The Quality Control Of The Residual Quantity Of Methylene Blue In Virus Inactivation Plasma

Objective Through enhance the combination control of raw materials and preparation processes explore how to decrease the residual quantity of Methylene Blue in plasma on the basis of improving efficiency of preparation for the virus inactivation plasma. Methods The fresh plasma was centrifugal separated from the whole blood (400ml/bag) on the same day. 30 bags of fresh plasma were chosen. Each one was about 245g (including the weight of the empty blood bag). The 30 bags were randomly divided into 3 groups (10 bags per group). They were called respectively the comparison group, the first experimental group and the second experimental group. The comparison group used the old-style virus-inactivating filter; the first and the second experimental groups used the new-style virus-inactivating filter. The 3 groups all used the method of methylene blue-photochemistry to inactivate the virus in plasma. The pre-preparation processes of the 3 groups were exactly the same. However, the stages of filtering the methylene blue were different among the 3 groups. Plasma with methylene blue was filtered only once for the comparison group and the first experimental group, but twice for the second experimental group. All of the operations above should be completed in 6 hours after the blood taking. The samples of each bag of virus-inactivating plasma should be kept respectively before and after the methylene blue filtered. The samples were used for assay the quantity of methylene blue, total protein and Factorâ…§before and after filtered, then were calculated the residual ratio of methylene blue, the recovery rate of total protein and Factorâ…§. Results About the released quantity of MB , the difference between the first experimental group and the comparison group was insignificant(P>0.05),the difference between the second experimental group and the comparison group was insignificant as well. And about the residual quantity/ratio of MB, the difference between the second experimental group and the comparison group was insignificant(P>0.05),but difference between the first experimental group and the comparison group was significant(P<0.01). The difference of the recovery rate of total protein and factorâ…§in the three groups was insignificant(P>0.05). Conclusion The secondary filter by the new-style virus-inactivating filter shorten the preparation for the virus-inactivating largely, while the recovery rate of total protein and Factorâ…§did not affect. Meanwhile, this method could keep the residual quantity of MB at a low level. For the residual ratio of MB, each bag of plasma in the second comparison group was all less than 15%. The low ratio reduces the risk of MB in human bodies, and decreases the transfusion reaction. This simple and effective method should be popularized and applied to the blood station.