盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
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%
110.452175042176402180292180212182302178850.14
210.462169932171972170950.07
单位质量响应值RSD%判断
20850.2420754.780.33数据可信
影响因素30天-供试品溶液-2025041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1201898-20189887.17587.881.0087.1787.881.00
2204292-20429288.20988.21
3204010-20401088.08788.09
4201082-20108286.82386.82
5203128-20312887.70687.71
6206826-20682689.30389.30
10min1214904-21490492.79193.180.9592.9493.330.94
2217210-21721093.78693.93
3217150-21715093.76093.91
4212452-21245291.73291.88
5215201-21520192.91993.07
6217903-21790394.08694.23
15min1219306-21930694.69195.080.8694.9995.380.86
2221354-22135495.57695.88
3221210-22121095.51395.82
4217063-21706393.72394.02
5219926-21992694.95995.26
6222358-22235896.00996.31
20min1221605-22160595.68496.160.7496.1496.620.74
2223841-22384196.64997.11
3223987-22398796.71297.17
4220271-22027195.10895.56
5222155-22215595.92196.38
6224442-22444296.90997.37
30min1224386-22438696.88597.300.8197.5097.920.81
2226606-22660697.84398.47
3227008-22700898.01798.64
4222550-22255096.09296.70
5224496-22449696.93297.55
6226984-22698498.00698.63
极限1226326-22632697.72297.960.9198.5098.740.91
2228324-22832498.58599.37
3227943-22794398.42199.21
4223453-22345396.48297.25
5226037-22603797.59898.38
6229162-22916298.94799.74
盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
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%
110.452174832176362176712173272175652175360.07
210.462167992168612168300.03
单位质量响应值RSD%判断
20816.8420729.450.30数据可信
影响因素30天-供试品溶液-2025041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1201146-20114686.97386.941.3786.9786.941.37
2203933-20393388.17888.18
3200742-20074286.79886.80
4196855-19685585.11885.12
5204181-20418188.28588.29
6199610-19961086.30986.31
10min1214331-21433192.67492.491.4692.8292.641.46
2217263-21726393.94294.09
3213736-21373692.41792.56
4209016-20901690.37690.52
5217021-21702193.83793.98
6212088-21208891.70491.85
15min1218837-21883794.62294.501.4894.9294.801.48
2221968-22196895.97696.28
3219306-21930694.82595.12
4213319-21331992.23692.53
5221427-22142795.74296.05
6216485-21648593.60593.90
20min1221216-22121695.65195.691.4796.1196.151.47
2225383-22538397.45397.92
3221546-22154695.79496.25
4215829-21582993.32293.77
5223534-22353496.65397.12
6220320-22032095.26495.72
30min1224562-22456297.09896.981.6097.7197.591.60
2228608-22860898.84799.47
3224137-22413796.91497.53
4218295-21829594.38894.99
5227098-22709898.19498.82
6223019-22301996.43197.04
极限1227588-22758898.40697.991.6399.1898.771.62
2230635-23063599.724100.51
3226921-22692198.11898.90
4220257-22025795.23696.00
5229310-22931099.15199.94
6225020-22502097.29698.07
盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
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%
110.452186992188562185782189222185262187160.08
210.462171422182312176860.36
单位质量响应值RSD%判断
20929.7620811.280.41数据可信
影响因素30天-供试品溶液-2025041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1198617-19861785.47986.671.8685.4886.681.86
2204090-20409087.83487.83
3206812-20681289.00689.01
4201079-20107986.53986.54
5201424-20142486.68786.69
6196342-19634284.50084.50
10min1211632-21163291.08092.411.8891.2292.551.88
2217508-21750893.60993.76
3220671-22067194.97095.12
4215399-21539992.70292.85
5213508-21350891.88892.03
6209584-20958490.19990.34
15min1215471-21547192.73394.571.9293.0394.861.92
2223294-22329496.09996.40
3225687-22568797.12997.44
4220390-22039094.85095.15
5218264-21826493.93594.23
6215284-21528492.65292.94
20min1218464-21846494.02195.801.9994.4796.251.99
2225590-22559097.08797.55
3229091-22909198.59499.06
4223409-22340996.14996.61
5221664-22166495.39895.85
6217310-21731093.52493.97
30min1222517-22251795.76597.111.7696.3797.731.76
2228528-22852898.35298.98
3231528-23152899.643100.28
4226032-22603297.27897.89
5224581-22458196.65397.27
6220680-22068094.97495.58
极限1223935-22393596.37598.161.8097.1498.941.80
2231195-23119599.500100.29
3233893-233893100.661101.46
4228940-22894098.52999.31
5227141-22714197.75598.53
6223419-22341996.15396.91
盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
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%
110.452172452170992176192174102172402173230.10
210.462170982170282170630.03
单位质量响应值RSD%判断
20796.4620751.720.16数据可信
影响因素30天-供试品溶液-2025041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1199956-19995686.45487.850.9786.4587.850.97
2204506-20450688.42188.42
3202009-20200987.34287.34
4202965-20296587.75587.76
5205018-20501888.64388.64
6204634-20463488.47788.48
10min1211741-21174191.55092.961.0791.6993.101.07
2214740-21474092.84692.99
3213932-21393292.49792.64
4214308-21430892.65992.81
5217245-21724593.92994.08
6217994-21799494.25394.40
15min1217148-21714893.88794.980.9894.1895.280.99
2219583-21958394.94095.24
3218609-21860994.51994.82
4218459-21845994.45494.75
5221188-22118895.63495.94
6223118-22311896.46996.77
20min1217648-21764894.10495.701.1594.5696.161.15
2220905-22090595.51295.97
3220724-22072495.43495.89
4220427-22042795.30595.76
5223401-22340196.59197.05
6224914-22491497.24597.71
30min1220015-22001595.12796.991.2195.7497.611.21
2224667-22466797.13897.76
3223680-22368096.71297.33
4223621-22362196.68697.30
5225835-22583597.64398.27
6228163-22816398.65099.28
极限1221766-22176695.88497.381.1896.6598.161.18
2224227-22422796.94897.73
3223872-22387296.79597.57
4224701-22470197.15397.93
5228465-22846598.78199.57
6228300-22830098.70999.50
盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
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%
110.452175912176922174002175832171712174870.10
210.462151932156982154460.17
单位质量响应值RSD%判断
20812.1520597.130.74数据可信
影响因素30天-供试品溶液-2025041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126026-2602611.2919.7310.1411.299.7310.14
221487-214879.3229.32
320062-200628.7038.70
420531-205318.9078.91
524114-2411410.46110.46
622404-224049.7199.72
10min152188-5218822.64120.716.7022.6620.736.70
247124-4712420.44420.46
345547-4554719.76019.77
443179-4317918.73218.75
549919-4991921.65621.67
648518-4851821.04821.06
15min175228-7522832.63630.784.0232.6930.834.03
271186-7118630.88230.93
369028-6902829.94629.99
466905-6690529.02529.07
572453-7245331.43231.49
670936-7093630.77430.83
20min191379-9137939.64337.952.4439.7538.062.44
286835-8683537.67137.77
387443-8744337.93538.03
484974-8497436.86436.96
587652-8765238.02638.13
686643-8664337.58837.69
30min1127227-12722755.19551.983.6955.3752.153.69
2121183-12118352.57352.74
3120493-12049352.27352.43
4114478-11447849.66449.82
5119106-11910651.67151.84
6116474-11647450.53050.69
极限1190691-19069182.72782.641.1583.0082.891.14
2186871-18687181.07081.32
3192520-19252083.52083.77
4191359-19135983.01783.26
5192390-19239083.46483.72
6189076-18907682.02682.28
盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
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%
110.452164522166332163992160222161402163290.12
210.462181232183542182380.08
单位质量响应值RSD%判断
20701.3420864.050.56数据可信
影响因素30天-供试品溶液-2025041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1196423-19642384.89387.341.9084.8987.341.90
2200410-20041086.61686.62
3200159-20015986.50786.51
4204426-20442688.35288.35
5207203-20720389.55289.55
6203833-20383388.09588.10
10min1209197-20919790.41392.991.7990.5593.141.80
2213658-21365892.34292.49
3213417-21341792.23792.38
4217430-21743093.97294.12
5220037-22003795.09895.25
6217225-21722593.88394.03
15min1213075-21307592.09095.022.1092.3895.322.09
2217096-21709693.82794.13
3217790-21779094.12794.43
4223291-22329196.50596.81
5225142-22514297.30597.61
6222695-22269596.24796.55
20min1215984-21598493.34796.041.9493.7996.491.94
2220226-22022695.18095.63
3219593-21959394.90795.36
4224359-22435996.96697.43
5227243-22724398.21398.68
6225828-22582897.60198.07
30min1219036-21903694.66697.362.0195.2797.982.00
2222570-22257096.19396.81
3222642-22264296.22496.84
4228463-22846398.74099.37
5230780-23078099.742100.38
6228082-22808298.57599.20
极限1221303-22130395.64698.211.9296.4099.001.92
2224738-22473897.13097.90
3224486-22448697.02197.79
4229939-22993999.378100.17
5232485-232485100.478101.28
6230537-23053799.636100.43
盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
