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%
114.25 1621661620661618641620701618021619940.10
214.25 1612971613631613300.03
单位质量响应值RSD%判断
11368.0011321.400.30数据可信
供试品溶液-24050601批-含0.005%羟丙基纤维素的pH4.5溶
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min173689-7368947.04843.358.1547.0543.358.15
272991-7299146.60246.60
368418-6841843.68343.68
460891-6089138.87738.88
569836-6983644.58844.59
661535-6153539.28839.29
10min194296-9429660.20558.407.0460.7358.887.01
294803-9480360.52961.05
383217-8321753.13153.62
486679-8667955.34255.77
5100957-10095764.45864.95
688883-8888356.74957.19
15min1107296-10729668.50568.944.4969.7070.074.48
2106249-10624967.83769.03
3103376-10337666.00267.08
4105189-10518967.16068.21
5117181-11718174.81676.03
6108571-10857169.31970.39
20min1119956-11995676.58876.537.0178.5478.426.95
2124416-12441679.43681.38
3109683-10968370.02971.84
4111064-11106470.91172.70
5131938-13193884.23886.28
6122094-12209477.95379.79
30min1136464-13646487.12886.205.4689.9388.955.43
2134634-13463485.96088.79
3123018-12301878.54381.13
4131399-13139983.89486.48
5144094-14409491.99994.98
6140435-14043589.66392.37
45min1146064-14606493.25790.605.2997.0394.305.29
2145284-14528492.75996.54
3134284-13428485.73689.20
4133057-13305784.95388.47
5152546-15254697.396101.40
6140160-14016089.48893.19
60min1151179-15117996.52393.146.50101.3397.866.44
2147402-14740294.11198.92
3134071-13407185.60090.01
4135995-13599586.82891.29
5159265-159265101.686106.77
6147404-14740494.11398.81
90min1152808-15280897.56393.775.78103.4499.525.76
2148918-14891895.079100.94
3135271-13527186.36691.73
4138647-13864788.52293.94
5157695-157695100.683106.90
6147878-14787894.415100.16
极限1154000-15400098.32493.446.45105.29100.236.37
2147331-14733194.066100.98
3134301-13430185.74792.07
4136133-13613386.91793.32
5157756-157756100.722108.05
6148606-14860694.880101.67
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%
114.25 1610911607981607861608071609651608890.09
214.25 1607491607381607440.01
单位质量响应值RSD%判断
11290.4611280.280.07数据可信
供试品溶液-24050602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%
5min161243-6124339.30743.2510.0339.3143.2510.03
263152-6315240.53240.53
376764-7676449.26949.27
461931-6193139.74939.75
574738-7473847.96947.97
666453-6645342.65142.65
10min197063-9706362.29762.807.7062.7363.287.71
291333-9133358.62059.07
3108280-10828069.49770.04
491321-9132158.61259.05
5105999-10599968.03368.57
693110-9311059.76060.23
15min1117873-11787375.65473.669.7776.7874.849.74
2107537-10753769.02070.12
3131885-13188584.64785.97
4100149-10014964.27865.37
5120976-12097677.64578.93
6110212-11021270.73771.87
20min1128905-12890582.73483.0510.6184.7085.0510.56
2125351-12535180.45382.32
3147765-14776594.83997.10
4108259-10825969.48371.29
5140613-14061390.24992.40
6125500-12550080.54982.47
30min1144591-14459192.80289.079.0395.6991.999.01
2133824-13382485.89188.65
3156920-156920100.715104.03
4119167-11916776.48479.06
5141512-14151290.82693.98
6136673-13667387.72090.54
45min1153186-15318698.31896.747.94102.24100.657.95
2145740-14574093.53997.26
3167505-167505107.508111.94
4131067-13106784.12287.55
5152738-15273898.031102.19
6154135-15413598.927102.72
60min1161753-161753103.81799.478.18108.83104.458.18
2151891-15189197.487102.24
3172332-172332110.607116.23
4134136-13413686.09190.46
5157236-157236100.918106.17
6152512-15251297.886102.78
90min1157944-157944101.37299.007.50107.54105.097.54
2152981-15298198.187104.03
3171232-171232109.901116.76
4135149-13514986.74292.06
5154264-15426499.010105.38
6153885-15388598.767104.75
极限1160136-160136102.77998.678.32110.07105.868.30
2151419-15141997.184104.11
3171816-171816110.275118.35
4132712-13271285.17891.46
5154173-15417398.952106.43
6152151-15215197.654104.73
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