依折麦布匹伐他汀钙片项目信息
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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
111.081276801276951276101277491276911276850.04
211.101298621300101299360.09
单位质量响应值RSD%判断
11523.9211705.951.11数据可信
供试品溶液-24020201批-匹伐他汀钙-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1118384-11838488.34387.354.4988.3487.344.49
2113775-11377584.90484.90
3122538-12253891.44391.44
4121384-12138490.58290.58
5108333-10833380.84280.84
6117868-11786887.95887.96
10min1118187-11818788.19688.254.5288.3488.404.52
2119951-11995189.51289.65
3122389-12238991.33291.48
4122647-12264791.52491.68
5108090-10809080.66180.80
6118318-11831888.29488.44
15min1117055-11705587.35188.324.8187.6588.624.80
2121557-12155790.71191.00
3121905-12190590.97091.28
4123508-12350892.16792.47
5107843-10784380.47780.75
6118256-11825688.24788.54
20min1116965-11696587.28488.164.8787.7288.604.86
2121868-12186890.94391.38
3121926-12192690.98691.44
4122862-12286291.68592.14
5107522-10752280.23780.64
6117715-11771587.84488.28
30min1117390-11739087.60188.114.8388.1988.704.82
2121808-12180890.89891.49
3121623-12162390.76091.37
4122874-12287491.69492.30
5107524-10752480.23980.78
6117195-11719587.45688.04
45min1117144-11714487.41887.924.8888.1588.654.87
2121626-12162690.76291.51
3121428-12142890.61491.37
4122522-12252291.43192.19
5107144-10714479.95580.63
6117000-11700087.31088.04
60min1116849-11684987.19787.724.9688.0788.604.95
2121417-12141790.60691.50
3121335-12133590.54591.46
4122524-12252491.43292.35
5106914-10691479.78480.59
6116248-11624886.74987.63
极限1116992-11699287.30487.584.8988.3388.604.88
2121164-12116490.41791.46
3120928-12092890.24191.30
4121971-12197191.02092.09
5106647-10664779.58480.52
6116446-11644686.89787.92
依折麦布匹伐他汀钙片项目信息
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DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.413818253817073813843817973817373816900.05
211.423847633852753850190.10
单位质量响应值RSD%判断
33452.2333714.450.56数据可信
供试品溶液-24020201批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119160-191605.1184.1249.665.124.1249.67
216928-169284.5224.52
319125-191255.1085.11
4-0.0000.00
520161-201615.3855.39
617167-171674.5854.59
10min128327-283277.5667.386.827.577.386.85
228220-282207.5387.55
328697-286977.6657.67
423883-238836.3796.38
527686-276867.3957.40
628933-289337.7287.74
15min129690-296907.9307.822.067.957.842.03
229393-293937.8517.87
329672-296727.9267.95
429234-292347.8097.82
528099-280997.5067.53
629553-295537.8947.91
20min128339-283397.5707.564.757.607.594.72
229079-290797.7677.80
325830-258306.8996.93
429091-290917.7707.79
527882-278827.4487.48
629532-295327.8887.92
30min129341-293417.8377.615.047.887.664.97
225981-259816.9406.99
328324-283247.5667.61
428983-289837.7427.78
528201-282017.5337.58
630201-302018.0678.11
45min129084-290847.7697.753.077.837.803.10
229530-295307.8887.95
329274-292747.8197.88
427646-276467.3857.43
528343-283437.5717.63
630153-301538.0548.11
60min129263-292637.8167.624.307.897.694.26
227599-275997.3727.44
326574-265747.0987.17
429312-293127.8307.89
528517-285177.6177.69
629818-298187.9658.04
极限129393-293937.8517.641.977.947.722.01
228462-284627.6027.69
328153-281537.5207.60
428353-283537.5737.65
528001-280017.4797.56
629157-291577.7887.88
依折麦布匹伐他汀钙片项目信息
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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
