替普瑞酮胶囊项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1118.05959755907225923985969765968195945780.48
2117.86025445990576008000.42
单位质量响应值RSD%判断
5038.805100.170.86数据可信
供试品溶液-JS3M批-pH6.8(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1215910-21591037.71946.4318.0437.7246.4318.04
2287619-28761950.24750.25
3261961-26196145.76445.76
4202668-20266835.40635.41
5310855-31085554.30654.31
6315697-31569755.15255.15
10min1347103-34710360.63860.724.4860.7060.804.49
2344333-34433360.15560.24
3358022-35802262.54662.62
4321105-32110556.09756.16
5347618-34761860.72860.82
6367287-36728764.16564.26
15min1389942-38994268.12267.444.3168.2967.624.31
2376837-37683765.83366.02
3399344-39934469.76569.95
4368622-36862264.39864.55
5371366-37136664.87765.07
6410178-41017871.65871.86
20min1404103-40410370.59672.302.9170.8772.592.93
2415226-41522672.53972.83
3411096-41109671.81872.11
4401168-40116870.08470.34
5416486-41648672.76073.06
6435074-43507476.00776.33
30min1455035-45503579.49479.992.4079.8980.402.41
2460911-46091180.52180.94
3450724-45072478.74179.16
4448367-44836778.32978.71
5453632-45363279.24979.67
6478515-47851583.59684.04
45min1500110-50011087.36987.371.7187.9087.921.72
2502565-50256587.79788.35
3487601-48760185.18385.73
4493413-49341386.19986.71
5506041-50604188.40588.96
6511107-51110789.29089.87
60min1523270-52327091.41591.691.3892.0992.381.38
2525122-52512291.73892.43
3512954-51295489.61290.30
4523220-52322091.40692.06
5531219-53121992.80393.50
6533360-53336093.17793.91
90min1551155-55115596.28696.420.8597.1197.260.85
2557829-55782997.45298.30
3544168-54416895.06595.90
4550376-55037696.15096.95
5553281-55328196.65897.51
6554814-55481496.92597.81
极限1562618-56261898.28997.961.1899.2798.961.17
2565592-56559298.80899.82
3548045-54804595.74396.74
4561593-56159398.11099.07
5560687-56068797.95198.97
6565951-56595198.87199.92
替普瑞酮胶囊项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1118.05780245780185786485790695812685790050.24
2117.85794765781185787970.17
单位质量响应值RSD%判断
4906.824913.390.10数据可信
供试品溶液-JS3M批-pH6.8(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1232010-23201041.84643.9613.5641.8543.9613.55
2258802-25880246.67846.68
3182282-18228232.87732.88
4254840-25484045.96445.96
5273872-27387249.39649.40
6260521-26052146.98846.99
10min1319196-31919657.57159.393.3557.6459.463.33
2331779-33177959.84159.92
3349608-34960863.05663.11
4327303-32730359.03359.11
5327211-32721159.01759.10
6320560-32056057.81757.90
15min1355835-35583564.17966.021.8464.3566.191.84
2365692-36569265.95766.13
3368839-36883966.52566.68
4376525-37652567.91168.09
5364558-36455865.75365.93
6364660-36466065.77165.95
20min1394923-39492371.22971.902.2371.5072.182.21
2388520-38852070.07570.36
3408141-40814173.61373.88
4395303-39530371.29871.59
5393995-39399571.06271.35
6411053-41105374.13974.42
30min1444601-44460180.18980.741.3580.5881.141.34
2441115-44111579.56179.97
3455422-45542282.14182.53
4444422-44442280.15780.56
5445263-44526380.30980.72
6454965-45496582.05982.47
45min1491360-49136088.62389.501.1689.1590.041.15
2489593-48959388.30488.84
3501302-50130290.41690.95
4497303-49730389.69590.24
5493659-49365989.03889.58
6504131-50413190.92691.47
60min1514718-51471892.83694.561.5693.5195.241.56
2518153-51815393.45694.14
3527651-52765195.16995.85
4523397-52339794.40195.09
5523582-52358294.43595.13
6538126-53812697.05897.75
90min1539463-53946397.29998.491.2198.1399.331.21
2542977-54297797.93398.77
3547536-54753698.75599.59
4543133-54313397.96198.81
5544867-54486798.27499.12
6558311-558311100.699101.56
极限1544759-54475998.25499.221.2499.24100.231.24
2545223-54522398.33899.34
3551673-55167399.501100.51
4545767-54576798.43699.45
5550574-55057499.303100.32
6562630-562630101.478102.50
