塞来昔布片项目信息
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510141-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
110.061503007150635715072471508378151135415072690.21
29.921508983151261015107960.17
单位质量响应值RSD%判断
149827.93152297.981.16数据可信
供试品溶液-2023010611批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1341909-34190922.54520.7710.0022.5420.779.99
2278077-27807718.33618.34
3312091-31209120.57820.58
4276132-27613218.20718.21
5341537-34153722.52022.52
6340439-34043922.44822.45
10min1661529-66152943.61944.3010.5043.6544.3310.49
2592224-59222439.05039.08
3653141-65314143.06643.10
4611067-61106740.29240.32
5757572-75757249.95249.99
6755514-75551449.81649.85
15min1920353-92035360.68563.4010.6760.7863.5010.67
2848189-84818955.92756.01
3944404-94440462.27162.37
4882383-88238358.18258.27
51088098-108809871.74671.85
61085747-108574771.59171.70
20min11130766-113076674.56076.596.6674.7576.786.67
21064380-106438070.18270.35
31170800-117080077.19977.39
41115373-111537373.54573.72
51286952-128695284.85885.07
61200970-120097079.18979.40
30min11410924-141092493.03293.353.0593.3393.663.07
21347279-134727988.83689.11
31446687-144668795.39095.70
41390436-139043691.68191.97
51468123-146812396.80497.15
61431037-143103794.35994.69
45min11484699-148469997.89798.081.1598.3498.521.16
21459648-145964896.24596.65
31477643-147764397.43297.88
41503853-150385399.16099.58
51496780-149678098.69399.18
61501886-150188699.03099.51
60min11496274-149627498.66098.411.1899.2599.011.18
21465324-146532496.61997.17
31480072-148007297.59298.19
41513896-151389699.822100.39
51494200-149420098.52399.16
61505338-150533899.25899.88
极限11506597-150659799.34198.461.48100.0899.201.48
21459761-145976196.25396.95
31475843-147584397.31398.05
41518541-1518541100.128100.85
51492386-149238698.40499.19
61506594-150659499.341100.11
塞来昔布片项目信息
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510141-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
110.061497043149989215008111499871150151714998270.12
29.921510733151036315105480.02
单位质量响应值RSD%判断
149088.17152272.981.50数据可信
供试品溶液-2023010711批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1433998-43399828.69126.8210.6928.6926.8110.69
2441776-44177629.20529.20
3437829-43782928.94428.94
4391931-39193125.91025.91
5327998-32799821.68321.68
6400285-40028526.46226.46
10min1858423-85842356.74855.569.3256.7955.609.32
2925167-92516761.16061.20
3906519-90651959.92859.97
4830222-83022254.88454.92
5705820-70582046.66046.69
6816499-81649953.97754.02
15min11165152-116515277.02576.256.7777.1576.376.78
21223485-122348580.88281.02
31208863-120886379.91580.05
41187291-118729178.48978.61
51010727-101072766.81766.92
61124616-112461674.34674.47
20min11364638-136463890.21388.563.7490.4688.803.75
21362014-136201490.03990.30
31362030-136203090.04090.29
41373130-137313090.77491.01
51240847-124084782.02982.23
61334913-133491388.24888.48
30min11489054-148905498.43897.841.1198.8298.211.09
21453719-145371996.10296.49
31467293-146729396.99997.39
41497025-149702598.96599.34
51489538-148953898.47098.80
61483388-148338898.06398.43
45min11489302-148930298.45498.211.1298.9898.721.11
21459507-145950796.48497.02
31475698-147569897.55598.09
41508787-150878799.742100.27
51492650-149265098.67599.15
61487470-148747098.33398.84
60min11491929-149192998.62898.281.2399.3098.941.21
21459604-145960496.49197.17
31473897-147389797.43698.12
41510933-151093399.884100.56
51498431-149843199.05799.68
61485230-148523098.18598.84
极限11483621-148362198.07898.231.1598.9099.041.13
21463308-146330896.73697.56
31475231-147523197.52498.35
41509949-150994999.819100.64
51500917-150091799.22299.99
61482564-148256498.00998.81
塞来昔布片项目信息
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510141-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
110.061471895147262214720811470796147122714717240.05
29.921467909146986314688860.10
单位质量响应值RSD%判断
146294.63148073.190.86数据可信
供试品溶液-2023010711批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1443794-44379430.03324.9413.2430.0324.9413.24
2316838-31683821.44121.44
3377361-37736125.53725.54
4373397-37339725.26925.27
5386780-38678026.17526.17
6312676-31267621.16021.16
10min1779193-77919352.73051.766.7952.7851.806.79
2685764-68576446.40846.44
3802871-80287154.33354.37
4813312-81331255.03955.08
5792475-79247553.62953.67
6715487-71548748.41948.45
15min11101395-110139574.53572.735.6674.6672.845.66
2977207-97720766.13066.23
31152778-115277878.01278.13
41094342-109434274.05774.18
51087624-108762473.60373.72
61034802-103480270.02870.13
20min11275091-127509186.28986.153.4486.5386.383.45
21204634-120463481.52181.72
31331245-133124590.08990.33
