Research Progress of in Vitro Release Evaluation Methods for Nano Preparation
XIE Yuan-biao, YUE Peng-fei*, DAN Ji-xiu, XU Jun-nan, ZHENG Qin, YANG Ming
Key Lab of Modern Preparation of Traditional Chinese Medicine, Ministry of Education, Jiangxi University of Traditional Chinese Medicine, Nanchang 330004, China
Abstract��In vitro release is an important index to evaluate the quality of nano preparation, but there is no pharmacopoeia standard of in vitro release evaluation METHODS of nano preparation exists at present, it seriously restricts the safety improvement of nano preparation and the progress of its product development. The main in vitro release evaluation METHODS of nano preparation at present are sample and separate method, flow through cell method, dialysis method, franz diffusion cell method, combination METHODS , and the new METHODS of electrochemical method, nonelectrochemical method and microdialysis method. With the aim to optimize the improvement and development of in vitro release evaluation METHODS of nano preparation, this paper combined with the special properties of nano preparation and provided mainly the research status of in vitro release evaluation METHODS of nano preparation in recent years and their strengths and shortcomings.
RUPALI L S, SHASHIKANT N D, NILESH K, et al. Nanosuspension:a review [J]. Int J Pharm Sci Rev Res, 2013, 22(1):98-106.
[2]
YUAN Y, SUN Y N, LU C H. An overview of researches on biological characteristics and mechanism of nanomedicine [J]. Chin Pharmacol Bull(�й�ҩ��ѧͨ��), 2013, 29(8):1180-1184.
[3]
D��SOUZA S S. A review of in vitro drug release test methods for nano-sized dosage forms [J]. Adv Pharm, 2014, Article ID 304757.
[4]
CHEN L, TANG M, LU W G. Stability and controlling strategies in particle size of nanosuspension [J]. World Clin Drugs(�����ٴ�ҩ��), 2010, 31(4):245-249.
[5]
YUE P F,DAN J X,XIE Y B, et al. Research progress and thinking on nano-suspensions delivery system of indissoluble substance of traditional Chinese medicine [J]. World Chin Med(������ҽҩ), 2015, 10(3):310-314.
[6]
LIU L, XU L Z, HE X W, et al. Preparation and in vitro release of self-assembled neurotoxin-loaded nanoparticles of core-shell type [J]. Chin Pharm J(�й�ҩѧ��־), 2009, 44(14):1084-1088.
[7]
CHIDAMBARAM N, BURGESS D J. A novel in vitro release method for submicron-sized dispersed systems [J]. AAPS Pharm Sci, 1999, 1(3):1-9.
[8]
WANG L, LIU Y, FENG N P. Development of in vitro release methods in lipid nanoparticles drug delivery system [J]. Chin J Exp Tradit Med Form(�й�ʵ�鷽��ѧ��־), 2013, 19(18):350-356.
[9]
SUN Q, YANG L, CHEN X L, et al. Evaluation of release behaviors of pyridostigmine bromide nanoemulsion in vitro [J]. Chin Hosp Pharm J(�й�ҽԺҩѧ��־), 2015, 35(2):132-135.
[10]
LV C H. Research of drug release:an overview [J]. Anhui Med Pharm J(����ҽҩ), 2007, 11(1):76-77.
[11]
D��SOUZA S S, DELUCA P P. Methods to assess in vitro drug release from injectable polymeric particulate systems [J]. Pharm Res, 2006, 23(3):460-474.
[12]
LAI F, PINI E, ANGIONI G, et al. Nanocrystals as tool to improve piroxicam dissolution rate in novel orally disintegrating tablets [J]. Eur J Pharm Biopharm, 2011, 7(5):1-7.
[13]
ZHANG Y Z, WANG H, LI C J, et al. A novel three-dimensional large-pore mesoporous carbon matrix as a potential nanovehicle for the fast release of the poorly water-soluble drug, celecoxib [J]. Pharm Res, 2014, 31(4):1059-1070.
[14]
CETIN M, ATILA A, KADIOGLU Y. Formulation and in vitro characterization of Eudragit�j L100 and Eudragit�jL100-PLGA nanoparticles containing diclofenac sodium [J]. AAPS Pharm Sci Tech, 2010, 11(3):1250-1256.
[15]
HENG D, CUTLER D J, CHAN H K, et al. What is a suitable dissolution method for drug nanoparticles? [J]. Pharm Res, 2008, 25(7):1696-1701.
[16]
YUE P F, LU X Y, ZHANG Z Z, et al. The study on the entrapment efficiency and in vitro release of puerarin submicron emulsion [J]. AAPS Pharm Sci Tech, 2009, 10(2):376-383.
