1 / 4
WHAT IS MEAN KINETIC TEMPERATURE?
什么是平均动力学温度？
Mean Kinetic Temperature (MKT) is a simplified way of expressing the overall effect of
temperature fluctuations during storage or transit of perishable goods.
平均动力学温度（MKT）一种简单明了的反应温度波动对不耐久货物在储存和输运时的影
响。
Consider the following example.
参考一下例子：
Example:
例：
A dozen eggs sat:
一打鸡蛋放置在：
In a 20º C room for 2 hours
20℃的房间放置2 小时
In 2º C refrigeration for 4 hours
2℃的冰箱放置4 小时
And on a 25º C loading dock for 1 hour
25℃码头放置1 小时
Using MKT we can calculate that temperature profile of the eggs was “thermally
equivalent” to storing them at 15.7º C for 7 hours.
使用MKT，我们可以计算出上述情况等同于鸡蛋在15.7℃放置7 小时
HOW IS MEAN KINETIC TEMPERATURE CALCULATED?
平均动力学温度怎么计算？
Technically speaking, MKT is an expression of cumulative thermal stress experienced by
a product at varying temperatures during storage and distribution. In other words, MKT
is a calculated, single temperature that is analogous to the effects of temperature
variations over a period of time.
严格的来说，平均动力学温度（MKT）是一种产品在温度不断变化的储存或分销过程中的
累积热效力表现方式。换句话来说，MKT 是用单一温度来近似计算一段时间温度不断变化
2 / 4
的影响。
MKT is not a simple weighted average. The calculation of MKT gives the higher
temperatures a greater weight when computing the average than would a simple
numerical average or an arithmetic mean. This weighting is determined by a geometric
transformation--the natural logarithm of the absolute temperature.
MKT 不是简单的计算平均值， MKT 计算值一般比简单的数值平均值或算术平均值有更高
的加权。这种加权取决于绝对温度自然对数的几何转换。
The International Conference on Harmonization (ICH) stability testing guidelines define
MKT as “a single derived temperature, which, if maintained over a defined period, would
afford the same thermal challenge to a pharmaceutical product as would have been
experienced over a range of both higher and lower temperatures for an equivalent defined
period”.
在人用药物注册技术要求国际协调会（ICH）稳定性测试指南中，定义MKT 为“单一推导温
度，如果在特定的时间，和同时经历较高和较低温度的情况相比，该推导温度可以对药品提
供相同的热挑战”
By using this unequal weighting of the higher temperatures in a temperature series, MKT
takes into consideration the accelerated rate of thermal degradation of materials at these
higher temperatures. Therefore, MKT provides for the non-linear effect of temperature.
在一系列温度中较高温度有着不同的加权，MKT 考虑了物料在较高温度下的热下降加速补
偿。因此，MKT 规定了温度的非线性结果。
yayya (2015-4-11 17:06:32)
MKT is expressed as:
MKT 表达式如下：
Where：
其中：
ΔH = activation energy (typically from 60 to 100 kJ/mol for solids and liquids)
ΔH=活化能量（通常对于固体和液体来说，从60 kj/mol 到100kj/mol）
3 / 4
R = 8.314472 J/mol-K (universal gas constant)
R=8.314472J/mol-K（通用气体常数）
T = temperature in degrees K
T=温度（用K 为单位）
n = the number of sample periods over which data is collected
n=数据搜集数量
Note : ln is the natural log and ex is the natural log base.
注意：ln 是自然对数e 是自然对数的底数
The above equation is valid only when the temperature readings are taken at the same
interval. A more general form for the above equation can be expressed as:
上述的公式只是适用于同样的时间间隔，应用更广泛的公式如下：
Where:
其中：
to are time intervals at each of the sample points
t1 至tn 为相应温度的时间
When = = = , this equation will be reduced to the former equation.
当t1=t2=…=tn 时，该公式和就上面的一致了。
WHY IS MKT IMPORTANT IN THE LIFE OF PHARMACEUTICALS AND PERISHABLE
GOODS?
为什么MKT对于药品和不耐久的货物来说是十分重要的呢？
The pharmaceutical and food industries are two closely regulated markets. The FDA
provides regulations that require warehouse and shipment temperatures to be closely
controlled and monitored. In addition, the FDA requires well-documented verification of
4 / 4
these storage environments and any corrective actions taken if temperatures exceed
specified storage conditions.
食品和药品是两种非常接近的管理市场，FDA 制定了法规要求对参数和运输温度进行严密
监测和控制。另外，FDA 要求归档环境温度确认和任何温度超出规定储存温度的纠正措施。
The calculation of MKT is regarded by the FDA as an action taken to verify if a particular
perishable has exceeded storage conditions.
MKT 计算被FDA 认为是确认某一不耐久物品超出其储存条件的纠正措施。
In addition to compliance with the FDA regulations, MKT can help Distributors and
Manufacturers determine if improper storage or handling of goods, that might have
occurred during shipment and/or unloading, has affected the shelf life of the their product.
