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%
110.661453420145324414538191452359145319614532080.04
210.611443491144410014437960.03
单位质量响应值RSD%判断
136323.45136078.790.13数据可信
供试品溶液-X0794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%
60min113184-131840.8941.2221.980.891.2222.09
222261-222611.5101.51
323130-231301.5691.57
417244-172441.1691.17
515946-159461.0811.08
615756-157561.0691.07
120min148685-486853.3023.5118.353.303.5018.32
265794-657944.4624.46
351757-517573.5103.51
459304-593044.0224.02
544183-441832.9963.00
640403-404032.7402.74
240min1115044-1150447.8027.9412.257.817.9512.21
2136136-1361369.2329.24
3124083-1240838.4158.42
4125142-1251428.4878.49
596734-967346.5606.57
6105575-1055757.1607.17
360min1163144-16314411.06411.907.7011.0811.927.72
2196362-19636213.31713.34
3183780-18378012.46312.48
4179713-17971312.18812.21
5161874-16187410.97810.99
6168279-16827911.41211.43
480min1218925-21892514.84715.506.7014.8815.546.73
2251893-25189317.08317.13
3237836-23783616.12916.17
4234271-23427115.88715.93
5213619-21361914.48714.52
6214691-21469114.56014.59
600min1244490-24449016.58017.107.0216.6417.167.03
2278520-27852018.88818.96
3256880-25688017.42117.48
4263776-26377617.88817.95
5230832-23083215.65415.71
6238049-23804916.14416.20
720min1292233-29223319.81820.015.7519.9020.105.75
2322578-32257821.87621.97
3306010-30601020.75320.84
4292442-29244219.83219.92
5276412-27641218.74518.82
6280987-28098719.05619.14
840min1323318-32331821.92621.764.8322.0421.884.83
2336593-33659322.82722.96
3339298-33929823.01023.13
4319132-31913221.64221.76
5302788-30278820.53420.64
6304303-30430320.63720.75
960min1357139-35713924.22024.174.6024.3624.324.61
2381802-38180225.89326.06
3356775-35677524.19524.35
4364912-36491224.74724.90
5338901-33890122.98323.12
6338670-33867022.96723.11
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1383077-38307725.97926.094.8126.1626.274.83
2416268-41626828.23028.43
3384589-38458926.08226.27
4390865-39086526.50726.70
5363621-36362124.66024.83
6369546-36954625.06125.23
1200min1394731-39473126.76926.684.4126.9926.904.43
2418245-41824528.36428.61
3396229-39622926.87127.10
4402414-40241427.29027.52
5368515-36851524.99125.20
6380131-38013125.77925.99
1320min1408625-40862527.71227.925.2027.9728.185.21
2449813-44981330.50530.79
3415739-41573928.19428.46
4412373-41237327.96628.24
5388492-38849226.34626.59
6395185-39518526.80027.05
1440min1420898-42089828.54428.995.1828.8529.305.19
2466777-46677731.65531.99
3426336-42633628.91329.23
4434826-43482629.48829.80
5402827-40282727.31827.60
6413428-41342828.03728.33
极限1441702-44170229.95529.936.3930.3030.286.37
2489425-48942533.19133.57
3432626-43262629.33929.70
4453977-45397730.78731.14
5409502-40950227.77128.10
6421162-42116228.56228.89
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%
110.661451426145145514519981450949145221314516080.04
210.611452662145259014526260.01
单位质量响应值RSD%判断
136173.36136911.030.39数据可信
供试品溶液-X0794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%
60min122157-221571.4991.3210.581.501.3210.59
218388-183881.2441.24
322208-222081.5021.50
417976-179761.2161.22
518069-180691.2221.22
618348-183481.2411.24
120min151774-517743.5023.246.263.503.246.22
244468-444683.0083.01
348194-481943.2603.26
444417-444173.0053.01
548061-480613.2513.25
650328-503283.4053.41
240min1123126-1231268.3297.609.398.347.619.38
2115270-1152707.7987.80
3106548-1065487.2087.21
494920-949206.4216.43
5122042-1220428.2568.26
6112195-1121957.5907.60
360min1183098-18309812.38611.288.8912.4111.308.90
2173623-17362311.74511.76
3163276-16327611.04511.06
4140075-1400759.4769.49
5174454-17445411.80111.82
6166250-16625011.24611.26
480min1234682-23468215.87614.837.5415.9114.867.54
2233188-23318815.77515.81
3218187-21818714.76014.79
4188809-18880912.77212.80
5221051-22105114.95414.99
6218993-21899314.81414.85
600min1262325-26232517.74616.627.7717.8116.687.76
2240674-24067416.28116.34
3244438-24443816.53616.59
4210754-21075414.25714.31
5258305-25830517.47417.53
6257365-25736517.41017.47
720min1304591-30459120.60519.486.9220.6919.566.91
2299987-29998720.29320.38
3286305-28630519.36819.45
4251083-25108316.98517.06
