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1.中国药科大学,南京 211198
2.天士力医药集团股份有限公司 中药先进制造技术国家地方联合工程实验室,天津 300410
3.浙江大学,杭州 310058
李瑶瑶,在读硕士,从事中药质量控制研究,E-mail:2581541008@qq.com
熊皓舒,高级工程师,从事中药国际化及先进制造技术研究,E-mail:xionghaoshu@tasly.com
* 章顺楠,研究员,从事中药国际化及先进制造技术研究,E-mail:zsn@tasly.com; *
收稿日期:2020-01-08,
网络出版日期:2020-02-18,
纸质出版日期:2020-11-05
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李瑶瑶,张凯旋,熊皓舒等.质构仪在药物制剂研究中的应用进展[J].中国实验方剂学杂志,2020,26(21):226-234.
LI Yao-yao,ZHANG Kai-xuan,XIONG Hao-shu,et al.Application Progress of Texture Analyzer in Pharmaceutical Preparation Research[J].Chinese Journal of Experimental Traditional Medical Formulae,2020,26(21):226-234.
李瑶瑶,张凯旋,熊皓舒等.质构仪在药物制剂研究中的应用进展[J].中国实验方剂学杂志,2020,26(21):226-234. DOI: 10.13422/j.cnki.syfjx.20201063.
LI Yao-yao,ZHANG Kai-xuan,XIONG Hao-shu,et al.Application Progress of Texture Analyzer in Pharmaceutical Preparation Research[J].Chinese Journal of Experimental Traditional Medical Formulae,2020,26(21):226-234. DOI: 10.13422/j.cnki.syfjx.20201063.
质构仪是一种多功能物性分析仪,通过压缩、穿刺、剪切及拉伸等多种测试模式,表征硬度、黏附性、弹性、内聚性等多种物性特征参数,结果客观、灵敏、准确,能够为药物制剂基础理论阐释、处方工艺优化、质量控制研究提供理论基础和参考。该文首先对质构仪原理、测试模式、测量指标以及测量数据分析方法进行概述;其次详述质构仪在固体制剂、半固体制剂、液体制剂、中药饮片及其中间体中的应用进展,并与当前常用物性指标测量方法进行对比分析;最后对质构仪应用前景和待完善研究内容进行评述,以期方便药学研究者利用质构仪推动制剂学相关领域发展,为药物制剂研究与开发提供新思路和新方法。
Texture analyzer is a multifunctional physical property analyzer. Through a variety of test modes such as compression, puncture, shearing and stretching, hardness, adhesion, elasticity, cohesiveness and other physical property parameters are characterized. The results are objective, sensitive, and accurate, which can provide theoretical basis and reference for interpretation of basic theoretical, optimization of prescription technology and quality control research of pharmaceutical preparations. Firstly, the principles, test modes, measurement indexes and measurement data analysis methods of texture analyzer were summarized in this paper. Secondly, the application progress of texture analyzer in solid preparations, semi-solid preparations, liquid preparations, traditional Chinese medicine decoction pieces and their intermediates was described in detail, and compared with the commonly used measurement methods of physical property indicators. Finally, the application prospects of texture analyzer and its research contents to be improved were reviewed, so as to facilitate the use of texture analyzer by pharmaceutical researchers to promote the development of related fields of pharmaceutics, and to provide new ideas and methods for the research and development of pharmaceutical preparations.
胡亚云 . 质构仪在食品研究中的应用现状 [J]. 食品研究与开发 , 2013 , 34 ( 11 ): 101 - 104 .
李里特 . 食品物性学 [M]. 北京 : 中国农业出版社 , 2001 : 96 - 100 .
李小城 , 牛智有 , 刘梅英 , 等 . 小麦茎秆弯曲性能的测试 [J]. 华中农业大学学报 , 2013 , 32 ( 1 ): 120 - 124 .
NASEREDDIN J M , WELLNER N , ALHIJIAJ M , et al . Development of a simple mechanical screening method for predicting the feedability of a pharmaceutical FDM 3D printing filament [J]. Pharm Res , 2018 , 35 ( 8 ): 151 - 164 .
朱如愿 , 刘海霞 , 柳辰玥 , 等 . 肉桂醛通过调节Cathepsin K改善高脂饮食C57BL/6小鼠骨微结构和骨强度的实验研究 [J]. 中华中医药学刊 , 2017 , 35 ( 8 ): 2108 - 2111 .
