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50
标示量(mg)200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%
19.681432612143359814326271431397143345314327370.07
29.651429915143146914306920.08
单位质量响应值RSD%判断
148010.02148258.240.12数据可信
中间条件36月-供试品溶液-2023010511批-pH4.5(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%
5min1141215-1412159.4959.394.209.499.384.20
2147136-1471369.8939.89
3142355-1423559.5719.57
4139725-1397259.3959.39
5129574-1295748.7128.71
6137557-1375579.2499.25
10min1375725-37572525.26223.807.2525.2823.817.25
2357841-35784124.06024.07
3378662-37866225.46025.47
4363469-36346924.43824.45
5311685-31168520.95720.97
6336205-33620522.60522.62
15min1603145-60314540.55337.897.7540.6137.947.76
2557348-55734837.47437.53
3609709-60970940.99541.05
4582141-58214139.14139.19
5496445-49644533.37933.42
6532741-53274135.82035.87
20min1813699-81369954.71050.877.8154.8250.987.81
2734296-73429649.37149.48
3820893-82089355.19455.31
4779163-77916352.38852.50
5667097-66709744.85344.95
6724422-72442248.70848.81
30min11148825-114882577.24371.737.7277.4471.917.72
21026159-102615968.99569.18
31156157-115615777.73677.93
41108178-110817874.51074.70
5958073-95807364.41764.58
61003472-100347267.47067.64
45min11353026-135302690.97388.603.6991.2888.883.70
21302313-130231387.56387.85
31370683-137068392.16092.47
41353869-135386991.02991.33
51252044-125204484.18384.44
61274100-127410085.66685.94
60min11392993-139299393.66093.831.7094.1194.251.72
21390069-139006993.46393.88
31427290-142729095.96696.42
41419487-141948795.44195.88
51368285-136828591.99992.38
61374705-137470592.43092.83
极限11426700-142670095.92694.961.1196.5195.521.13
21427934-142793496.00996.57
31417715-141771595.32295.92
41414983-141498395.13895.72
51391715-139171593.57494.10
61394743-139474393.77894.32
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50
标示量(mg)200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%
19.681429253143052214287971429516142541814287010.14
29.651428820142944814291340.04
单位质量响应值RSD%判断
147593.08148096.790.25数据可信
中间条件36月-供试品溶液-2023010511批-pH4.5(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%
5min1183912-18391212.3909.4515.8812.399.4515.86
2133709-1337099.0089.01
3124203-1242038.3678.37
4136579-1365799.2019.20
5124334-1243348.3768.38
6138595-1385959.3379.34
10min1442299-44229929.79724.8210.9229.8224.8410.93
2355157-35515723.92623.94
3340995-34099522.97222.98
4374034-37403425.19825.21
5327651-32765122.07322.09
6370819-37081924.98125.00
15min1686427-68642746.24340.298.7446.3140.348.75
2601591-60159140.52840.58
3560133-56013337.73537.78
4613089-61308941.30341.35
5533648-53364835.95136.00
6593648-59364839.99340.04
20min1896845-89684560.41953.197.9660.5553.307.97
2743619-74361950.09650.21
3755018-75501850.86450.97
4821061-82106155.31355.43
5726971-72697148.97549.07
6793883-79388353.48253.59
30min11215335-121533581.87574.126.6582.1074.316.65
21032308-103230869.54569.73
31052250-105225070.88871.07
41158947-115894778.07678.27
51044612-104461270.37470.55
61097558-109755873.94074.13
45min11452425-145242597.84790.983.8798.1991.283.88
21312022-131202288.38888.68
31316514-131651488.69188.98
41353348-135334891.17291.49
51327960-132796089.46289.74
61340252-134025290.29090.59
60min11408856-140885694.91294.130.9795.4094.570.98
21389152-138915293.58494.01
31385434-138543493.33493.75
41390418-139041893.67094.12
51390917-139091793.70394.12
61419044-141904495.59896.04
极限11425473-142547396.03198.437.6396.6799.017.59
21424863-142486395.99096.55
31415921-141592195.38895.95
41687181-1687181113.662114.25
51419033-141903395.59896.15
61394181-139418193.92394.50
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50
