依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017对照品来源自制对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.021722991725991728601728361727511726690.14
210.031758621758981758800.02
单位质量响应值RSD%判断
17232.4417535.391.24数据可信
供试品溶液-2024011621批-依折麦布-pH2.0(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142970-4297022.17522.4813.3522.1722.4813.35
233263-3326317.16517.17
342564-4256421.96521.97
446078-4607823.77923.78
550633-5063326.12926.13
645869-4586923.67123.67
10min1115600-11560059.65563.314.5159.7863.434.49
2129204-12920466.67666.77
3126745-12674565.40765.53
4120228-12022862.04462.18
5126441-12644165.25065.40
6117831-11783160.80760.94
15min1154867-15486779.91983.492.9780.3783.962.96
2166828-16682886.09286.56
3164437-16443784.85885.34
4158594-15859481.84382.32
5166238-16623885.78786.29
6159706-15970682.41682.89
20min1169836-16983687.64491.132.2188.5492.062.22
2176220-17622090.93891.88
3180094-18009492.93893.89
4176073-17607390.86391.79
5180775-18077593.28994.27
6176515-17651591.09192.02
30min1176050-17605090.85192.311.8492.2493.761.84
2176312-17631290.98692.44
3183772-18377294.83696.31
4175853-17585390.74992.19
5180573-18057393.18594.69
6180743-18074393.27394.71
45min1178866-17886692.30492.271.5994.1994.221.54
2179359-17935992.55894.51
3173245-17324589.40391.40
4180713-18071393.25795.20
5179718-17971892.74494.76
6180869-18086993.33895.29
60min1174254-17425489.92492.962.5092.3395.432.47
2177992-17799291.85394.32
3184157-18415795.03497.53
4176283-17628390.97193.43
5184083-18408394.99697.53
6184039-18403994.97397.44
极限1175394-17539490.51292.162.2893.4195.152.26
2176682-17668291.17794.16
3182600-18260094.23197.26
4173430-17343089.49992.46
5183502-18350294.69697.76
6179910-17991092.84395.84
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.173079763081683085163084723082233082710.08
211.113131843137833134840.14
单位质量响应值RSD%判断
27598.1228216.381.57数据可信
供试品溶液-2024011621批-阿托伐他汀钙-pH2.0(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1116793-11679334.57340.2428.2934.5740.2428.30
274552-7455222.06922.07
3125263-12526337.08037.08
4166809-16680949.37849.38
5152522-15252245.14945.15
6179738-17973853.20553.21
10min1252377-25237774.70876.7612.8274.9076.9912.87
2198372-19837258.72158.84
3257049-25704976.09176.30
4291456-29145686.27686.55
5277586-27758682.17082.42
6279096-27909682.61782.91
15min1294550-29455087.19287.877.0787.8088.527.15
2258097-25809776.40176.85
3293281-29328186.81687.44
4313685-31368592.85693.61
5312989-31298992.65093.36
6308436-30843691.30292.06
20min1312189-31218992.41394.074.8993.5095.204.99
2290485-29048585.98886.86
3316630-31663093.72894.84
4333386-33338698.68899.96
5329847-32984797.64098.86
6324139-32413995.95197.21
30min1316766-31676693.76893.662.2495.3795.322.37
2302732-30273289.61490.96
3317518-31751893.99195.62
4320400-32040094.84496.66
5322891-32289195.58197.35
6318101-31810194.16395.96
45min1318875-31887594.39293.242.8096.5295.422.79
2315067-31506793.26595.11
3299027-29902788.51790.67
4325257-32525796.28298.63
5318165-31816594.18296.48
6313526-31352692.80995.13
60min1305945-30594590.56592.611.6893.2295.301.74
2309600-30960091.64794.01
3313239-31323992.72495.37
4313005-31300592.65595.53
5321677-32167795.22298.04
6313578-31357892.82495.66
极限1305243-30524390.35791.621.8393.5194.831.82
2307572-30757291.04693.92
3311813-31181392.30295.46
4307151-30715190.92294.32
5319938-31993894.70798.05
6305342-30534290.38693.74
