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Article(id=1190375275151065119, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1190375270847710190, articleNumber=1001-2494(2025)03-0272-12, orderNo=null, doi=10.11669/cpj.2025.03.010, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1715184000000, receivedDateStr=2024-05-09, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1761737181699, onlineDateStr=2025-10-29, pubDate=1738944000000, pubDateStr=2025-02-08, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1761737181699, onlineIssueDateStr=2025-10-29, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1761737181699, creator=13701087609, updateTime=1761737181699, updator=13701087609, issue=Issue{id=1190375270847710190, tenantId=1146029695717560320, journalId=1190317699101192196, year='2025', volume='60', issue='3', pageStart='209', pageEnd='312', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1761737180673, creator=13701087609, updateTime=1761793989024, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1190613542412890252, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1190375270847710190, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1190613542412890253, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1190375270847710190, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=272, endPage=283, ext={EN=ArticleExt(id=1190375275385946146, articleId=1190375275151065119, tenantId=1146029695717560320, journalId=1190317699101192196, language=EN, title=Preparation and Evaluation of Curcumin-loaded PPC-PEG Shape Memory Gastroretentive Drug Delivery Systems, columnId=null, journalTitle=Chinese Pharmaceutical Journal, columnName=null, runingTitle=null, highlight=null, articleAbstract=

OBJECTIVE To develop a novel gastric retention drug delivery system incorporating curcumin(Cur), based on the shape memory polypropylene carbonate-polyethylene glycol (PPC-PEG), with the objective of enhancing the in vivo bioavailability of Cur. METHODS The curcumin-cyclodextrin inclusion complex (Cur_β-CD) was prepared and loaded onto the shape memory polypropylene carbonate-polyethylene glycol composite film (PPC-PEG) to create the expanded gastric retention drug delivery system (Cur_β-CD_PPC-PEG); multiple characterization, proliferation inhibition analysis of human gastric cancer cells (SGC-7901) in vitro, and pharmacokinetics analysis in rats were then performed. RESULTS After cyclodextrin inclusion, the water solubility of Cur_β-CD was 35.85 times higher than that of Cur. The deformation recovery rate of the composite film PPC-PEG(7.5∶2.5) is 88.6% at 37 ℃. The Cur was physically incorporated into the composite film of Cur_β-CD_PPC-PEG, and the loaded Cur exhibited excellent thermal stability. The loaded Cur has a certain effect on the shape memory performance of PPC-PEG; however, it still satisfies the requirement for deformation recovery rate as a deformable gastric retention formulation. The in vitro cumulative release rate of Cur_β-CD_PPC-PEG over a 48-hour period was determined to be 71.42%. The Cur_β-CD_PPC-PEG exhibits significant efficacy in vitro against the proliferation of gastric cancer SGC-7901 cells, with a remarkable inhibitory rate of 86.64% observed after 48 h of treatment. The pharmacokinetic results showed that the area under the curve (AUC0-24) and the retention time in vivo (MRT0-24) of Cur_β-CD_PPC-PEG were 9.73 times and 2.95 times higher than those of Cur. CONCLUSION In this study, a novel shape memory gastric retention drug delivery system of Cur_β-CD_PPC-PEG is successfully prepared. The system exhibits a favorable drug controlled release effect within 48 h, characterized by rapid onset, prolonged duration of efficacy, and high bioavailability.

, correspAuthors=Ning CHEN, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=null, fund=null, authors=null, authorsList=Wei ZHENG, Ping GONG, Ziwei ZHANG, Wanmei ZHOU, Ning CHEN), CN=ArticleExt(id=1190375721529868821, articleId=1190375275151065119, tenantId=1146029695717560320, journalId=1190317699101192196, language=CN, title=载姜黄素形状记忆聚碳酸亚丙酯-聚乙二醇胃滞留给药系统的制备与评价, columnId=1190352405612040510, journalTitle=中国药学杂志, columnName=论著, runingTitle=null, highlight=null, articleAbstract=

目的 姜黄素(Cur)具有良好的抗胃癌活性,但因其水溶性差,碱性pH条件下易降解,限制其在临床上的应用。本课题通过制备载Cur形状记忆聚碳酸亚丙酯-聚乙二醇(PPC-PEG)新型胃滞留给药系统来提高Cur的体内生物利用度。方法 制备Cur环糊精包合物(Cur_β-CD)并负载到PPC-PEG复合薄膜上,制备出可形变展开型胃滞留给药系统(Cur_β-CD_PPC-PEG),并对其进行特性表征、体外人胃癌细胞(SGC-7901)增殖抑制分析和大鼠体内药动学分析等。结果 经环糊精包合后,Cur_β-CD水溶性是Cur原料药的35.85倍。复合薄膜PPC-PEG(7.5∶2.5)在37 ℃条件下的形变恢复率为88.6%;将Cur_β-CD负载于PPC-PEG后,Cur与复合薄膜为物理共混,负载后的Cur热稳定性良好;Cur的载入对PPC-PEG载体的形状记忆性能产生一定的影响,但仍满足作为形变胃滞留剂型对形变恢复率的要求。Cur_β-CD_PPC-PEG胃滞留给药系统体外释药48 h的累积释放率为71.42%。Cur_β-CD_PPC-PEG体外抑制胃癌SGC-7901细胞增殖效果良好,作用48 h的细胞增殖抑制率可达86.64%。药动学结果表明,Cur_β-CD_PPC-PEG药-时曲线下面积 ( AUC0-24)和体内滞留时间(MRT0-24)分别是Cur的9.73倍和2.95倍。结论 本研究成功制备出一种新型的基于形状记忆PPC-PEG复合膜的载Cur_β-CD胃滞留递药系统,该系统在48 h内具有良好的药物控释作用,药效时间长,生物利用度高。

, correspAuthors=陈宁, authorNote=null, correspAuthorsNote=
*陈宁,男,博士,研究员 研究方向:新型胃滞留递药系统研究 Tel:(0451)84866922
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郑威,男,博士,副教授 研究方向:新型胃滞留递药系统研究

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郑威,男,博士,副教授 研究方向:新型胃滞留递药系统研究

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郑威,男,博士,副教授 研究方向:新型胃滞留递药系统研究

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Int J Biol Macromol, 2022, 30(217): 1037-1043., articleTitle=A drug-loaded amphiphilic polymer/poly(l-lactide) shapememory system, refAbstract=null)], funds=[Fund(id=1190959083369939815, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, awardId=2023-KYYWF-1037, language=CN, fundingSource=哈尔滨商业大学“青年科研创新人才”项目资助(2023-KYYWF-1037), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1190959078873645856, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, xref=null, ext=[AuthorCompanyExt(id=1190959078882034465, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, companyId=1190959078873645856, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=School of Pharmacy, Harbin University of Commerce, Harbin 150076, China), AuthorCompanyExt(id=1190959078890423074, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, companyId=1190959078873645856, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=哈尔滨商业大学药学院, 哈尔滨 150076)])], figs=[ArticleFig(id=1190959080702362433, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=EN, label=Fig.1, caption=Preparation and evaluation flowchart of Cur_β-CD_PPC-PEG gastric retention drug system, figureFileSmall=X0/jv2kmewZnigrv8bgrfA==, figureFileBig=+5RQH+eotmKtFxKthxDwZg==, tableContent=null), ArticleFig(id=1190959080761082690, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=CN, label=图1, caption=Cur_β-CD_PPC-PEG胃滞留给药系统的制备与评价流程图, figureFileSmall=X0/jv2kmewZnigrv8bgrfA==, figureFileBig=+5RQH+eotmKtFxKthxDwZg==, tableContent=null), ArticleFig(id=1190959080849163075, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=EN, label=Fig.2, caption=Phase solubility diagram of Cur in solutions with different β-CD concentrations, figureFileSmall=spVlHHUond4lyTyy+Dr9sg==, figureFileBig=/Gbzk189/r3j9bsGytOnTA==, tableContent=null), ArticleFig(id=1190959080903689028, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=CN, label=图2, caption=姜黄素(Cur)在不同浓度β环糊精(β-CD)溶液中的相溶解度图, figureFileSmall=spVlHHUond4lyTyy+Dr9sg==, figureFileBig=/Gbzk189/r3j9bsGytOnTA==, tableContent=null), ArticleFig(id=1190959080949826373, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=EN, label=Fig.3, caption=The characterization of Cur, β-CD, Cur_β-CD and Physical mixtures

A-ultraviolet spectrum; B-Fourier transform infrared(FT-IR)spectra; C-thermogravimetric curve.

