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%
110.661447809144774714480691448424144772214479540.03
210.611450292144874614495190.08
单位质量响应值RSD%判断
135830.58136618.190.41数据可信
供试品溶液-X0734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%
60min19797-97970.6640.5222.350.660.5221.95
28273-82730.5610.56
38312-83120.5640.56
44669-46690.3170.32
58240-82400.5590.56
67075-70750.4800.48
120min144193-441932.9972.6011.103.002.6011.09
241470-414702.8122.81
338265-382652.5952.60
431683-316832.1482.15
537212-372122.5232.52
637451-374512.5392.54
240min1114693-1146937.7777.069.687.787.079.67
2115165-1151657.8097.81
397333-973336.6006.60
495691-956916.4886.49
592779-927796.2916.30
6109510-1095107.4257.43
360min1182892-18289212.40111.099.0812.4211.119.10
2169169-16916911.47111.49
3170359-17035911.55111.57
4151433-15143310.26810.28
5141286-1412869.5809.59
6166379-16637911.28111.30
480min1247555-24755516.78615.187.5316.8215.217.53
2231780-23178015.71615.75
3228993-22899315.52715.56
4202463-20246313.72813.76
5206395-20639513.99514.02
6225973-22597315.32215.35
600min1282679-28267919.16716.669.5519.2316.729.55
2260847-26084717.68717.74
3241780-24178016.39416.45
4214283-21428314.53014.58
5234558-23455815.90415.95
6240235-24023516.28916.34
720min1326005-32600522.10520.135.9822.1920.215.98
2294167-29416719.94620.03
3303087-30308720.55120.63
4272240-27224018.45918.53
5288385-28838519.55419.63
6297805-29780520.19320.27
840min1372372-37237225.24922.786.8725.3722.896.87
2339863-33986323.04523.16
3335358-33535822.73922.85
4300465-30046520.37320.47
5328962-32896222.30522.41
6338427-33842722.94723.06
960min1406155-40615527.54025.126.1127.7025.266.12
2360193-36019324.42324.57
3378871-37887125.69025.83
4337805-33780522.90523.03
5365258-36525824.76724.90
6374120-37412025.36725.51
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1443692-44369230.08526.847.0330.2927.027.03
2387414-38741426.26926.45
3400049-40004927.12627.31
4357781-35778124.26024.42
5389895-38989526.43726.61
6396419-39641926.87927.06
1200min1460181-46018131.20327.867.2131.4528.087.21
2401500-40150027.22427.45
3421218-42121828.56128.78
4369581-36958125.06025.26
5404027-40402727.39527.61
6408399-40839927.69227.91
1320min1496621-49662133.67429.408.0933.9729.678.08
2421715-42171528.59528.86
3437826-43782629.68729.95
4390714-39071426.49326.73
5420307-42030728.49928.75
6434786-43478629.48129.75
1440min1515880-51588034.98030.687.8935.3230.997.88
2441742-44174229.95330.26
3460102-46010231.19731.51
4407498-40749827.63127.91
5440458-44045829.86530.16
6449402-44940230.47230.78
极限1529357-52935735.89331.547.7736.2931.897.76
2460151-46015131.20131.55
3472280-47228032.02332.38
4419184-41918428.42328.74
5453763-45376330.76831.11
6456233-45623330.93531.29
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%
110.661451431145140614501441450878145085714509430.04
210.611445797144562214457100.01
单位质量响应值RSD%判断
136110.98136259.190.08数据可信
供试品溶液-X0734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%
60min18895-88950.6030.7318.110.600.7318.33
213684-136840.9280.93
38555-85550.5800.58
411592-115920.7860.79
510073-100730.6830.68
611681-116810.7920.79
120min137880-378802.5692.675.962.572.675.95
240919-409192.7752.78
340735-407352.7632.76
441575-415752.8202.82
539627-396272.6882.69
635365-353652.3992.40
240min1102153-1021536.9287.313.186.937.313.18
2107000-1070007.2577.26
3110324-1103247.4837.49
4105886-1058867.1827.19
5110570-1105707.4997.50
6110702-1107027.5087.51
360min1167747-16774711.37711.343.5111.3911.353.53
2157845-15784510.70610.72
3175475-17547511.90211.92
4165407-16540711.21911.23
5165840-16584011.24811.26
6170456-17045611.56111.58
480min1230847-23084715.65715.451.8515.6915.481.84
2222701-22270115.10515.14
3233915-23391515.86515.90
4228949-22894915.52815.56
5224440-22444015.22315.26
6226014-22601415.32915.36
600min1266627-26662718.08417.426.5418.1417.486.52
2265547-26554718.01118.07
3269293-26929318.26518.32
4224060-22406015.19715.25
5256316-25631617.38517.44
6259411-25941117.59417.65
720min1331269-33126922.46820.615.9922.5520.695.98
2304105-30410520.62620.71
3315448-31544821.39521.48
4302228-30222820.49820.58
5279723-27972318.97219.05
