中药缓控释制剂研究进展

doi:10.19803/j.1672-8629.20240249

摘要/Abstract

摘要： 目的归纳中药缓控释制剂研究进展,为了解中药缓控释制剂制备工艺、处方和质量评价提供参考。方法通过文献检索,对不同缓控释制剂新类型的优缺点,中药缓控释制剂制备工艺、质量评价体系进行分析。结果缓控释制剂新类型涉及固体脂质纳米粒缓控释制剂、口服渗透泵缓控释制剂、胃滞留给药缓控释制剂、生物黏附微球、固体分散体,制备工艺采用多种筛选方法得出最佳工艺,中药缓控释制剂的质量评价方法包括体外释放度研究、体内释药和体内外相关性研究等。结论中药缓控释制剂研究主要集中在中药单体成分、中药提取物或有效部位、中药多个单体成分组合开发的中药制剂,质量评价体系主要有体内释放度、体外释放度和体内外相关性研究,可为中药缓控释制剂发展提供参考。

关键词: 中药缓控释制剂, 制备工艺, 质量评价, 处方

Abstract: Objective To summarize the research progress on the slow and controlled release preparations of traditional Chinese medicine, and provide a basis for understanding the preparation process, prescription and quality evaluation of slow and controlled release preparations of traditional Chinese medicine. Methods Through literature search,the advantages and disadvantages, preparation process, and quality evaluation system was summarized from different new types of sustained and controlled release formulations. Results The new types of sustained and controlled release formulations involve solid lipid nanoparticles sustained and controlled release formulations, oral osmotic pump sustained and controlled release formulations, gastric retention delivery sustained and controlled release formulations, bioadhesive microspheres, and solid dispersions, and the preparation process uses multiple screening methods to arrive at the optimal process, and the quality evaluation methods for the sustained and controlled release formulations of traditional Chinese medicines include in vitro release studies, in vivo release, and in vitro and in vivo correlation studies. Conclusion The research on slow and controlled release preparations of traditional Chinese medicine mainly focuses on the single component of traditional Chinese medicine, traditional Chinese medicine extracts or active parts, and combination of several single components of traditional Chinese medicine, and the quality evaluation system mainly includes in vivo release, in vitro release and in vitro and in vivo correlation studies, which can provide reference basis for the future development of slow and controlled release preparations of traditional Chinese medicine.

Key words: Chinese medicine sustained and controlled release preparation, preparation techniques, quality evaluation, prescription

中图分类号:

R969.1
R944

孙莉, 谢彬, 徐艳琴. 中药缓控释制剂研究进展[J]. 中国药物警戒, 2024, 21(8): 949-954.

SUN Li, XIE Bin, XU Yanqin. Research progress of sustained and controlled release preparations of Chinese medicine[J]. Chinese Journal of Pharmacovigilance, 2024, 21(8): 949-954.

