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%
110.989461649468829472499468699469119468150.05
210.959462339458959460640.03
单位质量响应值RSD%判断
86230.8786398.540.14数据可信
供试品溶液-24123101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%
5min182251-822518.55510.4858.438.5510.4758.45
271851-718517.4737.47
3219695-21969522.85022.85
486623-866239.0109.01
579931-799318.3148.31
663932-639326.6506.65
10min1278681-27868128.98532.9223.9429.0833.0424.05
2268596-26859627.93628.02
3460809-46080947.92848.18
4339405-33940535.30135.40
5288448-28844830.00130.09
6263221-26322127.37727.45
15min1387315-38731540.28443.3210.8340.7043.8010.98
2379466-37946639.46839.86
3468794-46879448.75949.55
4479709-47970949.89450.39
5392187-39218740.79141.22
6391614-39161440.73141.11
20min1435155-43515545.26045.866.6446.1246.836.88
2418142-41814243.49144.32
3485070-48507050.45251.78
4466766-46676648.54849.59
5408971-40897142.53743.42
6431650-43165044.89545.73
30min1429078-42907844.62846.704.9046.0048.175.13
2421973-42197343.88945.20
3471965-47196549.08950.98
4476435-47643549.55451.14
5447903-44790346.58647.94
6446478-44647846.43847.77
45min1435087-43508745.25347.043.5447.1249.043.79
2434955-43495545.23947.04
3466237-46623748.49350.93
4474177-47417749.31951.46
5450128-45012846.81748.69
6453160-45316047.13348.98
60min1431407-43140744.87047.073.1047.2449.593.31
2442603-44260346.03548.34
3461601-46160148.01150.98
4470687-47068748.95651.64
5451704-45170446.98149.37
6457582-45758247.59349.96
极限1448361-44836146.63448.231.9949.5051.262.17
2466174-46617448.48651.30
3465558-46555848.42251.93
4476940-47694049.60652.83
5462327-46232748.08651.00
6462666-46266648.12151.02
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%
19.992486832487022485142486492482522485600.08
29.932497882483682490780.41
单位质量响应值RSD%判断
24880.8825083.380.58数据可信
供试品溶液-24123101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%
5min120736-207368.27710.0962.968.2810.0962.94
217945-179457.1637.16
357150-5715022.81322.81
420689-206898.2588.26
521873-218738.7318.73
613294-132945.3075.31
10min180083-8008331.96735.6825.6432.0635.7925.75
276275-7627530.44730.53
3132634-13263452.94453.20
496244-9624438.41838.51
581190-8119032.40932.51
669859-6985927.88627.94
15min1126777-12677750.60653.6011.7951.0554.1111.97
2121790-12179048.61549.03
3159544-15954463.68564.53
4148136-14813659.13259.65
5128352-12835251.23551.69
6121079-12107948.33148.70
20min1160997-16099764.26563.737.8265.2764.838.03
2151375-15137560.42561.38
3181890-18189072.60574.15
4163989-16398965.46066.64
5148969-14896959.46460.49
6150661-15066160.14061.05
30min1179598-17959871.69073.544.3173.4175.354.56
2175543-17554370.07271.70
3196279-19627978.34980.71
4189722-18972275.73277.63
5186227-18622774.33776.02
6178000-17800071.05372.63
45min1201526-20152680.44481.822.4082.9684.452.65
2199434-19943479.60882.02
3211868-21186884.57287.80
4207746-20774682.92685.67
5207997-20799783.02785.54
6201319-20131980.36182.72
60min1208767-20876783.33485.751.6486.7589.291.77
2212697-21269784.90388.20
3217911-21791186.98491.15
4215556-21555686.04489.71
5217585-21758586.85490.29
6216453-21645386.40289.66
极限1221231-22123188.30990.301.1892.6594.791.28
2228445-22844591.18995.42
3228433-22843391.18496.32
4225727-22572790.10494.73
5226595-22659590.45094.85
6226860-22686090.55694.77
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%
110.989451269454319455839454399450879453330.03
210.959465929463729464820.02
单位质量响应值RSD%判断
86095.9086436.710.28数据可信
供试品溶液-24123101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%
5min125672-256722.6722.2938.892.672.2938.98
29742-97421.0141.01
326769-267692.7862.79
433840-338403.5223.52
520438-204382.1272.13
615806-158061.6451.64
10min161707-617076.4226.216.196.456.246.31
255571-555715.7835.79
362280-622806.4816.51
463820-638206.6426.68
560075-600756.2526.28
654857-548575.7095.73
15min167908-679087.0677.161.387.177.261.49
268587-685877.1387.21
370081-700817.2937.40
469499-694997.2337.35
569046-690467.1857.28
667600-676007.0357.12
20min168192-681927.0977.261.467.287.431.40
269655-696557.2497.40
371308-713087.4217.60
