贝派度酸依折麦布片项目信息
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2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.241143104114097911431771142360114260911424460.08
211.241138709113754011381240.08
单位质量响应值RSD%判断
101641.10101256.580.27数据可信
供试品溶液-1993854批-依折麦布-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150110-501104.4314.5517.044.434.5517.02
252811-528114.6704.67
338893-388933.4393.44
445017-450173.9813.98
560777-607775.3745.37
661187-611875.4105.41
10min178065-780656.9037.163.176.957.213.25
281775-817757.2317.28
380894-808947.1537.19
477918-779186.8906.93
584365-843657.4607.52
682704-827047.3137.37
15min186101-861017.6137.611.477.747.741.52
286652-866527.6627.79
386773-867737.6737.79
483681-836817.3997.52
587242-872427.7147.86
686256-862567.6277.77
20min186483-864837.6477.721.697.867.931.71
287519-875197.7397.96
388602-886027.8348.04
485035-850357.5197.72
586909-869097.6857.91
689068-890687.8768.10
30min187767-877677.7617.842.158.068.142.16
288614-886147.8358.14
389669-896697.9298.22
485976-859767.6027.89
588442-884427.8208.13
691654-916548.1048.42
45min186279-862797.6297.832.168.018.222.13
290426-904267.9968.39
390708-907088.0218.40
486381-863817.6388.01
588881-888817.8598.26
688712-887127.8448.25
60min186585-865857.6567.595.618.128.065.29
294944-949448.3958.87
384842-848427.5027.97
481002-810027.1627.62
583678-836787.3997.89
684061-840617.4337.92
极限187096-870967.7017.735.088.258.294.85
295944-959448.4849.06
386763-867637.6728.22
484012-840127.4297.96
583793-837937.4097.98
686918-869187.6858.26
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.05 3048663041523047673045853047053046150.10
210.09 3037203031143034170.15
单位质量响应值RSD%判断
30309.9530071.060.56数据可信
供试品溶液-1993854批-贝派度酸-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min181923-8192327.06028.0418.5627.0628.0418.56
289195-8919529.46229.46
362837-6283720.75620.76
472679-7267924.00624.01
596934-9693432.01832.02
6105698-10569834.91334.91
10min1164038-16403854.18355.804.4754.4856.114.55
2171372-17137256.60556.93
3162525-16252553.68353.91
4161223-16122353.25353.52
5174294-17429457.57157.93
6180151-18015159.50559.89
15min1216371-21637171.46970.952.1472.3771.882.21
2215546-21554671.19772.15
3210427-21042769.50670.33
4209452-20945269.18470.04
5214865-21486570.97271.97
6222158-22215873.38074.43
20min1238688-23868878.84078.802.2480.5480.522.28
2237554-23755478.46680.21
3239150-23915078.99380.59
4231374-23137476.42578.05
5236787-23678778.21380.00
6247856-24785681.86983.73
30min1263773-26377387.12687.281.6289.7089.881.66
2263264-26326486.95889.58
3266858-26685888.14590.62
4257508-25750885.05787.53
5263718-26371887.10889.76
6270362-27036289.30392.08
45min1275039-27503990.84791.651.5394.3995.221.54
2275068-27506890.85794.44
3282208-28220893.21596.67
4271678-27167889.73793.16
5278996-27899692.15595.78
6281843-28184393.09596.86
60min1278985-27898592.15189.802.3796.7094.382.28
2278055-27805591.84496.44
3273829-27382990.44894.94
4262281-26228186.63391.05
5267313-26731388.29692.94
6270764-27076489.43594.24
极限1287999-28799995.12893.401.51100.7098.981.37
2284114-28411493.84599.46
3286780-28678094.726100.22
4281514-28151492.98698.37
5277712-27771291.73097.36
6278556-27855692.00997.80
贝派度酸依折麦布片项目信息
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2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.241137526113725511376491137493113826311376370.04
211.241138679113845411385660.02
单位质量响应值RSD%判断
101213.26101295.910.06数据可信
供试品溶液-1993854批-依折麦布-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1414564-41456436.72736.3620.9736.7336.3620.97
2356121-35612131.54931.55
3514390-51439045.57145.57
4482409-48240942.73742.74
5276325-27632524.48024.48
6419012-41901237.12137.12
10min1923613-92361381.82477.1512.2882.2377.5612.32
2845936-84593674.94375.29
3959380-95938084.99385.50
4940855-94085583.35283.83
5668995-66899559.26759.54
6886355-88635578.52478.94
15min11051085-105108593.11790.878.2994.4392.148.37
21023350-102335090.66091.84
31095599-109559997.06198.51
41058165-105816593.74495.15
5858949-85894976.09677.03
61067451-106745194.56795.85
20min11075274-107527495.26095.545.6997.6197.825.80
21094180-109418096.93599.13
31124828-112482899.650102.18
