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新型光学颗粒计数器研制及在医药分析中应用

227    2024-05-24

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作者:张奇芳1, 范继来2, 鞠薇薇1, 吕慧明1, 刘伟2, 李晓旭2, 曲艳玲2

作者单位:1. 辽东学院医学院,辽宁 丹东 118003;
2. 丹东百特仪器有限公司研发中心,辽宁 丹东 118009


关键词:颗粒计数器;光阻法;散射法;医药分析;注射液;脂肪乳


摘要:

通过对一种高精度的光学法颗粒计数器原理、研制、验证和应用过程的描述,展示一种新的光阻法与散射法相结合的测量方式,提升测量范围和精度,尤其是设计厚度仅为20 μm的片状光源,提升计数效率。此外,在信号处理上采用了平滑比较器的数学模型,既能有效过滤噪声信号,又能精确提取有效信号的数量与高度,准确测量颗粒数量与粒径,95%重合误差极限为45000 个 / mL,对1.6、4.8、8、16、32 μm五种标准粒径物质混合测试,可以得到准确的五峰分布。对氯化钠注射液和脂肪乳进行测量验证,三个厂家的0.9%氯化钠注射液的不溶性微粒含量达到药典要求,三种脂肪乳样品,G1和G2的PFAT5<0.05%,符合药典要求,合格;而样品G3的PFAT5>0.05%,不符合药典要求,不合格。以上表明该仪器在医药领域具有良好的应用前景。


