金石颗粒制备工艺及质量标准研究

Preparation process and quality standard for Jinshi granules

目的:完善金石颗粒制备工艺并制定质量标准。方法:采用减压提取,经干燥、粉碎成细粉后与部分药材细粉混合制成金石颗粒。以TLC法对其中麦冬、连翘、白花蛇舌草进行鉴别,并按《中国药典》第四部颗粒剂项下方法对粒度、水分、装量差异进行检验。结果:麦冬、连翘、白花蛇舌草TLC色谱斑点清晰,专属性强,重复性良好,粒度、装量差异等检查项均符合规定。结论:制备工艺简单可行,制剂质量稳定,质量控制方法简便、可靠、准确,可用于该制剂的质量控制。

Objective：To investigate the preparation process and quality standard for Jinshi granules. Methods：Jinshi granules were prepared by vacuum extraction,drying,pulverizing into fine powder, and nfixing with the fine powder of other medicinal materials. Thin layer chromatography（TLC） was used for identification of Radix Ophiopogonis ,Forsythia suspense, and Hedyotis diffusa, and the differences in granule size ,water content, and loading quantity were analyzed according to the methods for granules in Chinese Pharmacopoeia Volume IV. Results：Radix Ophiopogonis, Forsythia suspense, and Hedyotis diffusa had clear TLC spots with good specificity and productivity, and the differences in granule size and loading quantity met related requirements. Conclusion：The preparation process is simple and feasible and the preparation has stable quality. The quality control method is simple,reliable,and accurate and can be used for quality control of this preparation.