111.081300071301051302151302511303691301890.11
211.101322581323011322800.03
单位质量响应值RSD%判断
11749.9111917.121.00数据可信
供试品溶液-24020201批-匹伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1121830-12183089.23490.641.9989.2390.642.00
2120273-12027388.09488.09
3124112-12411290.90690.91
4124692-12469291.33091.33
5124186-12418690.96090.96
6127401-12740193.31593.31
10min1130948-13094895.91393.312.3696.0693.462.36
2122378-12237889.63689.78
3128467-12846794.09594.25
4127010-12701093.02893.18
5126111-12611192.37092.52
6129440-12944094.80894.96
15min1133172-13317297.54293.362.7897.8593.672.78
2122577-12257789.78190.08
3127951-12795193.71794.03
4126836-12683692.90193.21
5125476-12547691.90592.21
6128753-12875394.30594.62
20min1133602-13360297.85793.592.8498.3394.052.83
2122412-12241289.66090.11
3128075-12807593.80894.27
4127509-12750993.39493.86
5126405-12640592.58593.04
6128637-12863794.22094.69
30min1133776-13377697.98493.482.8098.6294.102.79
2123041-12304190.12190.72
3127611-12761193.46894.09
4127211-12721193.17593.79
5125648-12564892.03192.64
6128444-12844494.07994.71
45min1133859-13385998.04593.342.9798.8494.122.97
2122431-12243189.67490.42
3127707-12770793.53994.32
4126705-12670592.80593.58
5125513-12551391.93292.70
6128396-12839694.04394.83
60min1132891-13289197.33692.852.7498.3093.782.74
2122291-12229189.57290.47
3127176-12717693.15094.08
4126321-12632192.52493.45
5125262-12526291.74892.67
6126673-12667392.78193.72
极限1132605-13260597.12692.422.9798.2593.502.96
2121288-12128888.83789.88
3125810-12581092.14993.24
4125633-12563392.02093.10
5124448-12444891.15292.22
6127308-12730893.24694.34
依折麦布匹伐他汀钙片项目信息
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DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.413855983862183860203860653859193859640.06
211.423922693912643917660.19
单位质量响应值RSD%判断
33826.8234305.251.00数据可信
供试品溶液-24020201批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121815-218155.7456.076.235.746.076.22
223984-239846.3166.32
320758-207585.4665.47
424282-242826.3946.39
523991-239916.3186.32
623531-235316.1976.20
10min127421-274217.2217.875.037.237.885.04
229059-290597.6527.66
330243-302437.9647.97
431514-315148.2998.31
531196-311968.2158.23
629824-298247.8547.86
15min131157-311578.2058.162.688.238.182.66
230582-305828.0538.08
332539-325398.5698.59
430174-301747.9467.97
530606-306068.0608.08
630824-308248.1178.14
20min132276-322768.4998.223.378.538.253.36
231989-319898.4248.46
331823-318238.3808.42
429835-298357.8577.89
529981-299817.8957.93
631317-313178.2478.28
30min131571-315718.3148.332.028.368.382.01
231883-318838.3968.45
331558-315588.3108.36
432457-324578.5478.60
531826-318268.3818.43
630522-305228.0378.09
45min132197-321978.4798.370.978.548.440.95
231659-316598.3378.40
331622-316228.3278.39
431927-319278.4078.47
531976-319768.4208.49
631338-313388.2528.32
60min131733-317338.3568.072.778.438.152.72
230221-302217.9588.04
330337-303377.9898.07
429426-294267.7497.83
531434-314348.2788.36
630815-308158.1158.19
极限131578-315788.3168.083.758.418.173.71
231071-310718.1828.27
332182-321828.4758.57
429407-294077.7447.84
529372-293727.7357.83
630427-304278.0128.10
依折麦布匹伐他汀钙片项目信息
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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
111.081300991301311301841301361300711301240.04
211.101317681318571318120.05