导出引用管理器 EndNote|Ris|BibTeX

链接本文: https://zgywjj.magtechjournal.com/CN/10.19803/j.1672-8629.20240249

https://zgywjj.magtechjournal.com/CN/Y2024/V21/I8/949

参考文献

[1] QIU CY.Study on the academic experience of professor Wu Bingcai in the application of pills[D]. Nanchang: Jiangxi University of Chinese Medicine, 2023.
[2] LI WM, ,YU Q, XU BL, et al. Research progress of sustained and controlled release preparations of Chinese medicine[J]. Chinese Medicine Modern Distance Education of China(中国中医药现代远程教育), 2023, 21(1): 200-203.
[3] FANG RH, YANG ZQ, LI BS, et al.Research progress of targeted treatment of brain diseases with Chinese medicine nanotechnology[J].Chinese Journal of Comparative Medicine(中国比较医学杂志), 2023, 33(6): 128-140.
[4] ZHAO JH, LlU YY, YAO D, et al. Research progress of solid lipid nanoparticles and nanostructure lipid carriers[J/OL]. China Oils and Fats(中国油脂), (2023-07-27)[2024-03-14]. https://doi.org/10.19902/j.cnki.zgyz.1003-7969.230028.
[5] GHASEMIYEH P, SOLIMAN MS.Solid lipid nanoparticles and nanostructured lipid carriers as novel drug delivery systems: applications, advantages and disadvantages[J]. Res Pharmaceut Sci, 2018, 13(4): 288-303.
[6] LIU JH, SUN LJ.Applications of lipid nanoparticles in treating skin diseases in transdermal drug delivery system[J].Guangdong Chemical Industry(广东化工), 2024, 51(6): 82-84.
[7] CHEN XY, YUAN F, SHI KQ, et al.Recent advances of film coating for osmotic drug delivery systems[J].Chinese Pharmaceutical Journal(中国药学杂志), 2021, 56(23): 1874-1879.
[8] SHENG XL, SONG XM, PENG J.Usage of sustained and controlled release preparations in a hospital[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2020, 17(10): 740-744.
[9] ZENG Y, ZHU LQ, PENG Y, et al.Optimization of the prescription and preparation process of difenidol hydrochloride single-layer osmotic pump controlled-release tablets[J]. China Pharmaceuticals(中国药业), 2021, 30(9): 22-26.
[10] PANG R, LI KY, WANG CY, et al.Preparation and in vivo pharmacokinetics of monolithic osmotic pump tablets of ursolic acid solid dispersions[J].Chinese Traditional Patent Medicine(中成药), 2022, 44(7): 2088-2093.
[11] LI YJ, ZHOU J.Preparation and optimization of brucine push-pull osmotic pump controlled release tablets formulation[J]. Chinese Journal of Modern Applied Pharmacy(中国现代应用药学), 2019, 36(22): 2805-2809.
[12] ZHANG XQ.Study on the preparation process of gastric floating slow release tablets for the relief of alcohol[D]. Harbin: Harbin University of Commerce, 2023.
[13] GENG YN, LOU TT, WU YJ, et al.Preparation of floating eucommia ulmoides tablets for pulsatile release[J]. China Pharmaceuticals(中国药业), 2020, 29(7): 82-86.
[14] RAHAMATHULLA M, SAISIVAM S, GANGADHARAPPA HV.Development of valsartan floating matrix tablets using low density polypropylene foam powder: in vitro and in vivo evaluation[J]. Aaps Pharmscitech, 2019, 20(1): 35.
[15] ZHANG PC, FANG D, HAO HJ, et al.Preparation of evodiamine gastric floating tablets and their protective effects on rabbitgastric mucosa injury[J]. Chinese Traditional Patent Medicine(中成药), 2023, 45(11): 3527-3533.
[16] HUANG ZY, FANG D, HAO HJ, et al.Preparation and evaluation of gastric floating tablets of Costunolide and Dehydrocostus lactone and study of drug release mechanism[D]. Chengdu: Chengdu University of Traditional Chinese Medicine, 2022.
[17] LIU W, LIU W, SONG XL, et al.Preparation and quality evaluation of breviscapine gastric adhesive tablets[J]. China Pharmacy(中国药房), 2020, 31(14): 1690-1694.
