活血止痛贴的制备工艺研究

Study on the Preparation Process of Huoxue Zhitong Plaster

摘要: 目的：本研究旨在优化活血止痛贴的制备工艺，以提高其临床适用性与质量稳定性。方法：研究采用单因素实验和正交实验设计，考察了基质中白凡士林、甘油、高岭土三种辅料的用量对贴膏剂性能的影响，参照《中国药典》四部通则0122贴膏剂、0952黏附力测定法，建立药典法定检测结合综合评分的评价体系，以外观性状、皮肤追随性、耐热性、剥离特性及膏体均匀性为指标进行综合评分。研究不仅考察了单一因素，还通过正交实验考察了多因素之间的交互影响，并设立了多维度的综合评分体系，使配方筛选过程看起来较为全面。结果：确定活血止痛贴的最佳基质配比为主药中药粉：甘油：白凡士林：高岭土 = 1:0.5:0.12:0.4。经六批次工艺验证表明，该配方所制备的贴膏剂各项指标均符合设计要求，且工艺重复性良好，具备稳定的生产能力。结论：通过本研究确定的活血止痛贴制备工艺所获得的贴剂色泽均匀一致，涂布性能良好，黏度适中，加热后膏体表面光滑且无油分析出，剥离后皮肤无残留物，符合外用贴剂的质量要求，具有良好的应用前景。

Abstract: Objective: The purpose of this study was to optimize the preparation process of Huoxue Zhitong Plaster to improve its clinical applicability and quality stability. Methods: In this study, single factor experiment and orthogonal experiment design were used to investigate the effect of the amount of white vaseline, glycerin and kaolin in the matrix on the performance of the patch. According to the “Chinese Pharmacopoeia” four general principles 0122 patch and 0952 adhesive force determination method, the evaluation system of pharmacopoeia method combined with comprehensive score was established. The appearance, skin following, heat resistance, peeling characteristics and paste uniformity were used as indicators for comprehensive score. The study not only examined a single factor, but also examined the interaction between multiple factors through orthogonal experiments, and established a multi-dimensional comprehensive scoring system to make the formula screening process look more comprehensive. Results: The optimum matrix ratio of Huoxue Zhitong Plaster was determined as follows: Chinese medicine powder: glycerol: white vaseline: kaolin = 1:0.5:0.12:0.4. The six batches of process verification showed that the indexes of the plaster prepared by the formula met the design requirements, and the process had good repeatability and stable production capacity. Conclusion: The patch obtained by the preparation process of Huoxue Zhitong patch determined in this study has uniform color, good coating performance, moderate viscosity, smooth surface of the paste after heating and no oil analysis, and no residue in the skin after peeling, which meets the quality requirements of the external patch and has a good application prospect.