罗斌 , 赵有斌 , 尹学清 , 等 . 质构仪在果蔬品质评定中应用的研究进展 [J]. 食品研究与开发 , 2019 , 40 ( 5 ): 217 - 221 .
张秋会 , 宋莲军 , 黄现青 , 等 . 质构仪在食品分析与检测中的应用 [J]. 农产品加工 , 2017 ( 12 ): 52 - 56 .
程学勋 , 林洁文 , 黄敏 , 等 . 质构仪及其在食品研究中的应用简介 [J]. 广东化工 , 2012 , 39 ( 9 ): 164 - 165 .
BUCK J , HUWYLER J , KÜHL P , et al . Pediatric dispersible tablets:a modular approach for rapid prototyping [J]. Pharm Res , 2016 , 33 ( 8 ): 2043 - 2055 .
LAFOUNTAINE J S , PRASAD L K , MILLER D A , et al . Mucoadhesive amorphous solid dispersions for sustained release of poorly water soluble drugs [J]. Eur J Pharm Biopharm , 2017 , 113 : 157 - 167 .
WANG C G , HU S Y , SUN C C . Expedited development of diphenhydramine orally disintegrating tablet through integrated crystal and particle engineering [J]. Mol Pharm , 2017 , 14 ( 10 ): 3399 - 3408 .
CHANG S Y , LI J X , SUN C C . Tensile and shear methods for measuring strength of bilayer tablets [J]. Int J Pharm , 2017 , 523 ( 1 ): 121 - 126 .
SHARMA O P , SHAH M V , PARIKH D C , et al . Formulation optimization of gastroretentive drug delivery system for allopurinol using experimental design [J]. Expert Opin Drug Deliv , 2015 , 12 ( 4 ): 513 - 524 .
SANKAR R , JAIN S K . Development and characterization of gastroretentive sustained-release formulation by combination of swelling and mucoadhesive approach:a mechanistic study [J]. Drug Des Devel Ther , 2013 , doi: 10.2147/DDDT.S52890 http://dx.doi.org/10.2147/DDDT.S52890 .
CHOI D H , LIM D G , SON H M , et al . Comprehensive evaluation of layer separation tendency of novel three-layered tablets with geometric and mechanical properties [J]. Int J Pharm , 2014 , 465 ( 1/2 ): 347 - 359 .
MALIK K , RANA V , SINGH I , et al . Gum ghatti—a pharmaceutical excipient:development,evaluation and optimization of sustained release mucoadhesive matrix tablets of domperidone [J]. Acta Pol Pharm , 2012 , 69 ( 4 ): 725 - 737 .
ARORA G , MALIK K , SINGH I . Formulation and evaluation of mucoadhesive matrix tablets of taro gum:optimization using response surface methodology [J]. Polim Med , 2011 , 41 ( 2 ): 23 - 34 .
KÖRNER A , LARSSON A , ANDERSSON A , et al . Swelling and polymer erosion for poly(ethylene oxide) tablets of different molecular weights polydispersities [J]. J Pharm Sci , 2010 , 99 ( 3 ): 1225 - 1238 .
El-ARINI S K , CLAS S K . Evaluation of disintegration testing of different fast dissolving tablets using the texture analyzer [J]. Pharm Dev Technol , 2002 , 7 ( 3 ): 361 - 371 .
SCHEUERLE R L , GERRARD S E , KENDALL R A , et al . Characterising the disintegration properties of tablets in opaque media using texture analysis [J]. Int J Pharm , 2015 , 486 ( 1/2 ): 136 - 143 .
DOR P J , FIX J A . In vitro determination of disintegration time of quick-dissolve tablets using a new method [J]. Pharm Dev Technol , 2000 , 5 ( 4 ): 575 - 577 .
RAHMAN Z , ZIDAN A S , KORANG-YEBOAH M , et al . Effects of excipients and curing process on the abuse deterrent properties of directly compressed tablets [J]. Int J Pharm , 2016 , 517 ( 1/2 ): 303 - 311 .
MEI X H , ETZLER F M , WANG Z R . Use of texture analysis to study hydrophilic solvent effects on the mechanical properties of hard gelatin capsules [J]. Int J Pharm , 2006 , 324 ( 2 ): 128 - 135 .
KUENTZ M , RÖTHLISBERGER D . Determination of the optimal amount of water in liquid-fill masses for hard gelatin capsules by means of texture analysis and experimental design [J]. Int J Pharm , 2002 , 236 ( 1/2 ): 145 - 152 .
