Marczyiński Zbigniew
Zakad Farmacji Aptecznej, Katedra Farmacji Stosowanej, Uniwersytet Medyczny w Łodzi.
Polim Med. 2009;39(4):51-60.
Direct tableting is simpler and more cost-effective from the point of view of good manufacturing practice (GMP) than wet granulation or dry compacting. Moreover, the use of dry plant extracts in the process of direct tableting, omitting granulation, decreases the possibility of biological activity loss of active substances. Thus, pharmaceutical industry uses this particular process more and more frequently. Only few therapeutic substances form under compression tablets meeting current requirements. Very often addition of auxiliary substances appears to be indispensable. The aim of this study was to obtain uncoated tablets by the method of direct tableting with the use of selected auxiliary substances. Dry extract from Solidago virgaurea L. was the study material. Shrimp chitosan, silicified microcrystalline cellulose (Prosolv), polyvinylpyrrolidone, calcium carbonate and sodium stearyl fumarate were used as auxiliary substances. Eleven tablet batches were manufactured in a reciprocating instrumented tableting machine (Ewreka). The produced tablets were subjected to morphological tests comprising the tablet size, determination of batching accuracy (determination of mass uniformity of individual tablets), test of mechanical resistance (crushing strength), determination of disintegration time. The statistical hardness of the manufactured tablets was also estimated. Pharmaceutical availability tests were performed of the biologically active substances released from tablets to the acceptor fluid. The study was based on general and detailed regulations of Polish Pharmacopoeia VII (PP VII). The obtained results allow to conclude that the applied auxiliary substances appeared to be useful in adequate proportions in manufacturing tablets containing dry extract from Solidago virgaurea L. The properties of the obtained batches of tablets were in majority consistent with the current requirements. The applied method provides technological reproducibility and high durability of the drug. These tablets as compared to available herbal mixtures and aqueous extracts can be a more comfortable form of a drug.
从良好生产规范（GMP）的角度来看，直接压片比湿法制粒或干法制粒更简单且更具成本效益。此外，在直接压片过程中使用干燥的植物提取物，省略制粒步骤，可降低活性物质生物活性丧失的可能性。因此，制药行业越来越频繁地使用这种特定工艺。只有少数治疗性物质能在压片过程中形成符合当前要求的片剂。通常添加辅助物质似乎是必不可少的。本研究的目的是通过使用选定的辅助物质，采用直接压片法获得未包衣片剂。来自兴安一枝黄花的干燥提取物作为研究材料。虾壳聚糖、硅化微晶纤维素（Prosolv）、聚乙烯吡咯烷酮、碳酸钙和硬脂酰富马酸钠用作辅助物质。在往复式仪器化压片机（Ewreka）中制造了11批片剂。对所生产的片剂进行形态学测试，包括片剂尺寸、配料精度测定（单个片剂质量均匀性测定）、机械抗性测试（抗压强度）、崩解时间测定。还估计了所制造片剂的统计硬度。对片剂中释放到接受液中的生物活性物质进行了药物可用性测试。该研究基于波兰药典VII（PP VII）的一般和详细规定。所得结果表明，所应用的辅助物质在适当比例下似乎可用于制造含有兴安一枝黄花干燥提取物的片剂。所获得的片剂批次的性质大多符合当前要求。所应用的方法提供了工艺可重复性和药物的高耐久性。与现有的草药混合物和水提取物相比，这些片剂可能是一种更方便的药物剂型。