5284018-28401819.21319.30
6301377-30137720.38720.47
840min1344776-34477623.32321.997.0923.4422.107.09
2328040-32804022.19122.31
3320699-32069921.69521.81
4282285-28228519.09619.19
5330111-33011122.33122.45
6344494-34449423.30423.42
960min1364809-36480924.67823.984.3824.8324.124.39
2369586-36958625.00225.15
3349841-34984123.66623.81
4325981-32598122.05222.18
5356806-35680624.13724.28
6359985-35998524.35224.50
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1393295-39329526.60526.004.0826.8026.184.09
2395784-39578426.77426.96
3381011-38101125.77425.95
4357078-35707824.15524.31
5379490-37949025.67225.86
6399679-39967927.03727.22
1200min1405206-40520627.41127.091.9527.6427.311.96
2411814-41181427.85828.08
3399259-39925927.00927.23
4392374-39237426.54326.74
5391465-39146526.48226.70
6402452-40245227.22527.45
1320min1417199-41719928.22328.601.5828.5028.861.58
2431331-43133129.17929.45
3421598-42159828.52028.78
4418385-41838528.30328.54
5417307-41730728.23028.49
6430890-43089029.14929.42
1440min1443566-44356630.00629.952.2530.3230.252.26
2449714-44971430.42230.73
3437570-43757029.60129.90
4434079-43407929.36429.64
5432782-43278229.27729.58
6458345-45834531.00631.32
极限1463690-46369031.36831.022.8631.7331.372.83
2458994-45899431.05031.41
3447002-44700230.23930.58
4461996-46199631.25331.57
5441524-44152429.86830.22
6478408-47840832.36332.72
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%
110.661442815144393014441991443112144426314436640.05
210.611455939145601114559750.01
单位质量响应值RSD%判断
135428.14137226.670.94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%
60min121059-210591.4271.0324.161.431.0424.14
217934-179341.2151.22
315702-157021.0641.06
412966-129660.8790.88
511632-116320.7880.79
612330-123300.8350.84
120min157562-575623.9002.9623.043.902.9623.03
254717-547173.7073.71
342010-420102.8462.85
435840-358402.4282.43
536558-365582.4772.48
635006-350062.3722.37
240min1123763-1237638.3866.9116.028.396.9216.02
2116318-1163187.8817.89
3105291-1052917.1347.14
483881-838815.6835.69
597908-979086.6346.64
684701-847015.7395.74
360min1173351-17335111.74610.3711.4511.7710.3911.45
2166719-16671911.29611.32
3161454-16145410.94010.96
4126963-1269638.6038.62
5150118-15011810.17110.19
6139810-1398109.4739.49
480min1215802-21580214.62213.379.0614.6613.409.07
2209310-20931014.18214.22
3208033-20803314.09614.13
4168127-16812711.39211.42
5197690-19769013.39513.42
6185290-18529012.55512.58
600min1249009-24900916.87215.148.7916.9315.198.80
2239131-23913116.20316.26
3228309-22830915.46915.52
4197157-19715713.35913.40
5221065-22106514.97915.03
6205918-20591813.95214.00
720min1289922-28992219.64417.558.0519.7317.628.07
2270103-27010318.30118.38
3266633-26663318.06618.14
4233481-23348115.82015.88
5253637-25363717.18617.26
6240198-24019816.27516.34
840min1330309-33030922.38119.698.0622.5019.798.08
2299260-29926020.27720.39
3295587-29558720.02820.13
4265668-26566818.00118.09
5280345-28034518.99519.09
6272262-27226218.44818.54
960min1363820-36382024.65121.398.7424.8021.528.74
2324568-32456821.99222.13
3319901-31990121.67521.81
4288198-28819819.52719.64
5303680-30368020.57620.70
6293645-29364519.89620.02
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1374247-37424725.35821.8410.1725.5422.0010.15
2339069-33906922.97423.15
3332773-33277322.54822.71
4295264-29526420.00620.15
5306514-30651420.76820.93
6286318-28631819.40019.55
1200min1380178-38017825.76021.8311.9325.9822.0311.90
2339778-33977823.02223.23
3336802-33680222.82123.02
4301890-30189020.45520.63
5305335-30533520.68820.88
6269283-26928318.24618.42
1320min1406271-40627127.52822.7913.4327.7923.0213.38
2352451-35245123.88124.12
3353181-35318123.93024.17
4317093-31709321.48521.69
5315763-31576321.39521.62
6273384-27338418.52418.73
1440min1423349-42334928.68523.5814.3928.9923.8414.34
2370933-37093325.13325.41
3365017-36501724.73225.00
4326972-32697222.15522.39
5324902-32490222.01422.27
6276878-27687818.76018.99
极限1435272-43527229.49324.5513.9829.8424.8513.93
2380288-38028825.76726.08
3387100-38710026.22926.54
4349816-34981623.70223.97
5334495-33449522.66422.95
6287328-28732819.46819.73
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