依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.393467723474643465333466553465203467890.12
210.413457123458113457620.03
单位质量响应值RSD%判断
33377.1933214.410.35数据可信
影响因素30天-裸放高温-供试品溶液-X024017批-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1170444-17044451.19149.2715.9351.1949.2715.93
2177346-17734653.26453.26
3171291-17129151.44651.45
4188930-18893056.74356.74
5162429-16242948.78448.78
6113837-11383734.19034.19
10min1294532-29453288.46087.863.8488.6188.013.83
2299120-29912089.83890.00
3297644-29764489.39489.55
4271294-27129481.48081.65
5302517-30251790.85891.00
6290183-29018387.15487.26
15min1305899-30589991.87492.463.3692.2992.873.33
2310277-31027793.18993.62
3307893-30789392.47392.90
4288983-28898386.79387.21
5316683-31668395.11395.53
6317269-31726995.28995.65
20min1307562-30756292.37393.212.9393.0793.902.91
2312398-31239893.82694.53
3310466-31046693.24593.95
4294261-29426188.37889.05
5317756-31775695.43596.14
6319562-31956295.97796.63
30min1309027-30902792.81393.642.6093.7894.612.58
2313464-31346494.14695.14
3311275-31127593.48894.47
4297841-29784189.45490.39
5320050-32005096.12497.11
6319057-31905795.82696.76
45min1309464-30946492.94493.642.5594.1994.882.53
2313854-31385494.26395.54
3310858-31085893.36394.62
4297939-29793989.48390.69
5319554-31955495.97597.25
6318947-31894795.79397.02
60min1310230-31023093.17493.752.6794.7095.282.65
2314839-31483994.55996.11
3310661-31066193.30494.84
4297530-29753089.36090.84
5320433-32043396.23997.81
6319177-31917795.86297.37
极限1325278-32527897.69498.001.1999.5099.821.16
2324723-32472397.52799.37
3326183-32618397.96699.79
4323577-32357797.18398.93
5324129-32412997.34999.20
6333947-333947100.298102.10
依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.393475493458413460693457503456143461650.23
210.413466043465783465910.01
单位质量响应值RSD%判断
33317.1333294.040.05数据可信
影响因素30天-裸放高湿-供试品溶液-X024017批-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1179201-17920153.80561.2018.9753.8161.2018.97
2232421-23242169.78469.78
3257009-25700977.16777.17
4171766-17176651.57351.57
5221853-22185366.61166.61
6160659-16065948.23848.24
10min1244610-24461073.44482.659.8573.6182.849.86
2296331-29633188.97389.18
3307531-30753192.33692.57
4264329-26432979.36579.52
5292434-29243487.80388.00
6246455-24645573.99874.14
15min1268819-26881980.71388.476.4281.0988.906.45
2308145-30814592.52193.00
3314943-31494394.56295.07
4289377-28937786.88587.28
5309054-30905492.79393.26
6277661-27766183.36883.73
20min1279457-27945783.90790.154.7884.5390.844.82
2309145-30914592.82193.57
3315542-31554294.74195.53
4296403-29640388.99589.65
5312012-31201293.68294.42
6288907-28890786.74487.36
30min1286730-28673086.09191.383.6586.9792.343.70
2311379-31137993.49294.52
3315699-31569994.78995.87
4299990-29999090.07290.99
5313223-31322394.04595.07
6299000-29900089.77590.65
45min1288800-28880086.71291.453.3687.8592.703.41
2310167-31016793.12894.44
3315816-31581694.82496.18
4300733-30073390.29591.49
5312927-31292793.95695.26
6299080-29908089.79990.95
60min1289427-28942786.90091.323.2088.2992.843.26
2310014-31001493.08294.67
3314773-31477394.51196.16
4300217-30021790.14091.60
5311910-31191093.65195.24
6298554-29855489.64191.06
极限1328415-32841598.60797.861.17100.2699.641.20
2325271-32527197.66399.53
3329401-32940198.903100.83
4325502-32550297.73299.46
5327983-32798398.477100.34
6318949-31894995.76497.45
依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.393492893477013478353477283476693480440.21
210.413495623478463487040.35
单位质量响应值RSD%判断
33497.9833497.020.01数据可信
影响因素30天-裸放光照-供试品溶液-X024017批-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1119389-11938935.64139.7824.8935.6439.7824.88
2103742-10374230.97030.97
393529-9352927.92127.92
4178649-17864953.33253.33
5158516-15851647.32247.32
6145779-14577943.51943.52
10min1237432-23743270.88180.159.1570.9980.279.17
2266423-26642379.53579.63
3242105-24210572.27672.36
4296611-29661188.54788.71
5278357-27835783.09883.24
6289949-28994986.55886.69
15min1262333-26233378.31489.646.6578.6390.006.66
2306616-30661691.53491.87
3296821-29682188.61088.91
4314024-31402493.74694.17
5317423-31742394.76095.15
6304452-30445290.88891.28
20min1269965-26996580.59391.756.2581.1592.386.25
2321046-32104695.84296.45
3310041-31004192.55693.12
4313772-31377293.67094.38
5321811-32181196.07096.75
6307345-30734591.75292.41
30min1279671-27967183.49092.885.5584.2993.795.54
2326614-32661497.50498.40
3317554-31755494.79995.64
4313521-31352193.59594.58
5324394-32439496.84197.81
6305051-30505191.06792.00
45min1283223-28322384.55092.935.0985.6094.125.09
2326668-32666897.52098.71
3318219-31821994.99896.13
4312884-31288493.40594.67
5322663-32266396.32597.58
6304171-30417190.80492.02
60min1284165-28416584.83292.774.8886.1394.234.87
2326047-32604797.33598.81
3318008-31800894.93596.35
4312003-31200393.14294.69
5320740-32074095.75097.29
6303618-30361890.63992.12
极限1332585-33258599.28797.962.39100.8499.702.30
2331168-33116898.863100.63
3339142-339142101.244102.94
4326798-32679897.55999.39
5321697-32169796.03697.87
6317510-31751094.78696.54
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