[18] AN Y, JIA L, LI L, et al.Preparation technology and in vitro properties of curcumin bioadhesive microspheres[J]. Journal of Heze Medical College(菏泽医学专科学校学报), 2020, 32(4): 88-91.
[19] LUO WQ.Study on the scale-up preparation of acyclovir-loaded bioadhesive microspheres[D]. Shanghai: Fudan University, 2012.
[20] ZHANG XY, YING ZH, GUO SB, et al.Research progress on preparation techniques and quality control of solid dispersions[J]. China Powder Science and Technology(中国粉体技术), 2024, 30(2): 96-112.
[21] SONG XL, YANG DB, WANG YL, et al.Optimizing preparation technology of strychnos alkaloids microcapsules by central composite design-response surface method[J]. China Journal of Traditional Chinese Medicine and Pharmacy(中华中医药杂志), 2018, 33(4): 1582-1587.
[22] MA QB, GAO JW, ZHU XJ, et al. Optimization of preparation technology of angelica oil microcapsules by Box-Behnken response surface methodology and quality evaluation[J/OL]. Chinese Archives of Traditional Chinese Medicine(中华中医药学刊), (2024-04-21)[2024-07-31]. http://kns.cnki.net/kcms/detail/21.1546.R.20240419.1350.022.html.
[23] QIU K, ZHOU LM, WANG S, et al.Preparation and quality evaluation of panax notoginseng saponins multivesicular liposomes[J]. Chinese Pharmaceutical Journal(中国药学杂志), 2023, 58(24):2259-2266.
[24] DENG XT, HAO HJ, HAN R, et al.Preparation technique of monolithic osmotic pump tablet containing inclusion complex of baicalein[J]. Academic Journal of Second Military Medical University(第二军医大学学报), 2015, 36(5): 513-517.
[25] PANG R, LI KY, WANG CY.Preparation and in vivo pharmacokinetics of monolithic osmotic pump tablets of ursolicacid solid dispersions[J].Chinese Traditional Patent Medicine(中成药), 2022, 44(7): 2088-2093.
[26] LI K, HE XX, HE ZL, et al.Preparation, quality evaluation and therapeutic effect of pseudolaric acid B liposome gel in mice with atopic dermatitis[J]. Chinese Journal of New Drugs(中国新药杂志), 2022, 31(16): 1623-1630.
[27] TU Q, JIAN YY, XIE DM, et al.Preparation and physicochemical properties of cinnamon essential oil liposomes[J]. Food and Fermentation Industries(食品与发酵工业), 2023, 49(17): 194-201.
[28] WANG FJ, LONG J, GAO N, et al.Study on preparation process of chelidonium majus total alkaloid sustained-release tablets[J].Chinese Journal of Ethnomedicine and Ethnopharmacy(中国民族民间医药), 2024, 33(4): 13-17.
[29] LIN QW, ZHONG HL, LI PB, et al.Preparation of berberine hydrochloride enteric-coated sustained release tablets[J]. Journal of Pharmaceutical Research(药学研究), 2022, 41(5): 307-311.
[30] LU DY.Preparation and quality evaluation of ligustrazine phosphate sustained-release pellets[D]. Nanchang: Jiangxi University of Chinese Medicine, 2021.
[31] LI CM, SHI TH, CHEN X, et al.Preparation process optimization and in vitro and in vivo properties of sanguinarine chitosan microspheres[J]. Special Wild Economic Animal and Plant Research(特产研究), 2024, 46(2): 36-46.
[32] CHEN C, DONG YS, LI WZ, et al.Preparation and quality evaluation of porous drug-loaded microsphere based on Bletilla striata polysaccharide[J]. Chemical Engineer(化学工程师), 2023, 37(9): 1-4.
[33] LI N, DENG YP.Preparation of solid lipid nanoparticles loaded with emodin based on quality by design principles[J]. Chinese Traditional and Herbal Drugs(中草药), 2024, 55(7): 2216-2226.
[34] LIU XJ.Antibacterial, anti-inflammatory function evaluation and preparation of microemulsion gel of essential oil from chrysanthemum stem and leaf and its compatible prescription[D]. Nanjing: Nanjing University of Chinese Medicine, 2022.