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017对照品来源自制对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.021848431821461809861801941793801815101.18
210.031763901767601765750.15
单位质量响应值RSD%判断
18114.7717604.692.02数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2024011621批-依折麦布-shui(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155069-5506927.66527.7820.0027.6627.7820.01
261969-6196931.13131.13
365582-6558232.94632.95
457486-5748628.87928.88
557643-5764328.95828.96
634068-3406817.11517.11
10min1143334-14333472.00673.834.3972.1673.984.40
2143342-14334272.01072.18
3159988-15998880.37380.56
4145782-14578273.23673.40
5144481-14448172.58272.74
6144858-14485872.77272.87
15min1185124-18512493.00090.573.0493.5591.133.03
2179390-17939090.12090.69
3186819-18681993.85294.48
4176859-17685988.84889.42
5171944-17194486.37986.94
6181528-18152891.19491.69
20min1187130-18713094.00893.491.0195.0894.561.01
2183977-18397792.42493.50
3187827-18782794.35895.51
4183631-18363192.25093.31
5186195-18619593.53894.58
6187826-18782694.35795.36
30min1187727-18772794.30894.141.6395.9095.721.57
2188357-18835794.62496.21
3183726-18372692.29893.97
4188397-18839794.64496.22
5184174-18417492.52394.09
6191946-19194696.42797.96
45min1180679-18067990.76791.831.5192.8893.941.47
2182163-18216391.51393.63
3182883-18288391.87494.06
4186679-18667993.78195.88
5179260-17926090.05492.13
6185102-18510292.98995.05
60min1174087-17408787.45588.831.9390.0891.451.85
2173268-17326887.04489.67
3174834-17483487.83190.53
4179655-17965590.25392.87
5177183-17718389.01191.59
6181874-18187491.36793.95
极限1171256-17125686.03385.901.8889.1489.011.81
2169099-16909984.95088.05
3168611-16861184.70587.89
4175145-17514587.98791.11
5167353-16735384.07387.15
6174424-17442487.62590.71
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.173281713242473220573206963192903228921.08
211.113140733155343148040.33
单位质量响应值RSD%判断
28907.0728335.191.42数据可信
供试品溶液-2024011621批-阿托伐他汀钙-shui(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1144775-14477541.78646.6723.6341.7946.6723.63
2139466-13946640.25440.25
3191093-19109355.15555.15
4154239-15423944.51844.52
5222493-22249364.21764.22
6118102-11810234.08734.09
10min1292541-29254184.43589.054.0384.6789.314.07
2305570-30557088.19688.42
3313101-31310190.36990.68
4316305-31630591.29491.54
5326013-32601394.09694.45
6297651-29765185.91086.10
15min1331827-33182795.77495.911.0596.4896.661.03
2334328-33432896.49697.21
3337425-33742597.39098.20
4328470-32847094.80595.56
5328540-32854094.82595.70
6333138-33313896.15396.82
20min1337745-33774597.48297.951.2198.7299.231.21
2341143-34114398.46399.71
3340591-34059198.30499.65
4331821-33182195.77297.05
5342885-34288598.966100.37
6341968-34196898.70199.90
30min1344449-34444999.41799.372.22101.19101.202.12
2353179-353179101.937103.73
3338020-33802097.56299.46
4340193-34019398.189100.00
5336085-33608597.00398.96
6353727-353727102.095103.84
45min1341893-34189398.67999.791.70101.01102.171.61
2351908-351908101.570103.93
3346203-34620399.923102.36
4345375-34537599.684102.04
5336932-33693297.24899.74
6352069-352069101.617103.93
60min1341141-34114198.46299.971.81101.34102.901.73
2348667-348667100.635103.56
3342873-34287398.962101.96
4342804-34280498.942101.85
5344699-34469999.489102.52
6357945-357945103.313106.19
极限1342427-34242798.83498.501.83102.26102.001.72
2345605-34560599.751103.24
3336718-33671897.186100.73
4341278-34127898.502101.96
5332121-33212195.85999.45
6349553-349553100.890104.35
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017对照品来源自制对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.021723011718861721351721051718391720530.12