单位质量响应值RSD%判断
11744.0411874.950.79数据可信
供试品溶液-24020201批-匹伐他汀钙-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%
5min1137220-137220100.70995.726.41100.7195.726.41
2120930-12093088.75388.75
3136350-136350100.070100.07
4123346-12334690.52790.53
5140077-140077102.806102.81
6124605-12460591.45191.45
10min1138005-138005101.28598.933.90101.4599.093.90
2133202-13320297.76097.91
3138484-138484101.637101.80
4130560-13056095.82195.97
5141070-141070103.535103.71
6127455-12745593.54293.69
15min1138320-138320101.51699.083.77101.8599.413.77
2134486-13448698.70299.01
3138267-138267101.477101.81
4130684-13068495.91296.22
5140729-140729103.284103.63
6127545-12754593.60893.92
20min1138248-138248101.46398.993.85101.9799.483.85
2134326-13432698.58599.06
3138165-138165101.403101.91
4130350-13035095.66796.14
5140780-140780103.322103.84
6127358-12735893.47193.94
30min1137463-137463100.88798.703.82101.5699.353.82
2134200-13420098.49399.13
3137789-137789101.127101.80
4130150-13015095.52096.15
5140402-140402103.044103.73
6126892-12689293.12993.75
45min1137180-137180100.68098.413.77101.5299.233.77
2133565-13356598.02698.83
3137348-137348100.803101.65
4129708-12970895.19695.98
5139940-139940102.705103.57
6126776-12677693.04493.82
60min1137134-137134100.64698.283.80101.6699.273.81
2133417-13341797.91898.89
3137134-137134100.646101.66
4129463-12946395.01695.96
5139783-139783102.590103.62
6126556-12655692.88293.81
极限1136291-136291100.02797.873.88101.2199.023.89
2133049-13304997.64898.78
3136715-136715100.338101.52
4129173-12917394.80395.91
5139319-139319102.249103.45
6125569-12556992.15893.24
依折麦布匹伐他汀钙片项目信息
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DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.413831233837773843063847113848523841540.19
211.423909153919273914210.19
单位质量响应值RSD%判断
33668.1934275.041.27数据可信
供试品溶液-24020201批-依折麦布-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%
5min119013-190135.0215.0710.445.025.0710.45
216089-160894.2494.25
318782-187824.9604.96
418939-189395.0015.00
522220-222205.8685.87
620213-202135.3385.34
10min123985-239856.3346.774.086.346.784.10
225322-253226.6876.69
326858-268587.0927.10
425744-257446.7986.81
526627-266277.0317.04
625241-252416.6656.67
15min128224-282247.4537.182.997.477.202.97
227869-278697.3597.38
326496-264966.9977.02
426385-263856.9686.99
527659-276597.3047.33
626540-265407.0097.03
20min127706-277067.3167.182.637.357.212.60
228062-280627.4107.44
327595-275957.2877.32
426344-263446.9576.99
526406-264066.9737.01
627019-270197.1357.17
30min127987-279877.3917.175.697.437.225.64
228626-286267.5597.60
326790-267907.0757.12
427559-275597.2787.32
527792-277927.3397.38
624259-242596.4066.45
45min127713-277137.3187.134.297.377.194.23
227957-279577.3837.44
327487-274877.2597.31
426171-261716.9116.97
527702-277027.3157.37
625039-250396.6126.67
60min127600-276007.2887.034.027.367.104.01
226452-264526.9857.05
327881-278817.3637.43
426862-268627.0947.16
525821-258216.8196.89
625062-250626.6186.68
极限127229-272297.1907.043.757.277.123.67
228003-280037.3957.47
327132-271327.1657.24
426286-262866.9417.02
526122-261226.8986.98
625178-251786.6496.73
依折麦布匹伐他汀钙片项目信息
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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
111.081302571304221303551303191304231303550.06
211.101334231332281333260.11
单位质量响应值RSD%判断
11764.8912011.351.47数据可信
