热重和差示扫描量热分析技术在药物分析中的应用进展

doi:10.19803/j.1672-8629.20230286

摘要/Abstract

摘要： 目的探讨热重分析（TGA）和差示扫描量热分析（DSC）在药物分析中的应用,为药品质量控制奠定基础。方法通过文献综述着重报道了这2种技术方法在水分含量分析、热稳定性研究、熔点测量、纯度分析、晶型分析等药物研究中的多方面应用研究情况。结果与结论 热重和差示扫描量热分析技术在药物的水分、熔点、纯度、晶型以及稳定性等相关分析中发挥重要作用,满足药品检验检测工作的更高分析需求。

关键词: 热重分析, 差示扫描量热分析, 水分含量, 热稳定性, 熔点, 纯度, 晶型, 安全性

Abstract: Objective To explore the application of thermogravimetric analysis (TGA) and Differential scanning calorimetry (DSC) in drug analysis to lay the foundation for pharmaceutical quality control. Methods a short overview of the applicative research on the water content, thermal stability, melting-point, purity, polymorphism and others in recent years, had been reported. The future development prospect was also discussed. Results and Conclusion TGA and DSC played an important role in the analysis of moisture, melting point, purity, crystallinity and stability of drugs to meet the higher analytical demands of pharmaceutical inspection and testing. It was looking forward to providing methods and ideas for the further research on drug quality and safety.

Key words: thermogravimetric analysis, differential scanning calorimetry, water content, thermal stability, melting-point, purity, polymorphism, safety

中图分类号:

R917

刘毅, 覃玲, 郭贤辉, 陈华, 裴宇盛. 热重和差示扫描量热分析技术在药物分析中的应用进展[J]. 中国药物警戒, 2024, 21(3): 283-289.

LIU Yi, QIN Ling, GUO Xianhui, CHEN Hua, PEI Yusheng. Applications of TGA and DSC in pharmaceutical analysis[J]. Chinese Journal of Pharmacovigilance, 2024, 21(3): 283-289.

