疮疡灵-明胶海绵复合物质量控制及主要成分体外释放率测定.docVIP

疮疡灵/明胶海绵复合物质量控制及主要成分体外释放率测定[摘要] 目的：研究疮疡灵/明胶海绵复合物体外释放率，探讨其质量控制的方法。方法：采用气相色谱法对疮疡灵/明胶海绵复合物主要成分进行体外释放度的测定。结果：溶液24 h内基本稳定，冰片1、2、24 h的累积释放率分别为36.79%、54.54%、96.12%，释放时间达24 h。结论：该制剂方法设计合理，稳定性良好，制备方法可行，所建立的质量标准可用于疮疡灵/明胶海绵复合物的质量控制。 [关键词] 疮疡灵/明胶海绵复合物；体外释放率；气相色谱法 [中图分类号] R944.9 [文献标识码] A [文章编号] 1673-7210（2011）11（c）-040-03 Quality standard and study on the main ingredients release in vitro of Chuangyangling /Absorbable Gelatin Sponge Compound ZHANG Rui1, ZHANG Peng2, WANG Na3 1.Department of Stomatology, Zhengzhou Center Hospital, He′nan Province, Zhengzhou 450007, China; 2.School of Stomatology, Zhengzhou University, He′nan Province, Zhengzhou 450052, China; 3.Department of Pharmaceutics, Zhengzhou Center Hospital, He′nan Province, Zhengzhou 450007, China [Abstract] Objective: To study on the release of Chuangyangling/Absorbable Gelatin Sponge Compound and establish its quality standard. Methods: Gas chromatography was used to examine the release rate in vitro of the main ingredients of Chuangyangling/Absorbable Gelatin Sponge Compound. Results: The solution was stable within 24 h basically. The release rate of Borneol at 1, 2, 24 h was 36.79%, 54.54%, 96.12% respectively. Conclusion: The method of design is reasonable with well stability. The established quality standard is applicable for the quality control of Chuangyangling/Absorbable Gelatin Sponge Compound. [Key words] Chuangyangling/Absorbable Gelatin Sponge Compound; Release rate in vitro; Gas chromatography 疮疡灵散是河南武警总队医院研制的纯中药外用制剂[批准文号：武制字（2011）F14002]。该药主要由冰片、珍珠、葛根等组成，具有消炎止疼、活血化瘀、去腐生肌、改善循环的作用，口腔科主要用于治疗拔牙术后干槽症的发生及各种原因所致的口腔黏膜溃疡性疾病。近年来，国内外利用生物粘附技术发展起来的黏膜粘附制剂发展迅速，由于口腔的特殊生理环境，现用于局部治疗口腔黏膜疾病的普通制剂如散剂、涂剂、含片、普通膜剂等多数在口腔内停留时间短，难以在病变部位达到持续有效的药物浓度，而黏膜粘附制剂则很好地解决了该问题[1]。笔者利用生物粘附原理研制了疮疡灵/明胶海绵复合物，并对其主要成分冰片进行体外释放度的研究，为该制剂的质量控制提供依据。 1 仪器和试药 1.1 仪器设备与试剂 仪器：岛津GC-14B气相色谱仪，氢火焰离子化检测器，101型电热鼓风干燥箱。 试剂：水杨酸甲酯（中国药品生物制品检定所），聚乙二醇20 000（PEG-20M），冰片对照品（中国药品生物制品检定所，批号：094328902，龙脑、异龙脑合并计算，归一化法测定结果为98.8%）。 1.2 疮疡灵/明