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DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75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%
111.149843579854119851419855769859649852900.07
211.159859269881919870580.17
单位质量响应值RSD%判断
88446.1488525.380.07数据可信
供试品溶液-24091201批-依折麦布-pH4.5SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1566771-56677157.50338.5529.4457.5038.5529.44
2247461-24746125.10725.11
3312683-31268331.72431.72
4335849-33584934.07434.07
5376857-37685738.23538.23
6440225-44022544.66444.66
10min1883754-88375489.66381.629.5190.3082.059.59
2670119-67011967.98868.27
3790707-79070780.22380.58
4782832-78283279.42479.80
5841611-84161185.38785.81
6857871-85787187.03787.53
15min1911087-91108792.43690.092.8894.0791.423.04
2848884-84888486.12587.16
3868146-86814688.08089.32
4890135-89013590.31091.57
5894012-89401290.70492.08
6915429-91542992.87794.34
20min1909414-90941492.26691.142.0094.9393.482.09
2901068-90106891.42093.41
3865210-86521087.78290.00
4893995-89399590.70292.97
5903345-90334591.65194.03
6916812-91681293.01795.51
30min1906483-90648391.96991.341.8495.6694.691.91
2902565-90256591.57294.58
3869226-86922688.18991.39
4899275-89927591.23894.51
5905293-90529391.84895.25
6918617-91861793.20096.73
45min1914795-91479592.81291.221.8797.5295.581.98
2899537-89953791.26495.29
3870736-87073688.34292.52
4891291-89129190.42894.71
5901970-90197091.51195.93
6916198-91619892.95597.52
60min1889712-88971290.26890.592.0996.0195.972.06
2908649-90864992.18997.23
3863905-86390587.64992.81
4881390-88139089.42394.71
5899185-89918591.22996.67
6914483-91448392.78198.38
极限1923749-92374993.72191.722.58100.4698.102.58
2920465-92046593.38899.45
3866488-86648887.91194.04
4886625-88662589.95496.24
5904139-90413991.73198.18
6922476-92247693.592100.22
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%
19.832478682475502475582475262473592475720.08
29.902508342511642509990.10
单位质量响应值RSD%判断
25185.3525353.430.48数据可信
供试品溶液-24091201批-贝派度酸-pH4.5SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min160879-6087924.02516.7827.7424.0216.7827.72
226697-2669710.53510.54
339178-3917815.46115.46
434831-3483113.74513.75
545871-4587118.10218.10
647689-4768918.82018.82
10min1116530-11653045.98641.5010.7946.2541.6910.86
285508-8550833.74433.86
3108895-10889542.97343.15
498324-9832438.80238.95
5111794-11179444.11744.32
6109958-10995843.39343.60
15min1144699-14469957.10354.495.1957.8855.135.28
2125141-12514149.38549.88
3143888-14388856.78357.43
4137111-13711154.10854.69
5140997-14099755.64256.33
6136573-13657353.89654.59
20min1160517-16051763.34562.252.4364.7663.512.55
2151990-15199059.98061.02
3161620-16162063.78065.06
4156795-15679561.87663.06
5160681-16068163.41064.72
6154911-15491161.13362.42
30min1185750-18575073.30373.182.3575.4275.132.37
2180938-18093871.40473.11
3189051-18905174.60676.59
4187648-18764874.05275.92
5189897-18989774.93976.95
6179424-17942470.80672.78
45min1217130-21713085.68682.693.0688.6285.443.11
2202079-20207979.74782.25
3214476-21447684.63987.46
4207532-20753281.89984.59
5213361-21336184.19987.05
6202586-20258679.94782.70
60min1214024-21402484.46186.422.1888.3490.102.10
2218348-21834886.16789.55
3226077-22607789.21792.98
4220965-22096587.20090.81
5221046-22104687.23291.01
6213520-21352084.26287.91
极限1230835-23083591.09591.672.2395.9296.312.15
2232898-23289891.90996.25
3239642-23964294.57099.32
4235663-23566393.00097.57
5230346-23034690.90295.65
6224393-22439388.55393.13
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DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75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%
111.149859579849349849389850709848209851440.05
211.159842189835989839080.05
单位质量响应值RSD%判断
88433.0388242.870.16数据可信
供试品溶液-24091201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%
5min137906-379063.8523.7819.483.853.7819.46
243054-430544.3754.38
343644-436444.4354.44
423774-237742.4162.42
539008-390083.9643.96
635687-356873.6273.63
10min167237-672376.8336.862.556.886.902.64
269325-693257.0457.09
369454-694547.0587.11