导出引用管理器 EndNote|Ris|BibTeX

链接本文: https://zgywjj.magtechjournal.com/CN/10.19803/j.1672-8629.20230286

https://zgywjj.magtechjournal.com/CN/Y2024/V21/I3/283

参考文献

[1] ZHANG JL.Progress and Application of Drug Analysis Technology (药物分析技术进展与应用)[M]. Beijing: Peking Union Medical College Press, 2021.
[2] Standardization Administration.GB/T 6425-2008[S]. Beijing: Standards Press of China, 2008: 1.
[3] BI CL, LIU R, ZHAO CG, et al. Rapid detection method for moisture and ash content in concentrated sulfuric acid (浓硫酸中水分及灰分含量的快速检测方法): China, 107478540A[P].2017-12-15.
[4] LIU Y, WU JM, YAN J, et al.Hygroscopicity study of vitamin B₁₂ chemical reference substance[J]. Chinese Pharmaceutical Journal(中国药学杂志), 2019, 54(10): 809-812.
[5] MA YX, WANG N, LI G.Qualitive and quantitative analysis of basic lanthanum carbonate and lanthanum carbonate tetrahydrate for medicinal use[J]. Analytical Instrumentation(分析仪器), 2021(4): 102-110.
[6] LYU XK.Study on the stability of amorphous nifedipine by differential scanning calorimetry[J]. Northwest Pharmaceutical Journal(西北药学杂志), 2018, 33(5): 600-604.
[7] WANG X.Determination of ABS oxidation induction temperature by differential scanning calorimetry and evaluation of its thermal oxidation stability[J]. Science and Technology Innovation Herald(科技创新导报), 2018, 15(24): 71-72.
[8] TAN XD, ZHANG YZ, DU L.Application of differential scanning calorimetry in research on stability of antibody drug conjugate[J]. Chinese Journal of Biologicals(中国生物制品学杂志), 2018, 31(3): 299-302, 306.
[9] ZHAO XX, DU HZ, LI LX, et al.Thermal property investigation of diacylglycerol by differential scanning calorimetry technique[J]. Food Research and Development(食品研究与开发), 2018, 39(6): 204-208.
[10] LUO AF, YAN XT, LYU HJ, et al.Studies on loading capacity of UiO-66 and its derivatives to enrofloxacin[J]. Acta Scientiarum Naturalium Universitatis Nankaiensis(Natural Science Edition)(南开大学学报自然科学版), 2022, 55(2): 107-112.
[11] YANG KN, PAN YF, CAI PX, et al.Preparation and drug release of redox/ph dual-responsive bagasse cellulose-based hydrogels[J]. Polymer Materials Science & Engineering(高分子材料科学与工程), 2021, 37(10): 145-152.
[12] XIONG J, LIU Y, NING BM, et al.Study on stability of methylparaben and sodium methyl parahydroxybenzoate reference standards[J]. Drug Evaluation Research(药物评价研究), 2020, 43(6): 1065-1070.
[13] DU C, LIU XN, TANG Y, et al.Comparative study of thermal stability and crystal form of bendamustine hydrochloride[J]. Journal of Yichun University(宜春学院学报), 2021, 43(6): 38-42.
[14] TAN JH, ZHAO TT, PAN HJ.Determination of gadolinium in four gadolinium contrast agents by thermogravimetric analysis[J]. Chinese Journal of Pharmaceuticals(中国医药工业杂志), 2020, 51(4): 520-523.
[15] ZHOU LB, YANG T, LIU ZY.Thermogravimetry and caloric value analysis of 4 kinds of heat-clearing and detoxicating drugs[J]. Shandong Chemical Industry(山东化工), 2021, 50(10): 93-96.
[16] FAN ZX, GUAN D, XIE B, et al.Preparation and solid-state characterization of higenamine hydrochloride polymorph A[J]. Pharmacy Today(今日药学), 2022, 32(4): 273-277.
[17] YAN XT, WEI DW, LUO AF, et al.Preliminary studies on the drug delivery system of the metal-organic frameworks UiO-66-NH2 modified with folic acid loaded and DOX[J]. Acta Scientiarum Naturalium Universitatis Nankaiensis(Natural Science Edition)(南开大学学报自然科学版), 2021, 54(6): 100-104.
[18] YANG LN, LIU CY. Synthesis, characterization and interaction with DNA of Zn(Ⅱ) complex based on N,N'-dimethyl-5-nitro-2,2'-biimidazole[J]. Chemical Engineer(化学工程师), 2021(8): 6: 21.
[19] WU J, ZHAO JH, SHEN JW, et al. Salt synthesis and crystal characterization of Elagolix intermediate[J]. Journal of China Prescription Drug(中国处方药), 2022, 20(2): 17: 18.
[20] QU XS, SHI D, ZHAO N, et al.Synthesis and in vitro antitumor activities of paradodecatungstate-B compound with bi-active center[J]. Journal of Northeast Normal University(Natural Science Edition)(东北师大学报自然科学版), 2022, 54(1): 89-93.
[21] LUO XL, LI Z, XU XM, et al.Preparation and in vitro release of cuicumin-loaded gold nanocomposite particles[J]. Technology & Development of Chemical Industry(化工技术与开发), 2021, 50(9): 14-49.
[22] Technical Committees.GB/T 28724-2012.Determination of melting point of solid organic chemicals-Differential scanning calorimetry method(固体有机化学品熔点的测定差示扫描量热法)[S]. Beijing: Standards Press of China, 2012:1.
[23] WANG J, ZHANG S, LIN P, et al.Rapid determination of purity and melting point of itaconic acid[J]. Hi-Tech Fiber & Application(高科技纤维与应用), 2018, 43(4): 23-26, 33.
