氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.751464901146141614617231468416146178214636480.21
210.671430491143057014305300.01
单位质量响应值RSD%判断
136153.30134070.291.10数据可信
供试品溶液-2024041821批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
60min153351-533513.6473.875.213.653.875.18
255802-558023.8153.82
359959-599594.0994.10
460430-604304.1314.13
556180-561803.8413.84
654105-541053.6993.70
120min1107109-1071097.3238.348.167.338.358.16
2121201-1212018.2868.29
3137095-1370959.3739.38
4126860-1268608.6738.68
5122694-1226948.3888.39
6117388-1173888.0268.03
240min1218672-21867214.95015.725.6114.9715.745.60
2230513-23051315.76015.78
3251777-25177717.21317.23
4227647-22764715.56415.58
5235320-23532016.08816.11
6216050-21605014.77114.79
360min1302547-30254720.68421.805.2420.7221.845.25
2311482-31148221.29521.34
3343739-34373923.50123.55
4331170-33117022.64122.68
5322422-32242222.04322.09
6301824-30182420.63520.67
480min1382207-38220726.13026.796.0126.2026.876.01
2382044-38204426.11926.19
3429120-42912029.33829.42
4407446-40744627.85627.93
5389518-38951826.63026.71
6361200-36120024.69424.76
600min1445095-44509530.43031.204.4630.5431.314.47
2447587-44758730.60030.71
3486367-48636733.25233.38
4472744-47274432.32032.44
5456093-45609331.18231.30
6430071-43007129.40329.51
720min1506462-50646234.62535.262.1634.7835.422.18
2502067-50206734.32534.48
3533311-53331136.46136.64
4517241-51724135.36235.53
5521320-52132035.64135.80
6513905-51390535.13435.29
840min1547385-54738537.42338.023.1937.6338.243.19
2528834-52883436.15536.37
3580079-58007939.65839.89
4567847-56784738.82239.04
5551981-55198137.73737.95
6560574-56057438.32538.53
960min1601367-60136741.11440.881.9941.3841.152.00
2587081-58708140.13740.40
3610923-61092341.76742.06
4610032-61003241.70641.98
5596596-59659640.78841.06
6581811-58181139.77740.04
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1640003-64000343.75544.163.4744.0844.493.46
2612129-61212941.85042.17
3667533-66753345.63745.99
4669518-66951845.77346.11
5631088-63108843.14643.48
6655182-65518244.79345.11
1200min1678996-67899646.42147.732.8046.8148.132.81
2671587-67158745.91546.30
3720772-72077249.27749.70
4715666-71566648.92849.34
5700681-70068147.90448.30
6701464-70146447.95748.35
1320min1706552-70655248.30550.924.7448.7651.384.72
2699674-69967447.83548.29
3769798-76979852.62953.12
4786606-78660653.77854.26
5742727-74272750.77851.25
6763076-76307652.16952.63
1440min1767235-76723552.45454.035.2552.9954.585.22
2725460-72546049.59850.13
3812706-81270655.56356.14
4841693-84169357.54458.11
5779371-77937153.28453.83
6814913-81491355.71356.25
1560min1811894-81189455.50757.506.0156.1258.125.97
2769933-76993352.63853.24
3842872-84287257.62558.28
4893972-89397261.11961.77
5824845-82484556.39257.02
6902408-90240861.69562.32
1680min1846710-84671057.88759.136.8858.5859.846.83
2767603-76760352.47953.16
3860917-86091758.85959.60
4916942-91694262.68963.43
5860702-86070258.84459.55
6936595-93659564.03364.75
1800min1880167-88016760.17562.124.3860.9662.924.36
2845088-84508857.77658.54
3926768-92676863.36164.19
4933604-93360463.82864.66
5911899-91189962.34463.14
6954212-95421265.23766.05
1920min1928641-92864163.48964.585.0364.3665.485.00
2871239-87123959.56460.41
3949641-94964164.92465.85
4995941-99594168.09069.02
5926344-92634463.33264.22
6995859-99585968.08468.99
2040min1948653-94865364.85765.994.8065.8266.984.78
2880557-88055760.20161.14
3986172-98617267.42268.45
4988445-98844567.57768.61
5975540-97554066.69567.68
61011837-101183769.17770.19
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2160min1964794-96479465.96067.093.7467.0268.183.74
2921873-92187363.02664.05
31004990-100499068.70969.83
41020783-102078369.78870.92
5968913-96891366.24267.33
61006549-100654968.81569.93
极限1987403-98740367.50667.843.1268.6769.033.12
2935147-93514763.93465.05
3999047-99904768.30269.53
41019088-101908869.67270.91
5993981-99398167.95669.14
61018967-101896769.66470.88
