地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DROM341122对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.101675271167942516782661678478168703616796950.27
210.151684264168472516844940.02
单位质量响应值RSD%判断
166306.44165960.000.15数据可信
供试品溶液-第1批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1651751-65175139.23140.932.6839.2340.922.68
2696543-69654341.92741.93
3684694-68469441.21441.21
4684106-68410641.17841.18
5664747-66474740.01340.01
6697601-69760141.99141.99
10min1826529-82652949.75151.101.7350.1951.561.72
2856146-85614651.53452.00
3841099-84109950.62851.09
4869306-86930652.32652.78
5854358-85435851.42651.87
6846391-84639150.94751.41
15min1905682-90568254.51555.141.0455.5056.161.03
2919716-91971655.36056.40
3913138-91313854.96455.98
4910923-91092354.83155.87
5932997-93299756.16057.18
6914194-91419455.02856.06
20min1917624-91762455.23457.093.5056.8358.723.42
2957725-95772557.64859.30
3909899-90989954.76956.40
4963387-96338757.98959.64
5941526-94152656.67358.31
61000417-100041760.21861.86
30min1937678-93767856.44159.923.0758.6562.193.00
21007730-100773060.65862.95
3993736-99373659.81662.06
4995399-99539959.91662.21
51015789-101578961.14363.41
61022557-102255761.55063.86
45min11036964-103696462.41863.621.1465.2566.561.18
21066901-106690164.22067.19
31049317-104931763.16166.07
41067218-106721864.23967.20
51056649-105664963.60366.55
61064740-106474064.09067.09
60min11043972-104397262.84064.031.7466.3767.681.66
21060303-106030363.82367.50
31095755-109575565.95669.56
41066432-106643264.19167.86
51048233-104823363.09666.75
61068231-106823164.30068.01
极限11105854-110585466.56467.471.5470.7971.821.51
21131262-113126268.09472.48
31097225-109722566.04570.38
41115552-111555267.14871.53
51138017-113801768.50072.86
61137374-113737468.46272.89
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DROM341122对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.101687486168793916810581682807169021116859000.23
210.151692293168888616905900.15
单位质量响应值RSD%判断
166920.79166560.590.16数据可信
供试品溶液-第2批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1680838-68083840.83239.415.0240.8339.415.03
2691056-69105641.44541.45
3684071-68407141.02641.03
4617804-61780437.05237.05
5648750-64875038.90838.91
6619941-61994137.18037.18
10min1827021-82702149.59947.258.3850.0547.688.35
2863776-86377651.80452.26
3849852-84985250.96951.42
4721306-72130643.25943.67
5737430-73743044.22644.66
6727342-72734243.62144.03
15min1917015-91701554.99751.519.3456.0052.489.29
2962244-96224457.70958.75
3909810-90981054.56455.59
4785331-78533147.09947.99
5804202-80420248.23149.15
6774852-77485246.47147.37
20min1929608-92960855.75252.849.8857.3754.389.82
2988426-98842659.27960.96
3952534-95253457.12758.76
4789041-78904147.32148.74
5838634-83863450.29651.76
6788437-78843747.28548.70
30min11012897-101289760.74756.2110.5062.9858.3310.41
21012367-101236760.71563.05
31052288-105228863.10965.37
4841385-84138550.46152.40
5858861-85886151.50953.53
6845245-84524550.69252.63
45min11040679-104067962.41357.7410.2565.3260.4910.18
21067292-106729264.00967.02
31047080-104708062.79765.76
4884746-88474653.06155.56
5886951-88695153.19355.78
6849991-84999150.97753.48
60min11070259-107025964.18759.539.6567.7962.929.62
21082611-108261164.92868.65
31085046-108504665.07468.74
4893425-89342553.58256.67
5925239-92523955.49058.67
6898869-89886953.90856.98
极限11117518-111751867.02162.9511.7171.3467.0011.55
21205817-120581772.31776.76
31152644-115264469.12873.51
4936242-93624256.15059.84
5950823-95082357.02460.82
6934662-93466256.05559.72
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DROM341122对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.101671812168692316909011694027169342616874180.55
210.151670501168513816778200.62
单位质量响应值RSD%判断
167071.09165302.460.76数据可信
供试品溶液-第3批-pH6.8(内含0.3%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11327739-132773979.89782.242.9579.9082.242.95
21343867-134386780.86780.87
31346513-134651381.02681.03
41400950-140095084.30284.30
51349568-134956881.21081.21
61431361-143136186.13286.13
10min11449742-144974287.23888.182.1988.1389.092.18
21459152-145915287.80488.70
31412807-141280785.01685.92
41494849-149484989.95290.89
51498311-149831190.16191.06
61477373-147737388.90189.86
15min11449526-144952687.22588.632.2689.0890.522.25
21489662-148966289.64091.51
31418944-141894485.38587.23
41512453-151245391.01292.95
51484871-148487189.35291.26
61481850-148185089.17091.12
20min11464784-146478488.14388.562.2490.9791.442.23
21461993-146199387.97590.85
31418222-141822285.34188.14
41501112-150111290.32993.28
51473597-147359788.67491.57
61511020-151102090.92693.86
30min11392079-139207983.76886.362.2587.5790.222.23
21451950-145195087.37191.22
31403986-140398684.48588.23
41477143-147714388.88792.84
51453354-145335487.45691.34
61432208-143220886.18390.13
45min11356996-135699681.65786.143.4386.3990.963.34
21424226-142422685.70390.52
31400928-140092884.30188.98
41454338-145433887.51592.45
51453597-145359787.47092.32
61498501-149850190.17295.08
60min11389547-138954783.61685.753.1389.2691.533.04
21469781-146978188.44494.21
31353756-135375681.46287.08
41456052-145605287.61893.53
51432713-143271386.21392.04
61448216-144821687.14693.05
极限11487089-148708989.48690.271.1096.0697.001.11
21522391-152239191.61098.36
31491171-149117189.73196.25
41510598-151059890.90097.78
51479876-147987689.05195.84
61509276-150927690.82197.69
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