非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.833711643714223703603708613709723709560.11
210.903747883751733749800.08
单位质量响应值RSD%判断
34252.6334401.830.31数据可信
供试品溶液-BXKBZ61批-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%
5min149477-4947764.80870.2220.1264.8170.2220.12
245007-4500758.95358.95
368555-6855589.79889.80
463223-6322382.81482.81
540463-4046353.00153.00
654910-5491071.92571.92
10min1120187-120187157.429176.9711.06157.79177.3611.07
2114194-114194149.579149.91
3151727-151727198.743199.24
4142675-142675186.886187.35
5135726-135726177.783178.08
6146121-146121191.400191.80
15min1189013-189013247.582260.043.80248.82261.413.83
2193318-193318253.221254.38
3205363-205363268.999270.60
4196222-196222257.025258.52
5198015-198015259.374260.66
6209205-209205274.031275.49
20min1230006-230006301.278312.792.85303.89315.612.84
2243540-243540319.006321.57
3242677-242677317.875320.97
4230348-230348301.726304.65
5241075-241075315.777318.50
6245116-245116321.070324.06
30min1273188-273188357.841369.402.50362.12373.962.48
2287328-287328376.362380.70
3283757-283757371.685376.55
4273378-273378358.090362.69
5289329-289329378.983383.46
6285097-285097373.440378.21
45min1304566-304566398.942410.931.94405.21417.541.93
2317271-317271415.584422.01
3314314-314314411.710418.64
4309405-309405405.280411.87
5321896-321896421.642428.22
6314878-314878412.449419.29
60min1321375-321375420.959429.641.76429.45438.531.75
2328483-328483430.270439.01
3326541-326541427.726436.94
4324059-324059424.475433.32
5338074-338074442.833451.76
6329477-329477431.572440.71
极限1343144-343144449.474450.541.22460.30461.811.18
2346369-346369453.698464.83
3340537-340537446.059457.65
4342510-342510448.644459.85
5351124-351124459.927471.31
6340041-340041445.409456.94
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.833751133749483760203754043757413754450.12
210.903734243736163735200.04
单位质量响应值RSD%判断
34667.1334267.890.82数据可信
供试品溶液-BXKBZ61批-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%
5min160958-6095879.52467.5924.7479.5267.5924.74
250475-5047565.84965.85
327904-2790436.40336.40
454446-5444671.02971.03
564303-6430383.88883.89
652783-5278368.85968.86
10min1144069-144069187.949169.2822.85188.39169.6522.85
2109260-109260142.538142.90
392483-92483120.651120.85
4163453-163453213.237213.63
5159110-159110207.571208.04
6110174-110174143.730144.11
15min1208474-208474271.970259.4513.62273.46260.7713.66
2175906-175906229.483230.64
3170669-170669222.651223.52
4228886-228886298.599300.18
5230022-230022300.081301.70
6179321-179321233.938235.12
20min1245915-245915320.815317.428.67323.81320.188.74
2228668-228668298.315300.75
3223866-223866292.050294.16
4264524-264524345.092348.33
5272110-272110354.988358.27
6224796-224796293.264295.74
30min1290076-290076378.426382.654.63383.21387.174.72
2285982-285982373.085377.18
3285248-285248372.128375.86
4306730-306730400.153405.31
5313194-313194408.586413.84
6278631-278631363.496367.61
45min1323930-323930422.592429.352.98429.47436.003.08
2324100-324100422.813428.98
3323731-323731422.332428.13
4338829-338829442.028449.41
5344005-344005448.781456.31
6320082-320082417.572423.70
60min1340528-340528444.245449.981.66453.47459.011.78
2340999-340999444.859453.37
3341477-341477445.483453.63
4352105-352105459.348469.18
5352469-352469459.823469.84
6341972-341972446.129454.58
极限1348938-348938455.216463.181.36466.91474.711.45
2355695-355695464.031475.01
3351046-351046457.966468.59
4358738-358738468.001480.39
5361910-361910472.139484.72
6353907-353907461.699472.63
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.833727853732823726133728383727723728580.07
210.903763383773473768420.19
单位质量响应值RSD%判断
34428.2534572.660.30数据可信
供试品溶液-BXKBZ61批-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%
5min129335-2933538.23230.5418.2238.2330.5418.22
218978-1897824.73424.73
327436-2743635.75735.76
421524-2152428.05228.05
523965-2396531.23331.23
619372-1937225.24725.25
10min171011-7101192.54891.439.3792.7691.609.38
261147-6114779.69279.83
381348-81348106.020106.22
467988-6798888.60888.76
571077-7107792.63492.81
668349-6834989.07989.22
15min1103768-103768135.240139.577.78135.97140.257.78
295504-95504124.470125.05
3121136-121136157.876158.66
4105816-105816137.909138.56
5108076-108076140.855141.54
6108236-108236141.063141.70
