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%
110.433516153508243499983511793509053509040.17
210.493501953506363504160.09
单位质量响应值RSD%判断
33643.7233404.770.51数据可信
供试品溶液-2024012521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%
5min1190221-19022156.74254.997.3856.7454.997.38
2168878-16887850.37650.38
3172500-17250051.45651.46
4206230-20623061.51761.52
5180194-18019453.75153.75
6187986-18798656.07556.08
10min1328243-32824397.91391.437.5998.0891.607.58
2266182-26618279.40179.55
3311552-31155292.93593.09
4319115-31911595.19195.38
5321482-32148295.89796.06
6292558-29255887.26987.44
15min1339512-339512101.27596.235.14101.7496.675.15
2293939-29393987.68188.07
3324761-32476196.87597.31
4327591-32759197.71998.19
5335500-335500100.078100.53
6314289-31428993.75194.18
20min1335901-335901100.19896.733.52100.9797.463.54
2305784-30578491.21491.87
3325154-32515496.99297.72
4325961-32596197.23398.00
5335328-335328100.027100.78
6317430-31743094.68895.40
30min1335463-335463100.06796.972.63101.1497.982.65
2312591-31259193.24494.17
3324370-32437096.75897.77
4324593-32459396.82597.88
5333563-33356399.500100.55
6319846-31984695.40996.40
45min1333837-33383799.58296.922.09100.9598.232.12
2316441-31644194.39395.60
3323312-32331296.44297.75
4323800-32380096.58897.93
5332071-33207199.055100.40
6320037-32003795.46696.75
60min1334158-33415899.67896.832.16101.3598.422.19
2316408-31640894.38395.87
3323130-32313096.38897.98
4323424-32342496.47698.11
5331641-33164198.927100.57
6318817-31881795.10296.67
极限1339830-339830101.370101.080.89103.34102.970.86
2341619-341619101.903103.68
3335241-335241100.001101.88
4334892-33489299.897101.82
5340597-340597101.599103.54
6341004-341004101.720103.57
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%
110.433499983514653512603522763514943512990.24
210.493509123503213506160.12
单位质量响应值RSD%判断
33681.5933423.830.55数据可信
供试品溶液-2024012521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%
5min1208968-20896862.28151.7812.2262.2851.7812.22
2178621-17862153.23753.24
3173627-17362751.74851.75
4148436-14843644.24044.24
5177376-17737652.86652.87
6155432-15543246.32546.33
10min1296749-29674988.44485.198.0888.6385.358.08
2295088-29508887.94988.11
3259814-25981477.43677.59
4285290-28529085.02985.16
5318743-31874394.99995.16
6259389-25938977.30977.45
15min1326982-32698297.45594.215.0897.9194.625.08
2316849-31684994.43594.86
3291638-29163886.92187.31
4327483-32748397.60497.99
5331632-33163298.84199.28
6301951-30195189.99490.37
20min1332619-33261999.13596.033.7199.8896.723.72
2318129-31812994.81695.52
3305057-30505790.92091.57
4333191-33319199.30599.99
5331334-33133498.75299.49
6312801-31280193.22893.87
30min1334330-33433099.64596.832.99100.6997.823.00
2317907-31790794.75095.74
3312344-31234493.09294.01
4335157-33515799.891100.87
5330698-33069898.56299.60
6318978-31897895.06995.99
45min1333388-33338899.36497.002.35100.7098.282.36
2318041-31804194.79096.07
3317135-31713594.52095.72
4334275-33427599.628100.91
5328552-32855297.92399.25
6321424-32142495.79897.00
60min1331661-33166198.84997.102.20100.4998.672.21
2316501-31650194.33195.89
3319593-31959395.25296.74
4334956-33495699.831101.41
5328585-32858597.93299.56
6323532-32353296.42697.92
极限1336678-336678100.344101.010.69102.28102.860.66
2338130-338130100.777102.62
3339963-339963101.324103.09
4336173-336173100.194102.07
5342156-342156101.977103.90
6340389-340389101.451103.23
