依折麦布片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DJ333-221017对照品来源自制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1000
标示量(mg)10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%
111.083733813738303734743736063741843736950.09
211.033763903761913762900.04
单位质量响应值RSD%判断
33726.9934115.140.81数据可信
供试品溶液-2023122421批-pH1.2盐酸溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min119089-190895.0485.3110.065.055.3110.09
222912-229126.0596.06
321385-213855.6555.66
418809-188094.9744.97
517359-173594.5914.59
620898-208985.5275.53
10min128321-283217.4907.553.447.507.563.42
229957-299577.9227.93
329229-292297.7307.74
428857-288577.6317.64
527336-273367.2297.24
627679-276797.3207.33
15min130965-309658.1898.081.308.218.101.30
231114-311148.2288.25
330351-303518.0268.05
430224-302247.9938.01
530329-303298.0218.04
630231-302317.9958.02
20min131008-310088.2008.113.868.238.143.84
230583-305838.0888.12
331593-315938.3558.39
431509-315098.3338.37
530832-308328.1548.19
628375-283757.5047.54
30min132072-320728.4828.293.088.538.343.03
231699-316998.3838.43
332193-321938.5148.56
431881-318818.4318.48
530396-303968.0388.09
629908-299087.9097.96
45min131703-317038.3848.252.948.458.322.95
231848-318488.4228.49
332280-322808.5378.60
431153-311538.2398.30
530349-303498.0268.09
629922-299227.9137.97
60min131260-312608.2678.383.748.348.453.71
231774-317748.4038.48
332156-321568.5048.58
433718-337188.9178.99
530666-306668.1108.18
630493-304938.0648.14
极限131537-315378.3408.292.948.438.382.92
232137-321378.4998.59
332073-320738.4828.57
431927-319278.4438.53
530195-301957.9858.07
630173-301737.9798.07
依折麦布片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DJ333-221017对照品来源自制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1000
标示量(mg)10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%
111.083777493779343778153781003779033779000.04
211.033796813795413796110.03
单位质量响应值RSD%判断
34106.5034416.230.64数据可信
供试品溶液-2023122421批-醋酸盐缓冲液（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%
5min122746-227465.9554.7118.925.964.7118.93
217776-177764.6544.65
318996-189964.9744.97
412173-121733.1873.19
518533-185334.8524.85
617694-176944.6334.63
10min130574-305748.0057.534.668.017.544.64
228904-289047.5687.58
329793-297937.8017.81
427002-270027.0707.08
528775-287757.5347.54
627534-275347.2097.22
15min130892-308928.0887.873.558.117.893.55
231116-311168.1478.17
330553-305538.0008.02
428990-289907.5907.61
528495-284957.4617.48
630225-302257.9147.93
20min126813-268137.0207.705.847.067.745.81
230693-306938.0368.07
331456-314568.2368.27
428052-280527.3457.37
529586-295867.7467.78
629971-299717.8477.88
30min130651-306518.0258.052.028.078.092.02
231434-314348.2308.28
331304-313048.1968.24
430622-306228.0188.06
530739-307398.0488.09
629690-296907.7747.82
45min131102-311028.1437.766.168.217.826.14
230412-304127.9638.02
331378-313788.2168.28
426517-265176.9437.00
529817-298177.8077.87
628598-285987.4887.55
60min131035-310358.1267.599.818.207.669.68
229247-292477.6587.73
323297-232976.1006.18
430281-302817.9288.00
530094-300947.8797.95
629895-298957.8277.90
极限131421-314218.2278.032.218.328.122.25
230597-305978.0118.10
330899-308998.0908.18
429728-297287.7847.86
531323-313238.2018.29
630075-300757.8747.96
依折麦布片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DJ333-221017对照品来源自制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1000
标示量(mg)10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%
111.083720133722163720823719223720113720490.03
211.033780703781483781090.02
单位质量响应值RSD%判断
33578.4334280.051.47数据可信
供试品溶液-2023122421批-磷酸盐缓冲液（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%
5min114781-147813.9083.4017.003.913.4017.06
210150-101502.6842.68
313062-130623.4543.45
414641-146413.8713.87
514375-143753.8013.80
610149-101492.6842.68
10min127653-276537.3126.795.147.326.805.17
223560-235606.2306.23
325526-255266.7496.76
425824-258246.8286.83
526095-260956.9006.91
625385-253856.7126.72
15min127459-274597.2607.304.437.287.324.44
226425-264256.9877.00
327946-279467.3897.41
428862-288627.6317.65
528992-289927.6667.68
626048-260486.8876.90
20min128031-280317.4127.463.597.447.483.58
228479-284797.5307.56
329505-295057.8017.83
427001-270017.1397.17
529037-290377.6787.71
627123-271237.1727.20
30min126001-260016.8757.374.556.927.414.51
227636-276367.3077.35
328669-286697.5807.62
428221-282217.4627.50
529643-296437.8387.88
627104-271047.1677.21
45min129434-294347.7837.455.537.847.515.50
225887-258876.8456.90
326792-267927.0847.14
428235-282357.4667.52
529882-298827.9017.96
628868-288687.6337.68
60min128405-284057.5117.474.267.587.544.25
226601-266017.0347.10
328221-282217.4627.53
428794-287947.6137.68
530137-301377.9698.04
627451-274517.2587.32
极限127923-279237.3837.372.057.467.442.04
227423-274237.2517.33
327218-272187.1977.28
428502-285027.5367.62
528555-285557.5507.63
627518-275187.2767.35
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