首页|细菌纤维素/胶原蛋白双层口腔分散膜的制备及性能研究

细菌纤维素/胶原蛋白双层口腔分散膜的制备及性能研究

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口腔分散膜(ODF)作为固体给药剂型有顺应性良好、快速起效等优点,然而常规单层ODF崩解快速、无法持续给药,应用范围受制约。设计利用细菌纤维素(BC)和经京尼平(GNP)交联的胶原蛋白(Col)分别为成膜剂,双氯芬酸钠(DS)为模型药物,经溶剂浇铸法制备双层DS 口腔分散膜(DS-ODF)。BC层快速释药,Col层因交联崩解缓慢,以对口腔溃疡类疾病达到快速镇痛和持久镇痛的治疗效果。通过正交试验法探究Col层制备过程中Col浓度、GNP添加量和增塑剂柠檬酸三乙酯(TEC)添加量的最优组合配方;主要评价了双层DS-ODF的外观形貌、释药速率、力学性能等。研究结果表明,所制备双层DS-ODF平整光滑、厚度均匀;于模拟口腔唾液中1 min即释放54。8%的药物含量、药物持续释放5 h,既能快速释放药物,又能持续给药;抗拉强度和断裂伸长率分别为50。4 MPa和2。1%;Col经GNP交联结构更加稳定,热分解温度提高至240 ℃,不受其热变性温度制约,满足后续加工需求。
Preparation and Properties of Bacterial Cellulose/Collagen Bilayer Oral Dispersion Film
Oral dispersible film(ODF),as a solid dosage form,has the advantages of good compliance and rapid onset of action,but the conventional monolayer ODF dissolves quickly and cannot be administered continuously,so its application range is limited.The bilayer DS oral dispersion film(DS-ODF)was prepared by solvent casting method using bacterial cellulose(BC)and collagen(Col)crosslinked with genipin(GNP)as the film-forming agent and sodium diclofenac(DS)as the model drug,respectively.With rapid drug release in the BC layer and slow disintegration of the Col layer due to crosslinking,the bilayer DS-ODF can achieve both rapid and lasting analgesia for oral ulcer diseases.The optimal combination of Col concentration,GNP addition and plasticiser triethyl citrate(TEC)addition during the preparation of the Col layer was investigated by orthogonal test.The appearance and morphology,drug release rate,and mechanical properties of bilayer DS-ODF were mainly evaluated.The results showed that the prepared bilayer DS-ODF was smooth with a uniform thickness.In the simulated oral saliva,54.8%of the drug content was released within 1 minute,and the drug was released continuously for 5 h,which was able to achieve both quick and sustained drug release.The tensile strength and elongation at the break were 50.4 MPa and 2.1%,respectively.The structure of Col was more stable by GNP cross-linking,and the thermal decomposition temperature was increased to 240 ℃,which was not constrained by its thermal denaturation temperature,and can meet the demand of subsequent processing.

oral disintegrating filmbacterial cellulosecollagengenipinsolvent casting methoddiclofenac sodium

吴晓艳、宋炜、陈爽、肖茹

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纤维材料改性国家重点实验室,上海 201620

东华大学材料科学与工程学院,上海 201620

口腔分散膜 细菌纤维素 胶原蛋白 京尼平 溶剂浇铸法 双氯芬酸钠

2024

山东化工
山东省化工研究院 山东省化工信息中心

山东化工

影响因子:0.249
ISSN:1008-021X
年,卷(期):2024.53(17)