, figureFileSmall=HC4zfhY0gfXPiVsd6TreNg==, figureFileBig=e4pZQ91t1BWzb/TV9UNhbQ==, tableContent=null), ArticleFig(id=1190959081025323846, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=CN, label=图3, caption=Cur、β-CD、Cur_β-CD和Cur与β-CD的物理混合物的表征谱图

A-紫外光谱;B-傅里叶变换红外光谱;C-热重曲线。

, figureFileSmall=HC4zfhY0gfXPiVsd6TreNg==, figureFileBig=e4pZQ91t1BWzb/TV9UNhbQ==, tableContent=null), ArticleFig(id=1190959081084044103, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=EN, label=Fig.4, caption=Drug release curve of Cur and Cur_β-CD inclusion complexes in 10 mg·mL-1 SDS simulated gastric fluid. n=6, $\bar{x}\pm s$, figureFileSmall=BPNq0cQUqE4erOphzdqaNA==, figureFileBig=YVV1OezZJJ1kmQlZ8/RR3w==, tableContent=null), ArticleFig(id=1190959081146958664, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=CN, label=图4, caption=Cur和Cur_β-CD包合物在10 mg·mL-1十二烷基硫酸钠(SDS)模拟胃液中的药物释放曲线。n=6, $\bar{x}\pm s$, figureFileSmall=BPNq0cQUqE4erOphzdqaNA==, figureFileBig=YVV1OezZJJ1kmQlZ8/RR3w==, tableContent=null), ArticleFig(id=1190959081256010569, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=EN, label=Fig.5, caption=Microscopic morphology of PPC-PEG composite films with different ratios(×200)

A-9.5∶0.5; B-8.5∶1.5; C-7.5∶2.5; D-6.5∶3.5; E-5.5∶4.5.

, figureFileSmall=K0teq3y2BIUOH4viiNpgvA==, figureFileBig=o5vF0cQg6EYmTASXB0Qx5A==, tableContent=null), ArticleFig(id=1190959081323119434, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=CN, label=图5, caption=不同配比的聚碳酸亚丙酯-聚乙二醇(PPC-PEG)复合薄膜微观形貌(×200)

A-9.5∶0.5; B-8.5∶1.5; C-7.5∶2.5; D-6.5∶3.5; E-5.5∶4.5。

, figureFileSmall=K0teq3y2BIUOH4viiNpgvA==, figureFileBig=o5vF0cQg6EYmTASXB0Qx5A==, tableContent=null), ArticleFig(id=1190959081386033995, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=EN, label=Fig.6, caption=Characterization spectra of shape memory PPC-PEG composite films with different ratios

A-FT-IR; B-thermogravimetric curves; C-differential-scanning calorimetry curves.

, figureFileSmall=sBcwUSGZ+MKNz4vgPzLUjg==, figureFileBig=hiYtAcqDelzGXG95MHe/Iw==, tableContent=null), ArticleFig(id=1190959081457337164, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=CN, label=图6, caption=不同配比的形状记忆PPC-PEG复合薄膜的表征图谱

A-傅里叶变换红外光谱;B-热重曲线;C-差示扫描量热曲线。

, figureFileSmall=sBcwUSGZ+MKNz4vgPzLUjg==, figureFileBig=hiYtAcqDelzGXG95MHe/Iw==, tableContent=null), ArticleFig(id=1190959081566389069, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=EN, label=Fig.7, caption=Characterization spectra of Cur-PPC-PEG and Cur_ β-CD-PPC-PEG drug loaded composite films

A-FT-IR; B-thermogravimetric curves; C-differential-scanning calorimetry curves.

, figureFileSmall=OI/dE9iGub/10JomavSCRQ==, figureFileBig=5ZFvOt4gbnpeRQ2xVX2xHg==, tableContent=null), ArticleFig(id=1190959081646080846, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=CN, label=图7, caption=Cur_PPC-PEG和Cur_β-CD_PPC-PEG载药复合薄膜的表征图谱

A-傅里叶变换红外光谱;B-热重曲线;C-差示扫描量热曲线。

, figureFileSmall=OI/dE9iGub/10JomavSCRQ==, figureFileBig=5ZFvOt4gbnpeRQ2xVX2xHg==, tableContent=null), ArticleFig(id=1190959081755132751, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=EN, label=Fig.8, caption=In vitro drug release of Cur_PPC-PEG and Cur_β-CD-PPC-PEG.n=6, $\bar{x}\pm s$, figureFileSmall=hyC6VRH0cEKaKT397J8EOA==, figureFileBig=Nw8VU7r/eqVYNTQdMngdvg==, tableContent=null), ArticleFig(id=1190959081834824528, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=CN, label=图8, caption=Cur_PPC-PEG和Cur_β-CD-PPC-PEG的体外释放曲线。n=6, $\bar{x}\pm s$, figureFileSmall=hyC6VRH0cEKaKT397J8EOA==, figureFileBig=Nw8VU7r/eqVYNTQdMngdvg==, tableContent=null), ArticleFig(id=1190959081918710609, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=EN, label=Fig.9, caption=Inhibitory effects of non-drug loaded PPC-PEG composite film extracts on SGC-7901 cell proliferation.n=6, $\bar{x}\pm s$, figureFileSmall=gd1oFsy8opPROMvFc9ghFQ==, figureFileBig=iHzk+xeMaIfuqscfIMy1+Q==, tableContent=null), ArticleFig(id=1190959081981625170, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=CN, label=图9, caption=非载药PPC-PEG复合膜浸提液对SGC-7901细胞增殖的抑制作用。n=6, $\bar{x}\pm s$, figureFileSmall=gd1oFsy8opPROMvFc9ghFQ==, figureFileBig=iHzk+xeMaIfuqscfIMy1+Q==, tableContent=null), ArticleFig(id=1190959082061316947, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=EN, label=Fig.10, caption=Inhibitory effects of four prepared formulations on the proliferation of SGC-7901 cells. n=6, $\bar{x}\pm s$, figureFileSmall=8KERMWsiSc5st2BA6hOrkA==, figureFileBig=UPImeaYxhwnFSxHBxb0xKA==, tableContent=null), ArticleFig(id=1190959082124231508, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=CN, label=图10, caption=4种制剂对SGC-7901细胞增殖的抑制。n=6, $\bar{x}\pm s$, figureFileSmall=8KERMWsiSc5st2BA6hOrkA==, figureFileBig=UPImeaYxhwnFSxHBxb0xKA==, tableContent=null), ArticleFig(id=1190959082174563157, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=EN, label=Fig.11, caption=HPLC chromatograms of samples for specificity

A-blank plasma+reference substance;B-plasma sample; C-blank plasma.

, figureFileSmall=gtgWJ+P6AqKoDnTb1JnNog==, figureFileBig=AElGHjoH+adBXhbww7eHoA==, tableContent=null), ArticleFig(id=1190959082241672022, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=CN, label=图11, caption=样品专属性考察HPLC色谱图

A-空白血浆+标准品;B-血浆样品;C-空白血浆。

, figureFileSmall=gtgWJ+P6AqKoDnTb1JnNog==, figureFileBig=AElGHjoH+adBXhbww7eHoA==, tableContent=null), ArticleFig(id=1190959082304586583, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=EN, label=Fig.12, caption=Drug-time curves of Cur, Cur_β-CD and Cur_β-CD_PPC-PEG(7.5∶2.5) in rats. n=6, $\bar{x}\pm s$, figureFileSmall=IYIX2Lg3Vw4iFdhb1Av2Eg==, figureFileBig=wWE1h9z5QAOFA5VKUDRJLg==, tableContent=null), ArticleFig(id=1190959082371695448, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=CN, label=图12, caption=Cur、Cur_β-CD和Cur_β-CD_PPC-PEG(7.5∶2.5)在大鼠体内的血药浓度-时间曲线。n=6, $\bar{x}\pm s$, figureFileSmall=IYIX2Lg3Vw4iFdhb1Av2Eg==, figureFileBig=wWE1h9z5QAOFA5VKUDRJLg==, tableContent=null), ArticleFig(id=1190959082426221401, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=EN, label=Tab.1, caption=

