[1] BANGHAM AD, STANDISH MM, WATKINS JC. Diffusion of univalent ions across the lamellae of swollen phospholipids[J].J Mol Biol, 1965, 13(1):238
[2] PETERSEN GH, ALZGHARI SK, CHEE W, et al. Meta-analysis of clinical and preclinical studies comparing the anticancer efficacy of liposomal versus conventional non-liposomal doxorubicin[J].J Control Release, 2016, 232: 255
[3] HYODO K, YAMAMOTO E, SUZUKI T, et al. Development of liposomal anticancer drugs[J].Biol Pharm Bull, 2013, 36(5):703
[4] ADLER-MOORE JP, GANGNEUX JP, PAPPAS PG. Comparison between liposomal formulations of amphotericin B[J].Med Mycol, 2016, 54(3):223
[5] BEZERRA CF, DE ALENCAR JU′NIOR JG, DE LIMA HONORATO R, et al. Antifungal activity of farnesol incorporated in liposomes and associated with fluconazole[J]. Chem Phys Lipids, 2020, 233: 104987
[6] 李和文, 潘弘, 甘莉. 布比卡因脂质体Exparel的发展及临床应用[J].中国处方药, 2021, 19(2):24
LI HW, PAN H, GAN L. Progress and clinical applications of the bupivacaine liposome injectable suspension Exparel[J].J China Prescript Drug, 2021, 19(2):24
[7] ALVING CR, BECK Z, MATYAS GR, et al. Liposomal adjuvants for human vaccines[J].Expert Opin Drug Deliv, 2016, 13(6):807
[8] DE SERRANO LO, BURKHART DJ. Liposomal vaccine formulations as prophylactic agents: design considerations for modern vaccines[J].J Nanobiotechnol, 2017, 15(1):83
[9] BRESSLER NM, BRESSLER SB. Photodynamic therapy with verteporfin(visudyne):impact on ophthalmology and visual sciences[J].Invest Ophthalmol Vis Sci, 2000, 41(3):624
[10] MUEHLMANN LA, JOANITTI GA, SILVA JR, et al. Liposomal photosensitizers: potential platforms for anticancer photodynamic therapy[J].Braz J Med Biol Res, 2011, 44(8):729
[11] AHMED KS, HUSSEIN SA, ALI AH, et al. Liposome: composition, characterisation, preparation, and recent innovation in clinical applications[J].J Drug Target, 2019, 27(7):742
[12] ZHANG H. Thin-film hydration followed by extrusion method for liposome preparation[J].Methods Mol Biol, 2017, 1522: 17
[13] MORTAZAVI SM, MOHAMMADABADI MR, KHOSRAVI-DARANI K, et al. Preparation of liposomal gene therapy vectors by a scalable method without using volatile solvents or detergents[J].J Biotechnol, 2007, 129(4):604
[14] HAS C, SUNTHAR P. A comprehensive review on recent preparation techniques of liposomes[J].J Liposome Res, 2020, 30(4):336
[15] JAAFAR-MAALEJ C, DIAB R, ANDRIEU V, et al.Ethanol injection method for hydrophilic and lipophilic drug-loaded liposome preparation[J].J Liposome Res, 2010, 20(3):228
[16] GENTINE P, BOUREL-BONNET L, FRISCH B. Modified and derived ethanol injection toward liposomes: development of the process[J].J Liposome Res, 2013, 23(1):11
[17] LUO Y, LIU Z, ZHANG X, et al. Effect of a controlled-release drug delivery system made of oleanolic acid formulated into multivesicular liposomes on hepatocellular carcinoma in vitro and in vivo[J].Int J Nanomed, 2016, 11: 3111
[18] SUN L, WANG T, GAO L, et al. Multivesicular liposomes for sustained release of naltrexone hydrochloride: design, characterization and in vitro/in vivo evaluation[J].Pharm Dev Technol, 2013, 18(4):828
[19] 王荷逸, 黄思凡, 王邦国, 等. 水溶性药物脂质体制备方法的研究进展[J].中国药学杂志, 2020, 55(23):1935
WANG HY, HUANG SF, WANG BG, et al. Progress on preparation method of water-soluble drug liposomes[J].Chin Pharm J, 2020, 55(23):1935
