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%
110.981482120147787814754211488488147936914806550.34
211.051500576149948415000300.06
单位质量响应值RSD%判断
134850.18135749.320.47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%
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
120min114848-148481.0141.8562.431.011.8562.46
234028-340282.3232.32
336823-368232.5142.51
414240-142400.9720.97
59623-96230.6570.66
652890-528903.6113.61
240min197588-975886.6625.0017.366.665.0117.33
272855-728554.9744.98
371856-718564.9064.91
460756-607564.1484.15
570923-709234.8424.84
665885-658854.4984.50
360min1148313-14831310.1259.779.0310.149.789.05
2150194-15019410.25410.26
3155833-15583310.63910.65
4119042-1190428.1278.13
5139942-1399429.5549.56
6145607-1456079.9409.95
480min1186984-18698412.76513.146.0412.7913.166.04
2200477-20047713.68613.71
3210325-21032514.35914.39
4187335-18733512.78912.81
5177162-17716212.09512.12
6192322-19232213.13013.16
600min1227702-22770215.54515.167.0415.5915.207.04
2224382-22438215.31815.37
3219287-21928714.97115.02
4192373-19237313.13313.17
5234784-23478416.02816.07
6233526-23352615.94315.99
720min1278235-27823518.99517.779.0319.0617.849.00
2284528-28452819.42419.49
3276357-27635718.86718.94
4258588-25858817.65417.71
5233741-23374115.95716.02
6230499-23049915.73615.81
840min1319655-31965521.82320.767.9021.9220.857.89
2326997-32699722.32422.42
3323812-32381222.10622.21
4272997-27299718.63718.72
5276561-27656118.88118.97
6304259-30425920.77120.87
960min1334273-33427322.82122.145.5222.9522.275.51
2346798-34679823.67623.81
3314449-31444921.46721.60
4316988-31698821.64021.75
5297646-29764620.32020.44
6335927-33592722.93323.06
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1080min1369701-36970125.23924.136.9425.4024.296.92
2375616-37561625.64325.81
3377989-37798925.80525.97
4337360-33736023.03123.18
5318009-31800921.71021.86
6341958-34195823.34523.51
1200min1390496-39049626.65925.237.9826.8625.437.95
2403267-40326727.53127.74
3390861-39086126.68426.89
4359887-35988724.56924.75
5332592-33259222.70622.89
6340283-34028323.23123.43
1320min1392388-39238826.78826.786.6027.0327.016.58
2423862-42386228.93729.18
3407594-40759427.82628.07
4393295-39329526.85027.07
5346340-34634023.64423.86
6390037-39003726.62726.86
1440min1413033-41303328.19727.865.9028.4828.135.90
2437491-43749129.86730.16
3427472-42747229.18329.47
4399408-39940827.26727.52
5369152-36915225.20225.45
6402102-40210227.45127.72
极限1422074-42207428.81528.494.7629.1428.804.77
2433559-43355929.59929.93
3433778-43377829.61429.94
4414806-41480628.31828.62
5379860-37986025.93326.22
6419545-41954528.64228.95
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%
110.981478894148642914813411478897147859414808310.23
211.051507942150644615071940.08
单位质量响应值RSD%判断
134866.21136397.650.80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%
60min18881-88810.6050.6481.230.600.6481.15
222325-223251.5201.52
38896-88960.6060.61
44222-42220.2880.29
511719-117190.7980.80
6-0.0000.00
120min131383-313832.1372.3226.662.142.3226.68
241978-419782.8592.86
337541-375412.5572.56
418524-185241.2621.26
543203-432032.9422.94
631740-317402.1622.16
240min177743-777435.2956.4011.795.306.4111.79
2107021-1070217.2887.30
386655-866555.9015.91
499781-997816.7956.80
5102858-1028587.0057.01
690200-902006.1436.15
360min1141096-1410969.60910.498.519.6210.508.52
2165199-16519911.25111.27
3136534-1365349.2989.31
4165199-16519911.25111.26
5165199-16519911.25111.27
6150971-15097110.28210.29
480min1218394-21839414.87314.3310.2914.9014.3610.28
2220992-22099215.05015.08
3196669-19666913.39413.42
4235315-23531516.02616.06
5217112-21711214.78614.82
6174160-17416011.86111.89
600min1275351-27535118.75216.1810.9218.8016.2310.89
2252867-25286717.22117.28
3225829-22582915.38015.43
4246812-24681216.80916.86
5202470-20247013.78913.84
6221953-22195315.11615.16
720min1293675-29367520.00019.737.9820.0819.817.97
2292309-29230919.90719.99
3284406-28440619.36919.44
4319135-31913521.73421.81
5299800-29980020.41720.49
6249104-24910416.96517.03
840min1326214-32621422.21620.7610.4222.3220.8710.37
2253573-25357317.26917.38
3325864-32586422.19222.29
4334630-33463022.78922.90
5308774-30877421.02921.14
6280168-28016819.08019.17
960min1349141-34914123.77824.154.2423.9224.284.24
2353786-35378624.09424.23
3339240-33924023.10323.24
4380887-38088725.94026.09
5361171-36117124.59724.73
6343250-34325023.37623.50
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1080min1384558-38455826.19026.293.3326.3726.463.35
2390952-39095226.62526.80
3374499-37449925.50525.67
4398857-39885727.16327.35
5399416-39941627.20227.38
6368054-36805425.06625.22
1200min1406746-40674627.70127.274.5127.9227.484.50
2405375-40537527.60727.82
3372425-37242525.36325.57
4418888-41888828.52828.75
5414147-41414728.20528.42
6384730-38473026.20126.40
1320min1423609-42360928.84929.295.3329.1129.545.33
2442874-44287430.16130.42
3413269-41326928.14528.39
4458611-45861131.23331.50
5445251-44525130.32330.58
6396983-39698327.03627.27
1440min1443992-44399230.23730.452.4030.5430.752.41
2441521-44152130.06930.37
3435416-43541629.65329.94
4465889-46588931.72932.04
5452728-45272830.83231.14
6443461-44346130.20130.48
极限1443713-44371330.21830.564.1430.5630.914.14
2447155-44715530.45330.80
3424670-42467028.92129.25
4477909-47790932.54732.91
5461179-46117931.40831.76
6438191-43819129.84230.16
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