Thermal performance parameters of PPC-PEG composite films with different ratios

, figureFileSmall=null, figureFileBig=null, tableContent=
Sample name Material proportion Tg/℃ Tm/℃
PPC - 32.1 -
PEG6000 - - 58.1
PPC-PEG 9∶0.5 34.3 55.3
PPC-PEG 8.5∶1.5 35.2 55.4
PPC-PEG 7.5∶2.5 36.1 56.3
PPC-PEG 6.5∶3.5 37.2 57.5
PPC-PEG 5.5∶4.5 37.8 57.8
), ArticleFig(id=1190959082480747354, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=CN, label=表1, caption=

不同配比的PPC-PEG复合薄膜的热性能参数

, figureFileSmall=null, figureFileBig=null, tableContent=
Sample name Material proportion Tg/℃ Tm/℃
PPC - 32.1 -
PEG6000 - - 58.1
PPC-PEG 9∶0.5 34.3 55.3
PPC-PEG 8.5∶1.5 35.2 55.4
PPC-PEG 7.5∶2.5 36.1 56.3
PPC-PEG 6.5∶3.5 37.2 57.5
PPC-PEG 5.5∶4.5 37.8 57.8
), ArticleFig(id=1190959082547856219, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=EN, label=Tab.2, caption=

The roll diameter and shape recovery rate of PPC-PEG composite films after shape recovery. n=3, $\bar{x}\pm s$

, figureFileSmall=null, figureFileBig=null, tableContent=
Material ratio
(PPC∶PEG)		 Film roll diameter after
shape recovery/mm		 Shape recovery
rate/%
9.5∶0.5 6.42±0.42 64.2
8.5∶1.5 6.96±0.34 69.6
7.5∶2.5 8.86±0.56 88.6
6.5∶3.5 5.32±0.34 53.2
5.5∶4.5 2.74±0.22 27.4
), ArticleFig(id=1190959082614965084, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=CN, label=表2, caption=

PPC-PEG复合薄膜形状恢复后的膜卷直径和形状恢复率。n=3, $\bar{x}\pm s$

, figureFileSmall=null, figureFileBig=null, tableContent=
Material ratio
(PPC∶PEG)		 Film roll diameter after
shape recovery/mm		 Shape recovery
rate/%
9.5∶0.5 6.42±0.42 64.2
8.5∶1.5 6.96±0.34 69.6
7.5∶2.5 8.86±0.56 88.6
6.5∶3.5 5.32±0.34 53.2
5.5∶4.5 2.74±0.22 27.4
), ArticleFig(id=1190959082669491037, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=EN, label=Tab.3, caption=

Thermal performance parameters of drug-loaded PPC-PEG composite films

, figureFileSmall=null, figureFileBig=null, tableContent=
Material Tg/℃ Tm/℃
PPC-PEG 36.1 56.3
Cur_PPC-PEG 37.3 60.8
Cur_β-CD_PPC-PEG 37.6 62.2
), ArticleFig(id=1190959082744988510, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=CN, label=表3, caption=

载药PPC-PEG复合薄膜的热性能参数

, figureFileSmall=null, figureFileBig=null, tableContent=
Material Tg/℃ Tm/℃
PPC-PEG 36.1 56.3
Cur_PPC-PEG 37.3 60.8
Cur_β-CD_PPC-PEG 37.6 62.2
), ArticleFig(id=1190959082803708767, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=EN, label=Tab.4, caption=

Shape recovery rate of drug-loaded PPC-PEG composite films.n=3, $\bar{x}\pm s$

, figureFileSmall=null, figureFileBig=null, tableContent=
Material Film roll diameter
after shape recovery/mm		 Shape recovery
rate/%
Cur_PPC-PEG 7.06±0.54 70.6
Cur_β-CD_PPC-PEG 6.54±0.48 65.4
), ArticleFig(id=1190959082883400544, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=CN, label=表4, caption=

载药PPC-PEG复合薄膜的形状恢复率。n=3, $\bar{x}\pm s$

, figureFileSmall=null, figureFileBig=null, tableContent=
Material Film roll diameter
after shape recovery/mm		 Shape recovery
rate/%
Cur_PPC-PEG 7.06±0.54 70.6
Cur_β-CD_PPC-PEG 6.54±0.48 65.4
), ArticleFig(id=1190959082942120801, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=EN, label=Tab.5, caption=

Fitting results of the in vitro release of Cur loaded Shape memory composite film

, figureFileSmall=null, figureFileBig=null, tableContent=
Model Equation r
Cur_PPC-PEG Zero-order release Q=0.521 93t+11.472 31 0.628 93
First-order release Q=90.968 5(1-e-0.773 2t) 0.971 53
Higuchi equation Q=4.527 91/2+4.809 62 0.856 47
Cur_β-CD_PPC-PEG Zero-order release Q=21.232 58t+1.253 06 0.778 7
First-order release Q=68.311 7(1-e-0.120 56t) 0.942 0
Higuchi equation Q=10.404 81t1/2+0.633 38 0.847 0
), ArticleFig(id=1190959083005035362, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=CN, label=表5, caption=

载Cur形状记忆复合膜的体外释放拟合结果

, figureFileSmall=null, figureFileBig=null, tableContent=
Model Equation r
Cur_PPC-PEG Zero-order release Q=0.521 93t+11.472 31 0.628 93
First-order release Q=90.968 5(1-e-0.773 2t) 0.971 53
Higuchi equation Q=4.527 91/2+4.809 62 0.856 47
Cur_β-CD_PPC-PEG Zero-order release Q=21.232 58t+1.253 06 0.778 7
First-order release Q=68.311 7(1-e-0.120 56t) 0.942 0
Higuchi equation Q=10.404 81t1/2+0.633 38 0.847 0
), ArticleFig(id=1190959083067949923, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=EN, label=Tab.6, caption=

IC50 values for the proliferative inhibitory activity of four prepared formulations. μmoL·L-1,n=6, $\bar{x}\pm s$

, figureFileSmall=null, figureFileBig=null, tableContent=
Formulations IC50(12 h)
/μmol·L -1		 IC50(24 h)
/μmol·L -1		 IC50(48 h)
/μmol·L -1
Cur 19.53±0.32 17.70±0.46 16.85±0.33
Cur_β-CD 19.42±0.37 16.17±0.41 13.60±0.25
Cur_PPC-PEG 19.64±0.34 18.24±0.24 17.58±0.57
Cur_β-CD_PPC-PEG 19.93±0.88 16.48±0.69 14.40±0.31
), ArticleFig(id=1190959083139253092, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=CN, label=表6, caption=

4种制剂对SGC-7901细胞的增殖抑制活性的半数抑制浓度(IC50)值。μmoL·L-1,n=6, $\bar{x}\pm s$

, figureFileSmall=null, figureFileBig=null, tableContent=
Formulations IC50(12 h)
/μmol·L -1		 IC50(24 h)
/μmol·L -1		 IC50(48 h)
/μmol·L -1
Cur 19.53±0.32 17.70±0.46 16.85±0.33
Cur_β-CD 19.42±0.37 16.17±0.41 13.60±0.25
Cur_PPC-PEG 19.64±0.34 18.24±0.24 17.58±0.57
Cur_β-CD_PPC-PEG 19.93±0.88 16.48±0.69 14.40±0.31
), ArticleFig(id=1190959083202167653, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=EN, label=Tab.7, caption=

Pharmacokinetic parameters in rat plasma after gavage administration. n=6, $\bar{x}\pm s$

, figureFileSmall=null, figureFileBig=null, tableContent=
Parameter Cur Cur_β-CD Cur_β-CD_PPC-PEG
ρmax/mg·L-1 0.19 ±0.02 0.78 ±0.04 0.41±0.03
tmax/h 0.33 ±0.07 0.19 ±0.05 6.00±2.32
AUC0-24/mg·h·L-1 0.30 ±0.03 0.91 ±0.14 2.92±0.54
AUC0-∞/mg·h·L-1 0.91 ±0.18 1.52 ±0.22 2.92±0.75
MRT0-24/h 2.37 ±0.24 2.52 ±0.09 6.99±0.84
MRT0-∞/h 17.14 ±3.16 16.98 ±1.63 7.86±1.56
), ArticleFig(id=1190959083256693606, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1190375275151065119, language=CN, label=表7, caption=

