Bioassay·Activity Analysis

Determination of molecular weight and distribution of mannatide by means of SEC-RI-MALLS

Expand
  • Sichuan Institute for Drug Control, NMPA Key Laboratory for Quality Control and Evaluation of Vaccines and Biological Products, SCMPA Key Laboratory for Quality Monitoring and Risk Assessment of Biological Products, Chengdu 610097, China

Received date: 2023-10-11

  Online published: 2024-06-21

Abstract

Objective: To establish a method for determining molecular weight and distribution of raw mannatide and its preparation with SEC-RI-MALLS. Methods: Specificity,accuracy, precision and robustness of SEC-RI-MALLS method was verified by performing on a Shodex OHpak SB-804 HQ column with 0.05 mol·L-1 sodium sulfate buffer as mobile phase at a flow rate of 0.5 mL·min-1 and a comparison between SEC-RI-MALLS and GPC was studied too. Resulst: The tablet excipient starch had no interference to the test. The relative accuracy error between the measured value and the labeled value of dextran standard was less than 3.0%. RSD of precision was 0.40% when the sample concentration was 2 mg·mL-1 and the RSD of reproducibility and robustness were less than 5.0%. There was no significant difference between Shodex OHpak SB-804 HQ column and TSK-GEL G4000 PWXL column by comparing the results of 79 batches of samples. Compared with the national standard method (GPC) for molecular weight determination, the molecular weight of SEC-RI-MALLS method was 19 509 Da higher on average, and the molecular weight distribution was more concentrated. Conclusion: SEC-RI-MALLS method can determine the molecular weight and distribution of mannatide without standard with good accuracy and robustness. Compared with the existing method, SEC-RI-MALLS method is more conducive to the safety and effectiveness control of the variety.

Cite this article

ZOU Jian, YANG Lei, LIN Tao, WANG Jue-xiao, MA Jin, CHEN Jie, LI Yan . Determination of molecular weight and distribution of mannatide by means of SEC-RI-MALLS[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44(2) : 256 -263 . DOI: 10.16155/j.0254-1793.2024.02.08

References

[1] 沈艳红,陈林枭.甘露聚糖肽的结构鉴定[J]. 高等学校化学学报,2016,37(6):1088
SHEN YH, CHEN LX. Structure identification of mannan peptides [J]. Chem J Chin Univ, 2016, 37 (6):1088
[2] 王允升,王晓燕. 甘露聚糖肽(多抗甲素)的药理作用与临床应用[J]. 中国药师,2004,7(4):302
WANG YS, WANG XY. Pharmacological effect and clinical application of mannatide [J]. Chin Pharm, 2004, 7 (4):302
[3] 国家药品标准:化学药品地方标准上升国家标准. 第16 册[S]. 2002: 148,157,162
National Drug Standards: Nation al Standards for Chemicals Promoted from Local Standards. Vol 16 [S]. 2002: 148,157,162
[4] 黄志萍.激光散射仪及应用[J]. 现代仪器,2006,12(6):49
HUANG ZP. Laser scatterer and its application [J]. Mod Instrum, 2006, 12(6):49
[5] 张卫东,胡川梅.SEC-MALLS法测定普鲁兰糖相对分子质量及分子质量分布[J]药物分析杂志,2015,35(7):1213
ZHANG WD, HU CM. Determination of relative molecular mass and molecular mass distribution of pullulan by SEC-MALLS method [J]. Chin J Pharm Anal,2015,35 (7):1213
[6] WYATT PJ. Light scattering and the absolute characterization of macromolecules[J]. Anal Chim Acta, 1993, 272:140
[7] 中华人民共和国药典2020年版. 四部[S]. 2020:66,480
ChP 2020.Vol Ⅳ [S]. 2020: 66,480
[8] 刘红妮,陈曼.GPC-MALLS技术测定PAMMO的分子量及分子量分布[J]. 分析测试技术与仪器,2010,16(1):27
LIU HN, CHEN M. Determination of molecular weight and molecular weight distribution of PAMMO by GPC-MALLS technology [J]. Anal Test Technol Instrum, 2010, 16(1):27
[9] 吴扬兰,王远亮.SEC-RI-MALLS技术在香菇多糖分子量与分子量分布分析方面的应用研究[J]. 药物分析杂志,2011,31(12):2256
WU YL, WANG YL. Application of sec-ri-malls technology in molecular weight and molecular weight distribution analysis of lentinus edodes polysaccharide [J]. Chin J Pharm Anal, 2011, 31 (12):2256
[10] OLIVA A, LlABRÉS M, FARIÑA JB. Comparative study of protein molecular weights by size-exclusion chromatography and laser-light scattering [J]. J Pharm Biomed Anal, 2001, 25(5-6): 833
[11] NORDMEIER E. Static and dynamic light-scattering solution behavior of pullulan and dextran in comparison [J]. J Phys Chem, 1993, 97(21): 5770
[12] HUGLIN MB. Light Scattering from Polymer Solutions[M]. New York:Academic Press, 1972:100
[13] THIEBAUD J, FANGETA I, JAUDINAUD I, et al. Development and validation of high-performance size exclusion chromatography methods to determine molecular size parameters of haemophilus influenzae type b polysaccharides and conjugates[J]. Anal Biochem, 2014, 453:22
[14] 范慧红. 激光光散射技术在生物大分子药物质控中的应用[J]. 食品与药品,2005,7(6A):59
FAN HH. Application of laser light scattering technology in quality control of biomacromolecule drugs [J]. Food and Drug, 2005, 7(6A): 59
[15] 李运景,李雪芹.甘露聚糖肽注射液致不良反应文献分析[J]. 中国药房,2011,22(10):919
LI YJ, LI XQ. Literature analysis of adverse reactions induced by mannatide injection [J]. China Pharm, 2011, 22(10):919
Outlines

/