激光散射法测定乳糖的粒度  

Measurement of particles size distribution of lactose by laser light scattering method

作　　者：邹文博[1] 许明哲[1] 王晨[1] 胡昌勤[1] 

机构地区：[1]中国药品生物制品检定所抗生素室,北京100050

出　　处：《药物分析杂志》2007年第9期1420-1423,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的：确定激光散射法测定乳糖粒度分布，并与传统的筛分法进行比较。方法：Malvem Mastersizer 2000激光粒度分析仪，Scirocco 2000干法进样器；振动进样速度为50％；分散气压，60目和200目为2×10^5Pa，70目、80目、100目为5×10^4Pa；背景及样品的扫描时间为15s；遮光度为0．5％～5％；颗粒折射率为1．347；颗粒吸收率为0．1。Sympatec Helos＆Rodos激光粒度分析仪，振动进样速度为60％；分散气压为5×10^4Pa；透镜为2．5mm，遮光度为4％～10％。OCTAGON DIGITAL高速筛分机；筛分时间2min；振动幅度9。结果：激光散射法可以测定各种规格的乳糖样品，由体积平均粒径D[4，3]可以直观地表征不同规格的乳糖颗粒大小的差异，由d（0．1）、d（0．5）和d（0．9）可以看出其粒度分布特征。基于米氏理论或弗朗霍夫理论进行运算的激光粒度仪均可用于乳糖的粒度分析，两者的测定结果无显著性差异。结论：虽然筛分法与激光散射法均可以表征乳糖的粒度分布，但激光散射法能更好地表征样品的粒度分布，同时可减少测量过程中人为操作误差的影响。Objective： To develop a laser light scattering method for determining particles size distribution of lactose and compare with the obtained results of traditionally sieving method. Methods： Two sets of particle size distribution analyzer（ Malvern Mastersizer 2000 and Sympatec Helos ＆ Rodos） were used in this study. Malvern Mastersizer 2000 with a Scirocco 2000 dry autosampler, sampling velocity ：50%, pressure：2 × 10^5 Pa （for 60 and 200 mesh） ,5 × 10^4 Pa （ for 70,80, and 100 mesh） ,background and sample measurement time ： 15 s, obscuration ：0. 5% - 5%, particle RI： 1. 347 ,particle AI：0. 1. The test parameters of Sympatec Helos ＆ Rodos were as follows： sampling velocity：60% ,pressure：5 × 10^4 Pa, obscuration：4% - 10%, lens：2.5 mm. An OCTAGON DIGITAL high performance test sieve shaker was used with the sieving time of 2 minutes and amplitude of 9. Results： A variety of lactose products could be analyzed by laser light scatting method. The volume weighted mean D [ 4,3 ] could indicate, apparently the size difference between different lactose particles. The profile of the particles size distribution could be reflected by the d（0. 1 ） ,d（0.5 ） ,and d（0. 9）. All particle size analyzers based on the Mie and Fraunhofer theories could be used to measure the particle size of lactose, and there were no significant differences between the data obtained from the different laser light scattering instruments. Conclusion：Ahhough both laser light scattering method and sieving method can measure the particles size distribution of lactose,laser light scattering method is a better indicator of particle size distribution and can reduce the error that is typically associated with operation procedure.

关 键 词：粒度分析 激光粒度仪 乳糖 

分 类 号：R917[医药卫生—药物分析学]