丹参多组分渗透泵片的制备及体外释放度的考察

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。

Preparation of multi-components osmotic pump tablets of Danshen (Radix Salviae Miltiorrhizae ) and release in vitro

Objective To study the formula and preparation technique of multi-components osmotic pump tablets of Danshen(Radix Salviae Miltiorrhizae),and observe the various factors influencing on the accumulative release of the tablets in order to make all components of Danshen to release simultaneously.Methods Taking the accumulative release of active principles of Danshen as indexes,the influences of various factors on the release were observed by using respectively single-factor test and orthogonal design test.Results The dosages of penetrating agent and porogen and coating weight gain rate had larger influences on the release.There were two index components with good similarity in release in vitro.The accumulative release of 12 hours was about 90% and showed a zero-order release.The final formula was obtained through orthogonal design test.Conclusion The extracts of Danshen can be prepared as osmotic pump tablets with constant speed and completed controlled release.