大鼠灌胃给药后血浆药代动力学参数。 n=6, $\bar{x}\pm s$

, figureFileSmall=null, figureFileBig=null, tableContent=
Parameter Cur Cur_β-CD Cur_β-CD_PPC-PEG
ρmax/mg·L-1 0.19 ±0.02 0.78 ±0.04 0.41±0.03
tmax/h 0.33 ±0.07 0.19 ±0.05 6.00±2.32
AUC0-24/mg·h·L-1 0.30 ±0.03 0.91 ±0.14 2.92±0.54
AUC0-∞/mg·h·L-1 0.91 ±0.18 1.52 ±0.22 2.92±0.75
MRT0-24/h 2.37 ±0.24 2.52 ±0.09 6.99±0.84
MRT0-∞/h 17.14 ±3.16 16.98 ±1.63 7.86±1.56
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载姜黄素形状记忆聚碳酸亚丙酯-聚乙二醇胃滞留给药系统的制备与评价
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郑威 , 宫苹 , 张紫微 , 周婉梅 , 陈宁 *
中国药学杂志 | 论著 2025,60(3): 272-283
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中国药学杂志 | 论著 2025, 60(3): 272-283
载姜黄素形状记忆聚碳酸亚丙酯-聚乙二醇胃滞留给药系统的制备与评价
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郑威, 宫苹, 张紫微, 周婉梅, 陈宁*
作者信息
  • 哈尔滨商业大学药学院, 哈尔滨 150076

    • 郑威,男,博士,副教授 研究方向:新型胃滞留递药系统研究

通讯作者:

*陈宁,男,博士,研究员 研究方向:新型胃滞留递药系统研究 Tel:(0451)84866922
Preparation and Evaluation of Curcumin-loaded PPC-PEG Shape Memory Gastroretentive Drug Delivery Systems
Wei ZHENG, Ping GONG, Ziwei ZHANG, Wanmei ZHOU, Ning CHEN*
Affiliations
  • School of Pharmacy, Harbin University of Commerce, Harbin 150076, China
出版时间: 2025-02-08 doi: 10.11669/cpj.2025.03.010
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摘要
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目的 姜黄素(Cur)具有良好的抗胃癌活性,但因其水溶性差,碱性pH条件下易降解,限制其在临床上的应用。本课题通过制备载Cur形状记忆聚碳酸亚丙酯-聚乙二醇(PPC-PEG)新型胃滞留给药系统来提高Cur的体内生物利用度。方法 制备Cur环糊精包合物(Cur_β-CD)并负载到PPC-PEG复合薄膜上,制备出可形变展开型胃滞留给药系统(Cur_β-CD_PPC-PEG),并对其进行特性表征、体外人胃癌细胞(SGC-7901)增殖抑制分析和大鼠体内药动学分析等。结果 经环糊精包合后,Cur_β-CD水溶性是Cur原料药的35.85倍。复合薄膜PPC-PEG(7.5∶2.5)在37 ℃条件下的形变恢复率为88.6%;将Cur_β-CD负载于PPC-PEG后,Cur与复合薄膜为物理共混,负载后的Cur热稳定性良好;Cur的载入对PPC-PEG载体的形状记忆性能产生一定的影响,但仍满足作为形变胃滞留剂型对形变恢复率的要求。Cur_β-CD_PPC-PEG胃滞留给药系统体外释药48 h的累积释放率为71.42%。Cur_β-CD_PPC-PEG体外抑制胃癌SGC-7901细胞增殖效果良好,作用48 h的细胞增殖抑制率可达86.64%。药动学结果表明,Cur_β-CD_PPC-PEG药-时曲线下面积 ( AUC0-24)和体内滞留时间(MRT0-24)分别是Cur的9.73倍和2.95倍。结论 本研究成功制备出一种新型的基于形状记忆PPC-PEG复合膜的载Cur_β-CD胃滞留递药系统,该系统在48 h内具有良好的药物控释作用,药效时间长,生物利用度高。

姜黄素  /  包合物  /  形状记忆复合物  /  胃滞留给药系统  /  SGC-7901细胞

OBJECTIVE To develop a novel gastric retention drug delivery system incorporating curcumin(Cur), based on the shape memory polypropylene carbonate-polyethylene glycol (PPC-PEG), with the objective of enhancing the in vivo bioavailability of Cur. METHODS The curcumin-cyclodextrin inclusion complex (Cur_β-CD) was prepared and loaded onto the shape memory polypropylene carbonate-polyethylene glycol composite film (PPC-PEG) to create the expanded gastric retention drug delivery system (Cur_β-CD_PPC-PEG); multiple characterization, proliferation inhibition analysis of human gastric cancer cells (SGC-7901) in vitro, and pharmacokinetics analysis in rats were then performed. RESULTS After cyclodextrin inclusion, the water solubility of Cur_β-CD was 35.85 times higher than that of Cur. The deformation recovery rate of the composite film PPC-PEG(7.5∶2.5) is 88.6% at 37 ℃. The Cur was physically incorporated into the composite film of Cur_β-CD_PPC-PEG, and the loaded Cur exhibited excellent thermal stability. The loaded Cur has a certain effect on the shape memory performance of PPC-PEG; however, it still satisfies the requirement for deformation recovery rate as a deformable gastric retention formulation. The in vitro cumulative release rate of Cur_β-CD_PPC-PEG over a 48-hour period was determined to be 71.42%. The Cur_β-CD_PPC-PEG exhibits significant efficacy in vitro against the proliferation of gastric cancer SGC-7901 cells, with a remarkable inhibitory rate of 86.64% observed after 48 h of treatment. The pharmacokinetic results showed that the area under the curve (AUC0-24) and the retention time in vivo (MRT0-24) of Cur_β-CD_PPC-PEG were 9.73 times and 2.95 times higher than those of Cur. CONCLUSION In this study, a novel shape memory gastric retention drug delivery system of Cur_β-CD_PPC-PEG is successfully prepared. The system exhibits a favorable drug controlled release effect within 48 h, characterized by rapid onset, prolonged duration of efficacy, and high bioavailability.