465682-656826.6756.70
567668-676686.8776.92
665437-654376.6506.69
15min171007-710077.2167.341.257.337.461.29
272978-729787.4177.54
373351-733517.4547.58
472497-724977.3687.47
572142-721427.3327.45
671423-714237.2587.37
20min172440-724407.3627.491.747.567.691.70
273538-735387.4737.68
375908-759087.7147.92
474295-742957.5507.73
573248-732487.4447.65
672629-726297.3817.58
30min174284-742847.5497.532.967.837.822.82
274621-746217.5837.88
376216-762167.7468.04
475924-759247.7167.98
570165-701657.1317.42
673524-735247.4727.75
45min174079-740797.5287.582.297.897.952.22
274085-740857.5297.91
377254-772547.8518.23
475303-753037.6538.01
574769-747697.5997.96
672081-720817.3257.69
60min174060-740607.5267.550.677.978.000.60
274252-742527.5468.01
374111-741117.5328.00
475238-752387.6468.08
574083-740837.5297.98
673836-738367.5047.94
极限173152-731527.4347.541.687.978.071.66
274480-744807.5698.11
376110-761107.7358.29
474978-749787.6208.14
573082-730827.4277.96
673193-731937.4387.96
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%
19.832474202508852501222503472504022498350.56
29.902478982472782475880.18
单位质量响应值RSD%判断
25415.5625008.891.15数据可信
供试品溶液-24091201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%
5min12298-22980.9091.1057.390.911.1057.40
24681-46811.8521.85
33767-37671.4901.49
4-0.0000.00
53094-30941.2241.22
62792-27921.1041.10
10min15774-57742.2842.509.652.292.519.78
26897-68972.7282.75
37198-71982.8472.86
45880-58802.3262.33
56356-63562.5142.53
65810-58102.2982.31
15min17181-71812.8403.3518.452.883.3918.33
29233-92333.6523.70
311287-112874.4654.51
47512-75122.9713.00
57575-75752.9963.04
67964-79643.1503.19
20min17695-76953.0443.4911.733.113.5711.84
29855-98553.8983.99
310116-101164.0014.10
47962-79623.1493.21
58142-81423.2213.30
69211-92113.6433.72
30min18658-86583.4253.9216.793.534.0416.61
210068-100683.9824.12
312665-126655.0105.15
48980-89803.5523.65
510923-109234.3214.43
68239-82393.2593.37
45min19238-92383.6543.703.613.793.863.89
29189-91893.6353.81
39983-99833.9494.15
49451-94513.7383.87
59152-91523.6203.78
69072-90723.5883.74
60min19145-91453.6173.622.683.803.822.83
29373-93733.7073.93
39154-91543.6213.86
49121-91213.6083.78
59408-94083.7213.92
68722-87223.4503.64
极限19394-93943.7163.927.103.944.167.02
29402-94023.7193.98
310909-109094.3154.60
49934-99343.9294.14
510604-106044.1944.43
69225-92253.6493.88
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DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75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%
111.149839429842919836559837009833349837840.04
211.159849039844579846800.04
单位质量响应值RSD%判断
88310.9588312.110.01数据可信
供试品溶液-24091201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%
5min158440-584405.9415.229.955.945.229.98
251160-511605.2015.20
355864-558645.6795.68
446959-469594.7744.77
545072-450724.5824.58
650388-503885.1225.12
10min172456-724567.3667.201.757.437.261.79
270950-709507.2137.27
372162-721627.3367.40
470065-700657.1237.18
569318-693187.0477.10
670241-702417.1417.20
15min173355-733557.4577.441.277.607.581.25
274870-748707.6117.75
372535-725357.3747.52
473451-734517.4677.60
572517-725177.3727.50
672497-724977.3707.51
20min174051-740517.5287.521.357.767.741.32
275608-756087.6867.91
373186-731867.4407.67
474284-742847.5527.77
574169-741697.5407.75
672736-727367.3947.61
30min173931-739317.5167.371.387.837.681.36
272916-729167.4127.72
371628-716287.2817.59
471684-716847.2877.59
573196-731967.4417.74
671587-715877.2777.58
45min172852-728527.4067.440.767.807.820.72
274102-741027.5337.92
373018-730187.4237.81
473334-733347.4557.83
573437-734377.4657.84
672495-724957.3707.75
60min173160-731607.4377.491.507.927.961.40
274276-742767.5518.02
374325-743257.5568.03
472662-726627.3877.85
575169-751697.6418.10
672354-723547.3557.82
极限173435-734357.4657.531.028.038.080.97
274794-747947.6038.16
374761-747617.6008.16
473980-739807.5218.07
574320-743207.5558.10
672907-729077.4127.96
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%
19.832478592482862487992479792484332482710.16
