地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP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)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.031666587166624116663851665987166661616663630.02
210.151672929167504716739880.09
单位质量响应值RSD%判断
166137.89164924.930.52数据可信
供试品溶液-24112201-1批-pH1.2(内含0.3%吐温20)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min195287-952875.7515.563.675.755.563.62
292654-926545.5925.59
388578-885785.3465.35
10min195108-951085.7405.711.505.805.771.48
295647-956475.7725.83
392966-929665.6115.67
15min194121-941215.6805.752.335.815.882.27
297890-978905.9086.03
393982-939825.6725.79
20min192153-921535.5625.734.215.755.914.08
299459-994596.0036.19
393051-930515.6165.80
30min196060-960605.7975.724.246.055.974.09
297995-979955.9146.17
390271-902715.4485.70
45min197419-974195.8795.743.666.206.063.59
296936-969365.8506.17
391163-911635.5025.81
60min195877-958775.7865.735.276.176.115.08
299319-993195.9946.38
389468-894685.4005.77
极限197504-975045.8855.817.196.336.256.88
2102449-1024496.1836.64
388791-887915.3595.79
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP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)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.031665112166477316658641665129166757716656910.07
210.151668920166736916681440.07
单位质量响应值RSD%判断
166070.89164349.160.74数据可信
供试品溶液-24112201-1批-pH4.5(内含0.3%吐温20)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1135156-1351568.1737.962.818.177.962.77
2131719-1317197.9657.97
3127776-1277767.7277.73
10min1136528-1365288.2568.032.528.358.122.55
2131761-1317617.9688.06
3130092-1300927.8677.95
15min1134132-1341328.1117.903.418.298.083.33
2125686-1256867.6007.78
3132326-1323268.0028.18
20min1145860-1458608.8208.206.559.098.466.42
2130697-1306977.9038.16
3130281-1302817.8788.14
30min1149852-1498529.0628.268.649.438.628.41
2127198-1271987.6928.04
3132828-1328288.0328.38
45min1162474-1624749.8258.2616.7710.308.7116.15
2128479-1284797.7698.20
3118890-1188907.1897.63
60min1170011-17001110.2818.9913.0010.869.5312.62
2132357-1323578.0048.52
3143648-1436488.6869.21
极限1173961-17396110.5199.1313.6911.219.7713.24
2133787-1337878.0908.70
3145363-1453638.7909.41
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP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)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.031678816167873516775471677006167674816777700.06
210.151665924166757116667480.07
单位质量响应值RSD%判断
167275.17164211.631.31数据可信
供试品溶液-24112201-1批-pH7.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11630623-163062398.29296.431.7498.2996.431.74
21577083-157708395.06595.07
31591289-159128995.92195.92
10min11632382-163238298.39898.251.0799.4999.321.06
21645840-164584099.210100.27
31611445-161144597.13698.20
15min11619038-161903897.59498.190.7599.78100.350.72
21625068-162506897.958100.12
31642513-164251399.009101.15
20min11610342-161034297.07096.880.51100.34100.140.50
21613337-161333797.250100.50
31598033-159803396.32899.57
30min11603714-160371496.67096.231.57101.02100.561.51
21616812-161681297.460101.79
31568626-156862694.55598.87
45min11565274-156527494.35394.310.6599.7899.710.59
21554228-155422893.68799.10
31574261-157426194.895100.26
60min11564518-156451894.30894.803.63100.78101.253.41
21633231-163323198.450104.90
31520245-152024591.63998.06
极限11549091-154909193.37892.791.09100.90100.291.07
21548799-154879993.360100.91
31520033-152003391.62699.06
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