[35] HUANG ZT, ZHANG SY, CHANG JH, et al.Preparation and in vitro dissolution determination of luteolin solid dispersion with different vehicles[J]. Chinese Journal of Hospital Pharmacy(中国医院药学杂志), 2023, 43(5): 494-500.
[36] ZHANG PC, FANG D, HAO HJ.Preparation of evodiamine gastric floating tablets and their protective effects on rabbit gastric mucosa injury[J]. Chinese Traditional Patent Medicine(中成药), 2023, 45(11): 3527-3533.
[37] XU ZJ.Preparation of imperatorin solid dispersion hydrogel matrix sustained-release tablets and pharmacokinetic evaluation[J]. Chinese Traditional and Herbal Drugs(中草药), 2022, 53(17): 5321-5329.
[38] TANG LR, WANG Q, LIU WJ, et al.Preparation and in vitro synchronous release of modified Maijunan liposome tablets[J]. Journal of Hubei University(Natural Science)(湖北大学学报自然科学版), 2022, 44(1): 106-112.
[39] ZHANG K, CHEN SS, WU L, et al.Preparation of bioerodible matrix sustained-release tablets of hawthorn leaf flavonoids[J]. Chinese Traditional Patent Medicine(中成药), 2014, 36(8): 1640-1643.
[40] HU CX, YAN W, FAN MS.Formulation optimization for controlled release push-pull osmotic pump tablets of imperatorin[J]. Chinese Traditional Patent Medicine(中成药), 2022, 44(1): 13-18.
[41] SHAO L, SUN L, FENG M, et al.In vivo release research of panax notoginseng saponins floating sustained-release tablets in rabbits[J]. Journal of Hubei University of Chinese Medicine(湖北中医药大学学报), 2017, 19(6): 46-49.
[42] MA XT, XIAO FQ, QIU MY, et al.Optimization of water extraction andethanol precipitation process and activity of compound lipid-lowering sustained-release tablets by multi-index comprehensive scoring method[J]. Chinese Journal of Hospital Pharmacy(中国医院药学杂志), 2019, 39(17): 1759-1765.
[43] CAI YQ, LI BY, ZHONG XY, et al.Study on shedding particles from chuanping sustained-release tablets based on multi-marker components balanced release[J]. Chinese Traditional and Herbal Drugs(中草药), 2019, 50(4): 836-843.
[44] GAO XM, ZOU GX, XIN XY, et al.Pharmacokinetics of puerarin in guanmaikang sustained-release capsule in beagle dogs[J]. Journal of Liaoning University of TCM(辽宁中医药大学学报), 2019, 21(4): 44-46.
[45] GUO H, CHEN XM, DUAN ZH.Study on the pharmacokinetics and relative bioavailability of enteric sustained-release capsule of oxymatrine phospholipid complex in mice[J]. Journal of Shandong University of TCM(山东中医药大学学报), 2017, 41(5): 482-485.
[46] CHEN J, ZHAO XQ, MA YQ, et al.Preparation and in vitro transdermal permeation of zedoary turmeric oil compound liposomes gel[J]. Chinese Journal of New Drugs(中国新药杂志), 2018, 27(7): 830-838.
[47] GUAN QX, WEN MX, LIU ZQ, et al.Tissue distribution of brucine-loaded solid lipid nanoparticles in mice in vivo[J]. Chinese Traditional Patent Medicine(中成药), 2017, 39(4): 714-718.
[48] LIU MY.Preparation and in vivo pharmacokinetic study of matrine pellets as a colon-targeting sustained release system[D]. Yinchuan: Ningxia Medical University, 2014.
[49] ZHANG T.The study on PK-PD sustained release evaluation of Ganershu pellets[D]. Naijing: Naijing University of Chinese Medicine, 2013.
[50] LAI HQ, HU Y, LI XD.The in vitro dissolution of total composition of the tablet of rhizomes of Ligusticum chuanxiong components and in vitro-in vivo correlation by the method of area under the absorbance-wavelength curve[J]. Acta Pharmaceutica Sinica(药学学报), 2015, 50(6): 788-792.
[51] LUO Y.Studies on the drug release kinetics in vitro and vivo of Chuangping sustained-release pellets[D]. Guangzhou: Guangdong Pharmaceutical University, 2014.