29.902477522474932476220.08
单位质量响应值RSD%判断
25256.4625012.320.69数据可信
供试品溶液-24091201批-贝派度酸-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%
5min18465-84653.3592.9524.693.362.9624.63
26845-68452.7162.72
38571-85713.4013.40
46091-60912.4172.42
54852-48521.9251.93
69821-98213.8973.90
10min114056-140565.5775.438.235.615.468.27
215045-150455.9696.00
314270-142705.6625.70
413006-130065.1605.19
511819-118194.6894.71
613922-139225.5245.57
15min120564-205648.1596.5613.548.266.6613.45
217523-175236.9527.05
315309-153096.0746.17
415354-153546.0926.18
514352-143525.6945.77
616114-161146.3936.50
20min116174-161746.4176.422.536.616.592.55
216872-168726.6946.87
316344-163446.4856.65
415806-158066.2716.42
516198-161986.4276.56
615743-157436.2466.42
30min117188-171886.8196.736.277.086.976.13
216364-163646.4936.74
319003-190037.5407.78
416099-160996.3876.61
516683-166836.6196.83
616458-164586.5306.77
45min119414-194147.7037.126.438.047.436.38
217040-170406.7617.08
319413-194137.7028.03
417394-173946.9017.19
517091-170916.7817.06
617250-172506.8447.16
60min117901-179017.1027.112.497.527.502.38
217712-177127.0277.42
317883-178837.0957.50
418639-186397.3957.76
517296-172966.8627.22
618110-181107.1857.58
极限118410-184107.3047.131.877.817.601.79
217720-177207.0317.50
317825-178257.0727.56
417973-179737.1317.58
518308-183087.2647.70
617555-175556.9657.44
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DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75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%
111.149828569828079830839821169825629826850.04
211.159875369878249876800.03
单位质量响应值RSD%判断
88212.3088581.170.30数据可信
供试品溶液-24091201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%
5min140467-404674.1104.699.844.114.699.85
248103-481034.8854.89
350535-505355.1325.13
442964-429644.3634.36
551619-516195.2425.24
643343-433434.4024.40
10min165599-655996.6626.751.536.716.801.53
265258-652586.6286.68
366721-667216.7766.83
467873-678736.8936.94
567355-673556.8416.90
666178-661786.7216.77
15min168400-684006.9476.912.057.077.041.98
268950-689507.0037.13
368993-689937.0077.14
469168-691687.0257.15
565637-656376.6666.80
667170-671706.8226.95
20min169205-692057.0287.143.187.237.343.11
269356-693567.0447.25
371461-714617.2587.47
474287-742877.5457.75
568648-686486.9727.18
668649-686496.9727.17
30min195649-956499.7149.0119.079.999.2918.47
270218-702187.1317.42
392073-920739.3519.64
4114834-11483411.66211.95
570116-701167.1217.41
689213-892139.0609.34
45min1101879-10187910.3479.8923.3210.7310.2722.62
270940-709407.2057.57
3102018-10201810.36110.76
4133984-13398413.60714.02
575288-752887.6468.01
699924-9992410.14810.53
60min1102926-10292610.45311.9622.8610.9512.4622.27
284636-846368.5969.04
3147208-14720814.95015.46
4153429-15342915.58216.15
5105799-10579910.74511.19
6112847-11284711.46111.95
极限1145398-14539814.76718.6017.0815.3819.2216.76
2150405-15040515.27515.81
3219209-21920922.26322.94
4205477-20547720.86821.61
5205286-20528620.84921.42
6172964-17296417.56618.18
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%
19.832475762470362473782470732471942472510.10
29.902493012486092489550.20
单位质量响应值RSD%判断
25152.7025146.970.02数据可信
供试品溶液-24091201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%
5min165980-6598026.16132.4619.2126.1632.4619.21
285749-8574934.00034.00
397556-9755638.68138.68
471785-7178528.46328.46
5102381-10238140.59440.59
667732-6773226.85626.86
10min1166398-16639865.97770.064.3066.2770.424.35
2173511-17351168.79869.18
3180765-18076571.67472.10
4176247-17624769.88370.20
5188911-18891174.90475.35
6174382-17438269.14369.44
15min1204804-20480481.20683.482.0682.2384.622.13
2207683-20768382.34783.49
3213462-21346284.63885.86
4212648-21264884.31685.41
5216391-21639185.80087.08
6208293-20829382.58983.66
20min1220700-22070087.50890.261.8689.4392.321.93
2227300-22730090.12592.18
3229057-22905790.82292.99
4226633-22663389.86191.89
5233768-23376892.69094.93
6228349-22834990.54192.53
30min1236022-23602293.58494.561.0296.4897.621.06
2236282-23628293.68796.75