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%
110.452176952178792178412180512180152178960.07
210.462187312181842184580.18
单位质量响应值RSD%判断
20851.2920885.090.12数据可信
影响因素30天-供试品溶液-790ACE批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1198398-19839885.39483.532.1685.3983.522.15
2197856-19785685.16085.16
3194146-19414683.56483.56
4193193-19319383.15383.15
5186771-18677180.38980.39
6193986-19398683.49583.49
10min1211120-21112090.86989.391.9491.0189.531.94
2212695-21269591.54791.69
3207932-20793289.49789.64
4206455-20645588.86289.00
5201252-20125286.62286.76
6206666-20666688.95289.09
15min1216078-21607893.00391.381.7493.3091.671.74
2216870-21687093.34493.64
3212200-21220091.33491.62
4210074-21007490.41990.71
5207116-20711689.14689.42
6211476-21147691.02391.31
20min1218216-21821693.92492.551.7494.3792.991.75
2220036-22003694.70795.16
3215206-21520692.62893.07
4213275-21327591.79792.23
5209533-20953390.18690.61
6213874-21387492.05592.49
30min1221997-22199795.55194.011.7896.1694.601.78
2223417-22341796.16296.77
3218271-21827193.94794.54
4217091-21709193.43994.03
5212623-21262391.51692.09
6217043-21704393.41994.01
极限1224005-22400596.41594.961.7397.1895.711.73
2225705-22570597.14797.92
3220809-22080995.04095.79
4219197-21919794.34695.09
5215172-21517292.61493.34
6218858-21885894.20094.95
盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
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%
110.452167502170642171372168252169112169370.08
210.462167302169092168200.06
单位质量响应值RSD%判断
20759.5220728.490.11数据可信
影响因素30天-供试品溶液-790ACE批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1186582-18658280.78981.321.8080.7981.321.80
2187260-18726081.08281.08
3190498-19049882.48482.48
4193030-19303083.58183.58
5185818-18581880.45880.46
6183709-18370979.54579.54
10min1201037-20103787.04887.742.0687.1887.882.06
2200750-20075086.92387.06
3205598-20559889.02289.16
4209476-20947690.70290.84
5201195-20119587.11687.25
6197802-19780285.64785.78
15min1209468-20946890.69890.371.9190.9890.651.91
2206672-20667289.48789.77
3211584-21158491.61491.90
4214564-21456492.90593.20
5206381-20638189.36189.64
6203550-20355088.13688.41
20min1211341-21134191.50991.602.0491.9492.032.04
2209447-20944790.68991.12
3214835-21483593.02293.46
4217994-21799494.39094.84
5209772-20977290.83091.26
6205864-20586489.13889.56
30min1215445-21544593.28693.301.8893.8793.891.88
2213309-21330992.36192.94
3218929-21892994.79595.39
4221420-22142095.87396.48
5213391-21339192.39792.98
6210437-21043791.11891.69
极限1218579-21857994.64394.641.8995.3895.381.89
2216827-21682793.88594.62
3220932-22093295.66296.41
4225382-22538297.58998.35
5215966-21596693.51294.25
6213733-21373392.54593.27
盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
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%
110.452177582181252177732175272175472177460.12
210.462168772167862168320.03
单位质量响应值RSD%判断
20836.9420729.640.37数据可信
影响因素30天-供试品溶液-790ACE批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1198797-19879785.91682.403.0685.9282.403.06
2186608-18660880.64880.65
3193471-19347183.61483.61
4194862-19486284.21584.21
5185077-18507779.98679.99
6185183-18518380.03280.03
10min1212233-21223391.72288.172.8291.8788.312.82
2199200-19920086.09086.22
3207466-20746689.66289.80
4207283-20728389.58389.72
5198885-19888585.95486.09
6199041-19904186.02186.15
15min1218003-21800394.21690.262.9594.5190.552.95
2204234-20423488.26588.54
3211329-21132991.33291.62
4212914-21291492.01792.31
5203166-20316687.80488.08
6203491-20349187.94488.22
20min1220278-22027895.19991.452.8395.6591.882.83
2206691-20669189.32789.75
3214494-21449492.69993.14
4215500-21550093.13493.58
5206321-20632189.16789.59
6206343-20634389.17789.60
30min1224202-22420296.89592.693.0097.5193.283.00
2209851-20985190.69391.27
3216556-21655693.59194.19
4218836-21883694.57695.17
5208202-20820289.98090.55
6209206-20920690.41490.99
极限1225858-22585897.61193.572.9598.3894.312.95
2211650-21165091.47092.20
3218971-21897194.63495.39
4220992-22099295.50896.26
5210540-21054090.99191.71
6211029-21102991.20291.92
盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
