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%
110.353055276305176930536953054138305211730533990.05
210.333072267306874430705060.09
单位质量响应值RSD%判断
295014.40297241.630.54数据可信
供试品溶液-6031101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%
5min1324955-32495510.93010.304.6810.9310.304.68
2290365-2903659.7669.77
3293875-2938759.8849.88
4309796-30979610.42010.42
5297934-29793410.02110.02
6319937-31993710.76110.76
10min1773620-77362026.02025.902.9326.0425.922.92
2738076-73807624.82524.84
3761133-76113325.60025.62
4796419-79641926.78726.80
5757049-75704925.46325.48
6793629-79362926.69326.71
15min11183720-118372039.81440.342.1639.8740.402.16
21176032-117603239.55539.61
31201913-120191340.42640.48
41249052-124905242.01142.07
51193787-119378740.15340.21
61192282-119228240.10240.16
20min11551877-155187752.19752.781.9652.3152.901.96
21545661-154566151.98852.10
31582757-158275753.23553.35
41625285-162528554.66654.78
51564006-156400652.60552.72
61546420-154642052.01352.13
30min12088324-208832470.24071.401.4570.4371.591.45
22116620-211662071.19271.38
32136914-213691471.87472.07
42174397-217439773.13573.34
52122107-212210771.37671.57
62098081-209808170.56870.76
45min12551040-255104085.80386.731.0286.1087.041.02
22600847-260084787.47887.77
32567821-256782186.36886.67
42619212-261921288.09688.41
52558137-255813786.04286.34
62575363-257536386.62186.92
60min12740835-274083592.18793.000.7892.6193.420.78
22796619-279661994.06394.49
32749302-274930292.47292.90
42785290-278529093.68294.12
52759503-275950392.81593.24
62757764-275776492.75693.19
极限12839389-283938995.50296.280.8296.0796.860.82
22902983-290298397.64198.21
32847810-284781095.78596.35
42875719-287571996.72497.31
52850234-285023495.86696.43
62859889-285988996.19196.76
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%
110.353050883305180330485613044549304126030474110.15
210.333053728305899030563590.13
单位质量响应值RSD%判断
294435.85295872.120.35数据可信
供试品溶液-6031102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%
5min1304578-30457810.2789.963.7410.289.963.74
2277630-2776309.3699.37
3307960-30796010.39210.39
4289911-2899119.7839.78
5298360-29836010.06810.07
6291950-2919509.8529.85
10min1776605-77660526.20726.283.8726.2226.303.88
2730785-73078524.66124.67
3822893-82289327.76927.78
4792815-79281526.75426.77
5780557-78055726.34026.36
6769555-76955525.96925.98
15min11227152-122715241.41141.372.9641.4741.432.95
21160917-116091739.17539.23
31254294-125429442.32742.38
41264857-126485742.68342.74
51224705-122470541.32841.38
61224522-122452241.32241.38
20min11606967-160696754.22854.432.4854.3454.542.47
21544219-154421952.11052.22
31640571-164057155.36255.48
41661990-166199056.08456.20
51609867-160986754.32554.44
61614153-161415354.47054.59
30min12147922-214792272.48273.071.8172.6873.271.81
22115584-211558471.39171.58
32192613-219261373.99074.19
42227451-222745175.16675.37
52152983-215298372.65372.85
62155231-215523172.72972.93
45min12605111-260511187.91088.841.1288.2289.151.12
22601385-260138587.78588.08
32647355-264735589.33689.65
42680820-268082090.46590.78
52626755-262675588.64188.95
62634608-263460888.90689.21
60min12776111-277611193.68194.710.8094.1295.150.80
22788971-278897194.11594.54
32806373-280637394.70295.15
42833601-283360195.62196.07
52805778-280577894.68295.12
62829215-282921595.47395.91
极限12877442-287744297.10097.640.4497.6898.220.44
22889397-288939797.50498.07
32884639-288463997.34397.93
42900528-290052897.87998.47
52894828-289482897.68798.27
62913274-291327498.30998.89
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