坎地氢噻片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
112.184659484656324653394652894651794654770.07
212.204630594629304629940.02
单位质量响应值RSD%判断
38216.5037950.330.50数据可信
供试品溶液-24073101-1-1批-氢噻-含0.35%吐温20的pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1257279-25727948.49544.936.3348.5044.936.33
2234997-23499744.29544.30
3232522-23252243.82943.83
4248397-24839746.82146.82
5243277-24327745.85645.86
6213697-21369740.28140.28
10min1388641-38864173.25669.884.1873.3469.964.18
2355831-35583167.07267.15
3371547-37154770.03470.11
4379577-37957771.54871.63
5380208-38020871.66771.74
6348704-34870465.72965.80
15min1427246-42724680.53379.722.2980.7479.922.29
2410046-41004677.29177.48
3423511-42351179.82980.02
4431049-43104981.25081.45
5433367-43336781.68781.88
6412536-41253677.76077.94
20min1445446-44544683.96483.711.8584.3084.031.86
2436039-43603982.19182.51
3442303-44230383.37183.69
4453997-45399785.57685.91
5452451-45245185.28485.62
6434220-43422081.84882.15
30min1466784-46678487.98687.781.1688.4688.241.17
2459460-45946086.60587.06
3463931-46393187.44887.91
4472513-47251389.06689.54
5470991-47099188.77989.25
6460471-46047186.79687.24
45min1488428-48842892.06691.860.6192.6992.470.62
2484890-48489091.39991.99
3487395-48739591.87192.48
4490810-49081092.51593.14
5489583-48958392.28392.91
6482992-48299291.04191.63
60min1503563-50356394.91994.860.4095.7095.630.41
2502473-50247394.71395.46
3503794-50379494.96295.72
4506390-50639095.45196.23
5503168-50316894.84495.62
6500278-50027894.29995.04
极限1520764-52076498.16199.350.7299.10100.270.71
2527052-52705299.346100.25
3528607-52860799.639100.56
4531188-531188100.126101.06
5525000-52500098.95999.89
6529846-52984699.873100.77
坎地氢噻片项目信息
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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
116.513160093163633163823165953164163163530.07
216.173109133110183109660.03
单位质量响应值RSD%判断
19161.3019231.050.26数据可信
供试品溶液-24073101-1-1批-坎地-含0.35%吐温20的pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1111902-11190232.72530.525.2932.7230.525.28
2102435-10243529.95629.96
3100938-10093829.51929.52
4106926-10692631.27031.27
5107601-10760131.46731.47
696451-9645128.20628.21
10min1205800-20580060.18558.083.5060.2458.133.50
2191761-19176156.07956.13
3201201-20120158.84058.89
4200547-20054758.64858.70
5203866-20386659.61959.67
6188393-18839355.09455.14
15min1256199-25619974.92373.922.0575.0874.072.05
2245204-24520471.70871.85
3255009-25500974.57574.72
4253984-25398474.27674.43
5258476-25847675.58975.74
6247708-24770872.44072.58
20min1283688-28368882.96282.351.7383.2482.621.74
2274282-27428280.21280.47
3283194-28319482.81883.09
4285692-28569283.54883.82
5285848-28584883.59483.87
6276800-27680080.94881.21
30min1309957-30995790.64490.681.1491.0691.091.14
2303894-30389488.87189.27
3311520-31152091.10291.51
4314156-31415691.87292.29
5311988-31198891.23891.66
6309020-30902090.37090.76
45min1327046-32704695.64295.790.6196.2196.350.61
2324654-32465494.94295.49
3328802-32880296.15696.72
4330528-33052896.66097.23
5326784-32678495.56596.13
6327448-32744895.76096.30
60min1331945-33194597.07597.150.3597.8097.860.34
2331567-33156796.96497.67
3333320-33332097.47798.20
4333117-33311797.41798.14
5330342-33034296.60697.33
6332851-33285197.34098.04
极限1335345-33534598.06997.850.3598.9698.730.34
2334925-33492597.94698.81
3334827-33482797.91898.80
4334989-33498997.96598.85
5332309-33230997.18198.07
6335261-33526198.04498.91
