塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
110.081515470151466815157211514895151491715151340.03
210.131514413151310715137600.07
单位质量响应值RSD%判断
150310.91149433.370.42数据可信
供试品溶液-2023010511批-pH1.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1186151-18615112.37110.7121.0712.3710.7121.09
2176042-17604211.69911.70
397111-971116.4546.45
4185048-18504812.29812.30
5172583-17258311.46911.47
6150360-1503609.9939.99
10min1456546-45654630.34127.0918.8930.3627.1118.89
2436107-43610728.98229.00
3265426-26542617.63917.65
4481953-48195332.02932.05
5420896-42089627.97227.99
6385001-38500125.58625.60
15min1728381-72838148.40643.1917.1348.4743.2517.14
2683159-68315945.40145.46
3445971-44597129.63829.67
4760737-76073750.55650.62
5658344-65834443.75243.81
6622855-62285541.39341.45
20min1971435-97143564.55957.5815.6164.7057.7015.61
2890405-89040559.17459.30
3624383-62438341.49541.58
41007438-100743866.95267.09
5873611-87361158.05858.18
6831245-83124555.24255.36
30min11251132-125113283.14778.3310.7683.3878.5310.77
21193875-119387579.34279.56
3938042-93804262.34062.48
41298002-129800286.26286.50
51227718-122771881.59181.80
61162746-116274677.27377.47
45min11393746-139374692.62491.394.0592.9891.724.08
21391796-139179692.49592.83
31262348-126234883.89284.13
41408350-140835093.59593.97
51395876-139587692.76693.10
61399350-139935092.99793.31
60min11428684-142868494.94694.651.2995.4495.121.33
21426377-142637794.79395.27
31388459-138845992.27392.64
41431237-143123795.11695.63
51428951-142895194.96495.44
61441860-144186095.82296.28
极限11459747-145974797.01196.940.6697.6597.540.69
21460474-146047497.05997.68
31443514-144351495.93296.43
41459426-145942696.98997.64
51455552-145555296.73297.35
61473342-147334297.91498.51
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
110.081510038151183315109551509621151006215105020.06
210.131512917151146115121890.07
单位质量响应值RSD%判断
149851.39149278.280.28数据可信
供试品溶液-第1批-pH1.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1154413-15441310.28310.179.1510.2810.179.14
2149595-1495959.9629.96
3174991-17499111.65311.65
4154667-15466710.30010.30
5151632-15163210.09810.10
6131223-1312238.7398.74
10min1415850-41585027.69326.867.4627.7126.887.46
2365100-36510024.31324.33
3449210-44921029.91429.93
4393273-39327326.18926.20
5416263-41626327.72027.74
6380350-38035025.32925.34
15min1654098-65409843.55943.197.5543.6243.247.55
2577711-57771138.47238.52
3723958-72395848.21148.27
4622156-62215641.43241.49
5670697-67069744.66444.72
6642296-64229642.77342.82
20min1860059-86005957.27457.867.5257.4057.987.52
2782351-78235152.09952.21
3976745-97674565.04565.18
4827624-82762455.11455.23
5883724-88372458.85058.97
6882905-88290558.79658.91
30min11184158-118415878.85779.034.0779.0779.244.08
21118530-111853074.48774.67
31247889-124788983.10183.33
41144050-114405076.18676.39
51208912-120891280.50680.72
61217281-121728181.06381.27
45min11406464-140646493.66193.151.5493.9993.481.54
21371466-137146691.33191.63
31383727-138372792.14792.50
41390234-139023492.58092.89
51431950-143195095.35895.69
61409229-140922993.84594.17
60min11452079-145207996.69996.011.2597.1796.471.26
21419127-141912794.50594.94
31432825-143282595.41795.91
41435175-143517595.57396.03
51471346-147134697.98298.46
61439603-143960395.86896.33
极限11468556-146855697.79697.421.0298.4198.031.03
21441053-144105395.96596.54
31464878-146487897.55198.19
41458576-145857697.13297.73
51486487-148648798.99099.61
61458324-145832497.11597.72