标示量(mg)200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%
19.681434153143333214330811433571143446714337210.05
29.651436884143472414358040.11
单位质量响应值RSD%判断
148111.67148787.980.33数据可信
中间条件36月-供试品溶液-2023010611批-pH4.5(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%
5min1147862-1478629.92110.2217.519.9210.2217.51
2182471-18247112.24312.24
3125330-1253308.4098.41
4187209-18720912.56112.56
5142503-1425039.5619.56
6128227-1282278.6038.60
10min1376164-37616425.23825.2315.8125.2525.2415.81
2440002-44000229.52129.54
3316381-31638121.22721.24
4455220-45522030.54230.56
5344835-34483523.13623.15
6323514-32351421.70621.72
15min1594168-59416839.86539.4813.9639.9239.5413.97
2668928-66892844.88144.94
3508803-50880334.13734.18
4703203-70320347.18147.25
5541308-54130836.31836.37
6514484-51448434.51934.56
20min1790342-79034253.02752.5612.0853.1452.6712.08
2870654-87065458.41558.55
3690658-69065846.33946.43
4918509-91850961.62661.76
5734871-73487149.30549.41
6694853-69485346.62046.72
30min11096704-109670473.58273.608.8373.7773.798.85
21171187-117118778.57978.80
3999969-99996967.09267.26
41247884-124788483.72583.95
51055002-105500270.78470.96
61010675-101067567.81067.98
45min11360233-136023391.26390.603.1591.5790.903.18
21381907-138190792.71793.05
31300056-130005687.22687.49
41409324-140932494.55794.91
51343158-134315890.11790.40
61307111-130711187.69987.97
60min11418724-141872495.18794.611.1895.6395.051.21
21416182-141618295.01795.49
31382710-138271092.77193.17
41431840-143184096.06796.56
51407945-140794594.46494.88
61403550-140355094.16994.57
极限11430850-143085096.00195.610.8996.5896.190.92
21430657-143065795.98896.61
31401703-140170394.04594.58
41438009-143800996.48197.12
51421948-142194895.40495.96
61426986-142698695.74296.28
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50
标示量(mg)200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%
19.681429857143111114301431430716143152514306700.05
29.651428920143025414295870.07
单位质量响应值RSD%判断
147796.49148143.730.17数据可信
中间条件36月-供试品溶液-2023010611批-pH4.5(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%
5min1130413-1304138.7788.835.348.788.835.35
2122161-1221618.2238.22
3124359-1243598.3718.37
4133402-1334028.9798.98
5137259-1372599.2399.24
6139816-1398169.4119.41
10min1317922-31792221.40022.368.0221.4122.388.03
2314007-31400721.13621.15
3303772-30377220.44720.46
4369524-36952424.87324.89
5327666-32766622.05622.07
6360290-36029024.25124.27
15min1504631-50463133.96735.958.9534.0136.008.95
2502011-50201133.79133.83
3492878-49287833.17633.22
4606833-60683340.84740.90
5516861-51686134.79034.84
6581380-58138039.13339.18
20min1680575-68057545.81048.808.6245.9148.908.62
2681893-68189345.89945.99
3677288-67728845.58945.68
4818206-81820655.07455.19
5702124-70212447.26147.36
6789703-78970353.15653.26
30min1974151-97415165.57169.957.3765.7470.127.38
2989534-98953466.60766.77
3988800-98880066.55766.72
41155393-115539377.77177.97
51011783-101178368.10468.27
61115594-111559475.09275.28
45min11273522-127352285.72289.043.5585.9989.323.56
21285500-128550086.52886.79
31303647-130364787.75088.01
41392398-139239893.72494.03
51315090-131509088.52088.79
61366469-136646991.97892.28
60min11396799-139679994.02094.751.0894.4195.171.10
21384276-138427693.17793.57
31407432-140743294.73695.13
41425696-142569695.96596.42
51419360-141936095.53995.94
61412689-141268995.08995.53
极限11430501-143050196.28896.341.0096.8296.891.01
21406092-140609294.64595.18
31430024-143002496.25696.79
41447194-144719497.41298.01
51442199-144219997.07697.62
61431258-143125896.33996.92
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50