坎地氢噻片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
112.184639104630174644804636884636624637510.12
212.204592284592314592300.01
单位质量响应值RSD%判断
38074.7937641.800.81数据可信
供试品溶液-24073101-1-2批-氢噻
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1320304-32030460.73657.957.3760.7457.957.38
2299702-29970256.82956.83
3280254-28025453.14153.14
4290973-29097355.17455.17
5299559-29955956.80256.80
6342878-34287865.01665.02
10min1411062-41106277.94577.634.2578.0577.724.25
2403830-40383076.57476.67
3402823-40282376.38376.47
4406488-40648877.07877.17
5390253-39025373.99974.09
6441877-44187783.78883.90
15min1436996-43699682.86383.593.2783.0983.823.28
2442974-44297483.99684.22
3438705-43870583.18783.40
4438244-43824483.09983.32
5421812-42181279.98380.20
6466251-46625188.41088.66
20min1450259-45025985.37786.502.5285.7586.872.52
2459623-45962387.15387.52
3459136-45913687.06187.42
4453678-45367886.02686.38
5440056-44005683.44383.79
6474477-47447789.97090.36
30min1471648-47164889.43389.952.1689.9490.462.17
2478399-47839990.71391.22
3479228-47922890.87191.37
4469504-46950489.02789.53
5458715-45871586.98187.47
6488725-48872592.67193.22
45min1490291-49029192.96893.321.6793.6393.981.67
2498296-49829694.48695.14
3496204-49620494.08994.74
4486340-48634092.21992.87
5479972-47997291.01291.65
6501935-50193595.17695.88
60min1503912-50391295.55195.891.4896.3796.711.48
2511969-51196997.07997.90
3510434-51043496.78897.60
4498722-49872294.56795.37
5495636-49563693.98294.77
6513566-51356697.38298.24
极限1521118-52111898.81499.501.4099.79100.481.39
2534428-534428101.337102.32
3531348-531348100.753101.72
4514115-51411597.48698.45
5523172-52317299.203100.15
6524354-52435499.427100.45
坎地氢噻片项目信息
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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
116.513162883162063164243161183161703162410.04
216.173094663091843093250.07
单位质量响应值RSD%判断
19154.5119129.560.10数据可信
供试品溶液-24073101-1-2批-坎地
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1140866-14086641.31239.157.1541.3139.157.15
2125772-12577236.88536.88
3123629-12362936.25636.26
4129391-12939137.94637.95
5132747-13274738.93038.93
6148516-14851643.55543.56
10min1227380-22738066.68366.013.7366.7566.083.73
2220165-22016564.56764.63
3221704-22170465.01965.08
4221605-22160564.99065.05
5218584-21858464.10464.17
6241067-24106770.69770.77
15min1267602-26760278.47978.662.7778.6678.842.77
2268964-26896478.87979.05
3265933-26593377.99078.16
4263189-26318977.18577.36
5261431-26143176.66976.84
6282273-28227382.78282.97
20min1289517-28951784.90685.841.9385.2286.141.94
2294613-29461386.40186.70
3292388-29238885.74886.05
4289326-28932684.85085.15
5287331-28733184.26584.56
6302948-30294888.84589.17
30min1314306-31430692.17693.001.3792.6393.451.38
2320059-32005993.86394.31
3319493-31949393.69794.14
4313602-31360291.97092.41
5312154-31215491.54591.98
6323015-32301594.73095.21
45min1327726-32772696.11297.031.1596.7297.631.15
2336049-33604998.55399.15
3332872-33287297.62198.22
4326650-32665095.79696.39
5328282-32828296.27596.87
6333524-33352497.81298.45
60min1331209-33120997.13398.081.2397.9098.851.22
2340079-34007999.734100.50
3336957-33695798.81999.58
4329120-32912096.52097.28
5332848-33284897.61498.37
6336409-33640998.65899.46
极限1331965-33196597.35598.471.3298.2899.401.32
2341903-341903100.269101.20
3338578-33857899.294100.22
4329737-32973796.70197.62
5335567-33556798.41199.33
6336941-33694198.81499.78
坎地氢噻片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
