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目的:筛选复方氢氯噻嗪双层片中酒石酸美托洛尔缓释片处方。方法:以体外释放度为主要考察指标,并以羟丙基甲基纤维素(HPMC)与卡波姆的总用量(A)及二者的质量比(B)、微晶纤维素用量比例(C)、聚丙烯吡咯烷酮(PVP)无水乙醇溶液浓度(D)为因素进行正交试验优选处方。结果:优化处方确定A为30%,B为1∶2,C为20%,D为5%。优化后所制3批酒石酸美托洛尔缓释片1h内的累积释放度均在25%～45%,4h内的累积释放度均在40%～75%,8h内的累积释放度均>75%,24h累积释放度均>90%。结论:所选酒石酸美托洛尔缓释片的处方合理、工艺简单。
OBJECTIVE: To screen prescriptions of metoprolol tartrate sustained release tablets in compound hydrochlorothiazide bilayer tablets. Methods: The release rate in vitro was taken as the main index. The ratio of HPMC to Carbopol (A) and their mass ratio (B), the proportion of microcrystalline cellulose C), the concentration of polyvinylpyrrolidone (PVP) absolute ethanol solution (D) as the factor of orthogonal test. RESULTS: The optimized prescription determined that A was 30%, B was 1: 2, C was 20% and D was 5%. The cumulative release of 3 batches of metoprolol tartrate sustained release tablets within 1 h after optimization was 25% -45%, and the cumulative release within 4 h was 40% -75%, and the cumulative release within 8 h was> 75%, 24h cumulative release were> 90%. Conclusion: The selected metoprolol tartrate sustained-release tablets prescription is reasonable and the process is simple.