标示量(mg)200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%
19.681433733143252114323481432051143413214329570.07
29.651432393143306714327300.04
单位质量响应值RSD%判断
148032.75148469.430.21数据可信
中间条件36月-供试品溶液-2023010711批-pH4.5(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%
5min1154195-15419510.3598.9212.0110.368.9212.02
2131562-1315628.8398.84
3122037-1220378.1998.20
4145853-1458539.7999.80
5132873-1328738.9278.93
6109890-1098907.3837.38
10min1377444-37744425.35823.267.8325.3723.277.83
2345577-34557723.21723.23
3319524-31952421.46721.48
4375776-37577625.24625.26
5346150-34615023.25623.27
6312889-31288921.02121.03
15min1596957-59695740.10637.496.1840.1637.546.18
2555815-55581537.34237.39
3519516-51951634.90334.95
4597057-59705740.11240.16
5558562-55856237.52637.57
6520421-52042134.96435.01
20min1804712-80471254.06350.915.5654.1851.025.56
2746880-74688050.17850.28
3719761-71976148.35648.45
4811688-81168854.53254.64
5752481-75248150.55450.66
6711440-71144047.79747.89
30min11130486-113048675.95072.334.8976.1472.514.89
21061077-106107771.28771.47
31017475-101747568.35768.53
41121203-112120375.32675.52
51114145-111414574.85275.03
61014911-101491168.18568.35
45min11387482-138748293.21690.622.1593.5290.902.16
21360732-136073291.41991.70
31306614-130661487.78388.05
41368070-136807091.91292.22
51337070-133707089.82990.12
61332695-133269589.53589.80
60min11437933-143793396.60594.981.4997.0595.401.50
21390485-139048593.41893.84
31396659-139665993.83294.24
41438426-143842696.63897.08
51417431-141743195.22895.66
61401405-140140594.15194.55
极限11447703-144770397.26295.691.0597.8696.261.06
21411779-141177994.84895.41
31419638-141963895.37695.92
41433967-143396796.33996.93
51407130-140713094.53695.11
61425691-142569195.78396.33
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50
标示量(mg)200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%
19.681424515142509914327511432382143123514291960.29
29.651426550142583814261940.04
单位质量响应值RSD%判断
147644.21147792.120.08数据可信
中间条件36月-供试品溶液-2023010711批-pH4.5(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%
5min1155263-15526310.4699.8711.2710.479.8611.27
2170716-17071611.51111.51
3127543-1275438.6008.60
4132950-1329508.9648.96
5137056-1370569.2419.24
6154430-15443010.41310.41
10min1378216-37821625.50125.289.4725.5225.309.47
2427409-42740928.81828.84
3327084-32708422.05422.07
4374165-37416525.22825.24
5346659-34665923.37423.39
6395905-39590526.69426.71
15min1597735-59773540.30340.158.5440.3640.208.54
2666243-66624344.92244.98
3530336-53033635.75835.80
4612859-61285941.32241.37
5544018-54401836.68136.73
6621888-62188841.93141.99
20min1805412-80541254.30553.787.4754.4253.907.48
2875830-87583059.05359.18
3726877-72687749.01049.11
4824727-82472755.60855.72
5726834-72683449.00749.11
6826258-82625855.71155.83
30min11130383-113038376.21774.616.0376.4174.806.04
21184719-118471979.88180.10
31034003-103400369.71869.89
41145511-114551177.23777.43
51015540-101554068.47468.65
61129221-112922176.13976.34
45min11387210-138721093.53491.843.1693.8492.153.17
21399602-139960294.36994.71
31325835-132583589.39589.67
41391865-139186593.84794.16
51292662-129266287.15987.44
61375793-137579392.76493.08
60min11432699-143269996.60195.311.5397.0595.761.55
21430718-143071896.46796.95
31394300-139430094.01294.42
41426150-142615096.15996.61
51380167-138016793.05993.47
61417452-141745295.57396.03
极限11450194-145019497.78097.011.7298.3897.601.73
21477791-147779199.641100.26
31428503-142850396.31896.87
41440372-144037297.11897.72
51403550-140355094.63595.19
61431917-143191796.54897.15
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50
标示量(mg)200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%
