摘要
依托泊苷软胶囊是一种常用的抗肿瘤药物剂型,已被广泛用于治疗多种恶性肿瘤。然而,其口服制剂的生物利用度相对较低,主要由于其水溶性差和在酸性环境中易分解的特性所致。为了提高依托泊苷软胶囊的口服给药效果,探索了其制备工艺和质量。首先,在制备工艺方面,采用了合适的胶囊外壳材料,并通过合理的填充剂选择和溶剂调配,提高依托泊苷的溶解度和稳定性,并对封闭方法进行了优化,确保药物的长期保存和释放性能。其次,在质量研究方面,使用高效液相色谱仪和紫外检测器对产品进行分析,通过对基苯甲酸丙酷的对照液和供试品溶液的色谱分析,评估了依托泊苷软胶囊中的杂质峰和依托泊苷的含量。最后,通过优化制备工艺和进行质量研究,成功提高了依托泊苷软胶囊口服制剂的质量和生物利用度。
Etoposide soft capsules are a commonly used anti-tumor drug formulation and have been widely used for the treatment of various malignant tumors.However,the bioavailability of its oral formulations is relatively low,mainly due to its poor water solubility and easy decomposition in acidic environments.In order to improve the oral administration effect of etoposide soft capsules,this study explored its preparation process and quality.Firstly,in terms of preparation process,appropriate capsule shell materials were used,and the solubility and stability of etoposide were improved through reasonable selection of fillers and solvent allocation.The sealing method was optimized to ensure the long-term storage and release performance of the drug.Secondly,in terms of quality research,the product was analyzed using high-performance liquid chromatography and UV detector.The impurity peaks and content of etoposide in the etoposide soft capsules were evaluated through chromatographic analysis of the control solution and test solution of p-phenylbenzoate propionate.Finally,by optimizing the preparation process and conducting quality research,the oral preparation quality and bioavailability of etoposide soft capsules were successfully improved.
作者
周晔
胡静
孙文奇
高芳
吴子鑫
Zhou Ye;Hu Jing;Sun Wen-qi;Gao Fang;Wu Zi-xin
出处
《化工设计通讯》
CAS
2023年第12期217-219,共3页
Chemical Engineering Design Communications
关键词
依托泊苷
软胶囊
制备工艺
质量研究
etoposide
soft capsule
preparation process
quality research
