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目的研究丹参多组分渗透泵控释片处方及其制备工艺,并对影响其累积释放度的各种因素进行考察,使丹参各组分达到同步释放。方法以丹参有效成分累积释放度为指标,分别采用单因素及正交设计法考察各因素对药物释放的影响。结果促渗剂的用量、致孔剂的用量以及衣膜增重率对药物释药具较大影响;两种指标性成分体外释放相似性良好,12 h累积释药均在90%左右且呈零级释放,并通过正交实验设计得到了最终处方。结论丹参提取物可制备成释药恒速、完全的渗透泵控释片,达到了控释目的。
OBJECTIVE To study the prescription of Salvia miltiorrhiza multi-component osmotic pump controlled release tablets and its preparation process, and investigate the various factors that affect the cumulative release rate of Salvia miltiorrhiza. Simultaneously, the components of Salvia miltiorrhiza reach synchronous release. Methods Salvia miltiorrhiza active ingredient cumulative release as an indicator, single factor and orthogonal design were used to examine the impact of various factors on drug release. Results The amount of penetration enhancer, the amount of porogen and the rate of weight gain of coating film had a significant effect on drug release. The similarity of release of two index components in vitro was good, and the accumulative drug release at 12 h was about 90% Zero-order release, and through the orthogonal experimental design has been the final prescription. Conclusion Salvia extract can be prepared as a sustained-release, complete osmotic pump controlled release tablets, to achieve the purpose of controlled release.