药品卫生是保证药品质量的重要因素,在药品生产的每一环节都应十分重视。现行生产实践中常用的灭菌方法有热压灭菌法、微波灭菌法、钴60-辐照灭菌法等,每种灭菌方法各有其特点。其中钴60-辐照灭菌法是近40年来发展的一种新的消毒灭菌工艺,其主要优点是:价廉、节能,可在常温下消毒灭菌而不破坏易挥发成分及热敏性物质,穿透力强一般可达40~60cm,消毒均匀、速度快、时间短、操作简单,便于连续作业。因此该技术越来越受到人们的关注。
按照卫生部的标准,允许辐照中药材品种共l98种,中成药70种,允许低剂量(3kGy)辐照中药材品种5种,不允许辐照中药材品种2种(含龙胆苦苷的药材如秦艽、龙胆及其制品)。 标准还规定。凡“通知”中未规定的中药,原则上不允许辐照,若要辐照,则需向卫生部药品检验所报批后,才能辐照。
以2005版的药典为例,原标准里允许辐照的中药材品种不到36%,而允许辐照的中成药不到13%。可以看到标准允许辐照的中药只是一小部分,并不是所有中药都能随意辐照灭菌,即便是允许辐照的中药也是有严格的规定的。然而,近几年许多报批审验新药及其他品种中成药大多采用辐照灭菌,但其并不全是允许辐射的中药品种,也未见有经60Co辐照后有效成分及安全试验材料。为了提醒药厂注意,现把这些成药品种列举如下:
据报道资料显示,经10kGy辐照后所含化学成分有明显变化的中药材有17种,补骨脂、赤芍、鹅不食草、佛手、红花、锦灯笼、绵马贯众、茜草、秦艽、乳香、天竺黄、吴茱萸、辛夷、淫羊藿、珍珠、浙贝母、紫菀。经5kGy辐照后所含化学成分有明显变化的中药材有8种,补骨脂、锦灯笼、秦艽、乳香、天竺黄、珍珠、浙贝母、紫菀。我们查了一下相关资料,含有大剂量辐照导致成分明显变化的中成药的品种有近百种,其中含有2种不允许辐照中药材品种(含龙胆苦苷的药材如秦艽、龙胆及其制品)的成药有10种。
1、含秦艽药材采的中成药:十三味榜嘎散、安坤赞育丸、祛风舒筋丸、骨刺消痛片。
2、含龙胆药材的中成药:清热片、龙胆泻肝丸(水丸)、龙胆泻肝丸(大蜜丸)、当归龙荟丸、黄连羊肝丸、清热解毒口服液。
3、含有补骨脂的中成药:七宝美髯颗粒、千金止带丸、四神丸、冯了性风湿跌打药酒、再造生血片、壮骨关节丸、肠胃宁片、补肾益脑片、青娥丸、国公酒、固本咳喘片、茴香橘核丸、首乌丸、蚕蛾公补片、荷丹片、益肾灵颗粒、锁阳固精丸、强阳保肾丸、安坤赞育丸。
4、含有乳香药材的中成药:十香止痛丸、十香返生丸、七厘散、八味沉香散、九分散、九圣散、化毒散、小金丸、小活络丸、止痛紫金丸、平肝舒络丸、再造丸、壮骨关节丸、安坤赞育丸、苏和香丸、妙济丸、冠心苏合丸、梅花点舌丸、跌打丸、舒筋丸、活血止痛胶囊、人参再造丸、伤痛宁片。
5、含天竺黄药材的中成药:二十五位松石丸、十二味翼首散、七珍丸、八味清心沉香散、百寿丸、平肝舒络丸、再造丸、人参再造丸。
6、含珍珠药材的中成药:二十五味松石丸、二十五味珍珠丸、二十五味珊瑚丸、七十味珍珠丸、化毒散、马应龙麝香痔疮膏、牛黄降压片、牛黄镇惊丸、仁青常觉、六应丸、四位土木香散、安宫牛黄丸、安宫牛黄散、安神补心丸、更年安片、脑立清丸、梅花点舌丸、清开灵口服液、清脑降压片。
7、含浙贝母药材的中成药:儿童清肺丸、乌贝散、利咽解毒胶囊、宝咳宁颗粒、桂林西瓜霜、黄氏响声丸、羚羊清肺丸、清肺抑火丸、解肌宁嗽丸、橘红丸、金嗓散结丸、狼疮丸。
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)
GEX辐照灭菌指示标签
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