41085821-108582196.19598.64
5961301-96130185.16386.94
61129493-1129493100.064102.40
30min11086887-108688796.28999.092.9099.70102.423.01
21129358-1129358100.052103.32
31137094-1137094100.737104.37
41113683-111368398.663102.17
51078765-107876595.56998.29
61165211-1165211103.228106.68
45min11094959-109495997.00499.922.48101.48104.352.41
21129833-1129833100.094104.47
31133419-1133419100.411105.17
41103155-110315597.730102.34
51131153-1131153100.211103.99
61174391-1174391104.041108.64
60min11080633-108063395.73599.102.22101.29104.652.20
21135727-1135727100.616106.11
31135410-1135410100.588106.46
41100318-110031897.479103.17
51114592-111459298.743103.64
61145258-1145258101.460107.21
极限11087758-108775896.36697.754.22102.99104.393.93
21023637-102363790.68697.30
31109361-110936198.280105.27
41102380-110238097.662104.44
51141112-1141112101.093107.09
61155702-1155702102.385109.26
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.05 3031003031503031393032343034363032120.05
210.09 3036083029683032880.15
单位质量响应值RSD%判断
30170.3530058.280.27数据可信
供试品溶液-1993854批-贝派度酸-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130169-301699.9909.4821.979.999.4821.98
227296-272969.0399.04
335503-3550311.75611.76
434026-3402611.26711.27
517943-179435.9425.94
626873-268738.8998.90
10min192953-9295330.78028.5613.7630.8928.6713.78
285864-8586428.43328.53
395769-9576931.71331.84
494798-9479831.39131.52
564115-6411521.23121.30
684007-8400727.81827.92
15min1143097-14309747.38544.269.8547.8444.689.90
2131925-13192543.68644.10
3145312-14531248.11948.60
4139996-13999646.35846.83
5109250-10925036.17736.48
6132435-13243543.85444.26
20min1173488-17348857.44955.297.0058.4356.217.09
2166472-16647255.12556.03
3178474-17847459.10060.12
4171456-17145656.77657.76
5144924-14492447.99048.69
6167050-16705055.31756.21
30min1212875-21287570.49169.673.6772.1171.203.80
2208485-20848569.03870.55
3218646-21864672.40274.08
4213459-21345970.68572.30
5196112-19611264.94066.18
6212729-21272970.44371.95
45min1248350-24835082.23881.781.7684.6484.081.88
2243430-24343080.60982.89
3252743-25274383.69386.17
4245264-24526481.21783.62
5241487-24148779.96681.92
6250560-25056082.97085.26
60min1265488-26548887.91487.921.7491.2391.141.85
2265462-26546287.90591.08
3273973-27397390.72394.13
4263553-26355387.27390.58
5260069-26006986.11988.97
6264581-26458187.61390.83
极限1286928-28692895.01393.194.5299.3097.384.32
2256008-25600884.77488.93
3286951-28695195.02199.44
4281868-28186893.33897.62
5289732-28973295.94299.75
6287003-28700395.03899.23
贝派度酸依折麦布片项目信息
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2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.241134883113564011354021135533113581711354550.04
211.241142120114158711418540.04
单位质量响应值RSD%判断
101019.13101588.430.40数据可信
供试品溶液-1993854批-依折麦布-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min177133-771336.8307.0814.486.837.0814.49
282765-827657.3297.33
360657-606575.3715.37
496440-964408.5408.54
579699-796997.0577.06
683066-830667.3557.36
10min193857-938578.3118.322.338.398.402.41
295797-957978.4838.56
390337-903377.9998.06
495954-959548.4978.59
592699-926998.2088.29
695280-952808.4378.52
15min195305-953058.4398.440.918.618.610.84
295563-955638.4628.64
396499-964998.5458.69
495031-950318.4158.60
593895-938958.3148.48
695702-957028.4748.65
20min197726-977268.6548.482.048.928.751.97
296660-966608.5598.83
397288-972888.6158.86
496347-963478.5318.81
592965-929658.2328.49
693817-938178.3078.58
30min193448-934488.2758.212.558.638.572.30
293097-930978.2448.61
396826-968268.5748.91
490044-900447.9738.35
591792-917928.1288.48
691219-912198.0778.44
45min192878-928788.2248.232.128.678.681.89
293025-930258.2378.69
395616-956168.4678.90
489959-899597.9668.43
594482-944828.3668.81
691994-919948.1468.60
60min189798-897987.9528.065.118.498.604.70
289119-891197.8918.44
393211-932118.2548.78
484891-848917.5178.07
598790-987908.7489.28
690581-905818.0218.56
极限191046-910468.0628.107.268.698.736.73
288659-886597.8518.49
390289-902897.9958.62
485878-858787.6048.24
5104553-1045539.2589.89
688557-885577.8428.47
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.05 3025883026263025253028033028643026810.05
210.09 3047303045423046360.05
单位质量响应值RSD%判断
