塞来昔布胶囊项目信息
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%
110.043001878300138829957642994674299074429968900.16
210.012996543298614829913460.25
单位质量响应值RSD%判断
298495.02298835.760.09数据可信
供试品溶液-20211229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%
5min123636-236360.7880.7219.930.790.7220.11
222730-227300.7580.76
323427-234270.7810.78
413633-136330.4550.45
519742-197420.6580.66
625609-256090.8540.85
10min140052-400521.3361.303.711.341.303.59
239945-399451.3321.33
340135-401351.3381.34
437735-377351.2581.26
536735-367351.2251.23
639682-396821.3231.32
15min143531-435311.4521.393.571.451.393.48
242059-420591.4031.41
341938-419381.3991.40
442472-424721.4161.42
539194-391941.3071.31
640921-409211.3651.37
20min143479-434791.4501.412.511.461.422.54
242790-427901.4271.43
342377-423771.4131.42
443496-434961.4511.46
541150-411501.3721.38
641178-411781.3731.38
30min141993-419931.4001.372.811.411.373.01
240919-409191.3651.37
340110-401101.3381.34
442567-425671.4201.43
540941-409411.3651.37
639464-394641.3161.32
45min140131-401311.3381.293.291.351.303.14
238734-387341.2921.30
338776-387761.2931.30
440300-403001.3441.35
537760-377601.2591.27
637073-370731.2361.25
60min138911-389111.2981.282.211.311.292.27
239233-392331.3081.32
337819-378191.2611.27
439366-393661.3131.32
538092-380921.2701.28
637286-372861.2431.25
极限139352-393521.3121.244.461.331.254.54
237123-371231.2381.25
337750-377501.2591.27
437862-378621.2631.28
536636-366361.2221.23
634369-343691.1461.16
塞来昔布胶囊项目信息
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%
110.043005242300162229869013005616297475029948260.46
210.013001858300730330045800.13
单位质量响应值RSD%判断
298289.44300157.840.45数据可信
供试品溶液-20211229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%
5min122358-223580.7440.6518.540.740.6518.78
223318-233180.7760.78
317773-177730.5920.59
421832-218320.7270.73
517145-171450.5710.57
614166-141660.4720.47
10min139513-395131.3151.273.461.321.273.52
239414-394141.3121.31
336011-360111.1991.20
438214-382141.2721.27
537351-373511.2431.24
637856-378561.2601.26
15min141528-415281.3821.391.061.391.391.07
241983-419831.3971.40
341525-415251.3821.38
441140-411401.3691.37
541287-412871.3741.38
642309-423091.4081.41
20min140993-409931.3651.391.341.371.401.41
241669-416691.3871.39
342064-420641.4001.40
441634-416341.3861.39
542703-427031.4211.43
642041-420411.3991.40
30min139368-393681.3101.332.611.321.342.56
240248-402481.3401.35
339431-394311.3131.32
438817-388171.2921.30
541474-414741.3811.39
641030-410301.3661.37
45min137389-373891.2451.282.221.251.282.30
237261-372611.2401.25
338623-386231.2861.29
438411-384111.2791.29
539008-390081.2981.31
639355-393551.3101.32
60min136283-362831.2081.252.501.221.262.54
236829-368291.2261.24
338000-380001.2651.28
437192-371921.2381.25
538933-389331.2961.31
637215-372151.2391.25
极限136510-365101.2151.221.911.231.241.83
236372-363721.2111.22
336198-361981.2051.22
436146-361461.2031.22
537866-378661.2601.27
637329-373291.2431.26
塞来昔布胶囊项目信息
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%
110.043004419300343830020643001720299462430012530.13
210.013026107302282930244680.08
单位质量响应值RSD%判断
298929.58302144.660.76数据可信
供试品溶液-2026010811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%
5min124844-248440.8230.858.640.820.858.71
227740-277400.9190.92
324377-243770.8080.81
422549-225490.7470.75
528515-285150.9450.95
625881-258810.8580.86
10min140176-401761.3311.332.271.331.332.13
240146-401461.3311.33
341343-413431.3701.37
438753-387531.2841.29
540792-407921.3521.35
639579-395791.3121.31
15min142418-424181.4061.383.261.411.383.22
240112-401121.3291.33
342818-428181.4191.42
442007-420071.3921.40
542416-424161.4061.41
639628-396281.3131.32
20min142252-422521.4001.363.711.411.373.64
238646-386461.2811.29
342021-420211.3931.40
441530-415301.3761.38
542032-420321.3931.40
639544-395441.3111.32
30min141570-415701.3781.335.141.391.335.06
237083-370831.2291.24
341442-414421.3731.38
440247-402471.3341.34
541819-418191.3861.39
637843-378431.2541.26
45min137955-379551.2581.274.821.271.284.80
235679-356791.1821.19
338375-383751.2721.28
440376-403761.3381.35
540484-404841.3421.35
637331-373311.2371.25
60min137468-374681.2421.197.631.251.207.62
231097-310971.0311.04
336938-369381.2241.24
436314-363141.2041.21
539130-391301.2971.31
635125-351251.1641.18
极限137436-374361.2411.167.551.251.187.33
229988-299880.9941.01
335492-354921.1761.19
436430-364301.2071.22
536290-362901.2031.22
634775-347751.1521.17
塞来昔布胶囊项目信息
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%
110.043029195301758430152963015017301527930184740.21
210.012970787297045929706230.01
单位质量响应值RSD%判断
300644.82296765.530.92数据可信
供试品溶液-2026010811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%
5min125768-257680.8590.876.240.860.876.25
227848-278480.9290.93
325072-250720.8360.84
423723-237230.7910.79
527898-278980.9300.93
625873-258730.8630.86
10min140290-402901.3431.322.381.341.322.28
239567-395671.3191.32
340657-406571.3561.36
439434-394341.3151.32
539808-398081.3271.33
637930-379301.2651.27
15min141185-411851.3731.363.941.381.363.85
241008-410081.3671.37
343485-434851.4501.45
440976-409761.3661.37
539513-395131.3181.32
638828-388281.2951.30
20min141029-410291.3681.344.151.371.343.93
240938-409381.3651.37
341914-419141.3981.40
440458-404581.3491.35
539383-393831.3131.32
637220-372201.2411.25
30min139121-391211.3051.294.481.311.304.61
239885-398851.3301.34
339906-399061.3311.34
439530-395301.3181.33
537690-376901.2571.26
635503-355031.1841.19
45min138289-382891.2771.252.891.291.262.91
238573-385731.2861.30
337825-378251.2611.27
437447-374471.2491.26
536268-362681.2091.22
635914-359141.1981.21
60min137432-374321.2481.202.631.261.212.59
236604-366041.2211.23
336660-366601.2221.23
435463-354631.1831.19
535398-353981.1801.19
634981-349811.1661.18
极限136055-360551.2021.156.851.221.176.92
235876-358761.1961.21
329933-299330.9981.01
435814-358141.1941.21
535543-355431.1851.20
634202-342021.1401.15
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