塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
110.053037064302231830370193015327303618830295830.34
210.103009382302359230164870.34
单位质量响应值RSD%判断
301451.04298662.080.66数据可信
供试品溶液-1批-pH6.8(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1252402-2524028.3788.155.808.388.155.79
2251937-2519378.3638.36
3266736-2667368.8548.85
4237404-2374047.8807.88
5226850-2268507.5307.53
6237777-2377777.8937.89
10min1669602-66960222.22721.294.0822.2421.314.08
2642197-64219721.31721.33
3668193-66819322.18022.20
4647048-64704821.47821.49
5612421-61242120.32920.34
6609319-60931920.22620.24
15min11063345-106334535.29734.283.5735.3634.343.57
21028664-102866434.14634.21
31059840-105984035.18135.24
41063299-106329935.29635.35
51008071-100807133.46233.52
6973085-97308532.30132.36
20min11428906-142890647.43246.223.6047.5646.343.60
21375983-137598345.67545.80
31427525-142752547.38647.52
41423203-142320347.24247.37
51398798-139879846.43246.55
61299105-129910543.12343.24
30min12016852-201685266.94864.224.4567.1764.444.44
21857553-185755361.66061.88
31987919-198791965.98866.22
41963199-196319965.16765.39
51983144-198314465.82966.04
61799495-179949559.73359.94
45min12435755-243575580.85478.012.6881.2178.362.68
22290169-229016976.02176.36
32376371-237637178.88279.24
42378076-237807678.93979.29
52355720-235572078.19778.54
62264377-226437775.16575.49
60min12619555-261955586.95585.021.4687.4885.531.47
22528690-252869083.93884.43
32570278-257027885.31985.84
42567048-256704885.21285.72
52569757-256975785.30285.81
62513035-251303583.41983.90
极限12745939-274593991.15089.820.8591.8590.500.85
22699828-269982889.61990.28
32678108-267810888.89889.59
42715285-271528590.13290.81
52696290-269629089.50290.18
62700728-270072889.64990.29
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
110.053046872303246730394593044021300958530344810.50
210.103022143304868930354160.62
单位质量响应值RSD%判断
301938.41300536.240.33数据可信
供试品溶液-22112201批-pH6.8(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1251565-2515658.3189.6811.958.329.6811.96
2286421-2864219.4709.47
3305745-30574510.10910.11
4341189-34118911.28111.28
5256262-2562628.4738.47
6316020-31602010.44910.45
10min1625631-62563120.68622.838.5120.7022.858.52
2685959-68595922.68022.70
3717079-71707923.70923.73
4790709-79070926.14426.17
5643950-64395021.29121.31
6679809-67980922.47722.50
15min1955619-95561931.59634.746.9131.6534.806.91
21065226-106522635.22035.28
31045064-104506434.55434.62
41173051-117305138.78638.86
51006270-100627033.27133.33
61059187-105918735.02135.09
20min11236115-123611540.87144.716.6940.9944.846.69
21350148-135014844.64144.78
31367030-136703045.19945.34
41510872-151087249.95550.11
51337756-133775644.23144.36
61310804-131080443.34043.48
30min11651025-165102554.58959.185.6254.7959.405.63
21770958-177095858.55558.78
31832345-183234560.58460.81
41953189-195318964.58064.83
51791282-179128259.22759.44
61740566-174056657.55057.77
45min12019230-201923066.76370.002.8967.0870.342.89
22101338-210133869.47869.82
32150287-215028771.09771.44
42194572-219457272.56172.94
52147078-214707870.99171.32
62089568-208956869.08969.43
60min12224981-222498173.56675.761.8574.0176.241.87
22256687-225668774.61575.09
32295867-229586775.91076.40
42334813-233481377.19877.72
52321455-232145576.75677.23
62314924-231492476.54077.02
极限12461644-246164481.39182.731.6181.9883.361.62
22499331-249933182.63783.27
32464487-246448781.48582.13
42551526-255152684.36385.04
52485858-248585882.19282.82
62549848-254984884.30884.94
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