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.751454348145631114587331465680145766014585460.30
210.671430491143057014305300.01
单位质量响应值RSD%判断
135678.70134070.290.85数据可信
供试品溶液-2024041821批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
60min156559-565593.8742.8526.713.872.8526.73
222980-229801.5741.57
341627-416272.8512.85
443882-438823.0053.01
546887-468873.2113.21
637851-378512.5922.59
120min1116368-1163687.9707.805.097.987.805.12
2106856-1068567.3187.32
3109842-1098427.5237.53
4115451-1154517.9077.91
5123245-1232458.4418.45
6111467-1114677.6347.64
240min1204188-20418813.98414.374.3614.0014.384.37
2198104-19810413.56713.58
3214258-21425814.67414.69
4216875-21687514.85314.87
5221695-22169515.18315.20
6203674-20367413.94913.96
360min1303820-30382020.80720.563.6520.8520.603.64
2294073-29407320.14020.17
3297143-29714320.35020.39
4289503-28950319.82719.87
5320418-32041821.94421.98
6296317-29631720.29420.33
480min1369657-36965725.31624.815.9325.3924.885.92
2343053-34305323.49423.56
3356671-35667124.42724.50
4348704-34870423.88123.95
5402089-40208927.53727.61
6353485-35348524.20924.28
600min1396802-39680227.17528.796.4227.2828.896.41
2409982-40998228.07828.18
3419029-41902928.69828.80
4409510-40951028.04628.15
5473312-47331232.41532.53
6413519-41351928.32028.42
720min1475809-47580932.58632.943.9732.7333.093.98
2476587-47658732.64032.78
3463620-46362031.75131.90
4469716-46971632.16932.32
5517654-51765435.45235.62
6482300-48230033.03133.18
840min1472179-47217932.33835.055.9932.5435.255.98
2522297-52229735.77035.96
3518397-51839735.50335.70
4492171-49217133.70733.90
5562051-56205138.49338.71
6503817-50381734.50434.70
960min1551850-55185037.79439.235.9638.0439.485.94
2594529-59452940.71740.96
3563514-56351438.59338.84
4523560-52356035.85736.10
5620646-62064642.50642.78
6583019-58301939.92940.18
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1621738-62173842.58042.814.9242.8843.124.90
2656222-65622244.94245.25
3599963-59996341.08941.40
4578933-57893339.64939.95
5650800-65080044.57144.91
6643033-64303344.03944.35
1200min1646609-64660944.28445.574.7744.6545.944.75
2712981-71298148.82949.20
3662979-66297945.40545.77
4621141-62114142.53942.90
5686396-68639647.00947.41
6662122-66212245.34645.72
1320min1663632-66363245.45049.737.3745.8850.187.33
2813604-81360455.72156.17
3687434-68743447.08047.52
4702876-70287648.13748.56
5747682-74768251.20651.68
6741822-74182250.80451.25
1440min1731102-73110250.07053.357.9450.5753.877.88
2895007-89500761.29561.82
3767445-76744552.55953.07
4722416-72241649.47549.97
5777674-77767453.26053.81
6780694-78069453.46753.98
1560min1771621-77162152.84557.327.5453.4257.927.49
2949136-94913665.00365.62
3850384-85038458.23958.83
4785413-78541353.79054.36
5823088-82308856.37057.00
6842542-84254257.70258.30
1680min1809231-80923155.42159.427.1156.0860.107.06
2983928-98392867.38568.10
3871207-87120759.66660.34
4825667-82566756.54757.20
5851101-85110158.28959.00
6864144-86414459.18259.87
1800min1878806-87880660.18663.316.4060.9264.086.37
21029687-102968770.51971.34
3936949-93694964.16864.93
4873416-87341659.81760.55
5887896-88789660.80861.61
6939601-93960164.35065.12
1920min1920058-92005863.01164.305.6263.8465.165.59
21029600-102960070.51371.44
3940586-94058664.41765.28
4872653-87265359.76560.59
5914019-91401962.59863.49
6956017-95601765.47466.34
2040min1946384-94638464.81466.173.1365.7467.143.12
21015085-101508569.51970.55
3972060-97206066.57367.53
4951024-95102465.13266.05
5930705-93070563.74064.73
6982093-98209367.26068.23
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2160min1970160-97016066.44266.043.4267.4667.103.41
21027009-102700970.33671.47
3934858-93485864.02565.08
4958583-95858365.65066.66
5944517-94451764.68665.77
6950871-95087165.12166.19
极限1962791-96279165.93866.892.0867.0668.052.08
2998627-99862768.39269.63
31005493-100549368.86270.01
4959773-95977365.73166.84
5961552-96155265.85367.03
6971611-97161166.54267.71
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