Development of a new optical particle counter and its application in pharmaceutical analysis
ZHANG Qifang1, FAN Jilai2, JU Weiwei1, Lü Huiming1, LIU Wei2, LI Xiaoxu2, QU Yanling2
1. Medical School,Eastern Liaoning University, Dandong 118003, China;
2. R&D center,Dandong Bettersize Instruments Co., Ltd., Dandong 118009, China
Abstract: A high-precision optical particle counter was introduced, which combines light obscuration and light scattering technologies, improving the measurement range and measurement precision of the apparatus. Cylindrical lens and roof prism characterize the design of the light source, resulting in a square-shaped laser beam whose thickness is only 20μm. The particle counting efficiency is therefore improved. The utilization of a mathematical model of smoothing comparator in terms of pulse signal extraction leads to not only effective signal noise filtration but also accurate extraction of the pulse number and intensity, and accurate calculation of the number and size of particles. The 95 % coincidence error limit is 45000 / mL,and the accurate five-peak distribution can be obtained by mixing the five standard particle size materials of 1.6,4.8,8,16,32 μm.Sodium chloride injection and fat emulsion were measured and verified. The content of insoluble particles in 0.9% sodium chloride injection from three manufacturers meets the requirements of the pharmacopoeia.In the three fat emulsion samples, the PFAT5 of G1 and G2 <0.05%, which meets the requirements of the pharmacopoeia,qualified; However, the PFAT5 of G3 >0.05%, which does not meet the requirements of the pharmacopoeia,unqualified.The above shows that the apparatus has a good application prospect in the medical analysis domain.
Keywords: particle counter;light obscuration method;light scattering method;pharmaceutical analysis;injection;fat emulsion
2024, 50(5):122-129  收稿日期: 2022-11-18;收到修改稿日期: 2023-01-09
基金项目:
作者简介: 张奇芳(1979-),女,辽宁阜新市人,讲师,硕士,主要从事医学、基础医学教学及临床实验工作。
参考文献
[1] 陈明. 基于光阻法的液体颗粒计数系统研究[D]. 杭州: 浙江大学, 2021: 1-12.
CHEN M. Research on liquid particle counting system based on photoresistance method [D]. Hangzhou: Zhejiang University, 2021: 1-12.
[2] 曹放, 张立平. 高性能光阻式颗粒计数仪的设计与实现[J]. 电子测量技术, 2014, 37(4): 130-133.
CAO F, ZHANG L P. Design and implementation of high performance photoresistive particle counter [J]. Electronic Measurement Technology, 2014, 37 (4): 130-133.
[3] 单颗粒的光学测量方法 第3部分:液体颗粒计数器光阻法: GB/T 29024.3—2012 [S]. 北京: 中国标准出版社, 2012.
Optical measurement methods for single particles - Part 3: Liquid particle counter resistance method: GB/T 29024.3-2012 [S]. Beijing: Standards Press of China, 2012.
[4] 赵鹏, 荆红莉. 无线PM2.5测试仪的设计与实现[J]. 电子测量技术, 2016, 39(6): 134-137.
ZHAO P, JING H L. Design and implementation of wireless PM2.5 tester [J].Electronic Measurement Technology, 2016, 39 (6): 134-137.
[5] 陈轩, 刘海生, 张佳亮, 等. 炼油厂循环水中微量油的检测方法[J]. 中国测试. 2017, 43(4): 45-47.
CHEN X, LIU H S, ZHANG J L, et al. Detection method for trace oil in circulating water of refineries [J]. China Measurement & Test, 2017, 43 (4): 45-47.
[6] 田昌, 胡边, 黄育明, 等. 角散射法运行中油品颗粒度在线测量装置研究[J]. 电子测量技术, 2016, 39(12): 189-191.
TIAN C, HU B, HUANG Y M, et al.Research on an online measurement device for oil particle size during the operation of angle scattering method [J].Electronic Measurement Technology, 2016, 39 (12): 189-191.
[7] 谭和平, 侯晓妮, 孙登峰, 等. 纳米材料的表征与测试方法[J]. 中国测试, 2013, 39(1): 8-12.
TAN H P, HOU X N, SUN D F, et al.Characterization and testing methods of nanomaterials [J].China Measurement & Test, 2013, 39 (1): 8-12.
[8] 粒度分析 单颗粒的光学测量方法 第2部分:液体颗粒计数器光散射法: GB/T 29024.2—2016 [S]. 北京: 中国标准出版社, 2016.
Particle size analysis - Optical measurement methods for single particles - Part 2: Liquid particle counter light scattering method: GB/T 29024.2-2016 [S].Beijing: Standards Press of China , 2016.
[9] 朱丽, 范晶, 张桂芹, 等. 激光粒度仪测试城市开放源颗粒物的关键参数优化研究[J]. 中国测试, 2022, 48(12): 67-73.
ZHU L, FAN J, ZHANG G Q, et al.Research on the key parameters optimization of laser particle size analyzer for measuring urban open-source particulate matter[J].China Measurement & Test, 2022, 48 (12): 67-73.
[10] 顾建飞, 葛师语, 陈晓兰, 等. 猝发叠加超声颗粒粒径表征方法研究[J]. 中国测试, 2021, 47(5): 33-38.
GU J F, GE S Y, CHEN X L, et al.Research of particle size characterization method based on burst superposed ultrasound[J].China Measurement& Test, 2021, 47 (5): 33-38.
[11] 李政阳, 付跃刚. 直角屋脊棱镜与立方角锥棱镜的光学特性[J]. 应用光学, 2008, 29(5): 834-835.
LI Z Y, FU Y G. The optical properties of right angled ridge prisms and cubic pyramid prisms [J].Journal of Applied Optics, 2008, 29 (5): 834-835.
[12] 周彦辰, 郭亮, 陈志涛, 等. 基于全内反射结构的多自由曲面准直透镜设计[J]. 光学学报. 2021, 41(4): 0422003.
ZHOU Y C, GUO L, CHEN Z T, et al. Design of multi freeform surface collimator lens based on total internal reflection structure [J]. Acta Optica Sinica,2021, 41 (4): 0422003.
[13] 巩畅畅, 刘鑫, 范斌, 等. 基于RGB三波段的消色差衍射透镜设计与分析[J]. 光学学报. 2021, 41(11): 1105001.
GONG C C, LIU X, FAN B, et al. Design and analysis of achromatic diffractive lenses based on RGB three bands [J].Acta Optica Sinica, 2021, 41 (11): 1105001.
[14] 鲁晨阳, 张佩. 鞘流技术在气溶胶颗粒物光学传感器上的应用研究[J]. 中国激光. 2019, (1). 202-210.
LU C Y, ZHANG P. Application research of sheath flow technology on optical sensors for aerosol particles [J].Chinese Journal of Lasers, 2019, (1) 202-210.
[15] 肖韶荣, 刘博涵, 石刘峰, 等. 光电探测器尺度效应对能见度测量不确定度的影响[J]. 中国激光. 2021, 48(12): 1204001.
XIAO S R, LIU B H, SHI L F, et al. The impact of scale effect of photodetectors on uncertainty in visibility measurement [J]. ChineseJournal of Lasers, 2021, 48 (12): 1204001.
[16] 侯春彩, 贾日波, 徐亚蛟, 等. 高稳定性光散射法颗粒物浓度传感器[J]. 激光与光电子学进展. 2021, 58(21): 2128002.
HOU C C, JIA R B, XU Y J, et al. High stability light scattering particle concentration sensor [J]. Laser & Optoelectronics Progress, 2021, 58 (21): 2128002.
[17] 许人良. 颗粒表征的光学技术及应用[M]. 北京: 化学工业出版社, 2022: 81-107.
XU R L. Optical technology and application of particle characterization [M]. Beijing: Chemical Industry Press, 2022: 81-107.
[18] 中华人民共和国国家药典委员会. 中国药典[S]. 北京: 中国医药科技出版社, 2020年版第四部.
Chinese Pharmacopoeia Commission. Chinese Pharmacopoeia [S]. Beijing: China Medical Science Press, 2020 forth.
[19] 中华人民共和国国家药典委员会. 中国药典[S]. 北京: 中国医药科技出版社, 2020年版第二部.
Chinese Pharmacopoeia Commission. Chinese Pharmacopoeia [S]. Beijing: China Medical Science Press, 2020 second.
[20] DRISCOLL D F, LING P R , QUIST W C , et al. Pathological consequences from the infusion of unstable lipid emulsion admixtures in guinea pigs [J]. Clinical Nutrition, 2005, 24: 105-113.