CAJ | 학술논문

目的：制备一种适用于大型动物腹部器官移植术后的免疫抑制药物栓剂，并对其进行质量评价。方法：以雷帕霉素（rapamycin）和他克莫司（tacrolmius）为原料药，聚乙二醇2000和聚乙二醇4000为主要基质，采用热熔法结合定量注模成型工艺制备复方栓剂，并对其外观、重量差异、融变时限、药物含量进行评价。结果：复方雷帕霉素栓剂外观呈白色半透明状，室温下硬度较好，长度短，重量差异、融变时限和药物含量均符合栓剂要求。结论：本方法制备的复方雷帕霉素栓剂质量符合栓剂要求，为该药物的新药开发奠定了基础。
목적：제비일충괄용우대형동물복부기관이식술후적면역억제약물전제，병대기진행질량평개。방법：이뢰파매소（rapamycin）화타극막사（tacrolmius）위원료약，취을이순2000화취을이순4000위주요기질，채용열용법결합정량주모성형공예제비복방전제，병대기외관、중량차이、융변시한、약물함량진행평개。결과：복방뢰파매소전제외관정백색반투명상，실온하경도교호，장도단，중량차이、융변시한화약물함량균부합전제요구。결론：본방법제비적복방뢰파매소전제질량부합전제요구，위해약물적신약개발전정료기출。
Objective:To develop a small type of suppository of immunosuppressive agents to suit for large animals after abdominal organ transplantation, and carry out it’s quality evaluation. Methods:Rapamycin and ta-crolimusas were chosed as active pharmaceutical ingredients, and polyethylene glycol 2000, polyethylene glycol 4000 were used as substrate. Melting followed with a quantitative injection molding process was used to prepare the small type of compound suppository. The appearance, weight difference, melting time and drug content of the suppository were evaluated. Results:The compound rapamycin suppository was translucent, white, and had good hardness at room temperature. It’s short, and the weight variation, melting time and drug content were con-formed to the requirements of the suppository. Conclusion:The compound rapamycin suppository prepared by this method conforms to the quality of suppository, which makes a good foundation for the development of the new drug.