熊去氧胆酸颗粒项目信息
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110755-202306对照品来源自制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200
标示量(mg)50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%
111.195394853689539845400453763538780.27
211.265397954372541760.52
单位质量响应值RSD%判断
4814.834811.370.06数据可信
供试品溶液-01批-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%
5min141095-4109576.53677.645.7076.5477.645.70
240457-4045775.34875.35
341829-4182977.90377.90
439457-3945773.48573.49
541034-4103476.42276.42
646256-4625686.14886.15
10min148859-4885990.99690.682.3091.1290.812.30
247558-4755888.57388.70
347898-4789889.20689.34
447996-4799689.38989.51
549264-4926491.75091.88
650560-5056094.16494.31
15min150406-5040693.87794.791.4094.1695.081.40
250616-5061694.26894.54
349998-4999893.11793.40
451178-5117895.31595.59
551192-5119295.34195.62
651998-5199896.84297.14
20min151176-5117695.31196.420.8995.7596.850.89
251346-5134695.62896.06
351578-5157896.06096.49
452232-5223297.27897.71
552165-5216597.15397.59
652116-5211697.06297.52
30min151722-5172296.32897.150.6696.9297.750.65
252215-5221597.24697.84
351983-5198396.81497.41
452687-5268798.12598.72
552381-5238197.55598.16
651989-5198996.82597.45
45min151524-5152495.95996.870.7596.7197.630.74
252354-5235497.50598.26
351639-5163996.17396.93
452514-5251497.80398.56
552040-5204096.92097.68
652000-5200096.84697.63
60min151347-5134795.63097.001.4996.5497.921.48
252521-5252197.81698.73
351580-5158096.06396.98
452680-5268098.11299.03
553090-5309098.87699.80
651279-5127995.50396.45
极限151533-5153395.97697.100.7797.0598.180.76
252601-5260197.96599.04
351854-5185496.57497.65
452482-5248297.74398.83
552107-5210797.04598.13
652248-5224897.30898.41
熊去氧胆酸颗粒项目信息
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110755-202306对照品来源自制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200
标示量(mg)50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%
111.195445555201550895518055189550230.59
211.265405254699543760.85
单位质量响应值RSD%判断
4917.164829.131.28数据可信
供试品溶液-01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%
5min14004-40047.3668.3213.657.378.3213.65
25378-53789.8939.89
34914-49149.0409.04
43710-37106.8256.82
54359-43598.0198.02
64779-47798.7928.79
10min14081-40817.5078.9220.467.528.9420.44
25742-574210.56310.58
36442-644211.85111.87
44362-43628.0248.04
54263-42637.8427.86
64205-42057.7367.75
15min14261-42617.8398.108.217.868.128.22
24306-43067.9217.96
35032-50329.2579.29
44607-46078.4758.50
54080-40807.5067.53
64118-41187.5767.60
20min14290-42907.8928.046.147.938.086.14
24132-41327.6017.65
34814-48148.8568.91
44086-40867.5177.56
54505-45058.2878.33
64384-43848.0658.11
30min14160-41607.6538.035.587.708.085.57
24023-40237.4017.46
34651-46518.5568.62
44478-44788.2388.29
54308-43087.9257.98
64564-45648.3968.45
45min14317-43177.9428.308.118.018.378.07
24151-41517.6367.71
35193-51939.5539.63
44498-44988.2758.34
54332-43327.9698.04
64575-45758.4168.48
60min14437-44378.1628.093.428.248.173.39
24274-42747.8637.95
34512-45128.3008.40
44450-44508.1868.27
54547-45478.3658.44
64157-41577.6477.73
极限14346-43467.9957.993.138.098.093.13
24609-46098.4798.58
34318-43187.9438.05
44244-42447.8077.90
54308-43087.9258.02
64244-42447.8077.90
熊去氧胆酸颗粒项目信息
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110755-202306对照品来源自制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200
标示量(mg)50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%
111.195392054905547705433854316544500.73
211.265425554721544880.61
单位质量响应值RSD%判断
4865.954839.080.40数据可信