[24] XIONG J, WU JM, WANG SC, et al.Equivalence studies of different methods for drug melting point determination[J]. Chinese Pharmaceutical Journal(中国药学杂志), 2018, 53(21): 1861-1868.
[25] WANG YF, WANG JY, LI YN, et al.Measurement of purity and thermodynamic properties of 2,3,6-trimethylphelnol with DSC[J]. Journal of Tianjing University of Science & Technology(天津科技大学学报), 2018, 33(6): 41-44.
[26] LIU CF.Study on the preparation and physicochemical property of genistein EDA salt[J]. Journal of North Pharmacy(北方药学), 2018, 15(6): 136-137.
[27] YANG J, LIU H, LI SS, et al.Research on the co-crystal and structures of the effective constituents in radonil[J]. Anhui Medical and Pharmaceutical Journal(安徽医药), 2021, 25(11): 2136-2139.
[28] HAUPTMANN A, HOELZL G, LOERTING T.Optical cryomicroscopy and differential scanning calorimetry of buffer solutions containing cryoprotectants[J]. European Journal of Pharmaceutics and Biopharmaceutics, 2021, 136: 127-140.
[29] HE Y, WANG GJ, SHANG ZC.Application of statistical test in the consistency analysis of melting point test by capillary method and DSC method[J]. Fujian Analysis & Testing(福建分析测试), 2020, 29(6): 56-59.
[30] WU R, LIN L, YAN J, et al.Applicability studies of differential scanning thermal melting point analysis[J]. Chemical Reagents(化学试剂), 2020, 42(3): 285-290.
[31] WU L, ZHANG L, YANG JY, et al.Assignment of arbutin chemical reference substance[J]. Chinese Journal of Pharmaceutical Analysis(药物分析杂志), 2019, 39(1): 171-177.
[32] ZHOU JY, HUANG YJ, BAI YC, et al.Determination of purity of Lindane by differential scanning calorimetry and mass balance[J]. Journal of Food Safety & Quality(食品安全质量检测学报), 2018, 9(15): 3932-3937.
[33] ZHANG YJ, WU XF, XIAO XY.Determination of the purity of sulfonamide chemical reference materials by differential scanning calorimetry[J]. Chinese Journal of Modern Applied Pharmacy(中国现代应用药学), 2022, 39(1): 93-96.
[34] CHANG WW, PENG H.Determination of the purity of 4-acetamidophenol by differential scanning calorimetry[J]. Chemical Analysis and Meterage(化学分析计量), 2020, 29(2): 36-39.
[35] XIE YF, ZHANG L, ZHANG BX, et al.Development and purity determination of medroxyprogesterone acetate as certified reference material for progesterone drugs[J]. Herald of Medicine(医药导报), 2020, 39(11): 1487-1491.
[36] YANG F, FU SL, WANG Y, et al.Purity analysis of self-prepared nitroaniline (sodium) standard salt[J]. Journal of Gannan Normal University(赣南师范大学学报), 2020(3): 69-72.
[37] XIONG J, LIU Y, LIU ZX, et al.Development of the first national reference substance of ritonavir as a candidate drug against COVID-19[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2022, 19(2): 137-141.
[38] XIONG J, XIONG J, LIU Y, et al.Development of the first national reference substance of favipiravir as a candidate drug against COVID-19[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2022, 19(1): 52-61.
[39] ZHAI TW.Application of differential scanning calorimetry in the purity analysis of reference substance-taking macrolide antibiotics as an example[J]. Practical Pharmacy and Clinical Remedies(实用药物与临床), 2019, 22(11): 1178-1181.
[40] WU R, LIU ZX, HUANG HW, et al.Discussion on the applicable regularity of DSC purity for chemical reference substances[J]. Chinese Journal of Pharmaceutical Analysis(药物分析杂志), 2020, 40(8): 1494-1502.
[41] WANG JY, ZHANG W, HUANG T, et al.Quantification of a volatile deuterated compound by the differential scanning calorimetry combined with quantitative nuclear magnetic resonance and its verification by the mass balance method combined with gas chromatography-mass spectrometry[J]. Talanta, 2022, 246: 1-8.
[42] ZHANG L, PENG HY, DE ZY, et al.Purity and uncertainty study of crm betulin by DSC[J]. Natural Products and Bioprospecting, 2020, 10: 317-324.
[43] ATTIA AK, ABDEL-MOETY MM, ABDEL-HAMID SG, et al.Thermal analysis study of antihypertensive drug doxazosin mesilate[J]. Arabian Journal of Chemistry, 2017, 10(S1): S334-S338.
[44] GUO Z, ZHANG QH, ZHAO B, et al.Development of a certified reference material of dicyanodiamide[J]. Journal of Food Safety & Quality(食品安全质量检测学报), 2018, 9(15): 3905-3912.
[45] XU S, GUO B, SUI F, et al.Purity determination and uncertainty evaluation of acrylonitrile by gas chromatography and differential scanning calorimetry[J]. Journal of Metrology Society of India, 2018, 33(3): 253-260.