[20] 顾华芳, 徐歌, 朱柯武, 等. 脂质体主动载药技术研究进展[J].中国药剂学杂志, 2021, 19(6):173
GU HF, XU G, ZHU KW, et al. A review on progress involving remote loading for liposomes preparation[J].Chin J Pharm, 2021, 19(6):173
[21] BARENHOLZ Y. Doxil®-the first fda-approved nano-drug: lessons learned[J].J Control Release, 2012, 160(2):117
[22] YU B, LEE RJ, LEE LJ. Microfluidic methods for production of liposomes[J].Methods Enzymol, 2009, 465: 129
[23] ELSANA H, OLUSANYA TOB, CARR-WILKINSON J, et al. Evaluation of novel cationic gene based liposomes with cyclodextrin prepared by thin film hydration and microfluidic systems[J].Sci Rep, 2019, 9(1):15120
[24] DENG NN, YELLESWARAPU M, HUCK WT. Monodisperse uni- and multicompartment liposomes[J].J Am Chem Soc, 2016, 138(24):7584
[25] PENOY N, GRIGNARD B, EVRARD B, et al. A supercritical fluid technology for liposome production and comparison with the film hydration method[J].Int J Pharm, 2021, 592: 120093
[26] KARN PR, CHO W, HWANG SJ. Liposomal drug products and recent advances in the synthesis of supercritical fluid-mediated liposomes[J].Nanomedicine, 2013, 8(9):1529
[27] LIM CB, ABUZAR SM, KARN PR, et al. Preparation, characterization, and in vivo pharmacokinetic study of the supercritical fluid-processed liposomal amphotericin B[J].Pharmaceutics, 2019, 11(11):589
[28] FDA. Cuidance for Industry: Liposome Dmg Products Chemistry, Manufacturing, and Controls, Human Pharmacokinetics and Bioavailabiliy, and Labeling Documentation[DB/OL].2018[2022-02-16].https://www.fda.gov/media/70837/download
[29] EMA. Reflection Paper on the Data Requirements for Intravenous Liposomal Products Developed with Reference to An Innovator Liposomal Product[DB/OL].2013[2022-02-16].https://www.ema.europa.eu/en/data-requirements-intravenous-liposomal-products-developed-reference-innovator-liposomal-product-0
[30] TAKECHI-HARAYA Y, GODA Y, SAKAI-KATO K. Atomic force microscopy study on the stiffness of nanosized liposomes containing charged lipids[J].Langmuir, 2018, 34(26):7805
[31] SYBACHIN AV, ZABOROVA OV, BALLAUFF M, et al. Composition and properties of complexes between spherical polycationic brushes and anionic liposomes[J] Langmuir, 2012, 28(46):16108
[32] SOHEYLA HONARY, ZAHIR F. Effect of zeta potential on the properties of nano-drug delivery systems—a review (part 2)[J].Trop J Pharm Res, 2013, 12(2):265
[33] HOFFMANN M, HERSCH N, GERLACH S, et al. Complex size and surface charge determine nucleic acid transfer by fusogenic liposomes[J].Int J Mol Sci, 2020, 21(6):2244
[34] SMITH MC, CRIST RM, CLOGSTON JD, et al. Zeta potential: a case study of cationic, anionic, and neutral liposomes[J].Anal Bioanal Chem, 2017, 409(24):5779
[35] HOSHYAR N, GRAY S, HAN H, et al. The effect of nanoparticle size on in vivo pharmacokinetics and cellular interaction[J].Nanomedicine (Lond), 2016, 11(6):673
[36] 杨莉斌, 胡荣. 抗肿瘤药物脂质体粒径对肿瘤靶向性的影响[J].国外医学(药学分册), 2007, 34(3):174
YANG LB, HU R. The size of liposomes: a factor which affects their targeting efficiency to tumors[J].Foregin Med Sci: Pharm, 2007, 34(3):174
[37] JOSHI S, COOKE JR, CHAN DK, et al. Liposome size and charge optimization for intraarterial delivery to gliomas[J].Drug Deliv Transl Res, 2016, 6(3):225