供试品溶液-01批-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%
5min1876-8761.6181.1256.891.621.1256.83
2618-6181.1421.14
3589-5891.0881.09
4-0.0000.00
51003-10031.8531.85
6567-5671.0471.05
10min1886-8861.6371.2828.371.641.2828.23
2562-5621.0381.04
3975-9751.8011.80
4507-5070.9370.94
5704-7041.3011.30
6533-5330.9850.99
15min1942-9421.7401.4320.961.751.4421.13
2696-6961.2861.29
3645-6451.1921.20
4613-6131.1321.13
51007-10071.8601.87
6746-7461.3781.38
20min11108-11082.0471.7018.562.061.7118.65
2904-9041.6701.68
3659-6591.2171.22
4816-8161.5071.51
5947-9471.7491.76
61095-10952.0232.03
30min11380-13802.5491.9417.822.561.9517.87
2929-9291.7161.72
3987-9871.8231.83
4852-8521.5741.58
51142-11422.1102.12
61024-10241.8921.90
45min11427-14272.6362.439.232.652.449.31
21303-13032.4072.42
31437-14372.6552.67
41160-11602.1432.15
51390-13902.5682.58
61186-11862.1912.20
60min11663-16633.0722.777.173.092.787.21
21598-15982.9522.97
31431-14312.6432.66
41413-14132.6102.62
51485-14852.7432.76
61406-14062.5972.61
极限11940-19403.5843.289.013.613.309.01
21875-18753.4643.48
31654-16543.0553.08
41518-15182.8042.82
51870-18703.4543.48
61808-18083.3403.36
熊去氧胆酸颗粒项目信息
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110755-202306对照品来源自制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200
标示量(mg)50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%
111.195396054436548455445654632544660.61
211.265451954736546280.29
单位质量响应值RSD%判断
4867.384851.510.24数据可信
供试品溶液-J227批-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%
5min142486-4248678.37284.353.6678.3784.353.66
246429-4642985.64685.65
345814-4581484.51184.51
445740-4574084.37584.37
546921-4692186.55386.55
646968-4696886.64086.64
10min148033-4803388.60591.961.9388.7492.101.93
250247-5024792.68992.83
349960-4996092.15992.30
449696-4969691.67291.81
550612-5061293.36293.51
650562-5056293.27093.41
15min150011-5001192.25394.061.3592.5394.361.36
250846-5084693.79494.09
351392-5139294.80195.10
450520-5052093.19293.49
551212-5121294.46994.77
651966-5196695.86096.16
20min150417-5041793.00294.071.6093.4394.521.60
251299-5129994.62995.08
349833-4983391.92592.38
451091-5109194.24694.69
551108-5110894.27794.73
652220-5222096.32896.79
30min150714-5071493.55095.611.5994.1496.221.59
251490-5149094.98295.59
352539-5253996.91797.52
451706-5170695.38095.99
551525-5152595.04695.66
653010-5301097.78598.41
45min151236-5123694.51396.571.7395.2697.341.73
251671-5167195.31596.08
353308-5330898.33599.10
452614-5261497.05597.82
551850-5185095.64696.42
653428-5342898.55699.34
60min151760-5176095.48096.771.7296.3897.701.71
251527-5152795.05095.98
353311-5331198.34199.27
452741-5274197.28998.22
551765-5176595.48996.42
653641-5364198.94999.90
极限153570-5357098.81897.860.8999.8898.950.88
252949-5294997.67398.76
352630-5263097.08498.18
452428-5242896.71297.80
553161-5316198.06499.16
653558-5355898.79699.91
熊去氧胆酸颗粒项目信息
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110755-202306对照品来源自制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200
标示量(mg)50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%
111.195358154525537145417154038540060.70
211.265467754500545880.23
单位质量响应值RSD%判断
4826.274847.960.32数据可信
供试品溶液-J227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%
5min14456-44568.2588.412.328.268.422.32
24557-45578.4458.44
34463-44638.2718.27
44483-44838.3088.31
54736-47368.7778.78
64547-45478.4268.43
10min14789-47898.8758.853.378.898.863.37
24798-47988.8928.91
34637-46378.5938.61
44651-46518.6198.63
55071-50719.3979.41
64693-46938.6978.71
