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目的:制备盐沙格雷酯不对称膜胶囊剂并研究其体外释药规律。方法:以盐酸沙格雷酯为药物模型,醋酸纤维素为囊膜材料,加入致孔剂F68,PEG-400为增塑剂,丙酮:乙醇=4:1为溶媒,采用蘸胶工艺制备囊壳。通过实验选择不同的致孔剂比例,研究其药物释放规律。结果:以60%、80%、100%F68为致孔剂制备的胶囊,药物在24 h时有90%以上从不对称膜胶囊中释放;致孔剂F68比例为40%时,药物释放符合零级方程,致孔剂比例为100%时,药物释放符合Higuchi方程。结论:药物盐酸沙格雷酯在致孔剂含量低的不对称膜胶囊中呈缓释释药,在致孔剂含量高的不对称膜胶囊中呈控释释药。
OBJECTIVE: To prepare ascorbic acid asymmetric membrane capsules and study its in vitro drug release. Methods: Sarcosine hydrochloride was used as the drug model and cellulose acetate was used as the capsular material. The porogen was prepared by adding the porogen F68 and PEG-400 as plasticizers and acetone: ethanol = 4: 1 as solvent. . Through the experiment choose different proportion of porogen to study its drug release law. Results: The capsules prepared with 60%, 80% and 100% F68 as porogen showed that more than 90% of the drug was released from the asymmetric membrane capsule at 24 h. The release rate of the drug was 40% Zero-order equation, porogen ratio of 100%, the drug release in line with Higuchi equation. Conclusion: The drug sarpogrelate hydrochloride is sustained release drug delivery in asymmetric membrane capsule with low porogen content, and controlled release drug in asymmetric membrane capsule with high porogen content.