curcumin  /  inclusion complex  /  shape memory complex  /  gastric retention drug delivery system  /  SGC-7901 cell
郑威, 宫苹, 张紫微, 周婉梅, 陈宁. 载姜黄素形状记忆聚碳酸亚丙酯-聚乙二醇胃滞留给药系统的制备与评价. 中国药学杂志, 2025 , 60 (3) : 272 -283 . DOI: 10.11669/cpj.2025.03.010
Wei ZHENG, Ping GONG, Ziwei ZHANG, Wanmei ZHOU, Ning CHEN. Preparation and Evaluation of Curcumin-loaded PPC-PEG Shape Memory Gastroretentive Drug Delivery Systems[J]. Chinese Pharmaceutical Journal, 2025 , 60 (3) : 272 -283 . DOI: 10.11669/cpj.2025.03.010
正文
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姜黄素(Cur)是从药用植物姜黄的根茎中提取的一种天然多酚[1],具有良好的抗炎、抗氧化作用,常被用于消炎和治疗胃肠道疾病,如消化不良、腹胀、腹泻,胃溃疡和十二指肠溃疡等[2-4]。近年来,相关研究表明Cur是一种极具前景的胃癌替代疗法[4-6];Cur发挥其抗肿瘤活性的方式主要是对肿瘤细胞产生诱导凋亡、控制生长、抑制转化与侵袭的作用,控制血管的形成,调节基因表达,对化学药物的增敏和逆转耐药性[7-12]。然而Cur具有多酚类结构,导致其不易溶于水,在碱性条件下易降解,口服后体内吸收差,生物利用度低[13],限制了Cur的应用范围。因此,亟须制备出一种新型的具备提高Cur水溶性和延长其在胃内滞留时间的递药系统;该系统的建立将为Cur的深度应用提供可行性解决方案。
胃滞留给药系统(gastro-retentive drug delivery system, GRDDS)常以高分子聚合物为材料进行制备,可延长药物在胃部的滞留时间,缓释长效,有效增加药物在胃肠道上端的吸收,提高水溶性差和肠内易降解药物的生物利用度[14]。根据胃滞留机制的不同,GRDDS可以分为漂浮型、黏附型和展开型等几大类[15]。其中,漂浮型和黏附型在应用中均存在一定的不足之处,如漂浮型胃滞留给药制剂的漂浮性能需要依赖胃内容物的存在且受体位等影响易被提前排出体外,黏附型给药系统会对胃壁造成一定的损伤。相比较而言,展开型具有一定的优势,通过小体积经口服给药进入胃部,在胃中展开使其尺寸大于幽门,从而延长药物在胃内的滞留时间。
形状记忆聚合物(shape memory polymer, SMP)是一类新型智能高分子材料[16],一般由固定相和可逆相组成[17]。可逆相在外界刺激下相态转变成玻璃态或高弹态,分子链间阻碍减小,可在外力作用下变成临时形状;固定相多为物理或化学交联点,起到固定材料临时形状和记忆材料初始形状的作用。当形状记忆材料再次受到外界刺激时,固定相可使其恢复到原始形状。根据响应的外部刺激条件不同,SMP可分为热响应、磁响应、光响应和pH响应等[18-22]。优异的形状记忆性,生物降解性,良好的生物相容性,以及缓释释药性使其在生物医药领域中的应用日益增多,可拓展应用到胃滞留给药系统中[23]。
本研究将Cur_β-CD包合物负载于聚碳酸亚丙酯(PPC)和聚乙二醇(PEG)共混形成的可展开型形状记忆性复合薄膜(PPC-PEG)上,构建一种新型的GRDDS。首先,对Cur_β-CD包合物的包合率、溶解度和体外释放等进行测定;其次,通过显微观察PPC-PEG复合薄膜微观形态,并对其进行红外、热重和差示扫描量热分析,同时考察PPC-PEG载药前后的形状恢复性能和载药后的药物体外释放性能;然后,采用3-(4,5-二甲基噻唑基-2)-2,5-二苯基四唑溴化物(MTT)分析载药PPC-PEG复合膜在体外对SGC-7901胃癌细胞的增殖抑制作用;最后,通过药代动力学实验评价基于PPC-PEG复合膜制备的新型GRDDS中Cur的生物利用度。Cur_β-CD_PPC-PEG胃滞留给药系统的制备与评价流程图见图1。
1 材料
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1.1 仪器
WH220-HT磁力搅拌器(德国WIGGENS公司);UV-7504型紫外可见分光光度计(上海精密仪器仪表有限公司);AS3120A超声波清洗器(天津奥特赛恩斯仪器有限公司);ThermoST8R热电高速冷冻离心机(美国赛默飞世尔科技公司);Rcz-6B3型药物溶出度仪(上海黄海药检仪器有限公司);Vaco2-80冷冻干燥机(德国Zirbus公司);FTIR-650傅里叶变换红外光谱仪(天津港东科技发展股份有限公司);DTG-60差热/热重分析仪(日本SHIMADZU公司);VHX-900光学显微镜(美国Keyence公司);JJ-1型强磁力搅拌器(上海予申仪器有限公司);SHA-B恒温水浴振荡器(常州金坛良友仪器有限公司);DSC-500L差式扫描量热分析仪(上海准权仪器设备有限公司);MR-96A酶标仪(深圳迈瑞生物医疗股份有限公司);高效液相色谱仪(美国Dionex公司)。
1.2 药品及试剂
Cur(批号C400271,纯度98%)、β-环糊精(β-CD,批号C104384)[Aladdin-阿拉丁试剂(上海)有限公司];聚乙二醇6000(PEG6000)、聚碳酸亚丙酯(PPC)(长春应用化学研究所);杜尔贝科改良伊格尔培养基(Dulbecco's modified eagle medium,DMEM)高糖培养基(武汉普诺赛生命科技有限公司);胎牛血清(浙江天杭生物科技股份有限公司);MTT(美国Sigma公司);甲醇为色谱纯;无水乙醇为分析纯;二甲基亚砜(DMSO, 天津市博迪化工有限公司);胰蛋白酶双抗溶液(碧云天生物科技有限公司);PBS溶液(武汉普诺赛生命科技有限公司)。
1.3 细胞及动物
人胃癌细胞株(SGC-7901,中科院上海细胞生物研究所);雄性Wistar大鼠,体质量范围180~220 g[辽宁长生生物技术股份有限公司,生产许可证号:SYXK(辽)2020-001]。
2 方法与结果
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2.1 Cur含量测定方法的建立
2.1.1 检测波长的选择
精密称取Cur对照品,无水乙醇稀释定容后于200~500 nm波长下进行紫外扫描,结果表明Cur在425 nm处有最大吸收峰,且β-CD在此波长处无吸收,故选择425 nm作为检测波长。
2.1.2 标准曲线的建立
以无水乙醇为溶剂,分别配制1.11,2.22,3.33,4.44,5.55,6.66 μg·mL-1的Cur标准液,于425 nm处测定其吸光度。以Cur质量浓度(ρ)为横坐标,对应吸光值(Y)为纵坐标,拟合的线性回归方程为Y=0.019 7ρ+0.006 6(r2=0.999 7),线性范围1.11~6.66 μg·mL-1。
2.2 Cur_β-CD包合物的制备与表征
2.2.1 冷冻干燥法制备Cur_β-CD
精密称取β-CD 800 mg,Cur 240 mg(物质的量比1∶1);分别用160 mL去离子水和10 mL乙醇溶解。将β-CD溶液置于磁力搅拌器上以400 r·min-1 的转速搅拌至充分溶解,将Cur乙醇溶液缓慢滴加其中进行包合,在40 ℃下搅拌12 h,混悬液以1 000 r·min-1 离心10 min,收集上清液;在-80 ℃冰箱中预冻12 h后,采用冷冻干燥机冻干24 h,获得Cur_β-CD包合物冻干粉末。
2.2.2 包合率的测定
准确称取3组不同批次制备得到的Cur_β-CD包合物冻干品适量,置于100 mL棕色量瓶中,加入无水乙醇溶解并定容。以无水乙醇为空白,在425 nm处测定包合物的吸光度,根据回归方程计算该包合物中Cur的含量,根据公式1计算包合率。
包合率(%)= 包 合 物 中 C u r 的 量 制 备 包 合 物 时 C u r 的 加 入 量×100%
通过对3组不同批次的Cur_β-CD包合率进行测定和计算,以物质的量比1∶1投料制备的Cur_β-CD包合率为(47.3±3.7)%。
2.2.3 包合常数的测定
