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目的:制备盐酸曲马多的缓释片并对其处方与工艺进行优化。方法:在单因素考察的基础上,以体外释放度为考察指标,通过均匀设计试验优化处方。结果:最优处方配比为HPMC K4M用量45%,十八醇用量35%,采用φ9mm冲模,控制片剂硬度为6～8kg·cm-2。制得的缓释片1,4,8h的累积释放度分别为25.75%,52.22%和76.28%。结论:制备的盐酸曲马多缓释片具有缓释12h的效果,且处方和工艺简单、易行,重复性好,适于工业化生产。
Objective: To prepare tramadol hydrochloride sustained-release tablets and to optimize its formulation and process. Methods: On the basis of single factor study, the in vitro release degree was taken as the index of investigation, and the prescription was optimized by uniform design test. Results: The optimal prescription ratio was 45% of HPMC K4M dosage and 35% of octadecyl alcohol dosage. The φ9mm die was used to control the tablet hardness of 6-8kg · cm-2. The cumulative release of 1,4,8h sustained-release tablets were 25.75%, 52.22% and 76.28% respectively. Conclusion: Tramadol Hydrochloride Sustained Release Tablets have the effect of sustained release for 12h, and the prescription and process are simple, easy and reproducible, and suitable for industrial production.