GRAB S , ROHAN L C . A quantitative disintegration method for polymeric films [J]. J Pharm Innov , 2018 , 13 ( 4 ): 321 - 329 .
KHATRI P , DESAI D , MINKO T . On the plasticizing properties of divalproex sodium:physicochemical and spectroscopic characterization studies [J]. Pharm Dev Technol , 2019 , 24 ( 4 ): 455 - 464 .
JANTRAWUT P , BOONSERMSUKCHAROEN K , THIPNAN K , et al . Enhancement of antibacterial activity of orange oil in pectin thin film by microemulsion [J]. Nanomaterials (Basel) , 2018 , 8 ( 7 ): 545 - 557 .
MENG-LUND E , MUFF-WESTERGAARD C , SANDER C , et al . A mechanistic based approach for enhancing buccal mucoadhesion of chitosan [J]. Int J Pharm , 2014 , 461 ( 1/2 ): 280 - 285 .
SINGH K , SURI R , TIWARY A K , et al . Chitosan films:crosslinking with EDTA modifies physicochemical and mechanical properties [J]. J Mater Sci Mater Med , 2012 , 23 ( 3 ): 687 - 695 .
HAGESAETHER E , HIORTH M , SANDE S A . Mucoadhesion and drug permeability of free mixed films of pectin and chitosan:an in vitro and ex vivo study [J]. Eur J Pharm Biopharm , 2009 , 71 ( 2 ) : 325 - 331 .
CHO C H , HWANG K M , SEOK S H , et al . Preparation and characterization of high drug-loaded microgranules:particle sizing and mechanical properties [J]. Powder Technol , 2018 , 326 : 344 - 355 .
THI T H H , LHAFIDI S , CARNEIRO S P , et al . Feasability of a new process to produce fast disintegrating pellets as novel multiparticulate dosage for pediatric use [J]. Int J Pharm , 2015 , 496 ( 2 ): 842 - 849 .
SRICHAN T , PHAECHAMUD T . Designing solvent exchange-induced in situ forming gel from aqueous insoluble polymers as matrix base for periodontitis treatment [J]. AAPS PharmSciTech , 2017 , 18 ( 1 ): 194 - 201 .
PUND S , PAWAR S , GANGURDE S , et al . Transcutaneous delivery of leflunomide nanoemulgel:mechanistic investigation into physicomechanical characteristics, in vitro anti-psoriatic and anti-melanoma activity [J]. Int J Pharm , 2015 , 487 ( 1/2 ): 148 - 156 .
CALIXTO G , YOSHII A C , SILVA H R E , et al . Polyacrylic acid polymers hydrogels intended to topical drug delivery:preparation and characterization [J]. Pharm Dev Technol , 2015 , 20 ( 4 ): 490 - 496 .
LU Z , FASSIHI R . Influence of colloidal silicon dioxide on gel strength,robustness,and adhesive properties of diclofenac gel formulation for topical application [J]. AAPS PharmSciTech , 2015 , 16 ( 3 ): 636 - 644 .
RAI V K , YADAV N P , SINHA P , et al . Development of cellulosic polymer based gel of novel ternary mixture of miconazole nitrate for buccal delivery [J]. Carbohydr Polym , 2014 , 103 : 126 - 133 .
HURLER J , ENGESLAND A , KERMANY B P , et al . Improved texture analysis for hydrogel characterization:gel cohesiveness,adhesiveness and hardness [J]. J Appl Polym Sci , 2012 , 125 ( 1 ): 180 - 188 .
MEHER J G , YADAV N P , SAHU J J , et al . Determination of required hydrophilic-lipophilic balance of citronella oil and development of stable cream formulation [J]. Drug Dev Ind Pharm , 2013 , 39 ( 10 ): 1540 - 1546 .
BHAGURKAR A M , ANGAMUTHU M , PATIL H , et al . Development of an ointment formulation using hot-melt extrusion technology [J]. AAPS PharmSciTech , 2016 , 17 ( 1 ): 158 - 166 .
YADAV N P , RAI V K , MISHRA N , et al . A novel approach for development and characterization of effective mosquito repellent cream formulation containing citronella oil [J]. Biomed Res Int , 2014 , doi: 10.1155/2014/786084 http://dx.doi.org/10.1155/2014/786084 .
CILURZO F , SELMIN F , MINGHETTI P , et al . Injectability evaluation:an open issue [J]. AAPS PharmSciTech , 2011 , 12 ( 2 ): 604 - 609 .