30117.5130191.870.18数据可信
供试品溶液-1993854批-贝派度酸-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110605-106053.5073.6016.803.513.6016.76
210977-109773.6303.63
37428-74282.4562.46
412053-120533.9863.99
511726-117263.8783.88
612489-124894.1304.13
10min119129-191296.3266.414.976.366.455.02
220051-200516.6316.67
317668-176685.8435.87
420411-204116.7506.79
519726-197266.5236.57
619303-193036.3836.43
15min124177-241777.9958.182.008.108.292.00
225389-253898.3968.51
324764-247648.1898.28
425202-252028.3348.45
524629-246298.1458.26
624235-242358.0148.13
20min127217-272179.0019.152.549.209.352.46
228474-284749.4169.62
328239-282399.3399.52
428192-281929.3239.53
527011-270118.9329.14
626909-269098.8999.10
30min129489-294899.75210.033.5510.0510.343.40
231665-3166510.47110.78
331678-3167810.47610.76
430167-301679.97610.29
529765-297659.84310.15
629273-292739.6809.99
45min131603-3160310.45110.803.7310.8611.213.61
233785-3378511.17311.60
334051-3405111.26111.66
433380-3338011.03911.46
531264-3126410.33910.75
631874-3187410.54110.95
60min131988-3198810.57811.013.7011.1011.543.56
234349-3434911.35911.91
335141-3514111.62112.15
433242-3324210.99311.54
532284-3228410.67611.21
632737-3273710.82611.36
极限132963-3296310.90111.163.1011.5411.823.01
234874-3487411.53312.21
335154-3515411.62512.28
433676-3367611.13611.81
533156-3315610.96511.61
632638-3263810.79311.44
贝派度酸依折麦布片项目信息
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2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.241151373115141111517731151687115199111516470.03
211.241134657113515211349040.04
单位质量响应值RSD%判断
102459.70100970.111.04数据可信
供试品溶液-1993854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%
5min162949-629495.5525.546.855.555.546.84
263496-634965.6005.60
369629-696296.1416.14
458534-585345.1625.16
557808-578085.0985.10
664192-641925.6615.66
10min183438-834387.3597.412.027.427.472.06
282338-823387.2627.32
386527-865277.6317.70
485425-854257.5347.59
582294-822947.2587.31
683992-839927.4087.47
15min189883-898837.9277.831.418.077.971.39
286827-868277.6587.80
389634-896347.9058.06
489471-894717.8918.03
589049-890497.8547.99
687549-875497.7217.87
20min190135-901357.9498.031.408.188.261.37
291074-910748.0328.26
391814-918148.0988.34
493031-930318.2058.43
589501-895017.8948.12
690516-905167.9838.21
30min191295-912958.0528.101.398.378.421.27
292320-923208.1428.46
390076-900767.9448.28
493912-939128.2838.60
591932-919328.1088.42
691566-915668.0768.40
45min191940-919408.1098.241.188.528.641.15
293454-934548.2428.65
393779-937798.2718.69
495193-951938.3968.81
593099-930998.2118.61
692770-927708.1828.59
60min189597-895977.9028.232.448.408.732.31
291678-916788.0868.58
393887-938878.2808.79
495435-954358.4178.92
595365-953658.4118.90
693898-938988.2818.78
极限191374-913748.0598.191.478.658.791.42
293459-934598.2438.83
392469-924698.1558.76
494752-947528.3578.96
591469-914698.0678.65
693833-938338.2768.87
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.05 3042153040793042453040153041933041490.04
210.09 3027733024873026300.07
单位质量响应值RSD%判断
30263.5829993.060.64数据可信
供试品溶液-1993854批-贝派度酸-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min14936-49361.6341.653.891.631.654.03
24903-49031.6231.62
35161-51611.7081.71
44814-48141.5931.59
55305-53051.7561.76
64855-48551.6071.61
15min16366-63662.1072.093.392.132.113.36
26135-61352.0312.05
36482-64822.1452.16
46104-61042.0202.04
56645-66452.1992.22
66196-61962.0512.07
20min17144-71442.3652.391.332.412.431.29
27204-72042.3842.43
37251-72512.4002.44
47154-71542.3682.41
57391-73912.4462.49
67144-71442.3652.41
30min18506-85062.8152.741.622.882.811.56
28267-82672.7362.80
38207-82072.7162.79
48261-82612.7342.80
58330-83302.7572.83
68106-81062.6832.75
45min19350-93503.0953.041.333.193.141.26
29195-91953.0433.14
39272-92723.0693.17
49241-92413.0593.16
59131-91313.0223.12
68999-89992.9793.08
60min19472-94723.1353.181.673.273.321.59
29441-94413.1253.26
39605-96053.1793.31
49728-97283.2203.35
59867-98673.2663.40
69588-95883.1743.30
极限110105-101053.3453.312.393.513.482.24
29904-99043.2783.44
39833-98333.2553.42
410122-101223.3503.52
59730-97303.2213.39
610390-103903.4393.60
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