469392-693927.2217.41
570005-700057.2857.46
670074-700747.2927.45
30min167398-673987.0147.131.197.277.391.07
269375-693757.2207.46
368542-685427.1337.40
468561-685617.1357.41
567940-679407.0707.32
669510-695107.2347.47
45min168976-689767.1787.281.697.517.611.51
271583-715837.4497.77
368833-688337.1637.51
469864-698647.2717.62
569100-691007.1917.52
671119-711197.4017.72
60min169472-694727.2307.331.747.657.741.64
271508-715087.4427.84
369951-699517.2807.70
471580-715807.4497.88
568708-687087.1507.56
671347-713477.4257.83
极限166335-663356.9037.363.187.407.852.95
272365-723657.5318.01
370849-708497.3737.88
471105-711057.4007.92
570959-709597.3857.88
672459-724597.5418.03
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%
19.992481882484862482152477412485312482320.13
29.932483992485022484500.03
单位质量响应值RSD%判断
24848.0525020.140.49数据可信
供试品溶液-24123101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%
5min14212-42121.6851.2455.061.681.2455.00
2-0.0000.00
33490-34901.3961.40
44545-45451.8181.82
53993-39931.5971.60
62318-23180.9270.93
10min18430-84303.3713.269.273.393.279.35
27949-79493.1793.18
38806-88063.5223.54
47733-77333.0933.11
58977-89773.5903.61
66951-69512.7802.79
15min19383-93833.7533.948.053.813.998.02
29776-97763.9103.95
310694-106944.2774.33
49001-90013.6003.65
510967-109674.3864.44
69352-93523.7403.78
20min19197-91973.6783.766.183.783.856.16
29692-96923.8763.95
39746-97463.8984.00
48861-88613.5443.64
510211-102114.0844.19
68701-87013.4803.56
30min19500-95003.7993.796.813.943.936.75
29965-99653.9854.11
38966-89663.5863.73
49020-90203.6073.74
510514-105144.2054.36
68931-89313.5723.69
45min19706-97063.8823.927.404.064.097.26
210500-105004.1994.37
39093-90933.6373.82
49196-91963.6783.85
510847-108474.3384.54
69393-93933.7573.92
60min19951-99513.9803.995.454.204.215.29
210137-101374.0544.27
39279-92793.7113.94
49530-95303.8114.03
510833-108334.3334.58
610144-101444.0574.26
极限19456-94563.7823.9510.404.054.2210.06
210496-104964.1984.46
39240-92403.6953.96
49207-92073.6823.94
511718-117184.6864.98
69189-91893.6753.92
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%
110.989467059470349469079468159468119468540.02
210.959449229454009451610.04
单位质量响应值RSD%判断
86234.4386316.070.07数据可信
供试品溶液-24123101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%
5min141122-411224.2793.1528.014.283.1528.06
223394-233942.4342.43
337426-374263.8943.89
429206-292063.0393.04
532080-320803.3383.34
618485-184851.9231.92
10min165284-652846.7936.556.326.846.596.41
258414-584146.0786.11
366052-660526.8736.92
466103-661036.8786.91
564486-644866.7106.75
657368-573685.9705.99
15min167896-678967.0657.251.987.197.362.00
269275-692757.2097.30
369900-699007.2747.39
471091-710917.3977.51
571277-712777.4177.53
668427-684277.1207.21
20min168054-680547.0817.312.027.287.501.98
271694-716947.4607.63
370807-708077.3687.57
470900-709007.3787.57
571229-712297.4127.61
669064-690647.1877.35
30min164808-648086.7447.022.647.027.292.50
270143-701437.2997.56
366649-666496.9357.22
468075-680757.0847.36
568076-680767.0847.36
667037-670376.9767.22
45min164180-641806.6787.073.087.037.422.93
270054-700547.2907.63
367985-679857.0747.43
469253-692537.2067.56
568990-689907.1797.53
667294-672947.0027.33
60min165667-656676.8337.132.847.267.562.62
271640-716407.4557.87
368122-681227.0897.53
469162-691627.1977.63
567879-678797.0637.50
668717-687177.1507.55
极限166312-663126.9007.123.227.417.632.93
272573-725737.5528.05
366980-669806.9707.49
468314-683147.1097.62
567858-678587.0617.57
668668-686687.1457.63
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%
19.992486552484382485412481362483702484280.08
29.932476982480732478860.11
单位质量响应值RSD%判断
24867.6724963.340.28数据可信
供试品溶液-24123101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%
5min110781-107814.3153.4322.344.313.4322.37
26681-66812.6742.67
310215-102154.0884.09
47970-79703.1903.19
59630-96303.8543.85
66181-61812.4742.47
10min119077-190777.6356.499.257.686.529.30
215198-151986.0836.11
316373-163736.5536.60
416020-160206.4126.45
515663-156636.2696.31
614932-149325.9766.00
15min117012-170126.8096.962.636.947.072.65
