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%
110.091672881167321716713371670637166883816713820.11
210.191683864168420716840360.02
单位质量响应值RSD%判断
165647.37165263.590.17数据可信
供试品溶液-ACSB24025批-pH6.8(内含0.5%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%
5min11452421-145242187.69689.921.9987.7089.921.99
21490715-149071590.00890.01
31499262-149926290.52490.52
41507938-150793891.04891.05
51528114-152811492.26692.27
61457047-145704787.97587.97
10min11579927-157992795.39495.721.6996.3796.721.68
21597831-159783196.47597.48
31536896-153689692.79693.80
41614109-161410997.45898.47
51600060-160006096.61097.63
61583503-158350395.61096.59
15min11567041-156704194.61696.271.1796.6598.341.17
21611136-161113697.27999.35
31606685-160668597.01099.05
41608973-160897397.14899.24
51597207-159720796.43898.54
61576002-157600295.15797.20
20min11584901-158490195.69596.261.1898.7899.391.14
21582562-158256295.55398.71
31630198-163019898.429101.54
41593380-159338096.20699.38
51595421-159542196.33099.50
61579162-157916295.34898.45
30min11555347-155534793.91094.980.7398.0699.180.73
21587385-158738595.844100.06
31577983-157798395.27799.49
41567409-156740994.63898.88
51581217-158121795.47299.71
61569263-156926394.75098.91
极限11568929-156892994.73094.001.6099.9299.251.52
21599198-159919896.558101.84
31539951-153995192.98098.25
41553484-155348493.79899.09
51550542-155054293.62098.92
61528485-152848592.28897.50
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%
110.091679115167870016778151675564167458416771560.12
210.191695025169461216948180.02
单位质量响应值RSD%判断
166219.62166321.690.05数据可信
供试品溶液-ACSB24025批-pH6.8(内含0.5%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%
5min11483448-148344889.13089.541.2689.1389.541.27
21499148-149914890.07390.07
31517420-151742091.17191.17
41493464-149346489.73189.73
51487799-148779989.39189.39
61460556-146055687.75487.75
10min11576002-157600294.69195.801.8295.6896.801.80
21629340-162934097.89598.90
31562904-156290493.90494.92
41625650-162565097.67498.67
51602874-160287496.30597.30
61570383-157038394.35395.33
15min11625016-162501697.63596.051.7499.6898.111.72
21597714-159771495.99598.08
31569171-156917194.28096.34
41621335-162133597.41499.50
51617396-161739697.17899.24
61560829-156082993.77995.80
20min11600367-160036796.15496.582.1799.2899.712.13
21608183-160818396.62499.78
31590333-159033395.55298.66
41670574-1670574100.373103.54
51609387-160938796.69699.84
61566118-156611894.09797.16
30min11567352-156735294.17194.071.9998.3798.261.96
21589845-158984595.52299.75
31549662-154966293.10897.27
41586055-158605595.29599.57
51589741-158974195.51699.73
61511112-151111290.79294.90
极限11556980-155698093.54894.231.2698.7999.471.25
21558239-155823993.62398.91
31573349-157334994.53199.73
41601952-160195296.250101.59
51573809-157380994.55999.84
61545475-154547592.85697.98
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%
110.091684259168160516827921684493168307216832440.07
210.191704692170424517044680.02
单位质量响应值RSD%判断
166822.99167268.690.19数据可信
供试品溶液-ACSB24005批-pH6.8(内含0.5%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%
5min11434126-143412685.76785.032.8585.7785.032.85
21376131-137613182.29882.30
31365246-136524681.64781.65
41445673-144567386.45786.46
51454332-145433286.97586.97
61455170-145517087.02587.03
10min11574183-157418394.14395.441.6695.1096.381.66
21556731-155673193.09994.01
31605907-160590796.04096.95
41615593-161559396.61997.58
51594958-159495895.38596.35
61627642-162764297.34098.31
15min11574119-157411994.13995.081.8696.1497.081.84
21570061-157006193.89695.84
31604310-160431095.94497.92
41615594-161559496.61998.65
51549958-154995892.69494.72
61625099-162509997.18799.24
20min11575128-157512894.19996.041.8997.2499.101.86
21571315-157131593.97196.96
31645381-164538198.400101.44
41601146-160114695.75598.86
51607116-160711696.11299.17
61635071-163507197.784100.91
30min11560769-156076993.34095.001.4597.4399.131.45
21560799-156079993.34297.38
31600925-160092595.74299.88
41608516-160851696.196100.37
51587721-158772194.95299.08
61611994-161199496.404100.62
极限11536418-153641891.88493.691.8897.0198.881.85
21530295-153029591.51896.59
31556792-155679293.10298.30
41597010-159701095.508100.75
51587053-158705394.912100.09
61592320-159232095.227100.51
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