19.682854393285488228509422852074285303328530650.06
29.652854913285531128551120.01
单位质量响应值RSD%判断
294738.12295866.530.28数据可信
中间条件36月-供试品溶液-2023010811批-pH4.5(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%
5min1281861-2818619.5079.777.359.519.777.34
2318740-31874010.75110.75
3270636-2706369.1289.13
4283647-2836479.5679.57
5269602-2696029.0939.09
6313213-31321310.56410.56
10min1719371-71937124.26325.164.7724.2825.174.77
2781689-78168926.36526.38
3712017-71201724.01524.03
4763262-76326225.74425.76
5711706-71170624.00524.02
6787299-78729926.55426.57
15min11140037-114003738.45139.443.6238.5039.493.62
21215789-121578941.00641.06
31129677-112967738.10238.15
41166450-116645039.34239.40
51137473-113747338.36538.41
61226987-122698741.38441.44
20min11505025-150502550.76251.613.0750.8751.723.07
21592934-159293453.72753.84
31482565-148256550.00450.11
41536755-153675551.83251.94
51486857-148685750.14950.26
61577591-157759153.20953.33
30min12040345-204034568.81770.202.0369.0070.392.03
22152752-215275272.60972.81
32039378-203937868.78568.97
42073791-207379169.94570.14
52085427-208542770.33870.52
62096921-209692170.72670.92
45min12531913-253191385.39785.942.1085.6886.232.10
22646276-264627689.25489.56
32484015-248401583.78284.07
42550274-255027486.01686.31
52538072-253807285.60585.89
62537614-253761485.58985.89
60min12736164-273616492.28693.011.3892.7093.431.38
22804644-280464494.59695.04
32701149-270114991.10591.52
42792432-279243294.18494.61
52761361-276136193.13693.55
62749936-274993692.75193.18
极限12812444-281244494.85995.371.3295.4195.931.32
22804456-280445694.58995.17
32787105-278710594.00494.55
42869169-286916996.77297.34
52878791-287879197.09797.65
62813263-281326394.88695.46
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50
标示量(mg)200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%
19.682855578285911028595122860253286056928590040.07
29.652853059285311728530880.01
单位质量响应值RSD%判断
295351.65295656.790.08数据可信
中间条件36月-供试品溶液-2023010811批-pH4.5(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%
5min1285781-2857819.6329.303.919.639.303.90
2284850-2848509.6019.60
3267389-2673899.0129.01
4260483-2604838.7808.78
5271684-2716849.1579.16
6284618-2846189.5939.59
10min1721810-72181024.32924.062.7724.3424.072.77
2728359-72835924.54924.56
3703531-70353123.71323.73
4687487-68748723.17223.18
5701152-70115223.63223.65
6740407-74040724.95624.97
15min11199415-119941540.42638.873.4740.4838.923.47
21151989-115198938.82838.88
31188632-118863240.06340.11
41108542-110854237.36437.41
51103968-110396837.20937.26
61166079-116607939.30339.35
20min11488290-148829050.16350.842.8450.2750.942.83
21531570-153157051.62251.73
31483186-148318649.99150.10
41572404-157240452.99853.10
51451137-145113748.91149.02
61522988-152298851.33251.44
30min12038638-203863868.71369.092.0668.9069.282.06
22100587-210058770.80170.99
32024984-202498468.25268.44
42055277-205527769.27369.46
51988375-198837567.01867.20
62091704-209170470.50170.69
45min12554430-255443086.09785.900.9586.3986.190.95
22570841-257084186.65086.94
32519487-251948784.92085.21
42544327-254432785.75786.04
52523602-252360285.05885.34
62578401-257840186.90587.20
60min12757333-275733392.93692.550.7493.3692.960.74
22755661-275566192.88093.30
32729596-272959692.00192.42
42751801-275180192.75093.17
52713439-271343991.45791.86
62766951-276695193.26093.68
极限12819893-281989395.04594.890.5095.6095.440.51
22832533-283253395.47196.03
32804227-280422794.51795.07
42818858-281885895.01095.57
52793458-279345894.15494.70
62822726-282272695.14095.70
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50
标示量(mg)200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%