分别配制β-CD浓度为40、80、120、160和200 mmol·L-1的溶液,并分别加入过量的Cur,搅拌24 h使其溶解达到平衡状态,取溶液1 mL过滤并用乙醇稀释,在425 nm下测定紫外吸光度,计算Cur浓度。以β-CD浓度(X)为横坐标,Cur浓度(Y)为纵坐标,绘制相溶解度曲线(图2),结果为Y=0.001 4X+0.002 4(r2=0.998 6),药物与β-CD的相溶解度图可分为A型和B型,其中A型表示生成可溶性包合物,该曲线Cur溶解度随着β-CD浓度增加而线性升高,为AL型,表明Cur_β-CD是由Cur与β-CD按1∶1比例结合所得的可溶性包合物。根据Higuchi理论[24],利用相溶解度法计算出的包合常数K越高,包合物越稳定。本研究制备的包合物的包合常数K=582.52 L·moL-1,包合平衡常数较大,表明制备的包合物较稳定。
2.2.4 溶解度的测定
制备水中过饱和的Cur和Cur_β-CD包合物溶液,过滤并用乙醇稀释,在425 nm下测定紫外吸光度,计算出二者在水中溶解度分别为0.041和1.47 mg·mL-1。Cur_β-CD包合物溶解度是Cur的35.85倍,表明经β-CD包合后Cur的水溶性显著提高。
2.2.5 紫外分析
分别取适量Cur、β-CD、Cur_β-CD包合物和Cur与β-CD的物理混合物溶解在无水乙醇中,在200~500 nm进行紫外扫描,结果见图3A,与Cur相比,Cur_β-CD包合物的最大吸收波长由425 nm蓝移至423 nm,而物理混合物的最大吸收波长仍为425 nm。
2.2.6 红外分析
分别取适量Cur、β-CD、Cur_β-CD包合物和Cur与β-CD的物理混合物研磨成细粉末并与溴化钾混合。然后将所得混合物压缩成薄片,在4 000~400 cm-1范围内进行红外扫描,分辨率为2 cm-1扫描16次,结果见图3B,Cur的红外光谱在3 510 cm-1处吸收峰由酚醛O—H伸缩振动所致。此外,在1 627 cm-1(Cur苯环的伸缩振动)、1 507 cm-1(Cur的C-O和C-C振动)、1 428 cm-1(烯烃C-H弯曲振动)、1 285 cm-1(芳香族C-O伸缩振动)和1 025 cm-1和856 cm-1(C-O-C伸缩振动)处观察到明显的吸收带。β-CD在2 920 cm-1处出现了C-H伸缩振动的特征峰。此外,1 644 cm-1、1 157 cm-1和1 027 cm-1处的峰分别对应于β-CD环上的O-H、C-O和C-O-C产生的吸收峰。Cur与β-CD物理混合物的特征峰显示为Cur和β-CD特征峰的叠加。在Cur_β-CD包合物图谱中,属于β-CD的所有特征峰都存在,而属于Cur的特征峰只有C-O-C伸缩振动向高波数移至860 cm-1。其余Cur特征峰(1 627、1 507、1 428、1 285和1 025 cm-1)均减弱消失。说明Cur在反应后进入了环糊精空腔内,特征吸收峰被环糊精所掩盖,证明了包合反应的成功。
2.2.7 热重分析
分别取适量Cur、β-CD、Cur_β-CD包合物和Cur与β-CD的物理混合物于铝坩埚中,以A12O3为参比,升温速度为10 ℃·min-1,氮气流速为30 mL·min-1,扫描范围为30~600 ℃,取样量为5 mg,进行热重分析,结果见图3C:Cur在260~570 ℃区间缓慢失重,在350 ℃失重率仅为22%,热稳定性良好。在初始温度至100 ℃之间,β-CD、物理混合物和Cur_β-CD包合物因水分达到沸点汽化流失而分别失重约16%、14%和10%,其中包合物粉末经冻干制备得到而含水量相对较低。在290~350 ℃之间,β-CD因β-CD交联键的断裂以及葡萄糖单元的分解而失重约65%;物理混合物受到β-CD交联键的断裂和Cur缓慢失重的共同影响失重约50%,是二者效果的叠加,证明β-CD和Cur仅为简单的物理共混;Cur_β-CD包合物失重曲线与β-CD失重曲线基本重合,仅表现出β-CD的特征且不同于普通物理混合物,说明Cur进入了环糊精空腔中,证明Cur_β-CD的成功制备。Cur_β-CD非失水因素的分解温度约为290 ℃,说明制备得到的包合物热稳定性能良好。
2.2.8 Cur_β-CD的体外释放
精密称取一定量的Cur原料药和等药量的Cur_β-CD包合物,采用浆法进行体外释放研究。在900 mL10 mg·mL-1十二烷基硫酸钠(SDS)模拟胃液介质、(37±0.5)℃和(50±1) r·min-1条件下进行溶出,分别于5、10、20、30、45和60 min各取5 mL溶液进行Cur含量检测,计算累积释放率,平行6组,每次取样后补充同温度等体积的模拟胃液。结果见图4,Cur在60 min内累积释放率仅为21.96%,而Cur_β-CD在10 min时累积释放率已达到83.25%,60 min时可达85.19%,是Cur累积释放率的4倍,该结果表明经β-CD包合后,Cur的释放速率和程度显著提高。
2.3 形状记忆PPC-PEG薄膜的制备和表征
2.3.1 溶液共混法制备PPC-PEG薄膜
将PPC和PEG6000共10 g按照9.5∶0.5、8.5∶1.5、7.5∶2.5、6.5∶3.5和5.5∶4.5的不同比例共混,加入40 mL二氯甲烷匀速搅拌3 h后倒入玻璃表面皿中(5 mm厚),挥干溶剂后得到不同配比的PPC-PEG复合薄膜。
2.3.2 显微观察PPC-PEG薄膜微观形态
使用VHX-900光学显微镜观察不同配比的PPC-PEG复合膜的表面,在200倍的放大倍数下获得了不同配比的形状记忆PPC-PEG复合膜的表面照片。结果见图5,共混后PPC形成“细胞状”小单元,PEG分布于其四周;当PEG添加量为5%(图5A)和15%(图5B)时,因PEG含量较少无法完全填充,结构不够紧密;当PEG添加量为25%(图5C)时,PEG较为均匀地填充在PPC小单元的周围,结构致密均匀;当PEG添加比例为35%(图5D)和45%(图5E)时,PEG同时存在于PPC周围及表面,材料表面变粗糙。形状记忆PPC-PEG复合薄膜中PEG为固定相,为PPC提供交联点,二者共混后结构是否均一紧密会影响复合薄膜的形状记忆性能。从外观上来看,当PPC和PEG共混比例为7.5∶2.5时,二者相容性更好,结构紧密均一。
2.3.3 傅里叶红外光谱分析
将不同比例共混的PPC-PEG复合薄膜加入适量溴化钾压片,采用傅里叶红外光谱仪在4 000~400 cm-1进行测定,分辨率为2 cm-1扫描16次。结果见图6A,5种共混比例的复合薄膜的吸收峰位置和峰形基本相似;1 748 cm-1、1 073 cm-1和788 cm-1处为PPC的特征吸收峰;961 cm-1和842 cm-1处为PEG的特征吸收峰;PPC-PEG复合薄膜仅表现出PPC与PEG特征峰的叠加,无新峰出现,表明PPC-PEG复合薄膜仅是物理共混。
2.3.4 热重分析
分别取不同比例共混的PPC-PEG复合薄膜进行热重分析,以A12O3为参比,升温速度为10 ℃·min-1,氮气流速为30 mL·min-1,扫描范围为30~600 ℃,取样量为5 mg,记录热重曲线,结果见图6B。5种不同比例复合薄膜仅在200~400 ℃存在一个由PPC及PEG6000主链分解引起的热分解过程,各复合薄膜热分解温度均超过200 ℃,在400 ℃附近均能分解完全,说明其热稳定性能良好。
2.3.5 差示扫描量热分析
分别取不同比例共混的PPC-PEG复合薄膜进行DSC热分析,以A12O3为参比,升温速度为10 ℃·min-1,氮气流速为20 mL·min-1扫描范围为0~200 ℃,取样量为5 mg,分别记录二次升温曲线。结果见图6C和表1,测量温度范围内PPC只在32.1 ℃有1个玻璃化转变温度(Tg);PEG6000仅在58.1 ℃有1个熔融峰(Tm)。5种不同配比的薄膜中,同时出现了Tg和Tm峰,复合薄膜的Tg随PEG比例增加而增大,趋近37 ℃,表明共混物中PPC链段的迁移受PEG6000晶体的限制。在5种不同配比的形状记忆复合膜中,Tg较低的PPC做临时相,当温度达到其玻璃化转变温度以上时,相态改变,可在外力作用下发生形变;Tm相对较高的PEG仍以结晶的形式存在,作为交联点在形状记忆聚合物中作固定相,起到固定永久形状的作用[16]。
2.3.6 PPC-PEG薄膜形状记忆性能考查
基于PPC-PEG制备的新型胃滞留给药系统应满足口服给药进入胃部后快速展开至尺寸大于胃幽门口径,以便阻止其通过幽门进入肠道。本研究将复合薄膜裁剪成8.4 mm×10 mm大小的尺寸,置于45 ℃恒温水槽中1 min,沿着宽边的方向将其卷成直径为3 mm的薄膜卷,保持外力不变将其转置于冰水中冷却得到临时形状;随后再将其置于37℃的恒温水槽中观察并记录各薄膜2 min后的展开直径,按公式2计算形状恢复率。
形状恢复率(%)= 展 开 后 直 径 ( m m ) 展 开 前 直 径 ( m m )×100%
