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目的:制备复方土荆皮涂膜剂,建立其质量控制方法,考察其稳定性,评价其质量,初步考察其临床疗效。方法:以聚乙烯醇为成膜材料制备本品;对本品的性状、鉴别、微生物限度、含量等各项指标进行研究,建立本品的质量控制方法并进行稳定性、皮肤刺激性及成膜性等研究。结果:建立了本品的质量标准;本品稳定性及成膜性良好,对皮肤无刺激性,临床疗效总有效率96.6%。结论:本品处方及制备工艺合理可行,质量标准可靠、准确、全面,本品使用方便,疗效肯定。
OBJECTIVE: To prepare compound Tujingjiao coating agent, establish its quality control method, investigate its stability, evaluate its quality and preliminary investigate its clinical efficacy. Methods: Polyvinyl alcohol was used as membrane-forming material to prepare this product. The properties, identification, microbial limit and content of this product were studied. The quality control method of this product was established and its stability, skin irritation and Membrane and other research. Results: The quality standards of this product have been established. The product has good stability and film-forming property and is non-irritating to the skin. The total effective rate of clinical efficacy is 96.6%. Conclusion: This product prescription and preparation process is reasonable and feasible, quality standards reliable, accurate and comprehensive, the product easy to use, efficacy is positive.