19.682862825287090928878882871589286039828707220.38
29.652861162286163128613960.02
单位质量响应值RSD%判断
296562.19296517.720.02数据可信
中间条件36月-供试品溶液-2023011011批-pH4.5(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%
5min1351485-35148511.80510.656.1711.8110.656.19
2312286-31228610.48910.49
3290931-2909319.7729.77
4313175-31317510.51910.52
5318524-31852410.69810.70
6315402-31540210.59410.59
10min1901388-90138830.27527.196.2030.2927.216.20
2786629-78662926.42126.44
3753532-75353225.30925.32
4791197-79119726.57426.59
5820296-82029627.55227.57
6804709-80470927.02827.04
15min11372981-137298146.11542.215.2146.1842.265.21
21239902-123990241.64541.70
31176828-117682839.52739.58
41227396-122739641.22541.28
51272913-127291342.75442.81
61249703-124970341.97442.03
20min11761729-176172959.17254.894.5059.3055.014.50
21579832-157983253.06253.18
31551038-155103852.09552.21
41614351-161435154.22254.34
51650866-165086655.44855.57
61647051-164705155.32055.44
30min12267403-226740376.15673.172.6876.3873.372.68
22120190-212019071.21271.41
32107295-210729570.77970.97
42187739-218773973.48073.68
52195961-219596173.75773.96
62192369-219236973.63673.84
45min12655947-265594789.20688.321.4289.5488.631.43
22588432-258843286.93987.24
32583078-258307886.75987.06
42638456-263845688.61988.93
52677429-267742989.92890.24
62633560-263356088.45488.77
60min12853458-285345895.84093.771.1996.3194.211.19
22758806-275880692.66193.10
32776698-277669893.26293.69
42797317-279731793.95594.40
52775048-277504893.20793.66
62788752-278875293.66794.11
极限12824171-282417194.85796.041.3895.4796.631.37
22874554-287455496.54997.12
32843256-284325695.49896.06
42846735-284673595.61496.20
52932144-293214498.48399.07
62835997-283599795.25495.84
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50
标示量(mg)200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%
19.682854539285661728598232855970285649528566890.07
29.652862353286332428628380.03
单位质量响应值RSD%判断
295112.50296667.150.38数据可信
中间条件36月-供试品溶液-2023011011批-pH4.5(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%
5min1349867-34986711.77712.1613.1611.7812.1613.16
2398249-39824913.40613.41
3394260-39426013.27113.27
4372636-37263612.54312.54
5381843-38184312.85312.85
6270941-2709419.1209.12
10min1879593-87959329.60829.659.8029.6329.679.81
2952979-95297932.07932.10
3960362-96036232.32732.35
4875557-87555729.47229.49
5895093-89509330.13030.15
6721311-72131124.28024.29
15min11355692-135569245.63545.468.9745.7045.528.97
21488356-148835650.10050.17
31440905-144090548.50348.57
41331149-133114944.80844.87
51350104-135010445.44645.51
61136550-113655038.25838.31
20min11720722-172072257.92257.536.3858.0557.666.39
21803081-180308160.69460.84
31787829-178782960.18160.32
41700552-170055257.24357.37
51740968-174096858.60358.74
61501262-150126250.53550.64
30min12230818-223081875.09275.044.2575.3175.264.26
22293392-229339277.19977.43
32298511-229851177.37177.60
42196354-219635473.93274.15
52299509-229950977.40577.63
62056528-205652869.22669.41
45min12642264-264226488.94289.132.0889.2789.452.10
22688378-268837890.49590.84
32662258-266225889.61589.96
42626584-262658488.41588.74
52712018-271201891.29091.63
62554689-255468985.99486.28
60min12777001-277700193.47894.041.0493.9494.501.05
22779244-277924493.55394.04
32818661-281866194.88095.36
42783193-278319393.68694.15
52839415-283941595.57996.05
62764651-276465193.06293.48
极限12828719-282871995.21995.540.8095.8296.140.80
22813178-281317894.69695.32
32837379-283737995.51096.13
42838119-283811995.53596.14
52880246-288024696.95397.57
62831923-283192395.32795.88
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50