110.053027884304273230005213022795302705130241970.51
210.103008060303860930233340.72
单位质量响应值RSD%判断
300915.12299340.000.38数据可信
供试品溶液-1批-pH6.8(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1399572-39957213.26011.588.7913.2611.588.79
2340607-34060711.30311.30
3313649-31364910.40910.41
4342763-34276311.37511.37
5367882-36788212.20912.21
6328442-32844210.90010.90
10min11458753-145875348.41044.784.1348.4444.804.13
21355113-135511344.97144.99
31323693-132369343.92843.95
41309921-130992143.47143.49
51326387-132638744.01844.04
61322438-132243843.88743.91
15min11704924-170492456.58053.223.2256.7053.333.22
21599824-159982453.09253.20
31599334-159933453.07653.18
41569227-156922752.07752.19
51568545-156854552.05452.17
61579799-157979952.42752.54
20min11914758-191475863.54360.352.6463.7860.572.65
21812268-181226860.14260.36
31807147-180714759.97260.19
41795050-179505059.57159.78
51787839-178783959.33159.55
61794446-179444659.55159.77
30min12419553-241955380.29678.471.4380.6678.811.44
22360929-236092978.35078.69
32330083-233008377.32677.66
42340202-234020277.66278.00
52388399-238839979.26279.60
62347801-234780177.91478.25
45min12721242-272124290.30790.221.6190.8390.721.60
22674904-267490488.77089.27
32714000-271400090.06790.56
42687525-268752589.18989.68
52799494-279949492.90493.40
62713663-271366390.05690.55
60min12837449-283744994.16494.261.5094.8794.941.49
22771497-277149791.97592.65
32815590-281559093.43994.11
42855269-285526994.75595.42
52887878-288787895.83796.52
62873725-287372595.36896.04
极限12899972-289997296.23997.181.0997.1398.051.08
22904326-290432696.38397.24
32894352-289435296.05296.91
42952975-295297597.99898.85
52959382-295938298.21099.08
62959642-295964298.21999.08
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
110.053029032299220030270722996759301337530116880.57
210.103020371304252030314460.52
单位质量响应值RSD%判断
299670.45300143.170.12数据可信
供试品溶液-22112201批-pH6.8(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1391659-39165913.00714.339.8113.0114.339.80
2367930-36793012.21912.22
3438723-43872314.57014.57
4455036-45503615.11215.11
5474942-47494215.77315.77
6460115-46011515.28115.28
10min1941447-94144731.26634.059.7331.2934.079.73
2866489-86648928.77628.80
31042561-104256134.62434.65
41084541-108454136.01836.05
51110750-111075036.88836.92
61105129-110512936.70236.73
15min11402344-140234446.57249.878.0446.6649.968.05
21319123-131912343.80943.89
31513053-151305350.24950.35
41609405-160940553.44953.55
51631542-163154254.18454.29
61533882-153388250.94151.04
20min11760873-176087358.47962.076.6658.6662.276.66
21711011-171101156.82356.99
31897459-189745963.01563.21
41977887-197788765.68665.90
52032831-203283167.51167.72
61834646-183464660.92961.14
30min12207749-220774973.32076.192.7373.6276.512.74
22266044-226604475.25675.54
32316184-231618476.92177.25
42369146-236914678.68079.02
52353076-235307678.14678.50
62252988-225298874.82275.15
45min12504656-250465683.18084.611.4683.6385.081.48
22510068-251006883.36083.79
32573779-257377985.47685.95
42593586-259358686.13486.63
52571981-257198185.41685.92
62532458-253245884.10484.58
60min12598938-259893886.31288.501.3986.9289.141.40
22677195-267719588.91189.51
32674615-267461588.82589.47
42698076-269807689.60490.27
52693628-269362889.45690.13
62647041-264704187.90988.55
极限12774248-277424892.13492.800.7892.9293.620.80
22762284-276228491.73692.51
32817972-281797293.58694.41
42797951-279795192.92193.77
52811777-281177793.38094.23
62801077-280107793.02593.85
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