6290304-29030419.69019.77
840min1373536-37353625.33523.274.7025.4523.384.69
2346164-34616423.47823.59
3340823-34082323.11623.23
4334969-33496922.71922.83
5328245-32824522.26322.37
6334734-33473422.70322.82
960min1421476-42147628.58625.815.6428.7425.965.62
2380895-38089525.83425.98
3379482-37948225.73825.89
4372567-37256725.26925.41
5359831-35983124.40524.55
6369118-36911825.03525.18
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1454976-45497630.85927.785.9631.0627.965.95
2415077-41507728.15228.34
3407040-40704027.60727.80
4399446-39944627.09227.27
5385996-38599626.18026.36
6394746-39474626.77326.96
1200min1486935-48693533.02629.017.3833.2729.247.35
2433837-43383729.42529.65
3425010-42501028.82629.06
4414704-41470428.12728.35
5400435-40043527.15927.38
6405091-40509127.47527.70
1320min1509564-50956434.56130.486.9834.8530.756.96
2451803-45180330.64330.92
3445931-44593130.24530.52
4436783-43678329.62529.89
5421590-42159028.59428.85
6430738-43073829.21529.48
1440min1535217-53521736.30131.917.2436.6532.237.22
2473227-47322732.09632.42
3465729-46572931.58831.91
4459159-45915931.14231.45
5437027-43702729.64129.94
6452428-45242830.68630.99
极限1572447-57244738.82632.809.4839.2333.179.44
2486853-48685333.02133.39
3474345-47434532.17232.54
4465412-46541231.56631.92
5444245-44424530.13130.48
6458417-45841731.09231.45
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%
110.661442775144309014420131441693144169714422540.05
210.611449743145066014502020.05
单位质量响应值RSD%判断
135295.87136682.560.73数据可信
供试品溶液-X0801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%
60min119794-197941.3440.8445.461.340.8445.59
213868-138680.9420.94
35491-54910.3730.37
417385-173851.1811.18
510915-109150.7410.74
67114-71140.4830.48
120min152138-521383.5412.9423.913.542.9523.85
246590-465903.1653.17
330765-307652.0902.09
455971-559713.8023.80
542771-427712.9052.91
631886-318862.1662.17
240min1124651-1246518.4676.8321.478.476.8421.45
2117307-1173077.9687.97
371121-711214.8314.83
4113620-1136207.7187.72
596787-967876.5746.58
680105-801055.4415.45
360min1167675-16767511.38910.1614.1411.4110.1714.17
2156829-15682910.65210.67
3113936-1139367.7397.75
4169587-16958711.51911.54
5152753-15275310.37610.39
6136370-1363709.2639.27
480min1217370-21737014.76513.3212.3814.8013.3512.39
2217821-21782114.79514.83
3159041-15904110.80310.83
4213992-21399214.53514.57
5188733-18873312.81912.85
6179589-17958912.19812.22
600min1229889-22988915.61514.7910.0815.6714.8410.07
2245348-24534816.66516.72
3195311-19531113.26613.31
4236204-23620416.04416.10
5199880-19988013.57713.63
6199499-19949913.55113.60
720min1251658-25165817.09417.184.9217.1817.254.92
2246772-24677216.76216.84
3256304-25630417.40917.47
4272316-27231618.49718.58
5255835-25583517.37717.45
6234550-23455015.93216.00
840min1276002-27600218.74719.103.1018.8619.203.09
2276365-27636518.77218.88
3287188-28718819.50719.59
4293990-29399019.96920.08
5283244-28324419.23919.34
6269991-26999118.33918.43
960min1315501-31550121.43021.264.4521.5721.394.45
2312126-31212621.20121.34
3326314-32631422.16522.28
4321954-32195421.86822.01
5315466-31546621.42821.55
6286620-28662019.46819.58
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1328461-32846122.31022.007.1722.4822.167.12
2326564-32656422.18222.35
3358425-35842524.34624.49
4326247-32624722.16022.33
5317643-31764321.57621.73
6286117-28611719.43419.58
1200min1316233-31623321.48022.3510.3621.6822.5410.29
2336365-33636522.84723.05
3378791-37879125.72925.91
4343187-34318723.31123.52
5324336-32433622.03022.22
6275265-27526518.69718.87
1320min1343526-34352623.33423.2313.0723.5723.4612.96
2347368-34736823.59523.83
3421145-42114528.60628.83
4323935-32393522.00322.24
5330844-33084422.47222.70
6285138-28513819.36819.57
1440min1351473-35147323.87324.6015.2324.1424.8615.10
2359276-35927624.40324.67
3465173-46517331.59631.86
4357774-35777424.30124.58
5340687-34068723.14123.40
6298918-29891820.30420.54
极限1376543-37654325.57625.4314.7925.8825.7314.68
2364124-36412424.73325.04
3476275-47627532.35032.66
4369640-36964025.10725.42
5351293-35129323.86124.15
6308903-30890320.98221.24
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