[46] GUO YS, GUO YH. Valuation and uncertainty evaluation in purity determination of antipyrine by using different principles methods[J]. Strait Pharmaceutical Journal(海峡药学), 2019, 31(10): 86: 88.
[47] LIU Y, WU JM, LU J, et al.Application of differential scanning calorimetry in the purity analysis of chemical reference substances[J]. Chinese Journal of New Drugs(中国新药杂志), 2017, 26(10): 1115-1118.
[48] LIU Y, LIU ZX, WU R, et al.Purity investigation by thermal analysis[J]. Chinese Pharmaceutical Affairs(中国药事), 2020, 34(3): 330-334.
[49] GAO XJ, LI HC, GUO JH, et al.Crystal form control of the reactive crystallization process of esomeprazole magnesium trihydrate[J]. Shandong Science(山东科学), 2022, 35(3): 138-144.
[50] LIU HH, ZHENG YL, CHEN YS, et al.Study on the crystal stability of fosfomycin calcium[J]. Chinese Journal of Modern Applied Pharmacy(中国现代应用药学), 2022, 39(3): 376-379.
[51] JIANG T, ZHENG LL, YUAN MY, et al.Preparation and quality evaluation of azelnidipine enteric solid dispersion[J]. China Pharmacy(中国药房), 2021, 32(15): 1862-1867.
[52] AI XL, LIU MH, WANG LF, et al.Polycrystalline study of compound CP0119[J]. Chinese Journal of New Drugs(中国新药杂志), 2021, 30(11): 1022-1030.
[53] GONÇALVES AD, ZHAO M, et al. A simultaneous differential scanning calorimetry-X-ray diffraction study of olanzapine crystallization from amorphous solid dispersions[J]. Molecular Pharmaceutics, 2020,17(11): 4364-4374.
[54] NIKOLAKAKIS I, KACHRIMANIS K.Crystallization kinetics of orthorhombic paracetamol from supercooled melts studied by non-isothermal DSC[J]. Drug Development Communications, 2017, 43(2): 257-263.
[55] LEGRAND V, DESCAMPS M, ALBA-SIMIONESCO C.Glass-forming meta-toluidine: a thermal and structural analysis of its crystalline polymorphism and devitrification[J]. Thermochimica Acta, 1997, 307(1): 77-83.
[56] LI HL, LIU H, XIONG LL, et al.Study on the glass transition temperature of binary solid solution composed with tanshinone Ⅱa and immediate-release excipients[J]. Chinese Journal of Modern Applied Pharmacy(中国现代应用药学), 2020, 37(12): 1417-1421.
[57] LI HL, LIU H, XIONG LL, et al.Influences of andrographolide on the glass transition temperature of different polymer-based precipitation inhibitors[J]. Research and Practice on Chinese Medicines(现代中药研究与实践), 2020, 34(2): 39-43.
[58] ZHANG J, ZHOU N, DU GF, et al.the effect of the test conditions on the temperature of the glass transition[J]. Yunnan Chemical Technology(云南化工), 2022, 49(5): 107-109.
[59] PANG CH, WU B, HUANG XB, et al.Optimization methods for glass transition temperature testing with DSC[J]. Synthetic Materials Aging and Application(合成材料老化与应用), 2019, 48(3): 23-25.
[60] JIN Y.Application of modulated DSC technology in the measurement of polyolefin glass transition temperature[J]. Advances in Fine Petrochemicals(精细石油化工进展), 2021, 22(1): 56-58.
[61] QIU ZX.Application of thermal analysis technology in drug inspection[J]. Cardiovascular Disease Journal of Integrated Traditional Chinese and Western Medicine(中西医结合心血管病电子杂志), 2018, 6(23): 40-41.
[62] ZHANG H.Advances in study on compatibility of drugs and excipients[J]. Biological Chemical Engineering(生物化工), 2018, 4(1): 111-112, 115.
[63] YUAN Y, CHEN LF, ZHOU ZY.Drug-excipients compatibility of piperazine ferulate tablets by DSC[J]. Chinese Journal of Drug Evaluation(中国药物评价), 2021, 38(6): 518-521.
[64] WU XJ, YAN XG, DENG YG.Study on the drug-excipient compatibility of entecavir tablets[J]. China Journal of Pharmaceutical Economics(中国药物经济学), 2021, 16(4): 115-120.
[65] ZHANG N, SU YC, SHEN JZ.Rapid identification of four traditional Chinese medicine formula particles by differential scanning calorimetry[J]. Strait Pharmaceutical Journal(海峡药学), 2019, 31(7): 43-45.
[66] GU JY, WU RG.Applications of differential scanning calorimetry in the study of the liposomes encapsulating traditional Chinese medicine[J]. Guiding Journal of Traditional Chinese Medicine and Pharmacology(中医药导报), 2018, 24(11): 63-65, 69.
[67] ZOU T, CHEN YD, MO DD, et al.Application of differential scanning calorimetry (DSC) in origin identification of Houttuynia cordata[J]. Analytical Instrumentation(分析仪器), 2021(1): 93-99.
[68] YUE GY, SUN ZQ, WANG BL, et al.TG-DSC thermal analysis of Larimichthys[J]. Chinese Journal of Marine Drugs(中国海洋药物), 2022, 40(1): 37-40.
[69] SHEN JZ, XU XF, SU YC.Identification of six kinds of marine and mineral drugs using DSC[J]. Medical Journal of National Defending Forces in Southwest China(西南国防医药), 2020, 30(12): 1084-1088.