112.184617484623844636054631484629504627670.16
212.204577214580944579080.06
单位质量响应值RSD%判断
37994.0137533.440.87数据可信
供试品溶液-24073101-1-3批-氢噻
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1324826-32482661.74862.8215.0961.7562.8215.09
2365483-36548369.47669.48
3377850-37785071.82771.83
4338439-33843964.33564.34
5339334-33933464.50564.51
6236796-23679645.01445.01
10min1418831-41883179.61780.455.4979.7280.565.51
2434286-43428682.55582.67
3442767-44276784.16784.29
4438405-43840583.33883.45
5425731-42573180.92981.04
6379204-37920472.08572.16
15min1437786-43778683.22185.633.6583.4685.873.66
2454789-45478986.45386.71
3466541-46654188.68788.95
4465471-46547188.48388.73
5453623-45362386.23186.47
6424544-42454480.70380.90
20min1447471-44747185.06287.882.8085.4488.262.82
2464272-46427288.25588.65
3474717-47471790.24190.65
4476100-47610090.50490.90
5465102-46510288.41388.80
6446152-44615284.81185.14
30min1462027-46202787.82990.592.0388.3491.122.04
2477474-47747490.76591.31
3485919-48591992.37092.93
4487731-48773192.71593.26
5475768-47576890.44190.97
6470333-47033389.40889.88
45min1494228-49422893.95093.870.9594.6194.540.98
2491747-49174793.47894.17
3499210-49921094.89795.61
4499226-49922694.90095.60
5490583-49058393.25793.94
6487760-48776092.72093.34
60min1490295-49029593.20295.441.4894.0296.271.49
2502570-50257095.53696.39
3511213-51121397.17998.05
4508215-50821596.60997.47
5501617-50161795.35596.19
6498383-49838394.74095.51
极限1506732-50673296.32799.391.6397.30100.381.62
2526027-52602799.995101.01
3526388-526388100.063101.10
4529109-529109100.581101.60
5520274-52027498.90199.90
6528398-528398100.445101.38
坎地氢噻片项目信息
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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
116.513152713156883165093161323163493159900.17
216.173088663088253088460.01
单位质量响应值RSD%判断
19139.3119099.940.15数据可信
供试品溶液-24073101-1-3批-坎地
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1142967-14296741.97742.1014.5341.9842.1014.54
2159963-15996346.96746.97
3160881-16088147.23747.24
4146839-14683943.11443.11
5145857-14585742.82542.83
6103756-10375630.46430.46
10min1231591-23159167.99867.746.4768.0767.816.48
2239401-23940170.29170.37
3242737-24273771.27171.35
4237205-23720569.64669.72
5231669-23166968.02168.09
6201599-20159959.19259.24
15min1267256-26725678.47079.993.7378.6580.173.74
2278321-27832181.71881.91
3280068-28006882.23182.43
4280363-28036382.31882.51
5274256-27425680.52580.71
6254316-25431674.67074.82
20min1286394-28639484.08986.882.8884.4087.192.89
2297730-29773087.41787.75
3301942-30194288.65488.99
4305902-30590289.81790.14
5298582-29858287.66787.99
6284768-28476883.61183.89
30min1309126-30912690.76393.762.0091.2294.222.00
2317550-31755093.23793.71
3323158-32315894.88395.37
4328340-32834096.40596.88
5319002-31900293.66394.13
6318810-31881093.60794.02
45min1329225-32922596.66497.411.1697.2798.021.15
2327671-32767196.20896.84
3332952-33295297.75998.40
4338054-33805499.25799.89
5329276-32927696.67997.30
6333343-33334397.87498.44
60min1322642-32264294.73297.591.7895.5098.371.77
2330089-33008996.91897.71
3334935-33493598.34199.14
4339839-33983999.781100.58
5331260-33126097.26298.04
6335486-33548698.50399.24
极限1323317-32331794.93098.111.7995.8599.051.78
2334773-33477398.29399.25
3335261-33526198.43799.40
4340670-340670100.025100.99
5332993-33299397.77198.72
6337915-33791599.216100.11
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