41285817-128581787.01587.25
51296398-129639887.73187.96
61245068-124506884.25784.47
30min11369792-136979292.69896.001.9493.0696.361.93
21438164-143816497.32597.65
31445119-144511997.79598.17
41411145-141114595.49695.86
51433261-143326196.99397.35
61414425-141442595.71896.05
45min11435380-143538097.13697.480.5997.6497.980.59
21440317-144031797.47097.94
31455952-145595298.52999.05
41431062-143106296.84497.35
51439277-143927797.40097.91
61441022-144102297.51898.00
60min11438478-143847897.34697.750.6498.0098.400.64
21449796-144979698.11298.73
31459087-145908798.74199.41
41435558-143555897.14897.80
51436660-143666097.22397.88
61447348-144734897.94698.57
极限11433948-143394897.03997.580.6897.8498.370.67
21449643-144964398.10298.86
31456828-145682898.58899.40
41434072-143407297.04897.84
51433615-143361597.01797.82
61443274-144327497.67198.44
塞来昔布片项目信息
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510141-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
110.062986189299504229892902993909298742229903700.14
29.922980383298094629806640.02
单位质量响应值RSD%判断
297253.48300470.160.77数据可信
供试品溶液-2023010811批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1536991-53699117.89717.534.9717.9017.544.97
2560086-56008618.66618.67
3549416-54941618.31118.31
4498399-49839916.61016.61
5504295-50429516.80716.81
6507368-50736816.90916.91
10min11175463-117546339.17539.002.9439.2039.032.93
21221102-122110240.69640.72
31196909-119690939.89039.92
41138774-113877437.95237.98
51155738-115573838.51838.54
61133325-113332537.77137.80
15min11725824-172582457.51757.082.4457.6057.162.43
21773486-177348659.10659.19
31743866-174386658.11958.21
41675009-167500955.82455.91
51686073-168607356.19256.28
61671529-167152955.70855.79
20min12125735-212573570.84571.362.4871.0271.532.48
22221961-222196174.05274.23
32192106-219210673.05773.23
42094833-209483369.81569.98
52114148-211414870.45970.63
62098288-209828869.93070.10
30min12659553-265955388.63689.061.7288.9189.331.72
22743190-274319091.42391.71
32702099-270209990.05490.34
42627700-262770087.57487.84
52676561-267656189.20389.48
62623691-262369187.44187.71
45min12983131-298313199.42099.370.7599.8399.780.76
23002936-3002936100.080100.51
32996437-299643799.863100.28
42963451-296345198.76499.17
52997525-299752599.900100.31
62946887-294688798.21298.61
60min13015723-3015723100.506100.270.67101.07100.840.68
23033076-3033076101.085101.66
33020095-3020095100.652101.22
42983771-298377199.44199.99
53014944-3014944100.480101.04
62984967-298496799.481100.03
极限13015783-3015783100.50899.800.86101.22100.520.87
23020867-3020867100.678101.41
33014679-3014679100.471101.19
42971478-297147899.03299.73
52961466-296146698.69899.41
62983572-298357299.435100.13
塞来昔布片项目信息
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510141-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
110.062992629299500829972892998178300037629966960.10
29.922991105299425929926820.08
单位质量响应值RSD%判断
297882.31301681.650.90数据可信
供试品溶液-2023010811批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1543656-54365618.06317.603.2618.0617.603.26
2538947-53894717.90717.91
3552267-55226718.34918.35
4512618-51261817.03217.03
5513749-51374917.07017.07
6517501-51750117.19417.19
10min11197261-119726139.78038.552.5539.8138.582.56
21178141-117814139.14439.17
31184274-118427439.34839.38
41138444-113844437.82537.85
51135107-113510737.71437.74
61128701-112870137.50237.53
15min11733932-173393257.61156.262.0057.7056.352.00
21708941-170894156.78056.87
31723554-172355457.26657.35
41681823-168182355.87955.96
51656701-165670155.04555.13
61655512-165551255.00555.09
20min12180021-218002172.43270.192.3272.6170.362.32
22149550-214955071.42071.59
32133688-213368870.89371.07
42079923-207992369.10669.27
52057779-205777968.37168.54
62074096-207409668.91369.08
30min12722079-272207990.44288.471.9590.7288.741.94
22702658-270265889.79790.07
32697166-269716689.61589.89
42643958-264395887.84788.12
52598928-259892886.35186.62
62611226-261122686.75987.03
45min12988182-298818299.28498.401.4899.7098.801.48
22981165-298116599.05199.46
33006127-300612799.880100.29
42972468-297246898.76299.16
52886659-288665995.91196.31
62934738-293473897.50897.91
60min13004031-300403199.81099.241.36100.3899.791.37
23014150-3014150100.147100.71
33030879-3030879100.702101.27
42988814-298881499.30599.85
52917751-291775196.94497.48
62965169-296516998.51999.06
极限13010490-3010490100.02599.181.57100.7499.881.57
23002472-300247299.759100.47
33043728-3043728101.129101.84
42995396-299539699.523100.22
52917724-291772496.94397.63
62941007-294100797.71698.41
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