3237032-23703293.98497.16
4240314-24031495.28598.31
5241972-24197295.94399.21
6239219-23921994.85197.84
45min1239897-23989795.12095.541.8099.0699.661.78
2232854-23285492.32796.43
3243052-24305296.371100.59
4241392-24139295.71399.80
5244527-24452796.956101.29
6243982-24398296.740100.78
60min1242582-24258296.18596.321.34101.18101.501.34
2236750-23675093.87299.00
3244002-24400296.748102.04
4244545-24454596.963102.11
5246051-24605197.560102.97
6243557-24355796.571101.69
极限1244148-24414896.80696.411.84102.87102.661.79
2235671-23567193.44499.61
3241816-24181695.881102.25
4241991-24199195.950102.18
5247932-24793298.306104.80
6247284-24728498.049104.24
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DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75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%
111.149852299851279849059853129850119851170.02
211.159858359854789856560.03
单位质量响应值RSD%判断
88430.6188399.640.03数据可信
供试品溶液-24091201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%
5min147528-475284.8264.1020.154.834.1020.21
229770-297703.0233.02
348443-484434.9194.92
431544-315443.2033.20
539744-397444.0364.04
645257-452574.5954.60
10min163962-639626.4956.553.696.556.603.73
263691-636916.4676.50
363668-636686.4656.52
461260-612606.2206.26
567376-673766.8416.89
667323-673236.8366.89
15min167274-672746.8316.910.826.967.030.78
268771-687716.9837.09
367924-679246.8977.02
467642-676426.8686.97
568513-685136.9577.08
668050-680506.9107.04
20min167161-671616.8196.931.927.027.131.86
269318-693187.0387.22
367028-670286.8067.01
467213-672136.8257.01
569019-690197.0087.21
669994-699947.1077.31
30min168296-682966.9358.0319.277.218.3018.68
282638-826388.3918.65
370024-700247.1107.39
467288-672886.8327.09
578699-786997.9918.27
6107551-10755110.92111.20
45min174779-747797.5938.6920.607.959.0619.92
2111107-11110711.28211.64
374459-744597.5607.92
467780-677806.8827.22
581750-817508.3018.67
6103748-10374810.53410.94
60min1103554-10355410.51510.3118.5810.9510.7718.08
2122882-12288212.47712.96
3103513-10351310.51110.95
472579-725797.3707.78
588146-881468.9509.41
6118826-11882612.06512.59
极限1165634-16563416.81813.4621.1417.3714.0320.55
2153086-15308615.54416.16
3116672-11667211.84712.41
497859-978599.93610.43
5109183-10918311.08611.64
6152676-15267615.50216.16
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%
19.832479532483542489562482842482842483660.15
29.902486892481642484260.15
单位质量响应值RSD%判断
25266.1225093.540.49数据可信
供试品溶液-24091201批-贝派度酸-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%
5min1122236-12223648.41037.4630.8948.4137.4630.89
260123-6012323.81123.81
3128881-12888151.04251.04
465989-6598926.13426.13
582515-8251532.67932.68
6107800-10780042.69342.69
10min1216540-21654085.75878.6711.3786.3079.0911.46
2171102-17110267.76368.03
3215292-21529285.26385.83
4169570-16957067.15667.45
5202577-20257780.22880.59
6216849-21684985.88086.35
15min1242750-24275096.13891.985.1997.6393.285.36
2218040-21804086.35287.37
3244869-24486996.97798.49
4218019-21801986.34387.38
5230647-23064791.34492.60
6239261-23926194.75696.18
20min1246052-24605297.44595.163.42100.0097.473.60
2227782-22778290.21092.19
3244532-24453296.84399.44
4232127-23212791.93193.93
5243747-24374796.53398.80
6247452-24745298.000100.48
30min1247743-24774398.11596.642.65101.76100.012.85
2233115-23311592.32295.30
3251441-25144199.580103.25
4240359-24035995.19198.21
5245150-24515097.088100.43
6246285-24628597.538101.11
45min1249663-24966398.87696.421.71103.61100.861.77
2237963-23796394.24298.25
3242691-24269196.114100.89
4246803-24680397.743101.82
5242176-24217695.910100.33
6241490-24149095.639100.29
60min1246643-24664397.67996.861.85103.51102.382.00
2236333-23633393.59698.65
3247922-24792298.186104.03
4246834-24683497.755102.92
5242265-24226595.946101.43
6247441-24744197.996103.71
极限1249949-24994998.98997.052.43105.90103.642.31
2239046-23904694.671100.76
3240799-24079995.365102.30
4253923-253923100.563106.81
5240749-24074995.345101.90
6245808-24580897.349104.15
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