The Breviscapine Sustained Release Tablets And The Study Of The Layer Osmotic Pump Tablets

In this paper, breviscarpin (DZHS) was selected as the model drug, to prepare DZHS matrix sustained-release tablet (SRT) with HPMC as matrix material. DZHS bi-layer osmotic pump ontrolled-release tablet (CRT) was also prepared with PEO.Both were administrated once a day.UV spectrophotometry was developed for the assay of solubility and drug release. HPLC method was applied in the determination of scutellarin content, related matters and in vivo drug concentration. The method was quick and accurate which could meet the requirement of the analysis.Single factor tests were carried out and it was found that the property of HPMC has greater effects on drug release. Based on the results of single factor tests, a optimal self-prepared SRT was screened. The results of quality studies on self-prepared SRT showed the homogeneity of one batch and the repeatability of three batches was good, but the in vitro release condition influenced its release behavior. Influencing factor test showed the release behavior of drug was effected by temperature and moisture and should preserved sealed. Finally drug release mechanism was confirmed as the combination result of hydrophilic gel diffusion and erosion.Single factor tests were carried out to DZHS osmotic pump controlled-released tablet (CRT) . The results showed that the main influencing factors were as follows, the content of NaCl, PEO in the push layer, the content of PEG4000 and coating thickness. HPMC can slightly modiiy the release behavior of CRT. Orthogonal experiment with five factors...