[17]
DANHIER F, LECOUTURIER N, VROMAN B, et al. Paclitaxel-loaded PEGylated PLGA-based nanoparticles:in vitro and in vivo evaluation [J]. J Controlled Release, 2009, 133(1):11-17.
[18]
WALLACE S J, LI J, NATION R L, et al. Drug release from nanomedicines:selection of appropriate encapsulation and release methodology [J]. Drug Deliv Transl Res, 2012, 2(4):284-292.
[19]
MAHKAM M, HOSSEINZADEH F, GALEHASSADI M. Preparation of ionic liquid functionalized silica nanoparticles for oral drug delivery [J]. J Biomater Nanobiotechnol, 2012, 3(3):391-395.
[20]
LI Y P, PEI Y Y, ZHANG X Y, et al. PEGylated PLGA nanoparticles as protein carriers:synthesis, preparation and biodistribution in rats [J]. J Controlled Release, 2001, 71(2):203-211.
[21]
PRABHA S, ZHOU W Z, PANYAM J, et al. Size-dependency of nanoparticle-mediated gene transfection:studies with fractionated nanoparticles [J]. Int J Pharm, 2002, 244(1-2):105-115.
[22]
FOTAKI N. Flow-through cell apparatus(USP apparatus 4):operation and features [J]. Dissol Technol, 2011, 18(4):46-49.
[23]
ZHAO J, YI H, LIU X Q, et al. Progress in application of flow-through cell method for determination of drug dissolution [J]. Chin Pharm J(�й�ҩѧ��־), 2014, 49(17):1486-1490.
[24]
HU P Y, ZHENG Q, LIU Y J, et al. Preparation and in vitro drug-release behavior of sophoridine nano-liposomes using pH-gradients method coupled with reverse evaporation technique [J]. Chin J New Drugs(�й���ҩ��־), 2011, 20(14):1275-1279.
[25]
LIU D, LI S B, BAO J, et al. Preparation, in vitro release and pharmacokinetics of paclitaxel lipid nanoparticles for intravenous injection [J]. Chin Pharm J(�й�ҩѧ��־), 2009, 44(17):1320-1326.
[26]
UPRIT S, SAHUK R K, ROY A, et al. Preparation and characterization of minoxidil loaded nanostructured lipid carrier gel for effective treatment of alopecia [J]. Saudi Pharm J, 2013, 21(4):379-385.
[27]
ABDEL-MOTTALEB M M A, LAMPRECHT A. Standardized in vitro drug release test for colloidal drug carriers using modified USP dissolution apparatus I [J]. Drug Dev Ind Pharm, 2011, 37(2):178-184.
[28]
CAO X, DENG W W, FU M, et al. In vitro release and in vitro-in vivo correlation for silybin meglumine incorporated into hollow-type mesoporous silica nanoparticles [J]. Int J Nanomed, 2012, 7(2):753-762.
[29]
MAGHSOUDI A, SHOJAOSADATI S A, VASHEGHANI FARAHANI E, et al. 5-fluorouracil-loaded BSA nanoparticles:formulation optimization and in vitro release study [J]. AAPS Pharm Sci Tech, 2008, 9(4):1092-1096.
[30]
BHARDWAJ U, BURGESS D J. A novel USP apparatus 4 based release testing method for dispersed systems [J]. Int J Pharm, 2010, 388(1-2):287-294.
[31]
MORA L, CHUMBIMUNI-TORRES K Y, CLAWSON C, et al. Real-time electrochemical monitoring of drug release from therapeutic nanoparticles [J]. J Controlled Release, 2009, 140(1):69-73.
[32]
HELLE A, HIRSJARVI S, PELTONEN L, et al. Novel, dynamic on-line analytical separation system for dissolution of drugs from poly(lactic acid) nanoparticles [J]. J Pharm Biomed, 2010, 51(1):125-130.
[33]
MICHALOWSKI C B, GUTERRES S S, COSTA T D. Microdialysis for evaluating the entrapment and release of a lipophilic drug from nanoparticles [J]. J Pharm Biomed, 2004, 35(5):1093-1100.
[34]
KUMAR R, NAGARWAL R C, DHANAWAT M, et al. In vitro and in vivo study of indomethacin loaded gelatin nanoparticles [J]. J Biomed Nanotechnol, 2011, 7(2):1-9.
[35]
YI Y N, TU L X, HU K L, et al. The construction of puerarin nanocrystals and its pharmacokinetic and in vivo-in vitro correlation(IVIVC) studies on beagle dog [J]. Colloid Surface B Biointerfaces, 2015, 133:164-170.
2016, Vol. 51 
