpyrrolidone in Normal Saline, was found to be unsafe for use as a
plasma expander in the emergency treatment of shock because povidone
accumulates in the body and may cause storage disease with the formation of
granulomas. Povidone also interferes with blood coagulation, hemostasis, and
blood typing and cross matching. Approval of the NDA for Polyvinylpyrrolidone
in Normal Saline was withdrawn on April 19, 1978 (see the Federal Register of
April 7, 1978 (43 FR 14743)).
类别:审评三部
浙公网安备33011002015279
本网站未发布麻醉药品、精神药品、医疗用毒性药品、放射性药品、戒毒药品和医疗机构制剂的产品信息