除了FDA 的法规要求外，MKT 可以帮助分销商和制造商确定在运输或卸载时错误的储存或
处理物品对产品保存期限的影响。
Other considerations:
其他注意事项：
It can assume activation energy of 83.14472 kJ/mol for its calculation. In fact, any value
between 60 and 100 kJ/mol, which covers most solids and liquids, will have only a small
effect on the final value.
ΔH 可以选用83.14472 kJ/mol 参与计算。事实上，对于固体和液体来说，任何在60 至
100 kJ/mol 都可以，对于结果的影响很小。
Of course, extreme temperatures even over a very small time period can damage most
foods or pharmaceuticals. Per the above example, putting an egg in a 75º C oven for 1/2
hour will bring the MKT to 45.4º C, but the egg will be irreversibly damaged (i.e. cooked).
Consequently, there are maximum and minimum temperature limits established by the
FDA.
当然，极端的温度在很短的时间内都可以对大部分药品或食品造成损坏，比如在上面的例子
中将一个鸡蛋放入75℃箱内0.5 小时，MKT 计算值为45.4℃，但是显然鸡蛋遭到了不可逆
的损坏（比如已经煮熟了）。所以，FDA 会建立最大和最小的温度限。
最新回复
ending (2015-4-11 17:02:58)
我个人认为，规定运输日期，并配合温度的稳定性试验是可以的。
feiya (2015-4-11 17:03:16)
但下限0度是不合适的
因为存在潜在相变的可能性
再由于误差
所以下限一定是2度
刘白白 (2015-4-11 17:03:43)
QUOTE:
粉针剂要考虑相变么?如果水针温度验证也包括-20度到0度之间区域的,可以么?
kulee (2015-4-11 17:04:01)
不建议这么设定，还是要设定在2-8度之间。因为你这样设定，无疑人为的放宽了运输控制指标，这是非自然因素改变，属于差错的一部分了。
但是这些材料你可以做，用于发生偏差时候使用，证明产品失效的风险可控或较小。
ujne (2015-4-11 17:04:24)
october7 (2015-4-11 17:04:42)
温度要保持一致。
newway (2015-4-11 17:05:06)
如果水针温度验证也包括-20度到0度之间区域的,可以么?
===================================
冻干粉还是要考虑一下
不过正像楼下所说
还是应该按照要求的条件运输
数据只是用于支持运输验证中超标的情况
即偏差调查决定是否放行
而不是你运输时直接改变运输条件
yayya (2015-4-11 17:05:26)
可以考虑计算平均动力学温度进行评估。
1 / 4
WHAT IS MEAN KINETIC TEMPERATURE?
什么是平均动力学温度？
Mean Kinetic Temperature (MKT) is a simplified way of expressing the overall effect of
temperature fluctuations during storage or transit of perishable goods.
平均动力学温度（MKT）一种简单明了的反应温度波动对不耐久货物在储存和输运时的影
响。
Consider the following example.
参考一下例子：
Example:
例：
A dozen eggs sat:
一打鸡蛋放置在：
In a 20º C room for 2 hours
20℃的房间放置2 小时
In 2º C refrigeration for 4 hours
2℃的冰箱放置4 小时
And on a 25º C loading dock for 1 hour
25℃码头放置1 小时
Using MKT we can calculate that temperature profile of the eggs was “thermally
equivalent” to storing them at 15.7º C for 7 hours.
使用MKT，我们可以计算出上述情况等同于鸡蛋在15.7℃放置7 小时
HOW IS MEAN KINETIC TEMPERATURE CALCULATED?
平均动力学温度怎么计算？
Technically speaking, MKT is an expression of cumulative thermal stress experienced by
a product at varying temperatures during storage and distribution. In other words, MKT
is a calculated, single temperature that is analogous to the effects of temperature
variations over a period of time.
严格的来说，平均动力学温度（MKT）是一种产品在温度不断变化的储存或分销过程中的
累积热效力表现方式。换句话来说，MKT 是用单一温度来近似计算一段时间温度不断变化
2 / 4
的影响。
MKT is not a simple weighted average. The calculation of MKT gives the higher
temperatures a greater weight when computing the average than would a simple
numerical average or an arithmetic mean. This weighting is determined by a geometric
transformation--the natural logarithm of the absolute temperature.
MKT 不是简单的计算平均值， MKT 计算值一般比简单的数值平均值或算术平均值有更高
的加权。这种加权取决于绝对温度自然对数的几何转换。
The International Conference on Harmonization (ICH) stability testing guidelines define
MKT as “a single derived temperature, which, if maintained over a defined period, would
afford the same thermal challenge to a pharmaceutical product as would have been
experienced over a range of both higher and lower temperatures for an equivalent defined
period”.
在人用药物注册技术要求国际协调会（ICH）稳定性测试指南中，定义MKT 为“单一推导温
度，如果在特定的时间，和同时经历较高和较低温度的情况相比，该推导温度可以对药品提
供相同的热挑战”
By using this unequal weighting of the higher temperatures in a temperature series, MKT
takes into consideration the accelerated rate of thermal degradation of materials at these
higher temperatures. Therefore, MKT provides for the non-linear effect of temperature.