替普瑞酮胶囊项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1118.05898185905775900945924315903485906540.18
2117.86039545996406017970.51
单位质量响应值RSD%判断
5005.545108.631.45数据可信
供试品溶液-ZJTJ3M批-pH6.8(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1314506-31450655.08253.106.5255.0853.106.52
2292270-29227051.18851.19
3308521-30852154.03454.03
4287585-28758550.36750.37
5334445-33444558.57458.57
6281845-28184549.36249.36
10min1376801-37680165.99264.413.4566.0864.493.45
2361357-36135763.28863.37
3389507-38950768.21868.31
4357717-35771762.65062.73
5360590-36059063.15363.25
6360487-36048763.13563.22
15min1410434-41043471.88370.783.6372.0870.973.62
2404711-40471170.88171.07
3429192-42919275.16875.37
4388422-38842268.02868.22
5399571-39957169.98070.18
6392432-39243268.73068.92
20min1430078-43007875.32375.662.7675.6475.972.76
2429049-42904975.14375.45
3453154-45315479.36579.69
4419756-41975673.51673.82
5436648-43664876.47476.79
6423293-42329374.13574.44
30min1466966-46696681.78482.142.3982.2382.582.39
2467615-46761581.89882.33
3489024-48902485.64786.11
4454805-45480579.65480.08
5470264-47026482.36182.81
6465284-46528481.48981.91
45min1503209-50320988.13188.802.3688.7189.382.37
2503431-50343188.17088.74
3529788-52978892.78693.39
4495795-49579586.83387.39
5509143-50914389.17189.75
6500860-50086087.72088.28
60min1526843-52684392.27192.502.5293.0093.222.52
2526419-52641992.19692.91
3549453-54945396.23196.99
4511350-51135089.55790.26
5535869-53586993.85194.58
6519035-51903590.90391.61
90min1548085-54808595.99196.382.4996.8897.262.49
2551902-55190296.65997.53
3571953-571953100.171101.09
4531386-53138693.06693.92
5556409-55640997.44998.34
6542135-54213594.94995.81
极限1557237-55723797.59498.611.9198.6499.651.91
2561654-56165498.36799.40
3578222-578222101.269102.36
4549142-54914296.17697.18
5572950-572950100.346101.40
6559051-55905197.91198.93
替普瑞酮胶囊项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1118.05948255944415975985929305918025943190.37
2117.86021686013876017780.10
单位质量响应值RSD%判断
5036.605108.471.01数据可信
供试品溶液-ZJTJ3M批-pH6.8(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1303340-30334052.96249.937.8052.9649.937.80
2259557-25955745.31845.32
3290015-29001550.63550.64
4313276-31327654.69754.70
5259468-25946845.30245.30
6290199-29019950.66850.67
10min1387558-38755867.66662.296.3467.7562.376.34
2323368-32336856.45956.53
3351575-35157561.38461.47
4375615-37561565.58165.67
5356017-35601762.15962.23
6346506-34650660.49960.58
15min1410528-41052871.67768.113.7671.8868.303.76
2371924-37192464.93665.11
3389664-38966468.03468.22
4401168-40116870.04270.24
5376022-37602265.65265.83
6391438-39143868.34368.53
20min1445313-44531377.75073.973.3378.0774.263.33
2402957-40295770.35570.63
3421263-42126373.55173.85
4431640-43164075.36375.68
5419916-41991673.31673.60
6420722-42072273.45673.76
30min1491829-49182985.87182.772.6286.3283.202.63
2458557-45855780.06280.46
3463815-46381580.98081.40
4483080-48308084.34484.79
5477113-47711383.30283.71
6470090-47009082.07682.50
45min1536441-53644193.66091.212.1894.2591.782.19
2503815-50381587.96488.49
3515956-51595690.08490.64
4522615-52261591.24691.83
5526851-52685191.98692.54
6528885-52888592.34192.90
60min1556930-55693097.23895.461.7097.9996.171.71
2537263-53726393.80494.48
3536566-53656693.68294.39
4557775-55777597.38598.12
5543660-54366094.92195.62
6548266-54826695.72596.44
90min1581509-581509101.52999.541.52102.44100.411.53
2559417-55941797.67298.50
3560175-56017597.80498.67
4573732-573732100.171101.07
5574074-574074100.231101.09
6571824-57182499.838100.71
极限1585522-585522102.230100.041.42103.31101.081.43
2563990-56399098.47099.46
3564096-56409698.48999.52
4574504-574504100.306101.37
5574053-574053100.227101.26
6575765-575765100.526101.56