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
110.081509392151073415092621508575150971015095350.06
210.131512250151236815123090.01
单位质量响应值RSD%判断
149755.46149290.130.23数据可信
供试品溶液-2023010511批-pH1.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1128745-1287458.5768.9312.398.588.9312.41
2144751-1447519.6429.64
3157580-15758010.49710.50
4132837-1328378.8498.85
5132474-1324748.8248.82
6107994-1079947.1947.19
10min1332220-33222022.13022.669.8322.1422.679.83
2388039-38803925.84825.86
3367448-36744824.47624.49
4331613-33161322.08922.10
5329767-32976721.96621.98
6292195-29219519.46419.47
15min1537503-53750335.80436.769.0135.8536.809.01
2635591-63559142.33842.39
3579408-57940838.59638.65
4535505-53550535.67135.72
5531996-53199635.43735.48
6490964-49096432.70432.74
20min1730333-73033348.64950.198.6248.7550.298.62
2867218-86721857.76757.88
3784031-78403152.22652.34
4733714-73371448.87448.97
5726255-72625548.37748.48
6678999-67899945.23045.32
30min11036261-103626169.02872.096.3069.2072.276.30
21191207-119120779.34979.55
31133096-113309675.47875.67
41057834-105783470.46570.64
51069108-106910871.21671.39
61005698-100569866.99267.15
45min11301769-130176986.71490.062.8286.9990.352.83
21394602-139460292.89793.22
31394862-139486292.91593.22
41358924-135892490.52190.80
51338990-133899089.19389.47
61323242-132324288.14488.40
60min11414141-141414194.19995.060.7694.6195.480.76
21428226-142822695.13795.60
31445284-144528496.27396.71
41428603-142860395.16295.58
51418473-141847394.48794.90
61428041-142804195.12595.51
极限11454571-145457196.89297.080.7297.4497.650.74
21468312-146831297.80798.41
31469651-146965197.89798.48
41459675-145967597.23297.79
51443722-144372296.16996.72
61448752-144875296.50497.04
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
110.081507887150755315078581507424150794715077340.02
210.131517244151448215158630.13
单位质量响应值RSD%判断
149576.79149640.970.04数据可信
供试品溶液-第1批-pH1.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1127909-1279098.5159.428.298.529.428.30
2134807-1348078.9758.97
3131174-1311748.7338.73
4156660-15666010.42910.43
5149717-1497179.9679.97
6148820-1488209.9079.91
10min1357595-35759523.80624.166.8723.8224.176.86
2319472-31947221.26821.28
3370101-37010124.63924.65
4373805-37380524.88624.90
5361512-36151224.06724.08
6394688-39468826.27626.29
15min1588913-58891339.20638.867.6839.2538.917.68
2511449-51144934.04934.09
3617219-61721941.09041.14
4571346-57134638.03738.09
5571523-57152338.04838.10
6641771-64177142.72542.78
20min1802367-80236753.41652.687.7553.5252.797.75
2695975-69597546.33446.43
3843360-84336056.14656.26
4764492-76449250.89551.01
5774062-77406251.53251.64
6867841-86784157.77557.89
30min11126315-112631574.98374.706.1275.1774.886.12
21029233-102923368.52068.69
31183097-118309778.76378.96
41082833-108283372.08872.27
51094390-109439072.85773.04
61216328-121632880.97581.18
45min11392546-139254692.70791.982.3293.0192.282.34
21332596-133259688.71688.98
31409441-140944193.83294.15
41357105-135710590.34790.64
51381899-138189991.99892.29
61416613-141661394.30994.64
60min11439294-143929495.81995.950.5496.2696.390.54
21448532-144853296.43496.84
31445519-144551996.23396.69
41427328-142732895.02295.45
51440603-144060395.90696.34
61446423-144642396.29496.76
极限11460275-146027597.21697.640.2997.8098.220.28
21472538-147253898.03298.58
31469583-146958397.83598.43
41465780-146578097.58298.15
51464819-146481997.51898.09
61466764-146676497.64898.26
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