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目的:考察处方因素对体外释药行为的影响,筛选最佳片芯处方制备盐酸青藤碱膜控型肠溶控释片。方法:采用均匀设计优化片芯中乙基纤维素和微晶纤维素的用量,湿法制粒压片,滚转包衣锅法制备盐酸青藤碱膜控型肠溶控释片,进行体外释放度测定。结果:最佳片芯处方为:乙基纤维素52.1g,微晶纤维素39.5g。按处方制备3批样品,在pH6.8磷酸盐缓冲液中释放符合零级方程,零级释药相关系数(r=0.9975),10h内累积释药90%以上。结论:制备的盐酸青藤碱肠溶片基本符合设计要求。
OBJECTIVE: To investigate the influence of prescription factors on drug release in vitro and screen the best core tablet for the preparation of sinomenine hydrochloride controlled-release enteric-coated controlled release tablets. Methods: The uniform design was used to optimize the dosage of ethylcellulose and microcrystalline cellulose in the core. The wet granulation tablet and the pan-coating pan method were used to prepare the sinomenine-controlled enteric controlled release tablets for in vitro release Degree measurement. Results: The best tablet core prescription: 52.1g ethyl cellulose, microcrystalline cellulose 39.5g. Three batches of samples were prepared according to the prescription and released in pH 6.8 phosphate buffer in accordance with the zero-order equation. The correlation coefficients of zero-order drug release (r = 0.9975) and cumulative drug release over 90% within 10 h were obtained. Conclusion: Sinomenine hydrochloride enteric-coated tablets basically meet the design requirements.