20min1130672-130672170.304176.746.01171.78178.196.03
2123771-123771161.310162.58
3147962-147962192.838194.50
4134911-134911175.829177.24
5137422-137422179.101180.57
6138931-138931181.068182.49
30min1170899-170899222.731228.104.38225.16230.544.41
2163302-163302212.830215.00
3186167-186167242.630245.37
4175132-175132228.248230.64
5175834-175834229.163231.63
6178788-178788233.013235.44
45min1207693-207693270.685277.152.96274.35280.853.00
2203257-203257264.903268.25
3220743-220743287.693291.78
4214041-214041278.958282.62
5213365-213365278.077281.82
6216806-216806282.562286.28
60min1232746-232746303.336309.192.09308.50314.432.13
2230011-230011299.772304.59
3242419-242419315.943321.63
4239108-239108311.628316.84
5237523-237523309.562314.85
6241620-241620314.902320.19
极限1252943-252943329.659334.471.31336.51341.431.36
2252941-252941329.656336.14
3261671-261671341.034348.47
4257396-257396335.462342.40
5256562-256562334.375341.38
6258287-258287336.624343.66
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.833737543736113739643739163743453739180.08
210.903749093748523748800.02
单位质量响应值RSD%判断
34526.1334392.660.28数据可信
供试品溶液-BXKBZ61批-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%
5min124988-2498832.60533.5713.8632.6133.5713.86
226201-2620134.18834.19
320137-2013726.27626.28
428017-2801736.55836.56
530665-3066540.01340.01
624346-2434631.76831.77
10min171585-7158593.40799.024.4693.5999.214.47
274740-7474097.52497.71
373757-7375796.24196.39
475627-7562798.68298.88
580805-80805105.438105.66
678813-78813102.839103.02
15min1107347-107347140.071147.293.73140.77148.023.73
2113085-113085147.558148.29
3110990-110990144.825145.51
4110632-110632144.358145.11
5119073-119073155.372156.18
6116139-116139151.543152.29
20min1136812-136812178.518184.222.83180.00185.772.84
2142732-142732186.243187.79
3138921-138921181.270182.76
4137872-137872179.902181.45
5147224-147224192.104193.78
6143509-143509187.257188.85
30min1177743-177743231.927235.791.88234.40238.371.90
2182064-182064237.565240.15
3179465-179465234.174236.67
4176784-176784230.676233.23
5185952-185952242.639245.38
6182226-182226237.777240.41
45min1215809-215809281.597284.271.23285.36288.161.25
2217848-217848284.258288.16
3217431-217431283.714287.51
4214456-214456279.832283.67
5221924-221924289.576293.66
6219683-219683286.652290.60
60min1239174-239174312.085314.701.12317.41320.161.14
2240220-240220313.450318.94
3241518-241518315.144320.51
4237879-237879310.395315.78
5245283-245283320.056325.75
6242987-242987317.060322.60
极限1258115-258115336.800337.790.80343.86345.010.80
2257704-257704336.264343.49
3258644-258644337.490344.61
4256678-256678334.925342.04
5259536-259536338.654346.13
6262572-262572342.616349.92
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.833755723754983758853758623762563758150.08
210.903781353778953780150.05
单位质量响应值RSD%判断
34701.2934680.280.05数据可信
供试品溶液-BXKBZ61批-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%
5min14681-46816.0676.8012.646.076.8012.64
24858-48586.2976.30
34722-47226.1206.12
45409-54097.0117.01
56432-64328.3378.34
65381-53816.9756.97
10min114382-1438218.64120.438.4318.6720.468.43
215312-1531219.84619.88
315614-1561420.23820.27
416391-1639121.24521.28
518075-1807523.42823.47
614795-1479519.17619.22
15min123758-2375830.79432.895.9730.9333.045.98
224996-2499632.39832.54
325210-2521032.67632.82
427038-2703835.04535.20
527325-2732535.41735.59
623923-2392331.00731.15
20min129139-2913937.76839.875.7738.0840.215.78
229869-2986938.71439.04
330280-3028039.24739.57
433309-3330943.17343.52
532650-3265042.31942.69
629337-2933738.02538.34
30min136803-3680347.70250.035.4648.2250.595.46
238345-3834549.70050.24
337475-3747548.57349.12
441901-4190154.30954.90
540369-4036952.32452.93
636707-3670747.57748.11
45min145734-4573459.27861.434.7360.0662.274.74
247013-4701360.93561.75
345281-4528158.69059.51
451099-5109966.23167.12
549028-4902863.54764.45
646230-4623059.92060.71
60min151272-5127266.45669.474.6167.5770.644.62
252928-5292868.60269.76
352921-5292168.59369.73
457861-5786174.99676.26
555001-5500171.28972.54
651591-5159166.86967.99
极限156473-5647373.19775.513.7874.6877.083.80
257277-5727774.23975.77
358334-5833475.60977.13
462268-6226880.70882.39
558851-5885176.27977.93
656363-5636373.05474.55
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