216757-167576.7076.80
317803-178037.1257.24
417564-175647.0307.14
517933-179337.1777.29
617308-173086.9277.02
20min117501-175017.0047.112.187.217.302.19
217412-174126.9697.14
317896-178967.1637.36
418011-180117.2097.39
518381-183817.3577.55
617456-174566.9867.16
30min116744-167446.7026.993.336.997.263.17
217309-173096.9287.18
317214-172146.8907.17
417476-174766.9947.26
518499-184997.4047.68
617583-175837.0377.29
45min117136-171366.8587.122.127.227.462.03
217708-177087.0877.41
318177-181777.2757.63
417987-179877.1997.54
518037-180377.2197.58
617653-176537.0657.39
60min117638-176387.0597.263.497.507.693.15
218042-180427.2217.63
318031-180317.2177.65
418993-189937.6028.02
517392-173926.9617.40
618798-187987.5247.93
极限118531-185317.4177.202.237.937.702.04
218333-183337.3377.82
317869-178697.1527.67
417449-174496.9847.49
517707-177077.0877.60
618060-180607.2287.72
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%
110.989416999420809416229420779410889417130.05
210.959479769478529479140.01
单位质量响应值RSD%判断
85766.2186567.490.66数据可信
供试品溶液-24123101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%
5min128340-283402.9532.5822.332.952.5822.32
231433-314333.2753.27
328864-288643.0073.01
421335-213352.2232.22
520744-207442.1612.16
617661-176611.8401.84
10min158664-586646.1126.057.066.146.087.12
261761-617616.4356.47
362543-625436.5166.55
456578-565785.8955.92
557837-578376.0266.05
651155-511555.3305.35
15min164963-649636.7686.842.996.876.943.08
266511-665116.9307.04
367287-672877.0117.12
465642-656426.8396.93
567517-675177.0357.13
662204-622046.4816.56
20min166278-662786.9056.921.657.087.091.74
266607-666076.9407.12
367607-676077.0447.23
466882-668826.9687.13
566673-666736.9477.12
664370-643706.7076.86
30min161865-618656.4466.541.846.706.791.78
264101-641016.6796.94
362995-629956.5636.83
460980-609806.3536.60
563001-630016.5646.81
663617-636176.6286.85
45min162179-621796.4786.682.136.807.002.07
264360-643606.7067.04
365827-658276.8587.19
462793-627936.5426.86
564882-648826.7607.08
664551-645516.7267.03
60min162082-620826.4686.732.456.867.132.25
264688-646886.7407.15
364207-642076.6907.10
465001-650016.7727.16
564726-647266.7447.14
667011-670116.9827.36
极限161802-618026.4396.601.736.917.071.73
264854-648546.7577.24
363574-635746.6247.11
463040-630406.5687.03
564080-640806.6767.15
662534-625346.5156.97
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%
19.992468002473142471042467482466882469310.11
29.932491642488672490160.09
单位质量响应值RSD%判断
24717.8225077.141.03数据可信
供试品溶液-24123101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%
5min169223-6922327.72724.6222.2627.7324.6222.26
276380-7638030.59430.59
375077-7507730.07230.07
452343-5234320.96620.97
550711-5071120.31220.31
645066-4506618.05118.05
10min1183980-18398073.69268.1412.1274.0068.4212.16
2187084-18708474.93575.28
3187935-18793575.27675.61
4164802-16480266.01066.24
5161951-16195164.86865.09
6135015-13501554.07954.28
15min1220817-22081788.44786.306.8589.5787.336.89
2225156-22515690.18591.36
3220109-22010988.16389.33
4212581-21258185.14886.11
5226906-22690690.88691.83
6187134-18713474.95575.76
20min1234480-23448093.91990.604.8096.0392.584.91
2235166-23516694.19496.37
3233093-23309393.36495.51
4226564-22656490.74992.66
5220579-22057988.35190.31
6207219-20721983.00084.63
30min1239767-23976796.03792.173.9399.1995.174.04
2239779-23977996.04299.26
3232079-23207992.95896.15
4228914-22891491.69094.61
5222641-22264189.17792.12
6217494-21749487.11689.67
45min1238914-23891495.69595.052.1199.9299.072.28
2239884-23988496.084100.37
3244744-24474498.031102.25
4236100-23610094.56898.51
5233398-23339893.48697.41
6230748-23074892.42595.95
60min1238528-23852895.54196.251.25100.82101.331.12
2240867-24086796.478101.83
3240183-24018396.204101.51
4243133-24313397.385102.38
5235536-23553694.34299.31
6243564-24356497.558102.11
极限1239980-23998096.12296.131.36102.47102.281.47
2238223-23822395.419101.85
3243941-24394197.709104.09
4242080-24208096.964103.04
5241121-24112196.579102.60
6234647-23464793.98699.62
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