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%
110.452179072176152176442172262177542176290.12
210.462186422182312184360.14
单位质量响应值RSD%判断
20825.7420882.980.20数据可信
影响因素30天-供试品溶液-790ACE批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1194872-19487283.93283.272.3383.9383.272.33
2195321-19532184.12584.13
3189067-18906781.43281.43
4200157-20015786.20886.21
5187947-18794780.94980.95
6192589-19258982.94882.95
10min1208460-20846089.78488.882.2789.9289.022.27
2209255-20925590.12790.27
3201217-20121786.66586.80
4212357-21235791.46391.61
5200488-20048886.35186.49
6206346-20634688.87489.01
15min1213327-21332791.88090.942.4292.1791.222.42
2213710-21371092.04592.34
3206627-20662788.99589.27
4218158-21815893.96194.26
5204161-20416187.93388.21
6210847-21084790.81291.10
20min1215722-21572292.91292.042.4693.3592.482.46
2217121-21712193.51493.96
3209039-20903990.03490.46
4220650-22065095.03495.49
5206556-20655688.96489.39
6213091-21309191.77992.22
30min1218526-21852694.12093.332.3494.7293.922.34
2220236-22023694.85695.46
3212048-21204891.33091.91
4223211-22321196.13796.75
5209792-20979290.35890.93
6216327-21632793.17293.76
极限1220944-22094495.16194.002.4495.9294.752.44
2220338-22033894.90095.66
3213686-21368692.03592.77
4225903-22590397.29798.07
5211209-21120990.96891.69
6217474-21747493.66794.41
盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
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%
110.452172942168612170292176692175622172830.16
210.462157452160432158940.10
单位质量响应值RSD%判断
20792.6320639.960.53数据可信
影响因素30天-供试品溶液-790ACE批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1144852-14485262.80562.482.5462.8062.482.54
2146745-14674563.62563.63
3147891-14789164.12264.12
4143160-14316062.07162.07
5137481-13748159.60959.61
6144497-14449762.65162.65
10min1166556-16655672.21572.661.7572.3272.761.76
2168961-16896173.25873.36
3171845-17184574.50874.62
4168464-16846473.04273.15
5163115-16311570.72370.82
6166559-16655972.21672.32
15min1177292-17729276.87077.171.5777.0977.401.58
2178839-17883977.54177.77
3181875-18187578.85779.09
4179379-17937977.77578.00
5173546-17354675.24675.46
6176995-17699576.74176.97
20min1183057-18305779.36979.991.5479.7280.341.54
2185078-18507880.24680.60
3188554-18855481.75382.12
4186584-18658480.89981.25
5180718-18071878.35578.70
6182935-18293579.31779.67
30min1191807-19180783.16383.921.5283.6584.411.51
2194027-19402784.12684.62
3198017-19801785.85686.35
4195557-19555784.78985.28
5189913-18991382.34282.82
6192023-19202383.25783.74
极限1198376-19837686.01186.711.3886.6487.341.38
2200011-20001186.72087.35
3204096-20409688.49189.13
4202343-20234387.73188.36
5196827-19682785.34085.95
6198254-19825485.95886.58
盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
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%
110.452181042182792176102178512180922179870.12
210.462156492156712156600.01
单位质量响应值RSD%判断
20860.0020617.590.83数据可信
影响因素30天-供试品溶液-790ACE批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1186804-18680480.90882.412.2780.9182.412.27
2188177-18817781.50281.50
3197986-19798685.75185.75
4191759-19175983.05483.05
5190522-19052282.51882.52
6186417-18641780.74080.74
10min1200050-20005086.64588.242.2186.7888.382.21
2201994-20199487.48787.62
3211396-21139691.55991.70
4205646-20564689.06989.21
5204220-20422088.45188.59
6199056-19905686.21486.35
15min1204000-20400088.35690.262.2088.6390.542.20
2206128-20612889.27789.56
3216085-21608593.59093.89
4210856-21085691.32591.61
5208711-20871190.39690.68
6204546-20454688.59288.87
20min1206914-20691489.61891.232.1490.0491.662.14
2208566-20856690.33390.76
3218051-21805194.44194.89
4213278-21327892.37492.81
5210855-21085591.32591.76
6206104-20610489.26789.69
30min1209729-20972990.83792.612.2391.4193.202.23
2211396-21139691.55992.14
3221841-22184196.08396.69
4216577-21657793.80394.40
5213895-21389592.64193.23
6209476-20947690.72791.30
极限1212102-21210291.86593.502.1792.5994.242.17
2213725-21372592.56893.30
3223880-22388096.96697.74
4218049-21804994.44195.19
5216245-21624593.65994.40
6211227-21122791.48692.21
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