[38] ONG SG, MING LC, LEE KS, et al. Influence of the encapsulation efficiency and size of liposome on the oral bioavailability of griseofulvin-loaded liposomes[J].Pharmaceutics, 2016, 8(3):25
[39] BREWER JM, TETLEY L, RICHMOND J, et al. Lipid vesicle size determines the Th1 or Th2 response to entrapped antigen[J].J Immunol, 1998, 161(8):4000
[40] WANG N, ZHEN Y, JIN Y, et al. Combining different types of multifunctional liposomes loaded with ammonium bicarbonate to fabricate microneedle arrays as a vaginal mucosal vaccine adjuvant-dual delivery system (vadds)[J].J Control Release, 2017, 246: 12
[41] 中华人民共和国药典2020年版.四部[S].2020:147, 178
ChP 2020. Vol Ⅳ[S].2020: 147, 178
[42] PALIWAL S, TILAK A, SHARMA J, et al. Flurbiprofen-loaded ethanolic liposome particles for biomedical applications[J].J Microbiol Methods, 2019, 161: 18
[43] PIROK BWJ, ABDULHUSSAIN N, AALBERS T, et al. Nanoparticle analysis by online comprehensive two-dimensional liquid chromatography combining hydrodynamic chromatography and size-exclusion chromatography with intermediate sample transformation[J].Anal Chem, 2017, 89(17):9167
[44] RILEY KR, EL HADRI H, TAN J, et al. High separation efficiency of gold nanomaterials of different aspect ratio and size using capillary transient isotachophoresis[J].J Chromatogr A, 2019, 1598: 216
[45] SINGH P, BODYCOMB J, TRAVERS B, et al. Particle size analyses of polydisperse liposome formulations with a novel multispectral advanced nanoparticle tracking technology[J].Int J Pharm, 2019, 566: 680
[46] 项心妍, 杜爽, 丁杨, 等. 脂质体注射剂的应用现状及其发展趋势[J].中国药科大学学报, 2020, 51(4):383
XIANG XY, DU S, DING Y, et al. Application and development of liposome injection[J].J China Pharm Univ, 2020, 51(4):383
[47] 宋丹军, 潘家琪, 李鹏旭, 等. 溶血磷脂酰胆碱在肝脏疾病中的研究进展[J].中国药理学通报, 2014, 30(12):1642
SONG DJ, PAN JQ, LI PX, et al. Research progress of lysophosphatidylcholine in liver diseases[J].Chin Pharmacol Bull, 2014, 30(12):1642
[48] 彭佩, 施红, 杨成雄, 等. HPLC-ELSD法同时测定复合磷脂脂质体中SPC、HSPC、胆固醇含量的方法及其应用[J].荆楚理工学院学报, 2016, 31(2):12
PENG P, SHI H, YANG CX, et al. Simultaneous determination of SPC, HSPC and cholesterol in compound phospholipid liposomes by HPLC-ELSD method and its application[J].J Jingchu Univ Technol, 2016, 31(02):12
[49] 李晗, 龚伟, 张慧, 等. HPLC-电喷雾检测器法测定长春瑞滨热敏脂质体中溶血磷脂含量[J].中国新药杂志, 2014, 23(13):1493
LI H, GONG W, ZHANG H, et al. Determination of lysolipid in vinorelbine liposome for injection by HPLC-charged aerosol detector[J].Chin J New Drugs, 2014, 23(13):1493
[50] 张艺, 杭太俊, 宋敏. 载药脂质体包封率测定方法的研究进展[J].中国药科大学学报, 2021, 52(2):245
ZHANG Y, HANG TJ, SONG M. Progress in research on the determination of entrapment efficiency of liposomes[J].J China Pharm Univ, 2021, 52(2):245
[51] RAN C, CHEN D, XU M, et al. A study on characteristic of different sample pretreatment methods to evaluate the entrapment efficiency of liposomes[J].J Chromatogr B Analyt Technol Biomed Life Sci, 2016, 1028: 56
[52] 曾慧琳, 王姗姗, 符旭东. 盐酸罗哌卡因多囊脂质体含量及包封率测定[J].中国药师, 2015, 18(1):14
ZENG HL, WANG SS, FU XD. Determination of content and entrapment efficiency of ropivacaine hydrochloride-loaded multivesicular liposomes[J].China Pharm, 2015, 18(1):14
[53] LV Y, HE H, QI J, et al. Visual validation of the measurement of entrapment efficiency of drug nanocarriers[J].Int J Pharm, 2018, 547(1-2):395
