盐酸司来吉兰片项目信息
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101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
110.13 2444992444762451592447632447482447290.12
210.082440832436912438870.12
单位质量响应值RSD%判断
24158.8424195.140.11数据可信
供试品溶液-24082701批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1110310-11031045.39851.8519.7845.4051.8519.78
287097-8709735.84535.84
3131606-13160654.16254.16
4154630-15463063.63863.64
5148132-14813260.96460.96
6124206-12420651.11751.12
10min1147420-14742060.67071.8214.4160.8171.9814.41
2145360-14536059.82359.93
3164378-16437867.65067.81
4195888-19588880.61780.81
5198007-19800781.49081.67
6196013-19601380.66980.82
15min1161590-16159066.50277.3112.4666.8277.6812.47
2162835-16283567.01567.30
3177271-17727172.95673.32
4204055-20405583.97984.41
5209187-20918786.09186.52
6212146-21214687.30887.70
20min1170170-17017070.03380.3210.8370.5580.9210.85
2174485-17448571.80972.30
3185089-18508976.17376.76
4208602-20860285.85086.53
5214542-21454288.29488.98
6218045-21804589.73690.39
30min1182074-18207474.93283.898.2875.6684.748.32
2191130-19113078.65979.36
3194007-19400779.84380.66
4214620-21462088.32789.27
5218480-21848089.91590.87
6222796-22279691.69192.62
45min1191853-19185378.95786.406.2779.9187.496.34
2200289-20028982.42983.37
3203269-20326983.65584.71
4220161-22016190.60791.81
5220301-22030190.66591.88
6223687-22368792.05893.26
60min1197229-19722981.16987.864.9282.3689.224.99
2208262-20826285.71086.90
3208765-20876585.91787.22
4222248-22224891.46692.94
5220336-22033690.67992.17
6224091-22409192.22493.70
极限1222959-22295991.75891.910.4493.1993.520.48
2223608-22360892.02693.47
3222937-22293791.74993.31
4224354-22435492.33394.09
5221780-22178091.27393.04
6224256-22425692.29294.05
盐酸司来吉兰片项目信息
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101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
110.13 2443342441182436832438712436562439320.12
210.082443182444552443860.04
单位质量响应值RSD%判断
24080.1624244.640.49数据可信
供试品溶液-24082703批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1129440-12944053.30452.3617.8853.3052.3617.88
2113560-11356046.76446.76
397039-9703939.96139.96
4165461-16546168.13768.14
5126131-12613151.94151.94
6131301-13130154.07054.07
10min1185661-18566176.45570.2813.7876.6270.4413.78
2162601-16260166.95967.10
3132735-13273554.66054.78
4200234-20023482.45782.66
5162489-16248966.91367.07
6180321-18032174.25674.42
15min1197027-19702781.13674.7212.2481.5375.0912.26
2173436-17343671.42171.76
3145755-14575560.02260.31
4207811-20781185.57786.03
5172596-17259671.07571.43
6192018-19201879.07379.46
20min1204803-20480384.33877.4310.8984.9778.0210.91
2179846-17984674.06174.62
3156152-15615264.30464.77
4210913-21091386.85487.56
5178058-17805873.32573.89
6198340-19834081.67782.30
30min1212043-21204387.32080.459.0888.2181.289.12
2188145-18814577.47878.26
3168497-16849769.38770.04
4214998-21499888.53789.51
5186134-18613476.65077.44
6202395-20239583.34784.21
45min1221890-22189091.37583.787.4192.5284.857.46
2197253-19725381.22982.24
3181380-18138074.69375.56
4217728-21772889.66190.90
5196018-19601880.72181.74
6206427-20642785.00786.12
60min1223673-22367392.10985.925.8593.5387.245.93
2203189-20318983.67484.93
3191119-19111978.70379.79
4220866-22086690.95392.46
5203096-20309683.63584.90
6209876-20987686.42787.80
极限1227396-22739693.64294.801.9395.3496.381.82
2231818-23181895.46396.97
3235208-23520896.85998.18
4232918-23291895.91697.69
5231106-23110695.17096.68
6222837-22283791.76593.40
盐酸司来吉兰片项目信息
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101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
110.13 2444482439972441522443022439722441740.09
210.082439632435932437780.11
单位质量响应值RSD%判断
24104.0524184.330.24数据可信
供试品溶液-2180621批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1200719-20071982.71870.2614.3082.7270.2614.30
2164048-16404867.60667.61
3167983-16798369.22769.23
4197052-19705281.20781.21
5155443-15544364.05964.06
6137674-13767456.73756.74
10min1229988-22998894.78086.217.0295.0386.437.04
2200634-20063482.68382.89
3209964-20996486.52886.74
4223134-22313491.95592.20
5198574-19857481.83482.03
6192925-19292579.50679.68
15min1238381-23838198.23989.826.1498.7790.296.16
2213540-21354088.00288.45
3218242-21824289.93990.41
4227927-22792793.93194.45
5207284-20728485.42485.86
6202355-20235583.39283.80
20min1240063-24006398.93291.205.4499.7691.945.47
2217276-21727689.54190.26
3220023-22002390.67391.41
4230639-23063995.04895.85
5211813-21181387.29087.98
6208006-20800685.72186.38
30min1241584-24158499.55992.115.14100.6893.125.16
2218711-21871190.13391.12
3221810-22181091.41092.42
4232691-23269195.89496.98
5214795-21479588.51989.47
6211485-21148587.15588.07
45min1241013-24101399.32492.654.61100.7593.944.65
2221764-22176491.39192.64
3223495-22349592.10493.39
4232864-23286495.96597.34
5215907-21590788.97790.20
6213937-21393788.16589.34
60min1240716-24071699.20192.844.26100.9294.414.30
2221957-22195791.47093.00
3224304-22430492.43894.00
4232160-23216095.67597.34
5216455-21645589.20390.69
6216129-21612989.06990.51
极限1239579-23957998.73393.533.44100.7595.383.49
2225486-22548692.92594.73
3225999-22599993.13694.97
4231797-23179795.52697.47
5217700-21770089.71691.47
6221196-22119691.15792.87
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