实验结果见表2,随着PEG含量的增加复合薄膜的形状恢复率先增大后减小,当PPC和PEG共混配比为7.5∶2.5时,记忆性能最佳,恢复率达88.6%;恢复后薄膜卷直径为(8.86±0.56) mm,可以在大鼠体内发挥良好的胃滞留效果。
2.4 载药形状记忆PPC-PEG胃滞留给药系统的制备和表征
2.4.1 载药薄膜的制备
将PPC和PEG按最佳性能比7.5∶2.5共混,加入二氯甲烷匀速搅拌2.5 h,再加入一定量的Cur或Cur_β-CD包合物使最终载药量为总质量的10%;继续搅拌30 min后将混合液倒入玻璃表面皿中,挥干溶剂后获得Cur_PPC-PEG和Cur_β-CD_PPC-PEG载药复合薄膜。
2.4.2 红外光谱分析
为鉴别PPC-PEG负载Cur或Cur_β-CD后药物和薄膜间是否会相互影响,用锉子将Cur_PPC-PEG和Cur_β-CD_PPC-PEG载药复合薄膜磨成细粉,分别与KBr混合后压片,采用傅里叶红外光谱仪在4 000~400 cm-1进行测定,分辨率为2 cm-1,扫描16次。结果见图7A,Cur_PPC-PEG的特征吸收峰是Cur和PPC-PEG吸收峰的叠加,没有发生峰位置的偏移且无新峰出现,表明PPC-PEG对Cur进行负载仅为物理共混,没有改变Cur的性质;同样,Cur_β-CD_PPC-PEG的特征吸收峰是Cur_β-CD和PPC-PEG特征吸收峰的叠加,没有发生峰位置的偏移且无新峰出现,表明PPC-PEG对Cur_β-CD进行负载也仅为物理共混,没有改变Cur的性质。综上,Cur和薄膜间没有形成相互影响。
2.4.3 热重分析
热重曲线体现出高分子材料的热分解速率,从而反映材料的热稳定性。良好的载药材料要具备提高药物热稳定性的能力。分别取适量Cur_PPC-PEG和Cur_β-CD_PPC-PEG载药复合薄膜进行热重分析,以A12O3为参比,升温速度为10 ℃·min-1,氮气流速为30 mL·min-1,扫描范围为30~600 ℃,取样量为5 mg,分别记录热重图谱。结果见图7B,在200~400 ℃,经PPC-PEG负载的Cur起始热分解温度(380 ℃)明显高于游离Cur的热分解温度(275 ℃),表明PPC-PEG的负载可以提高Cur的热稳定性。在280~400 ℃,Cur_β-CD_PPC-PEG与Cur_β-CD相比降解速率明显减慢,表明PPC-PEG的负载可以提高Cur_β-CD稳定性。Cur_PPC-PEG和Cur_β-CD_PPC-PEG的起始热分解温度均超过200 ℃,表明薄膜热稳定性良好。
2.4.4 差示扫描量热分析
分别取Cur_PPC-PEG和Cur_β-CD_PPC-PEG载药复合薄膜进行DSC分析,以A12O3为参比,升温速度为10 ℃·min-1,氮气流速为20 mL·min-1,扫描范围为0~200 ℃,取样量为5 mg,记录二次升温曲线。结果见表3和图7C,载药后二者的Tg和Tm值相对于空白PPC-PEG均有所升高,同时Tm峰变宽,表明药物的载入会限制PPC链间的移动,对PPC-PEG载体的形状记忆性能产生影响。
2.4.5 载药PPC-PEG复合薄膜形状记忆性能分析
将载药复合薄膜置于37℃模拟胃液中,观察其在2 min内的形状恢复率,结果见表4,与未载药PPC-PEG薄膜相比,Cur和Cur_β-CD的加入会影响PPC-PEG复合薄膜的形状记忆性能,使形状恢复率降低。由后续的大鼠体内的血浆药动学研究结果和解剖实验结果可知,即使载药后记忆材料形状恢复率降低,但制剂仍能在大鼠体内有效发挥胃滞留效果并持续释药。
2.4.6 载药PPC-PEG复合薄膜体外释药性能分析
在恒温振荡器中研究载药PPC-PEG复合薄膜的Cur释放特性。将干燥的Cur_PPC-PEG复合薄膜(2 cm×2 cm)和Cur_β-CD_PPC-PEG复合薄膜(2 cm×2 cm)称重并计算出Cur含量,分别置于1% SDS模拟胃液中,于(37±0.5)℃下恒温振荡,转速100 r·min-1,分别于0.5、1、2、4、8、12、24和48 h取样3 mL,同时补加同温等量介质,平行6组,425 nm的波长下测定紫外吸光度A,计算Cur含量。按公式3计算累积释放度:
Er= V e ∑ 1 n - 1 C i + V 0 C n m
式中,Er为累积释放度,Ve为每次取样体积,n为取样次数,Ci为第i次取样时的药物浓度,V0为释放介质初始体积,Cn为第n次取样时的药物浓度,m为复合薄膜中药物的初始含量。
以释放时间t为横坐标,累积释放度Q%为纵坐标绘制释放曲线(图8)。在1% SDS模拟胃液中,Cur_PPC-PEG与Cur_β-CD-PPC-PEG载药复合薄膜均具有缓释性能,48 h内的累计释放率分别为31.44%和71.42%。
`应用origin软件对Cur_PPC-PEG和Cur_β-CD_PPC-PEG的体外释放数据进行拟合分析。结果见表5,Cur从Cur_PPC-PEG或Cur_β-CD-PPC-PEG中的释放可拟合为一级速率过程,形状记忆复合膜中的Cur可缓慢、持续释放。
2.5 MTT实验
实验分组:Cur原料药组、Cur_β-CD组、PPC-PEG薄膜组、Cur_PPC-PEG薄膜组、Cur_β-CD_PPC-PEG薄膜组、空白组和对照组。细胞接种:取对数生长期的SGC-7901细胞制成细胞悬液,调整细胞浓度为每毫升5×103个;细胞接种到96孔板中,每孔接种200 μL细胞悬液,每组6个重复(空白组不接种细胞)。接种后将细胞放回培养箱中继续培养待细胞贴壁。
首先应用MTT法检测PPC-PEG薄膜对胃癌SGC-7901细胞的毒性作用。将PPC-PEG薄膜置于6孔板中,加入含10%胎牛血清和1.2%双抗溶液的DMEM高糖培养基浸提24 h,制备成100%浓度的材料浸提液,分别稀释至50%、25%、12.5%和6.25%浓度。接种的细胞贴壁后将96孔板中的培养基弃掉,用稀释前后的PPC-PEG浸提液培养SGC-7901细胞12,24或48 h,进行细胞毒性试验。结果见图9,不同浓度的PPC-PEG浸提液对细胞分别培养12,24或48 h后,SGC-7901细胞存活率均在95%以上,表明未载药PPC-PEG薄膜对SGC-7901细胞无毒性。
其次考察原料药和各载药组对SGC-7901细胞的抑制作用。将适量二甲基亚砜加入到DMEM高糖培养液中作为浸提液,向浸提液中分别添加一定质量的Cur、Cur_β-CD、Cur_PPC-PEG和Cur_β-CD-PPC-PEG浸提24 h,按照Cur计各组浓度梯度为5,10,20,40和80 μmol·L-1。用上述浓度的各组浸提液培养SGC-7901细胞12,24或48 h。同时设置空白组和对照组,用酶标仪在490 nm处测定OD值,按照公式4~5计算SGC-7901细胞的存活率和抑制率;通过Graphpad prism 9拟合计算半数抑制浓度IC50。
细胞存活率(%)=(OD给药组-OD空白对照组)/(OD正常对照组-OD空白对照组)×100%
细胞抑制率(%)=[1-(OD给药组-OD空白对照组)/(OD正常对照组-OD空白对照组)]×100%
4种制剂对SGC-7901细胞的增殖均产生了显著的抑制作用,且具有浓度依赖性和时间依赖性,4组药物的细胞抑制率均随药物的浓度及培养时间的增加而增大(图10)。其中,按照Cur计,80 μmol·L-1的Cur_β-CD作用48 h后可以抑制88.84%以上的SGC-7901胃癌细胞,Cur_β-CD-PPC-PEG载药薄膜的细胞增殖抑制率次之,在相同载药浓度与时间下可以抑制86.64%的SGC-7901细胞增殖。
由表6可知,在给药12 h后,4种制剂对SGC-7901细胞的半数抑制浓度(IC50)相差不大,但随着给药时间延长至24 h和48 h,4种制剂的IC50值差异显著。Cur_β-CD组和Cur_β-CD_PPC-PEG组对SGC-7901细胞作用24 和48 h的IC50值明显小于Cur组和Cur_PPC-PEG组,说明制备为包合物后药物对细胞的抑制作用更强,这可能与包合物在较长时间范围内保持Cur的稳定性有关[25],Cur从包合物中缓慢地释放持续发挥细胞毒性作用。虽然Cur_β-CD_PPC-PEG载药薄膜的浸提液对SGC-7901的抑制作用稍逊色于Cur_β-CD,但Cur_β-CD_PPC-PEG载药薄膜具有形变性能,在胃中展开后可实现胃滞留的效果,因此Cur_β-CD_PPC-PEG载药薄膜作为新型胃癌抑制剂更具优势。
2.6 Cur体内分析方法的建立
2.6.1 色谱条件
高效液相色谱仪;色谱柱:Kromasil C18色谱柱;流动相:甲醇-体积分数1%磷酸(72∶28),柱温:25 ℃;流速为1.0 mL·min-1;检测波长:425 nm;进样量20 μL。
2.6.2 血液样品处理