[54] YANAGIDA Y, NAMBA M, FUKUTA T, et al. Release rate is a key variable affecting the therapeutic effectiveness of liposomal fasudil for the treatment of cerebral ischemia/reperfusion injury[J].Biochem Biophys Res Commun, 2020, 531(4):622
[55] HIOKI A, WAKASUGI A, KAWANO K, et al. Development of an in vitro drug release assay of pegylated liposome using bovine serum albumin and high temperature[J].Biol Pharm Bull, 2010, 33(9):1466
[56] KHATIB I, TANG P, RUAN J, et al .Formation of ciprofloxacin nanocrystals within liposomes by spray drying for controlled release via inhalation[J].Int J Pharm, 2020, 578: 119045
[57] 高文慧, 陈美华, 曹雨酥, 等. 长循环吗啡脂质体的制备及质量评价[J].中国药师, 2020, 23(4):643
GAO WH, CHEN MH, CAO YS, et al. Preparation and quality evaluation of long-circulation morphine liposomes[J].China Pharm, 2020, 23(4):643
[58] MANNA S, WU Y, WANG Y, et al. Probing the mechanism of bupivacaine drug release from multivesicular liposomes[J].J Control Release, 2019, 294: 279
[59] OHNISHI N, TOMIDA H, ITO Y, et al. Characterization of a doxorubicin liposome formulation by a novel in vitro release test methodology using column-switching high-performance liquid chromatography[J].Chem Pharm Bull (Tokyo), 2014, 62(6):538
[60] 张春晓, 彭玉帅, 许卉, 等. 流池法的研究进展及应用[J].药物分析杂志, 2021, 41(2):195
ZHANG HX, PENG YS, XU H, et al. Development and application of flow through cell method[J].Chin J Pharm Anal, 2021, 41(2):195
[61] TANG J, SRINIVASAN S, YUAN W, et al. Development of a flow-through usp 4 apparatus drug release assay for the evaluation of amphotericin b liposome[J].Eur J Pharm Biopharm, 2019, 134: 107
[62] YUAN W, KUAI R, DAI Z, et al. Development of a flow-through USP-4 apparatus drug release assay to evaluate doxorubicin liposomes[J].AAPS J, 2017, 19(1):150
[63] BRAND W, NOORLANDER CW, GIANNAKOU C, et al. Nanomedicinal products: a survey on specific toxicity and side effects[J].Int J Nanomedicine, 2017, 12: 6107
[64] SOARES GC, LEARMONTH DA, VALLEJO MC, et al. Supercritical CO2 technology: the next standard sterilization technique?[J].Mater Sci Eng C Mater Biol Appl, 2019, 99: 520
[65] DELMA KL, LECHANTEUR A, EVRARD B, et al. Sterilization methods of liposomes: drawbacks of conventional methods and perspectives[J].Int J Pharm, 2021, 597: 120271
[66] 中华人民共和国药典 2020年版. 四部[S].2020:178
ChP 2020.Vol Ⅳ [S].2020: 178
[67] 国家食品药品监督管理局药品审评中心. 纳米药物质量控制研究技术指导原则[DB/OL].2021[2022-07-11].https://www.cde.org.cn/zdyz/index
CDE. Technical Guidelines for Quality Control of Nanodrugs[DB/OL].2021[2022-07-11].https://www.cde.org.cn/zdyz/index
[68] 潘卫松, 周永标, 张讷敏, 等. 多西他赛脂质体热原和细菌内毒素检查方法的研究[J].药物分析杂志, 2013, 33(2):326
PAN WS, ZHOU YB, ZHANG NM, et al. Study on theinspection method of pyrogen and bacterial endotoxin in docetaxel liposomes[J].Chin J Pharm Anal, 2013, 33(2):326
[69] 孙丹. 依托泊苷脂质微球注射液热原及细菌内毒素检查方法[J].中国医药科学, 2022, 12(3):71
SUN D. Methods for testing pyrogen and bacterial endotoxin in etoposideloaded lipid microsphere injection[J].China Med Pharm, 2022, 12(3):71
[70] HARMON P, CABRAL-LILLY D, REED RA, et al. The release and detection of endotoxin from liposomes[J].Anal Biochem, 1997, 250(2):139
[71] GIANNAKOU C, AIMONEN K, BLOOIS LV, et al. Sensitive method for endotoxin determination in nanomedicinal product samples[J].Nanomedicine (Lond), 2019, 14(10):1231