15min14779-47798.8569.001.898.889.031.89
24929-49299.1349.16
34767-47678.8348.86
44927-49279.1319.16
54965-49659.2019.23
64780-47808.8588.89
20min14670-46708.6548.973.158.709.023.12
24916-49169.1109.15
35077-50779.4099.45
44854-48548.9959.04
54856-48568.9999.04
64684-46848.6808.72
30min14772-47728.8439.011.128.909.071.13
24888-48889.0589.12
34835-48358.9609.02
44927-49279.1319.19
54894-48949.0699.13
64864-48649.0149.07
45min15143-51439.5319.384.749.609.454.69
25512-551210.21510.29
34961-49619.1949.27
44957-49579.1869.26
54867-48679.0199.10
64925-49259.1279.20
60min15029-50299.3209.082.029.419.182.00
24789-47898.8758.97
35017-50179.2979.39
44830-48308.9519.04
54873-48739.0319.12
64873-48739.0319.12
极限14969-49699.2089.189.519.319.289.42
24806-48068.9069.01
35861-586110.86110.97
44782-47828.8628.97
54794-47948.8848.99
64498-44988.3368.44
熊去氧胆酸颗粒项目信息
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110755-202306对照品来源自制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200
标示量(mg)50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%
111.195497954938547605477454552548010.31
211.265495354677548150.36
单位质量响应值RSD%判断
4897.324868.120.43数据可信
供试品溶液-J227批-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%
5min11592-15922.9232.961.602.922.961.67
21587-15872.9142.91
31615-16152.9652.96
41606-16062.9482.95
51632-16322.9963.00
61656-16563.0403.04
10min12246-22464.1234.172.094.134.172.07
22230-22304.0944.10
32350-23504.3144.32
42224-22244.0834.09
52291-22914.2064.21
62276-22764.1784.18
15min12402-24024.4104.511.964.424.521.93
22474-24744.5424.55
32512-25124.6124.62
42389-23894.3864.40
52471-24714.5364.55
62477-24774.5474.56
20min12545-25454.6724.652.604.694.662.57
22463-24634.5224.54
32526-25264.6374.66
42468-24684.5314.55
52537-25374.6584.68
62644-26444.8544.87
30min12538-25384.6594.721.254.694.741.22
22540-25404.6634.69
32603-26034.7794.81
42580-25804.7374.76
52546-25464.6744.70
62607-26074.7864.81
45min12607-26074.7864.771.004.824.801.00
22605-26054.7824.82
32613-26134.7974.83
42571-25714.7204.75
52628-26284.8254.86
62561-25614.7024.74
60min12725-27255.0034.822.275.054.862.27
22629-26294.8274.87
32634-26344.8364.88
42626-26264.8214.86
52541-25414.6654.71
62603-26034.7794.82
极限12881-28815.2894.855.165.344.905.11
22488-24884.5684.62
32623-26234.8164.87
42671-26714.9044.95
52663-26634.8894.94
62539-25394.6614.71
熊去氧胆酸颗粒项目信息
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110755-202306对照品来源自制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200
标示量(mg)50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%
111.195509155118550395512155045550830.08
211.265501355113550630.13
单位质量响应值RSD%判断
4922.524890.140.47数据可信
供试品溶液-02批-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%
5min146646-4664685.22485.025.4285.2285.025.42
243817-4381780.05680.06
346343-4634384.67184.67
445041-4504182.29282.29
546141-4614184.30284.30
651218-5121893.57893.58
10min151539-5153994.16493.851.3994.3194.001.40
250439-5043992.15492.29
352162-5216295.30295.44
450856-5085692.91693.05
551042-5104293.25693.40
652174-5217495.32495.48
15min153209-5320997.21596.530.9597.5196.830.95
252281-5228195.52095.81
353587-5358797.90698.21
452382-5238295.70496.00
552841-5284196.54396.84
652696-5269696.27896.59
20min153709-5370998.12997.080.8398.5997.540.82
252736-5273696.35196.80
353610-5361097.94898.41
452685-5268596.25896.71
553106-5310697.02797.48
652955-5295596.75197.23
30min153898-5389898.47497.370.9699.1097.980.97
252864-5286496.58597.19
353864-5386498.41299.04
452641-5264196.17896.79
553226-5322697.24697.86