在一系列温度中较高温度有着不同的加权，MKT 考虑了物料在较高温度下的热下降加速补
偿。因此，MKT 规定了温度的非线性结果。
yayya (2015-4-11 17:06:32)
MKT 表达式如下：
Where：
其中：
ΔH = activation energy (typically from 60 to 100 kJ/mol for solids and liquids)
ΔH=活化能量（通常对于固体和液体来说，从60 kj/mol 到100kj/mol）
3 / 4
R = 8.314472 J/mol-K (universal gas constant)
R=8.314472J/mol-K（通用气体常数）
T = temperature in degrees K
T=温度（用K 为单位）
n = the number of sample periods over which data is collected
n=数据搜集数量
Note : ln is the natural log and ex is the natural log base.
注意：ln 是自然对数e 是自然对数的底数
The above equation is valid only when the temperature readings are taken at the same
interval. A more general form for the above equation can be expressed as:
上述的公式只是适用于同样的时间间隔，应用更广泛的公式如下：
Where:
其中：
to are time intervals at each of the sample points
t1 至tn 为相应温度的时间
When = = = , this equation will be reduced to the former equation.
当t1=t2=…=tn 时，该公式和就上面的一致了。
WHY IS MKT IMPORTANT IN THE LIFE OF PHARMACEUTICALS AND PERISHABLE
GOODS?
为什么MKT对于药品和不耐久的货物来说是十分重要的呢？
The pharmaceutical and food industries are two closely regulated markets. The FDA
provides regulations that require warehouse and shipment temperatures to be closely
controlled and monitored. In addition, the FDA requires well-documented verification of
4 / 4
these storage environments and any corrective actions taken if temperatures exceed
specified storage conditions.
食品和药品是两种非常接近的管理市场，FDA 制定了法规要求对参数和运输温度进行严密
监测和控制。另外，FDA 要求归档环境温度确认和任何温度超出规定储存温度的纠正措施。
The calculation of MKT is regarded by the FDA as an action taken to verify if a particular
perishable has exceeded storage conditions.
MKT 计算被FDA 认为是确认某一不耐久物品超出其储存条件的纠正措施。
In addition to compliance with the FDA regulations, MKT can help Distributors and
Manufacturers determine if improper storage or handling of goods, that might have
occurred during shipment and/or unloading, has affected the shelf life of the their product.
除了FDA 的法规要求外，MKT 可以帮助分销商和制造商确定在运输或卸载时错误的储存或
处理物品对产品保存期限的影响。
Other considerations:
其他注意事项：
It can assume activation energy of 83.14472 kJ/mol for its calculation. In fact, any value
between 60 and 100 kJ/mol, which covers most solids and liquids, will have only a small
effect on the final value.
ΔH 可以选用83.14472 kJ/mol 参与计算。事实上，对于固体和液体来说，任何在60 至
100 kJ/mol 都可以，对于结果的影响很小。
Of course, extreme temperatures even over a very small time period can damage most
foods or pharmaceuticals. Per the above example, putting an egg in a 75º C oven for 1/2
hour will bring the MKT to 45.4º C, but the egg will be irreversibly damaged (i.e. cooked).
Consequently, there are maximum and minimum temperature limits established by the
FDA.
当然，极端的温度在很短的时间内都可以对大部分药品或食品造成损坏，比如在上面的例子
中将一个鸡蛋放入75℃箱内0.5 小时，MKT 计算值为45.4℃，但是显然鸡蛋遭到了不可逆
的损坏（比如已经煮熟了）。所以，FDA 会建立最大和最小的温度限。
刘白白 (2015-4-11 17:07:12)
=====================================================
可三可油
就这么办,我把运输温度设定成平均动力学温度2-8度,这下不算错吧
S6044 (2015-4-11 17:08:34)
S6044 (2015-4-11 17:08:55)
woshi (2015-4-11 17:09:17)
woshi (2015-4-11 17:09:33)
打错了，是不会贴。
youyou99 (2015-4-11 17:09:46)
当然必须是和产品的储藏温度相一致
刘白白 (2015-4-11 17:10:17)
QUOTE:
为什么呢为什么呢
字数总算够了
youyou99 (2015-4-11 17:10:39)
QUOTE:
是为了证明产品在运输过程中不会对产品质量造成影响！~33号 (2015-4-11 17:10:56)
国内药监部门认可MTK的方式吗？
bs4665 (2015-4-11 17:11:25)
=======================================
不知道你计算过没有，上面的一些计算是错误的
veiwu (2015-4-11 17:11:43)
这个帖子有你的问题的答案。是根据去年高级研修学院的培训做的，原创-药品冷链管理及验证
cuturl('http://www.ouryao.com/forum.php?') ... 56&fromuid=6294
【求助】冷链药品贮藏温度和运输温度必须一致么?