WATANABE I , HOSHI H , SATO M , et al . Rheological and adhesive properties to identify cohesive and dispersive ophthalmic viscosurgical devices [J]. Chem Pharm Bull (Tokyo) , 2019 , 67 ( 3 ): 277 - 283 .
彭诗涛 , 张先灵 , 袁金凤 , 等 . 基于张仲景学术思想的炮附子4种炮制方法的比较研究 [J]. 世界科学技术—中医药现代化 , 2018 , 20 ( 5 ): 716 - 721 .
陈彦琳 , 周林 , 杜杰 , 等 . 不同炮制方法制备附片的质构分析 [J]. 中国现代中药 , 2015 , 17 ( 10 ): 1075 - 1077 .
畅柯飞 . 不同加工方式对鹿茸制品物理化学特性的影响 [D]. 长春 : 吉林大学 , 2017 .
王玲 , 鲜洁晨 , 洪燕龙 , 等 . 塑制法制备中药丸剂中丸条物理特性与丸粒质量相关性研究 [J]. 中国中药杂志 , 2012 , 37 ( 9 ): 1206 - 1211 .
冯欣 , 徐冰 , 杜菁 , 等 . 蜜丸合坨过程物理特性参数表征方法研究 [J]. 世界科学技术—中医药现代化 , 2015 , 17 ( 1 ): 272 - 277 .
GAO Y , HONG Y L , XIAN J C , et al . A protocol for the classification of wet mass in extrusion-spheronization [J]. Eur J Pharm Biopharm , 2013 , 85 ( 3 ): 996 - 1005 .
李磊 , 沈岚 , 王晓柠 , 等 . 基于软材物性参数的黄芪总皂苷生物黏附微丸的制备和黏附性能评价 [J]. 药学学报 , 2019 , 54 ( 11 ): 2093 - 2099 .
孙阳恩 , 李丽 , 史兆松 , 等 . 阿胶凝胶强度标准化检测方法研究 [J]. 中国现代中药 , 2017 , 19 ( 12 ): 1750 - 1753 .
佟晔 , 丁雪鹰 , 高静 , 等 . 中药口崩片体外崩解时限测定方法的研究 [J]. 第二军医大学学报 , 2009 , 30 ( 7 ): 846 - 849 .
PODCZECK F . Methods for the practical determination of the mechanical strength of tablets—from empiricism to science [J]. Int J Pharm , 2012 , 436 ( 1/2 ): 214 - 232 .
吕琳 , 王国杰 , 何晓明 , 等 . 生物黏附给药系统黏附性能的体外评价方法的研究进展 [J]. 中国药师 , 2016 , 19 ( 9 ): 1752 - 1755 .
岳素荣 , 贺吉香 , 王剑 . 高乌甲素凝胶贴膏的流变学研究 [J]. 中国现代应用药学 , 2016 , 33 ( 7 ): 900 - 904 .
REINEKE J , CHO D Y , DINGLE Y L , et al . Can bioadhesive nanoparticles allow for more effective particle uptake from the small intestine [J]. J Control Release , 2013 , 170 ( 3 ): 477 - 484 .
PAWAR J , NARKHEDE R , AMIN P , et al . Design and evaluation of topical diclofenac sodium gel using hot melt extrusion technology as a continuous manufacturing process with Kolliphor ® P407 [J]. AAPS PharmSciTech , 2017 , 18 ( 6 ): 2303 - 2315 .
ICH . Test procedures and acceptance criteria for new drug substances and new drug products:chemical substances [EB/OL]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q6a-specifications-test-procedures-and-acceptance-criteria-new-drug-substances-and-new-drug-products https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q6a-specifications-test-procedures-and-acceptance-criteria-new-drug-substances-and-new-drug-products , 2000-12-01 / 2020-01-05 .
FDA . Container closure system for packaging human drugs and biologics [EB/OL]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/container-closure-systems-packaging-human-drugs-and-biologics https://www.fda.gov/regulatory-information/search-fda-guidance-documents/container-closure-systems-packaging-human-drugs-and-biologics , 1999 - 05 / 2020-01-05 .
张兆旺 . 中药药剂学 [M]. 北京 : 中国中医药出版社 , 2007 : 334 .
THAPA P , THAPA R , CHOI D H , et al . Effects of pharmaceutical processes on the quality of ethylcellulose coated pellets:quality by design approach [J]. Powder Technol , 2018 , 339 : 25 - 38 .
国家药典委员会 . 中华人民共和国药典:四部 [M]. 北京 : 中国医药科技出版社 , 2015 : 59 - 61 .
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