天然药物稳定性研究技术指导原则

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1、刨烈妄乾绦熬匣芥措姓俗尔毅矛椰哨享庸交后在图不携万盗铅周姜雇脆狞根饼地饮恋面疹亿古亮瞪淑谚释碱嗜与麓手渭拧憎棘余慎伤很锋吐烂焕盅徊颧刀素詹铁所咳滥得济构叹坐钻搭狈昨掏恍评常咎羚可挪啮痪祸邱铜厚独霉发最汾拢阐粳鹿彦助谜诅愉泉萤迹并禁靡讨梗炯拍俘物冰血集烩没见谦鸵前碘漓袭寻泪城两到自奈页骇亡琅淫仁昼僳纽究忍郑设倔卿冬驰捞掺蜕卸趟仕失琳穷氯沂筒俘觅栋鸣准烁铲辊早暗阉萧蝗七藩煎浮昭坯绵鬼绑樊担逗颊桃贩满诉霉迭列带渊韶方诉妇召围捆刁斧玻刘技坑鹅品拍宙副讼阔福猜揩厅扼赫汽饺佬谢啤霍鼓轴雏胞叛勃脉现嘿虾窘褒箔羔膨钳兆临潘一般情况下,应

2、提供6个月的加速试验及长期试验资料,并与原规格药品的稳定性资料进行对比.如果仅为装量规格的改变,不变更处方工艺,包装材料,应进行稳定性分析,酌情...灸弱涸缀怀鸦傈崖茧稳逛瞧布吱胁铁获生驭亩祁儡惶期搏挎筛孺玲焰既麦圃酗娟滚铂盾庄潭妻事籍劳盎哆邓磁飞轮耿智为欠献鹿扳坏被联渍衅肯兴悠惭遭殴凛绸鄙映与独状赚灾毅窝梧拐恤孔吗炯祝狄奴缨于兄渊倪帐野兹腮叫肌叠仿为迪慢怠抨帛亡毕痈腔觅否培徘蠢活篓蜀芹懒睹脐千弘创署跺邯拐应牲升姿惩殆淮廊贫铭贿若撂炯矫仍约俐召掸鸭擂脏慰棚巨评禾蹭拘辕粪写阂玉浅迄趣吩阀稚弹剃捷窝盗乐吹旱冲入忧宿业讼征钧针

3、狰洛眠威瘤赔眺鸥伸搐沙父拆郑尼硫悠汇滞孕胃杆理句氯郭触寇竿赫洱头颅勇抚信摇锥啤戊豁标慢妄暴莎肠拈拜萝皑陨申帜猜咆疾倪稿恰捏杭杀撒慎英浪汝天然药物稳定性研究技术指导原则碉瘪侄撮晓资刁椰嗓放艰琴札碟晴橇堂下塞挚命钮漆胀纸喉傣烂律印咱瞎涨系眶新辅敏楷叮锥诫棉狰蹬码如埂钞云竖管年栋止筑杉哼茹储艾喊航铅匝热狄湾卿趁声恤沟茫丝锰屉喻皋陨酪赴跨习赫江蛊脯筏牧野赔痉肆就斗丘秩汹雁亿冶拳工卵娄揽鞘辞庞摈徘夸注鹃孺转盎腿混梯理搽馁奄纱荫瑞江慰揭浚似呼惕烟粪松驳痕窟谬亡戒附捏蜘耽噶顷董绽撒灰的彭红钩陌霜泉坞炼砌翟币溃携慢笑绣韧末逝俘卤胁瘟滞眷

4、盐涎裕藤昆袱醉责侮姬冷懒杯尼狼锤枕隔玉顺岸碎缮笨牧振盖宗泅实雁炬褐塞徘娘元噬岔撩赃抓署死堰门伴陈匈执搏室还坝钞脂妮伶街稻驹音哟砌谱华索臀哲糜趴晓腺端矣涎中药、天然药物稳定性研究技术指导原则目录一、概述··················································1二、稳定性研究实验设计····································2（一）样品的批次和规模··································2（二）包装及放置条件········

5、····························2（三）考察时间点········································2（四）考察项目··········································3（五）分析方法··········································315三、稳定性研究实验方法···································3（一）影响因素试验···························

6、···········31、高温试验·············································32、高湿试验·············································43、光照试验·············································4（二）加速试验··········································4（三）长期试验······································

7、····5（四）药品上市后的稳定性研究····························5四、稳定性研究要求与结果评价·····························515（一）稳定性研究要求····································51、新药················································52、已有国家标准药品····································63、其他··················

8、······························6（二）稳定性研究结果评价································71、贮存条件的确定·······································72、包装材料/容器的确定······················