供试品溶液-24020201批-匹伐他汀钙-pH4.5(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1110811-11081180.79588.904.6580.8088.904.65
2126733-12673392.40492.40
3122204-12220489.10289.10
4123185-12318589.81789.82
5124882-12488291.05591.05
6123719-12371990.20790.21
10min1124192-12419290.55291.581.2690.6991.731.26
2128364-12836493.59393.75
3124167-12416790.53390.68
4125392-12539291.42691.58
5126331-12633192.11192.26
6125153-12515391.25291.40
15min1126524-12652492.25291.681.1992.5491.981.19
2128115-12811593.41293.72
3124068-12406890.46190.76
4125260-12526091.33091.63
5126075-12607591.92492.23
6124433-12443390.72791.03
20min1126438-12643892.18991.521.1492.6391.971.14
2127838-12783893.21093.68
3123765-12376590.24090.69
4125096-12509691.21191.66
5125295-12529591.35691.81
6124697-12469790.92091.37
30min1125744-12574491.68391.241.1892.2891.851.18
2127648-12764893.07193.69
3123690-12369090.18690.79
4124415-12441590.71491.32
5125407-12540791.43792.05
6123905-12390590.34290.95
45min1124730-12473090.94490.851.4491.6991.611.43
2127695-12769593.10693.88
3122789-12278989.52990.28
4124057-12405790.45391.21
5125285-12528591.34892.11
6123086-12308689.74590.50
60min1125572-12557291.55890.861.1992.4691.771.19
2126603-12660392.30993.24
3122246-12224689.13390.03
4123969-12396990.38991.30
5124608-12460890.85591.77
6124701-12470190.92391.83
极限1124701-12470190.92390.451.3591.9791.521.35
2126406-12640692.16693.25
3121668-12166888.71189.76
4123411-12341189.98291.04
5125052-12505291.17992.25
6123105-12310589.75990.82
依折麦布匹伐他汀钙片项目信息
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DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.413861643869303875343877333877473872220.18
211.423903013903543903280.01
单位质量响应值RSD%判断
33937.0734179.330.51数据可信
供试品溶液-24020201批-依折麦布-pH4.5(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1208891-20889155.01959.726.4855.0259.726.48
2237974-23797462.67962.68
3248142-24814265.35765.36
4224888-22488859.23259.23
5213713-21371356.28956.29
6226743-22674359.72159.72
10min1317970-31797083.74885.003.8383.8485.093.83
2334225-33422588.03088.13
3335139-33513988.27188.38
4310554-31055481.79581.89
5307348-30734880.95181.04
6331009-33100987.18387.28
15min1350272-35027292.25693.092.1592.4993.332.16
2361347-36134795.17395.42
3359455-35945594.67594.93
4345274-34527490.94091.17
5344765-34476590.80691.03
6359570-35957094.70594.95
20min1364623-36462396.03696.651.6796.4297.051.68
2373465-37346598.36598.77
3369912-36991297.42997.84
4361367-36136795.17995.57
5359175-35917594.60194.98
6373234-37323498.30498.71
30min1375728-37572898.96199.711.2099.51100.261.20
2383305-383305100.957101.53
3380431-380431100.200100.78
4373653-37365398.41598.96
5374495-37449598.63699.17
6383749-383749101.074101.64
45min1379576-37957699.975101.161.02100.68101.881.03
2387845-387845102.152102.89
3385062-385062101.419102.16
4380175-380175100.132100.84
5382872-382872100.843101.54
6388906-388906102.432103.17
60min1383674-383674101.054101.611.09101.93102.501.09
2387731-387731102.122103.03
3384964-384964101.394102.31
4381729-381729100.542101.42
5383345-383345100.967101.84
6393248-393248103.576104.48
极限1382433-382433100.727101.121.05101.77102.181.05
2385009-385009101.406102.49
3382551-382551100.758101.84
4379178-37917899.870100.91
5383259-383259100.945101.98
6391147-391147103.022104.10
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