精密吸取血浆100 μL于2 mL的离心管,加入0.5 mL乙酸乙酯,涡旋混匀3 min后以3 000 r·min-1的转速离心10 min,取上层乙酸乙酯,重复3次,合并3次上层乙酸乙酯层,于40 ℃的水浴锅中挥干后,用100 μL的流动相复溶,涡旋3 min,以5 000 r·min-1的转速离心10 min,备用。
2.6.3 专属性实验
分别取大鼠空白血浆、空白血浆加Cur对照品、大鼠灌胃给药后的血浆,按“2.6.2”项下方法处理血浆样品,按“2.6.1”项下条件进样分析。结果见图11,Cur的保留时间为10 min,且血浆中的内源性物质对Cur的测定不产生干扰,表明此方法专属性良好。
2.7 Cur_β-CD_PPC-PEG在大鼠体内的血浆药动学研究
将体质量(200±20) g的SPF级雄性Wistar大鼠随机分为3组(n=6)。给药前12 h禁食不禁水,实验期间自由饮水。分别灌胃给予Cur原料药混悬液、Cur_β-CD包合物混悬液和Cur_β-CD_PPC-PEG载药薄膜,给药剂量为按照Cur计50 mg·kg-1。Cur和Cur_β-CD包合物混悬液组:用蒸馏水配制成浓度为5 mg·mL-1的Cur和Cur_β-CD包合物口服制剂;Cur_β-CD_PPC-PEG载药薄膜组:按照“2.3.6”项下方法对薄膜进行处理后用镊子送至大鼠胃中。于给药后5、10、15、30、45 min、1、 2、4、6、8、10、12和24 h经大鼠眼眶取血约0.3 mL,置于1.5 mL肝素化离心管中,离心10 min,转速5 000 r·min-1,用HPLC法分析上清液,记录相应的峰面积,根据线性回归方程Y=0.859 6X+0.001 7(r2=0.999 1)计算Cur浓度。采用DAS2.0药动学软件中的非房室模型对主要药动学参数进行计算,即药时曲线下面积(AUC)、平均驻留时间(MRT)、达峰时间(tmax)和达峰浓度(ρmax)。
大鼠灌胃给药后血药浓度-时间曲线见图12,主要药动学参数结果见表7。与原料药相比,Cur_β-CD包合物tmax缩短, ρmax、AUC0-24分别增加至4.10倍和3.03倍,表明药物经包合后生物利用度显著提高。与Cur_β-CD相比,Cur_β-CD_PPC-PEG的tmax由0.19 h延长至6 h,AUC0-24和MRT0-24分别增加至3.21倍和2.77倍,表明经PPC-PEG负载后,Cur在血液中的半衰期和体内滞留时间显著延长,在大鼠体内的生物利用度进一步显著提高,药物稳定性增强。经环糊精包合改性和PPC-PEG负载的Cur_β-CD_PPC-PEG药代动力学参数最佳,在6 h可达到最大吸收浓度,ρmax为0.41 mg·L-1,AUC0-24为2.91 mg·L-1·h,MRT0-24为6.99 h,分别是Cur原料药ρmax、AUC0-24和MRT0-24的2.16、9.73和2.95倍,表明Cur_β-CD_PPC-PEG胃滞留给药系统可延长药物在体内的滞留时间,在生物体内维持相对稳定的血药浓度,从而提高Cur的生物利用度。
3 讨论
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本研究以提高Cur口服生物利用度为目的,制备了一种基于形状记忆复合物的展开型胃滞留给药系统。该系统可在37 ℃条件下改变制剂尺寸,使其大于胃幽门,从而实现胃内滞留的效果,丰富了胃滞留给药系统的制备方法。据文献报道,人的胃幽门尺寸为9 mm左右[26],当制剂最小两个维度的尺寸大于12 mm时可实现良好的胃滞留效果[27-28]。
采用冷冻干燥法将水溶性较差的Cur与β-CD制成包合物,使Cur的溶解度提高了35.85倍。采用溶液共混法以PPC和PEG为材料制备形状记忆复合薄膜,其中PPC为临时相,PEG为固定相,为PPC提供交联点,一方面限制其链间运动,另一方面为其形状恢复提供支持。PPC和PEG的混合比例对复合薄膜的形状记忆性能影响较大,若薄膜中PEG含量较少则交联点不足,在形状恢复时不能提供足够的“动力”;若PEG含量较高,则PPC链间移动受到限制,形状恢复率降低。这与Cheng等[29]的研究结果一致,将PPC与PCL熔融共混后,PPC也是作为临时相来响应外界刺激而发生形变。本研究制备的5种不同PPC和PEG配比的复合膜中,PPC-PEG(7.5∶2.5)形状记忆性能最佳,大于或小于该比例均会导致形状恢复率降低。此外,以形状记忆材料作为药物传输系统,最让人担心的问题就是药物的负载会影响形状记忆性能[30]。Cur负载于PPC-PEG复合膜后形状恢复率降低,其原因可能是药物限制了可逆相的链间移动,这与Ren等[31]的研究结果一致。虽然药物的存在影响了Cur_β-CD_PPC-PEG复合膜形状记忆恢复率,但其受热诱导展开后仍能发挥胃滞留效果。
胃癌细胞体外增殖抑制实验结果表明,Cur_β-CD_PPC-PEG对胃癌细胞的抑制作用较强,且存在时间依赖性和浓度依赖性;载药浓度为80 μmol·L-1的Cur_β-CD_PPC-PEG作用48 h可以杀死86.64%的SGC-7901细胞。药物体外释放结果表明Cur_β-CD_PPC-PEG的释放符合一级速率释药,具有良好的缓释效果。Cur_β-CD_PPC-PEG的累积释放率是Cur_PPC-PEG的2.27倍,说明将Cur_β-CD负载于PPC-PEG后不会破坏Cur和β-CD间的包合作用。Cur_β-CD_PPC-PEG在胃部作用48 h时药物不能完全释放,累积释放率为71.42%,前8 h释放率为63.68%,进一步提高药物累积释放率是下一步课题研究的重点之一。
体内药动学研究结果表明Cur_β-CD_PPC-PEG的AUC0-t和MRT0-24分别是原料药Cur的9.73倍和2.95倍,且Cur在碱性环境下易降解肠内吸收较差,证明药物体内滞留时间显著延长与Cur_β-CD_PPC-PEG载药薄膜胃中滞留时间较长有关。说明将Cur制备成Cur_β-CD后负载于PPC-PEG上可以增加Cur在大鼠体内的循环时间,显著提高其生物利用度。此外,解剖实验结果表明,大鼠灌胃给药4 h内其胃内载药薄膜较为完整,第4 h解剖获得的薄膜质地开始软化,第5 h时胃中薄膜的4个角已发生断裂,第6 h仅在大鼠胃中找到零散的薄膜碎片,此时已经失去胃内滞留功能。药动学实验和大鼠解剖实验结果表明本课题制备的Cur_β-CD_PPC-PEG载药薄膜具有良好的胃内滞留效果,胃内滞留时间约为5~6 h。
综上,本研究成功制备出载Cur_β-CD形状记忆PPC-PEG胃滞留给药系统;该给药系统的制备为提高药物水溶性和延长药物胃内滞留时间等相关剂型的开发提供参考。
基金
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  • 哈尔滨商业大学“青年科研创新人才”项目资助(2023-KYYWF-1037)
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2025年第60卷第3期
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doi: 10.11669/cpj.2025.03.010
  • 接收时间：2024-05-09
  • 首发时间：2025-10-29
  • 出版时间：2025-02-08
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  • 收稿日期：2024-05-09
基金
哈尔滨商业大学“青年科研创新人才”项目资助(2023-KYYWF-1037)
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    哈尔滨商业大学药学院, 哈尔滨 150076

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*陈宁,男,博士,研究员 研究方向:新型胃滞留递药系统研究 Tel:(0451)84866922
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
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红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
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光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
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