替普瑞酮胶囊项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1118.05915075921315968895964795955945945200.43
2117.85906775908075907420.02
单位质量响应值RSD%判断
5038.315014.790.34数据可信
供试品溶液-JS3M批-pH6.8(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1226662-22666239.93538.1124.1739.9338.1124.17
2216651-21665138.17138.17
3175220-17522030.87130.87
4267426-26742647.11747.12
5273194-27319448.13348.13
6138704-13870424.43824.44
10min1381793-38179367.26663.106.9667.3363.166.96
2321134-32113456.57956.64
3365208-36520864.34464.40
4386449-38644968.08768.17
5340788-34078860.04260.12
6353510-35351062.28362.32
15min1408065-40806571.89569.543.8272.0769.703.81
2392461-39246169.14669.30
3389534-38953468.63068.79
4409066-40906672.07272.26
5368567-36856764.93665.12
6400336-40033670.53370.68
20min1430129-43012975.78373.943.9576.0874.233.94
2420597-42059774.10374.38
3408962-40896272.05372.33
4437853-43785377.14377.46
5392412-39241269.13769.43
6428113-42811375.42775.69
30min1465849-46584982.07680.813.1582.5081.223.14
2465350-46535081.98882.38
3453028-45302879.81780.21
4470027-47002782.81283.25
5431665-43166576.05376.46
6466205-46620582.13982.53
45min1495185-49518587.24486.212.8787.8186.762.87
2499785-49978588.05588.59
3485026-48502685.45585.98
4499166-49916687.94688.52
5462824-46282481.54382.07
6494012-49401287.03887.56
60min1515552-51555290.83389.912.6291.5490.602.61
2522177-52217792.00092.68
3507438-50743889.40390.07
4519154-51915491.46792.19
5485191-48519185.48486.15
6512334-51233490.26690.94
90min1536480-53648094.52093.322.1095.3894.162.10
2536117-53611794.45695.29
3530908-53090893.53894.36
4536870-53687094.58995.47
5507872-50787289.48090.29
6529846-52984693.35194.17
极限1541619-54161995.42594.282.0396.4495.272.03
2543559-54355995.76796.76
3537176-53717694.64395.62
4540366-54036695.20596.24
5514204-51420490.59591.55
6533847-53384794.05695.03
替普瑞酮胶囊项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1118.05781995767425782205781525789035780430.14
2117.85852005859415855700.09
单位质量响应值RSD%判断
4898.674970.881.04数据可信
供试品溶液-ZJTJ3M批-pH6.8(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1267249-26724947.96346.4019.6247.9646.4019.62
2284534-28453451.06551.07
3164216-16421629.47229.47
4314384-31438456.42356.42
5253916-25391645.57045.57
6266777-26677747.87947.88
10min1366798-36679865.82967.784.0265.9167.864.03
2399698-39969871.73471.82
3362551-36255165.06765.12
4390561-39056170.09470.19
5365723-36572365.63765.71
6380703-38070368.32568.40
15min1401363-40136372.03373.663.4172.2273.843.42
2427133-42713376.65876.86
3404863-40486372.66172.82
4429426-42942677.06977.28
5400263-40026371.83572.02
6399387-39938771.67871.87
20min1427754-42775476.76977.592.5477.0877.902.55
2452350-45235081.18481.52
3422948-42294875.90776.19
4437344-43734478.49078.83
5427781-42778176.77477.08
6425750-42575076.41076.72
30min1455104-45510481.67883.601.9982.1284.052.00
2481714-48171486.45486.92
3460481-46048182.64383.05
4469653-46965384.28984.76
5466358-46635883.69884.13
6461670-46167082.85683.30
45min1486889-48688987.38289.181.5387.9689.771.54
2507973-50797391.16691.78
3493192-49319288.51389.06
4498200-49820089.41290.02
5502596-50259690.20190.77
6492707-49270788.42689.01
60min1505699-50569990.75892.251.1991.4892.981.20
2520688-52068893.44894.21
3510535-51053591.62692.32
4513900-51390092.23092.99
5521505-52150593.59594.32
6511749-51174991.84492.57
90min1525765-52576594.35995.201.1595.2396.081.14
2531507-53150795.39096.31
3526214-52621494.44095.28
4527544-52754494.67995.59
5542003-54200397.27498.15
6529700-52970095.06695.94
极限1535652-53565296.13495.671.0697.1696.721.05
2529828-52982895.08996.17
3527549-52754994.68095.68
4528430-52843094.83895.91
5542362-54236297.33898.38
6534650-53465095.95496.99
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