标示量(mg)200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%
19.682866458286301228635372863032286334228638760.06
29.652853816285543428546250.05
单位质量响应值RSD%判断
295854.96295816.060.01数据可信
中间条件36月-供试品溶液-2023011111批-pH4.5(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%
5min1300879-30087910.1309.297.4110.139.297.40
2266418-2664188.9708.97
3256533-2565338.6378.64
4303037-30303710.20210.20
5266272-2662728.9658.96
6262785-2627858.8478.85
10min1772324-77232426.00224.386.2226.0224.396.23
2701859-70185923.63023.64
3678769-67876922.85222.87
4788653-78865326.55226.57
5696821-69682123.46023.47
6705575-70557523.75523.77
15min11187504-118750439.98038.324.7540.0338.374.76
21107654-110765437.29237.34
31081737-108173736.41936.47
41221421-122142141.12241.18
51107900-110790037.30037.35
61123434-112343437.82337.87
20min11533111-153311151.61650.364.0551.7350.464.05
21475598-147559849.67949.78
31435648-143564848.33448.44
41596428-159642853.74853.86
51444103-144410348.61948.72
61489339-148933950.14250.25
30min12094843-209484370.52868.813.5870.7268.993.58
21983292-198329266.77266.95
32004510-200451067.48767.66
42148966-214896672.35072.55
51959704-195970465.97866.16
62070766-207076669.71769.90
45min12574803-257480386.68784.991.9386.9885.281.93
22473659-247365983.28283.56
32495291-249529184.01084.29
42584321-258432187.00787.31
52479582-247958283.48183.76
62538610-253861085.46885.75
60min12742334-274233492.32791.850.7892.7592.260.78
22697784-269778490.82791.23
32743293-274329392.35992.76
42749993-274999392.58593.02
52708448-270844891.18691.59
62727473-272747391.82792.24
极限12802326-280232694.34794.270.4094.9194.820.41
22789198-278919893.90594.45
32793568-279356894.05294.59
42818969-281896994.90795.48
52791981-279198193.99994.54
62804156-280415694.40994.96
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50
标示量(mg)200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%
19.682855257285474528556622856040285821128559830.05
29.652851698285054128511200.03
单位质量响应值RSD%判断
295039.57295452.850.10数据可信
中间条件36月-供试品溶液-2023011111批-pH4.5(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%
5min1296324-2963249.9969.945.3410.009.945.35
2312208-31220810.53210.53
3272564-2725649.1959.19
4283109-2831099.5519.55
5311832-31183210.52010.52
6291891-2918919.8479.85
10min1736934-73693424.86025.374.1424.8825.384.13
2771115-77111526.01326.03
3703530-70353023.73323.75
4745301-74530125.14225.16
5793964-79396426.78426.80
6761004-76100425.67225.69
15min11148779-114877938.75439.254.2738.8139.304.27
21190292-119029240.15440.21
31099286-109928637.08437.13
41187179-118717940.04940.10
51233949-123394941.62741.68
61121934-112193437.84837.90
20min11498794-149879450.56151.513.6750.6751.623.68
21538592-153859251.90452.02
31479228-147922849.90150.01
41560674-156067452.64952.76
51616092-161609254.51854.64
61468633-146863349.54449.65
30min12029438-202943868.46269.362.9968.6569.553.00
22079289-207928970.14470.34
31966630-196663066.34366.52
42125034-212503471.68771.88
52116083-211608371.38571.59
62020353-202035368.15668.34
45min12482296-248229683.73984.741.7984.0385.031.79
22529588-252958885.33585.63
32442653-244265382.40282.68
42567194-256719486.60386.90
52542638-254263885.77586.08
62507520-250752084.59084.88
60min12691058-269105890.78291.470.8491.2091.900.84
22716085-271608591.62692.05
32696332-269633290.96091.36
42749743-274974392.76193.19
52722132-272213291.83092.27
62694110-269411090.88591.30
极限12784023-278402393.91894.490.6594.4795.040.66
22798256-279825694.39894.96
32778848-277884893.74394.28
42828244-282824495.41095.98
52805889-280588994.65595.23
62810210-281021094.80195.35
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