对乙酰氨基酚布洛芬口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100179-202308对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)96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%
19.984777194776554777294776184781784777800.05
210.034767404763634765520.06
单位质量响应值RSD%判断
47873.7547512.660.54数据可信
供试品溶液-25121601批-布洛芬-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min196382-9638218.92717.755.7518.9317.755.76
294388-9438818.53518.54
393827-9382718.42518.43
484102-8410216.51616.52
588482-8848217.37617.38
685110-8511016.71316.71
10min1156422-15642230.71728.375.1430.8228.465.15
2147418-14741828.94929.05
3147295-14729528.92529.03
4136672-13667226.83926.93
5141089-14108927.70627.80
6137850-13785027.07027.16
15min1203056-20305639.87537.094.5040.1537.354.50
2188698-18869837.05637.32
3192706-19270637.84338.11
4181490-18149035.64035.88
5187815-18781536.88237.13
6179472-17947235.24435.49
20min1236514-23651446.44543.624.0446.9444.084.05
2222068-22206843.60944.08
3227018-22701844.58145.05
4214957-21495742.21242.65
5221023-22102343.40343.86
6211253-21125341.48541.92
30min1295276-29527657.98553.165.0558.7453.865.04
2269532-26953252.92953.64
3271926-27192653.40054.12
4259636-25963650.98651.66
5271222-27122253.26153.96
6256495-25649550.36951.04
45min1341192-34119267.00260.696.1068.0861.696.07
2312219-31221961.31262.32
3307582-30758260.40161.42
4293951-29395157.72558.68
5312380-31238061.34462.34
6286985-28698556.35757.31
60min1365420-36542071.75965.265.7973.2166.605.78
2333312-33331265.45466.80
3333920-33392065.57466.93
4317406-31740662.33163.61
5334435-33443565.67567.01
6309443-30944360.76762.03
90min1397306-39730678.02170.106.3379.8771.806.30
2353506-35350669.42071.13
3359054-35905470.50972.23
4337001-33700166.17967.80
5360440-36044070.78172.48
6334646-33464665.71667.32
120min1407651-40765180.05372.265.9582.3374.355.92
2361512-36151270.99273.09
3374970-37497073.63575.74
4348198-34819868.37770.37
5365587-36558771.79273.88
6349842-34984268.70070.67
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1428843-42884384.21475.466.0186.9477.965.98
2379819-37981974.58777.08
3374701-37470173.58276.10
4371300-37130072.91475.29
5386587-38658775.91678.41
6364454-36445471.57073.92
240min1425484-42548483.55476.925.9286.7579.835.89
2388978-38897876.38679.29
3399242-39924278.40181.33
4378658-37865874.35977.14
5400995-40099578.74581.66
6356719-35671970.05172.80
极限1426214-42621483.69878.564.2587.3681.904.29
2401527-40152778.85082.18
3405926-40592679.71483.08
4378526-37852674.33377.52
5403746-40374679.28682.64
6384456-38445675.49878.63
对乙酰氨基酚布洛芬口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100018-202312对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数50
标示量(mg)640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%
1 35.065713865712485716065714295722255715790.07
2 35.065700195696655698420.05
单位质量响应值RSD%判断
16302.8816253.340.22数据可信
供试品溶液-25121601批-对乙酰氨基酚-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1540492-54049293.29293.621.8293.2993.631.82
2540811-54081193.34793.35
3528928-52892891.29691.30
4536706-53670692.63992.64
5555399-55539995.86595.87
6552184-55218495.31095.31
10min1560176-56017696.69096.461.7097.2196.981.70
2554978-55497895.79296.31
3545828-54582894.21394.72
4553133-55313395.47495.99
5570903-57090398.54199.07
6567956-56795698.03298.56
15min1574966-57496699.24298.932.12100.3099.992.12
2570409-57040998.45699.51
3553679-55367995.56896.60
4570412-57041298.45699.50
5590600-590600101.941103.02
6578976-57897699.935101.01
20min1568325-56832598.09699.611.9499.70101.211.94
2574349-57434999.136100.73
3564014-56401497.35298.91
4576847-57684799.567101.16
5595103-595103102.718104.36
6583809-583809100.769102.40
30min1591835-591835102.154101.372.10104.31103.532.10
2586481-586481101.230103.38
3566852-56685297.84299.94
4581464-581464100.364102.51
5602605-602605104.013106.23
6594520-594520102.618104.81
45min1588155-588155101.519100.171.75104.24102.891.75
2581570-581570100.382103.09
3566597-56659797.798100.44
4572280-57228098.779101.48
5594261-594261102.573105.37
6579033-57903399.944102.70
60min1583773-583773100.76399.441.94104.05102.711.93
2576006-57600699.422102.69
3559964-55996496.65399.84
4570504-57050498.472101.72
5592433-592433102.257105.62
6573835-57383599.047102.36
90min1575310-57531099.30298.482.06103.14102.312.04
2565842-56584297.668101.49
3554848-55484895.77099.50
4561512-56151296.920100.72
5584653-584653100.914104.85
6581146-581146100.309104.17
120min1566663-56666397.80997.172.05102.20101.542.02
2552969-55296995.44699.81
3558470-55847096.395100.65
4548502-54850294.67599.01
5575829-57582999.391103.88
6575278-57527899.296103.72
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1564590-56459097.45196.901.23102.39101.821.25
2554962-55496295.790100.68
3555450-55545095.874100.67
4555387-55538795.863100.73
5569716-56971698.336103.38
6568128-56812898.062103.04
240min1544569-54456993.99694.681.8799.48100.141.81
2552438-55243895.354100.78
3545341-54534194.12999.46
4546952-54695294.40799.80
5566259-56625997.740103.33
6535663-53566392.45897.98
极限1552129-55212995.30194.441.37101.30100.421.37
2551134-55113495.129101.08
3538158-53815892.88998.74
4537304-53730492.74298.66
5554596-55459695.726101.86
6549387-54938794.827100.86
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