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%
110.031659091166015316615271655680165612816585160.16
210.151661178166436616627720.14
单位质量响应值RSD%判断
165355.53163819.900.66数据可信
供试品溶液-ACSB24005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%
5min199045-990456.0126.030.376.016.020.39
299697-996976.0516.05
399068-990686.0136.01
10min197483-974835.9176.021.725.986.091.73
2100898-1008986.1246.19
399198-991986.0216.09
15min198032-980325.9505.991.456.086.121.52
2100336-1003366.0906.23
397715-977155.9316.06
20min197623-976235.9266.023.826.126.223.72
2103463-1034636.2806.48
396366-963665.8496.05
30min197035-970355.8905.8810.776.156.1510.41
2107323-1073236.5146.79
386446-864465.2475.51
45min196428-964285.8536.118.066.186.447.82
2110020-1100206.6787.02
395552-955525.8006.12
60min1103191-1031916.2646.337.936.666.737.64
2113094-1130946.8657.28
396682-966825.8686.26
极限196322-963225.8476.2612.366.316.7311.86
2117797-1177977.1507.65
395185-951855.7786.23
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%
110.031662371166359516612701661156166208916620960.06
210.151664007167136816676880.32
单位质量响应值RSD%判断
165712.46164304.240.61数据可信
供试品溶液-ACSB24005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%
5min1137293-1372938.3128.381.328.318.381.35
2140529-1405298.5088.51
3137465-1374658.3238.32
10min1137226-1372268.3088.134.048.408.223.98
2127957-1279577.7477.84
3137435-1374358.3218.41
15min1139475-1394758.4448.342.058.638.522.07
2134474-1344748.1428.32
3139255-1392558.4318.62
20min1137874-1378748.3478.271.158.638.541.21
2134830-1348308.1638.43
3136966-1369668.2928.57
30min1136549-1365498.2678.210.658.648.580.65
2135587-1355878.2098.57
3134804-1348048.1628.53
45min1139872-1398728.4688.422.688.938.882.65
2134972-1349728.1728.62
3142277-1422778.6149.08
60min1135524-1355248.2058.363.798.768.923.65
2134761-1347618.1598.70
3144178-1441788.7299.29
极限1137289-1372898.3128.343.218.968.983.07
2133559-1335598.0868.72
3142340-1423408.6189.27
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%
110.031669431167034316677911666670166791616684300.09
210.151676482166965416730680.29
单位质量响应值RSD%判断
166343.97164834.290.65数据可信
供试品溶液-ACSB24005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%
5min11491467-149146789.98288.585.3289.9888.575.32
21381106-138110683.32483.32
31531857-153185792.41992.42
10min11413934-141393485.30484.720.7286.3085.700.69
21404655-140465584.74585.67
31393989-139398984.10185.13
15min11410517-141051785.09883.672.7187.0585.592.63
21406382-140638284.84986.72
31343457-134345781.05383.01
20min11403692-140369284.68781.435.8587.5884.285.65
21386058-138605883.62386.43
31259211-125921175.97078.83
30min11405629-140562984.80386.722.3588.6490.492.20
21472660-147266088.84792.59
31434116-143411686.52290.23
45min11489783-148978389.88188.641.9294.6693.371.83
21437098-143709886.70291.43
31480840-148084089.34194.01
60min11459043-145904388.02689.391.4593.8095.101.30
21484324-148432489.55195.24
31501616-150161690.59496.25
极限11469147-146914788.63689.571.5095.3996.271.38
21510099-151009991.10697.79
31474539-147453988.96195.63
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