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%
110.433518473513553518163520443512093516540.11
210.493508093515023511560.14
单位质量响应值RSD%判断
33715.6333475.310.51数据可信
供试品溶液-X013576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%
5min1104814-10481431.19928.9010.8531.2028.9010.85
290107-9010726.82226.82
394272-9427228.06128.06
4112841-11284133.58933.59
583308-8330824.79824.80
697173-9717328.92528.92
10min1233001-23300169.35671.9512.6569.4572.0412.65
2230035-23003568.47368.55
3238405-23840570.96471.05
4302494-30249490.04190.14
5229151-22915168.21068.28
6217239-21723964.66464.75
15min1307153-30715391.42889.494.2591.7389.804.25
2306275-30627591.16791.45
3292473-29247387.05887.36
4314843-31484393.71794.09
5303949-30394990.47490.75
6279198-27919883.10783.39
20min1330799-33079998.46795.252.9299.0495.822.90
2329418-32941898.05698.61
3310316-31031692.37092.93
4314778-31477893.69894.35
5324220-32422096.50897.06
6310406-31040692.39692.93
30min1336215-336215100.07996.752.62100.9597.612.59
2332686-33268699.02899.88
3315593-31559393.94094.78
4315635-31563593.95394.89
5325702-32570296.94997.79
6324358-32435896.54997.36
45min1337472-337472100.45397.082.58101.6298.222.54
2332738-33273899.044100.19
3316799-31679994.29995.42
4316554-31655494.22695.44
5326135-32613597.07898.21
6327103-32710397.36698.46
60min1336241-336241100.08797.032.50101.5698.462.47
2333103-33310399.152100.60
3316290-31629094.14895.55
4317051-31705194.37495.87
5326511-32651197.19098.61
6326590-32659097.21498.60
极限1336887-336887100.27997.522.00102.0599.241.98
2332832-33283299.072100.82
3319783-31978395.18896.87
4321382-32138295.66497.44
5327087-32708797.36299.08
6327663-32766397.53399.21
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%
110.433519593527403506543521893515793518240.23
210.493502303501613501960.02
单位质量响应值RSD%判断
33731.9333383.790.74数据可信
供试品溶液-X013576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%
5min192113-9211327.45027.747.9427.4527.747.93
291003-9100327.11927.12
393908-9390827.98527.98
4105917-10591731.56331.56
592675-9267527.61727.62
682980-8298024.72824.73
10min1234034-23403469.74270.634.6769.8270.724.66
2241103-24110371.84971.93
3248996-24899674.20174.28
4220086-22008665.58665.68
5247605-24760573.78673.87
6230346-23034668.64368.72
15min1293029-29302987.32388.234.4687.6188.524.45
2299491-29949189.24989.55
3297618-29761888.69089.00
4273741-27374181.57581.87
5314641-31464193.76394.07
6297899-29789988.77489.05
20min1309486-30948692.22793.471.8992.7894.031.90
2310668-31066892.57993.14
3313040-31304093.28693.86
4308874-30887492.04592.58
5324772-32477296.78297.37
6315101-31510193.90094.45
30min1313659-31365993.47194.651.7594.3095.491.75
2313954-31395493.55994.40
3315970-31597094.15995.01
4316619-31661994.35395.17
5328618-32861897.92898.80
6316967-31696794.45695.28
45min1315223-31522393.93794.881.8295.0596.001.82
2312927-31292793.25294.38
3317067-31706794.48695.62
4317626-31762694.65395.75
5329555-32955598.20899.38
6317893-31789394.73295.84
60min1314132-31413293.61294.751.8695.0096.161.86
2312252-31225293.05194.45
3317525-31752594.62396.04
4317220-31722094.53295.91
5329136-32913698.08399.55
6317437-31743794.59695.99
极限1313854-31385493.52994.971.8595.2096.661.84
2311575-31157592.85094.53
3319006-31900695.06496.77
4324114-32411496.58698.25
5326804-32680497.38899.15
6316765-31676594.39696.08
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