210.031719211716651717930.11
单位质量响应值RSD%判断
17170.9617127.920.18数据可信
供试品溶液-2024011621批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136512-3651219.09827.4215.5919.1027.4215.59
256922-5692229.77429.77
354414-5441428.46228.46
452845-5284527.64227.64
554088-5408828.29228.29
659739-5973931.24831.25
10min1144592-14459275.63176.612.1575.7476.762.17
2146593-14659376.67876.84
3144403-14440375.53375.69
4143177-14317774.89175.04
5148259-14825977.54977.71
6151731-15173179.36679.54
15min1170471-17047189.16891.542.1789.6992.122.17
2177605-17760592.89993.49
3178822-17882293.53694.11
4173471-17347190.73791.31
5171129-17112989.51290.10
6178513-17851393.37493.99
20min1185965-18596597.27297.061.5298.2998.141.52
2184574-18457496.54597.65
3185570-18557097.06698.16
4181334-18133494.85095.92
5185822-18582297.19798.28
6190078-19007899.424100.56
30min1193160-193160101.03699.991.06102.60101.611.02
2187421-18742198.03499.68
3190490-19049099.639101.28
4191914-191914100.384101.98
5191941-191941100.398102.02
6191993-191993100.425102.11
45min1189927-18992799.34599.650.48101.47101.820.48
2191475-191475100.154102.34
3189063-18906398.893101.08
4191391-191391100.110102.27
5190530-19053099.660101.84
6190628-19062899.711101.95
60min1188557-18855798.62899.261.61101.30101.991.57
2184501-18450196.50699.25
3189211-18921198.970101.71
4191724-191724100.285103.00
5192342-192342100.608103.34
6192262-192262100.566103.36
极限1190049-19004999.40899.271.45102.63102.561.42
2189947-18994799.355102.64
3185421-18542196.988100.28
4189960-18996099.362102.63
5189307-18930799.020102.32
6194060-194060101.506104.86
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.173061383061693063733064023063753062910.05
211.113048833055423052120.16
单位质量响应值RSD%判断
27420.8627471.830.14数据可信
供试品溶液-2024011621批-阿托伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1247276-24727674.41880.766.5774.4280.776.57
2265345-26534579.85679.86
3260627-26062778.43678.44
4260779-26077978.48278.48
5298146-29814689.72789.73
6278008-27800883.66783.67
10min1344531-344531103.687104.201.04104.10104.651.06
2341667-341667102.825103.27
3344482-344482103.672104.11
4346153-346153104.175104.61
5348695-348695104.940105.44
6351855-351855105.891106.36
15min1338938-338938102.004103.061.16102.99104.091.16
2343043-343043103.239104.25
3339891-339891102.291103.30
4343917-343917103.502104.52
5339512-339512102.177103.26
6349436-349436105.163106.22
20min1346339-346339104.231103.531.56105.79105.131.56
2340022-340022102.330103.92
3339492-339492102.171103.75
4339634-339634102.213103.80
5345550-345550103.994105.64
6352941-352941106.218107.86
30min1348593-348593104.909103.261.51107.04105.441.48
2335030-335030100.828102.98
3339683-339683102.228104.38
4346618-346618104.315106.47
5342196-342196102.984105.21
6346655-346655104.326106.55
45min1338946-338946102.006101.840.76104.72104.590.73
2340584-340584102.499105.22
3334696-334696100.727103.44
4341543-341543102.788105.52
5336401-336401101.240104.04
6338239-338239101.793104.60
60min1336194-336194101.178101.361.47104.46104.681.45
2328357-32835798.819102.11
3334712-334712100.732104.01
4341813-341813102.869106.18
5338981-338981102.017105.38
6340730-340730102.543105.92
极限1338219-338219101.787101.261.62105.63105.141.58
2337551-337551101.586105.42
3327886-32788698.678102.51
4337952-337952101.707105.59
5333258-333258100.294104.22
6344005-344005103.529107.47
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