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目的:研究骨伤消痛喷雾剂的质控方法,并对3批产品的稳定性进行考察。方法:采用薄层色谱法对骨伤消痛喷雾剂的大黄和薄荷脑进行鉴别,并对3批产品进行喷射试验和稳定性考察。结果:制剂的TLC斑点清晰,重复性好;3批产品喷射试验结果误差小;3批产品均表现良好的稳定性。结论:骨伤消痛喷雾剂质控方法简单、可行,该制剂稳定性良好。
OBJECTIVE: To study the quality control methods of Gundiao Xiao Tong Spray and to investigate the stability of 3 batches of products. Methods: The rhubarb and menthol were identified by thin-layer chromatography, and three groups of products were sprayed and tested for stability. Results: TLC spots of the preparation were clear and reproducible. The results of three batches of products were less error and the three batches of products showed good stability. Conclusion: The quality control method of Gu Shang Xiao Tong Spray is simple and feasible, and the stability of the preparation is good.