653253-5325397.29697.93
45min153749-5374998.20297.170.9198.9997.950.91
252893-5289396.63897.41
353775-5377598.24999.04
452580-5258096.06696.84
553081-5308196.98197.76
653014-5301496.85997.66
60min153734-5373498.17597.521.1099.1398.461.10
253044-5304496.91497.84
353736-5373698.17899.13
452658-5265896.20997.14
554169-5416998.96999.91
652916-5291696.68097.64
极限153755-5375598.21397.070.7099.3398.180.70
252905-5290596.66097.75
353265-5326597.31898.44
452664-5266496.22097.31
553140-5314097.08998.20
653058-5305896.93998.06
熊去氧胆酸颗粒项目信息
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110755-202306对照品来源自制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200
标示量(mg)50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%
111.195552055442553915519655148553390.29
211.265558555468555260.15
单位质量响应值RSD%判断
4945.404931.260.21数据可信
供试品溶液-02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%
5min14409-44098.0037.8810.178.007.8810.20
24416-44168.0168.02
33523-35236.3956.39
44562-45628.2818.28
54303-43037.8117.81
64835-48358.7768.78
10min14635-46358.4138.246.108.438.266.10
24540-45408.2418.25
34019-40197.2957.31
44636-46368.4158.43
54579-45798.3128.32
64844-48448.7938.81
15min14585-45858.3238.173.728.358.193.72
24594-45948.3398.37
34194-41947.6137.64
44438-44388.0568.08
54517-45178.1998.23
64661-46618.4618.49
20min14611-46118.3708.147.988.418.187.95
24247-42477.7097.75
33930-39307.1347.17
44472-44728.1188.16
54684-46848.5028.54
64952-49528.9899.03
30min14506-45068.1798.035.788.238.085.77
24711-47118.5518.61
34044-40447.3417.39
44673-46738.4828.54
54341-43417.8807.93
64268-42687.7477.81
45min15266-52669.5598.539.589.638.609.56
24574-45748.3038.37
34068-40687.3847.44
44948-49488.9829.05
55001-50019.0789.15
64346-43467.8897.96
60min16078-607811.0338.8216.2211.128.9016.11
24332-43327.8637.95
34000-40007.2617.33
44609-46098.3668.45
54600-46008.3508.43
65547-554710.06910.15
极限14903-49038.9008.444.499.008.544.53
24615-46158.3778.47
34302-43027.8097.89
44749-47498.6208.72
54564-45648.2858.38
64768-47688.6558.76
熊去氧胆酸颗粒项目信息
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110755-202306对照品来源自制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200
标示量(mg)50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%
111.195559555637555465564055576555990.08
211.265697456991569820.03
单位质量响应值RSD%判断
4968.635060.571.30数据可信
供试品溶液-02批-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%
5min1779-7791.3930.8179.621.390.8179.63
2527-5270.9420.94
3714-7141.2761.28
4-0.0000.00
5-0.0000.00
6695-6951.2421.24
10min1-0.0000.79110.660.000.79110.62
2-0.0000.00
3837-8371.4961.50
4-0.0000.00
51003-10031.7931.79
6798-7981.4271.43
15min1972-9721.7381.3722.731.741.3822.64
2586-5861.0481.05
3921-9211.6461.65
4607-6071.0851.09
5641-6411.1461.15
6877-8771.5681.57
20min11056-10561.8881.5815.591.891.5815.61
2783-7831.4001.40
3991-9911.7721.78
4702-7021.2551.26
5810-8101.4481.45
6953-9531.7041.71
30min11225-12252.1901.9111.902.201.9212.00
2947-9471.6931.70
31152-11522.0592.07
4894-8941.5981.60
51061-10611.8971.90
61132-11322.0242.03
45min11376-13762.4602.337.792.472.347.86
21274-12742.2782.29
31378-13782.4632.48
41114-11141.9922.00
51304-13042.3312.34
61366-13662.4422.46
60min11544-15442.7602.716.782.782.726.82
21556-15562.7822.79
31508-15082.6962.71
41320-13202.3602.37
51624-16242.9032.92
61530-15302.7352.75
极限11866-18663.3363.253.853.363.273.89
21722-17223.0783.10
31842-18423.2933.32
41736-17363.1033.12
51842-18423.2933.31
61888-18883.3753.40
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