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230401FK对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6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%
114.541656371658891661871661971664251660670.19
214.581684821685331685080.03
单位质量响应值RSD%判断
11421.3911557.480.84数据可信
供试品溶液-24032901批-含0.005%羟丙基纤维素的pH4.5溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min187813-8781355.36161.4315.9555.3661.4315.96
280372-8037250.67050.67
3124990-12499078.79978.80
493206-9320658.76158.76
5103669-10366965.35865.36
694622-9462259.65459.65
10min1135542-13554285.45279.859.2286.0780.539.22
2108455-10845568.37568.94
3137703-13770386.81487.69
4132077-13207783.26783.92
5129883-12988381.88482.61
6116251-11625173.29073.95
15min1149499-14949994.25186.367.7995.8287.937.79
2122120-12212076.99078.31
3143627-14362790.54992.39
4127776-12777680.55682.13
5144448-14444891.06792.70
6134425-13442584.74886.22
20min1146817-14681792.56085.987.7995.1788.517.81
2118882-11888274.94977.13
3144470-14447091.08093.93
4132877-13287783.77286.24
5143479-14347990.45693.10
6131781-13178183.08185.50
30min1154379-15437997.32786.579.37100.9790.069.31
2118477-11847774.69377.70
3146250-14625092.20396.06
4130386-13038682.20185.61
5142374-14237489.75993.41
6132039-13203983.24386.59
45min1152360-15236096.05586.458.54100.7890.908.52
2120320-12032075.85579.70
3145772-14577291.90196.78
4131186-13118682.70687.02
5142028-14202889.54194.19
6131092-13109282.64686.91
60min1149490-14949094.24586.308.20100.0391.718.21
2120632-12063276.05280.74
3148072-14807293.35199.26
4131620-13162082.97988.22
5140766-14076688.74594.39
6130729-13072982.41787.60
90min1150392-15039294.81484.768.82101.6591.138.77
2118119-11811974.46880.00
3143234-14323490.30197.24
4127552-12755280.41586.57
5139003-13900387.63494.26
6128407-12840780.95487.05
极限1149580-14958094.30284.068.71102.1991.378.66
2118821-11882174.91081.27
3142557-14255789.87497.82
4125487-12548779.11386.16
5136653-13665386.15293.76
6126921-12692180.01787.02
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230401FK对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6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%
114.541676801676741675321662931661871670730.46
214.581666961665821666390.05
单位质量响应值RSD%判断
11490.5811429.290.38数据可信
供试品溶液-24032902批-含0.005%羟丙基纤维素的pH4.5溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1100525-10052563.53764.214.7763.5464.214.76
298313-9831362.13962.14
3102609-10260964.85464.85
4106026-10602667.01467.01
594544-9454459.75759.76
6107484-10748467.93567.94
10min1128366-12836681.13474.505.4181.8475.215.38
2115276-11527672.86073.55
3112371-11237171.02471.74
4121347-12134776.69777.44
5111279-11127970.33471.00
6118579-11857974.94875.70
15min1135992-13599285.95475.736.7987.5677.276.70
2117993-11799374.57776.08
3113721-11372171.87773.39
4117256-11725674.11275.71
5115344-11534472.90374.35
6118550-11855074.93076.52
20min1132716-13271683.88375.196.2686.4577.586.19
2115432-11543272.95975.29
3113441-11344171.70074.01
4122294-12229477.29679.72
5114213-11421372.18874.44
6115696-11569673.12675.55
30min1134466-13446684.98975.766.3388.4878.976.26
2115631-11563173.08576.22
3114163-11416372.15775.26
4121567-12156776.83680.12
5117125-11712574.02977.09
6116193-11619373.44076.67
45min1131197-13119782.92374.086.1587.3678.146.09
2113595-11359571.79875.75
3112580-11258071.15675.06
4118144-11814474.67378.81
5112107-11210770.85774.74
6115638-11563873.08977.14
60min1131201-13120182.92674.175.9788.2979.055.92
2114147-11414772.14776.90
3113425-11342571.69076.39
4117819-11781974.46879.43
5113079-11307971.47276.14
6114373-11437372.28977.15
90min1129902-12990282.10572.766.7088.3978.476.60
2111874-11187470.71076.26
3109492-10949269.20474.70
4116729-11672973.77979.57
5109730-10973069.35574.82
6112980-11298071.40977.07
极限1128906-12890681.47572.376.5388.6778.886.44
2108537-10853768.60174.94
3111297-11129770.34576.61
4115663-11566373.10579.71
5109953-10995369.49675.73
6112635-11263571.19177.65
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230401FK对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6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%
114.541678351677561677241660371660171670740.58
214.581679921677141678530.12
单位质量响应值RSD%判断
11490.6511512.550.14数据可信
供试品溶液-24013102批-含0.005%羟丙基纤维素的pH4.5溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min157683-5768336.32641.187.6536.3341.187.65
263942-6394240.26840.27
366897-6689742.12942.13
462650-6265039.45439.45
570358-7035844.30844.31
670779-7077944.57444.57
10min181923-8192351.59256.755.8752.0057.215.87
292757-9275758.41458.86
393248-9324858.72459.19
485934-8593454.11754.56
590576-9057657.04157.53
696285-9628560.63661.13
15min185753-8575354.00456.596.4854.9857.686.46
292891-9289158.49959.60
390660-9066057.09458.21
480430-8043050.65151.69
592875-9287558.48959.61
696541-9654160.79761.97
20min1106223-10622366.89567.515.4168.4769.235.35
2106389-10638966.99968.75
3106236-10623666.90368.66
499975-9997562.96064.56
5117819-11781974.19775.97
6106564-10656467.10968.95
30min1124274-12427478.26274.724.2380.5877.194.16
2118184-11818474.42776.92
3120492-12049275.88178.38
4109372-10937268.87871.18
5120774-12077476.05878.66
6118801-11880174.81677.41
45min1130510-13051082.19078.834.2485.3882.124.15
2122838-12283877.35880.68
3124780-12478078.58181.92
4117893-11789374.24477.31
5132095-13209583.18886.63
6122897-12289777.39580.82
60min1126165-12616579.45378.163.8983.5682.343.87
2122760-12276077.30981.49
3125778-12577879.21083.42
4115861-11586172.96476.86
5130382-13038282.10986.48
6123721-12372177.91482.20
90min1134897-13489784.95279.614.9289.9484.654.75
2128785-12878581.10386.14
3122643-12264377.23582.33
4116566-11656673.40878.11
5128238-12823880.75986.04
6127377-12737780.21685.36
极限1136104-13610485.71279.665.2491.6485.585.04
2125029-12502978.73884.68
3127160-12716080.08086.03
4115751-11575172.89578.41
5125579-12557979.08485.26
6129305-12930581.43187.47
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