他克莫司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D230603FK对照品来源自制对照品使用方法直接使用
对照品含量(%)97.04对照品水分(%)0对照品稀释倍数17500
标示量(mg)1供试品稀释倍数1.4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.111563121560941560411561301560771561310.07
214.171555921552681554300.15
单位质量响应值RSD%判断
11065.2710968.950.62数据可信
供试品溶液-24111101批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min152828-5282833.50332.243.9933.5032.243.98
252353-5235333.20233.20
347270-4727029.97829.98
450159-5015931.81131.81
550608-5060832.09532.10
651829-5182932.87032.87
10min175804-7580448.07546.773.8048.4547.133.79
275599-7559947.94548.31
371811-7181145.54245.88
468919-6891943.70844.06
575563-7556347.92248.28
674813-7481347.44647.81
15min182470-8247052.30255.113.4053.2155.993.36
289460-8946056.73557.64
385325-8532554.11354.95
486408-8640854.80055.64
590726-9072657.53858.43
687030-8703055.19456.09
20min195863-9586360.79661.493.5662.2862.983.54
297960-9796062.12663.66
393469-9346959.27860.72
493197-9319759.10560.55
5102078-10207864.73866.27
699140-9914062.87464.38
30min1108607-10860768.87869.662.8971.0471.842.88
2111436-11143670.67272.89
3106512-10651267.55069.65
4107440-10744068.13870.24
5115244-11524473.08775.34
6109832-10983269.65571.86
45min1127618-12761880.93579.632.2883.8682.582.27
2127731-12773181.00784.01
3121454-12145477.02679.88
4122793-12279377.87580.74
5125467-12546779.57182.63
6128300-12830081.36784.35
60min1134948-13494885.58484.882.0389.4188.722.01
2137659-13765987.30391.21
3130900-13090083.01686.72
4133284-13328484.52888.26
5135490-13549085.92789.87
6130798-13079882.95286.83
90min1134641-13464185.38986.952.4490.1791.722.36
2142396-14239690.30795.18
3133308-13330884.54389.17
4139401-13940188.40893.07
5135719-13571986.07390.97
6137160-13716086.98691.79
极限1135283-13528385.79685.932.6491.5291.672.55
2141914-14191490.00195.88
3131499-13149983.39688.96
4136445-13644586.53392.18
5133432-13343284.62290.48
6134378-13437885.22290.99
他克莫司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D230603FK对照品来源自制对照品使用方法直接使用
对照品含量(%)97.04对照品水分(%)0对照品稀释倍数17500
标示量(mg)1供试品稀释倍数1.4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.111566231564501564791550201549761559100.54
214.171539911540891540400.05
单位质量响应值RSD%判断
11049.6110870.851.16数据可信
供试品溶液-24111102批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min145910-4591029.26829.533.2729.2729.523.26
246524-4652429.66029.66
345452-4545228.97628.98
444677-4467728.48228.48
546210-4621029.46029.46
649104-4910431.30531.30
10min172474-7247446.20345.782.2546.5346.102.25
270357-7035744.85445.18
372026-7202645.91846.24
469372-6937244.22644.54
573275-7327546.71447.04
673339-7333946.75547.10
15min187563-8756355.82356.762.4156.6657.592.39
292251-9225158.81259.64
387665-8766555.88856.72
486535-8653555.16855.98
589772-8977257.23158.08
690369-9036957.61258.48
20min1101318-10131864.59263.932.3466.0565.402.33
2100687-10068764.19065.67
399921-9992163.70165.15
495776-9577661.05962.48
5102169-10216965.13566.62
6101786-10178664.89066.40
30min1114937-11493773.27472.652.1675.4574.822.15
2115756-11575673.79775.99
3112607-11260771.78973.95
4109548-10954869.83971.94
5115757-11575773.79776.00
6115126-11512673.39575.62
45min1126711-12671180.78180.031.6483.7783.021.63
2127953-12795381.57284.59
3124325-12432579.25982.22
4122857-12285778.32481.20
5127305-12730581.15984.19
6124084-12408479.10682.15
60min1135876-13587686.62384.742.6390.5188.622.59
2136494-13649487.01790.94
3130927-13092783.46887.31
4127161-12716181.06784.81
5134415-13441585.69289.62
6132681-13268184.58788.51
90min1134374-13437485.66685.991.9090.5290.801.88
2136120-13612086.77991.67
3133133-13313384.87589.64
4131480-13148083.82188.47
5135258-13525886.22991.11
6138909-13890988.55793.42
极限1135467-13546786.36385.711.2992.1791.481.31
2136737-13673787.17293.02
3132456-13245684.44390.15
4132361-13236184.38389.96
5134654-13465485.84491.68
6135008-13500886.07091.92
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