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目的通过加速实验和长期实验,以婴幼儿支气管炎中药洗液中的主要药材麻黄及白芍的有效成分量作为主要考察指标,考察洗液的稳定性。方法根据婴幼儿支气管炎中药洗液药品质量标准指标,通过薄层色谱法鉴别样品中的麻黄、茯苓、白芍、枳壳、淫羊藿,HPLC法测定样品中麻黄(盐酸麻黄碱和盐酸伪麻黄碱总量)和白芍(芍药苷量)的有效成分量,平皿法检测样品中微生物的限度,并评定中药洗液样品的稳定性。结果洗液样品经加速和长期实验测定,性状为深褐色液体;均可检出麻黄、茯苓、白芍、枳壳、淫羊藿;麻黄和白芍的有效成分量分别高于0.18、0.72 mg/m L;需氧菌总数、霉菌酵母菌总数均未超过100 cfu/m L,均未检测出大肠埃希菌、铜绿假单胞菌以及金黄色葡萄球菌,符合质量标准规定。结论 3批婴幼儿支气管炎中药洗液的加速稳定性和长期稳定性良好,可为本品的包装、运输、贮存及有效期的制订提供必要依据。
OBJECTIVE To investigate the stability of lotion by accelerating experiments and long-term experiments with the effective components of Ephedra and Radix Paeoniae Alba as the main herbs in infant bronchitis Chinese lotion. Methods According to the standard of Chinese medicine lotion bronchitis drug quality standards, the samples were identified as ephedra, tuckahoe, white peony root, Citrus aurantium and Epimedium by TLC, HPLC was used to determine the content of ephedrine (ephedrine hydrochloride and pseudoephedrine hydrochloride Total amount) and white peony root (paeoniflorin amount), the limit of microorganisms in the sample by the plate method, and the stability of the traditional Chinese medicine lotion sample were evaluated. Results The lotion samples were tested by accelerated and long-term experiments, the traits as dark brown liquid; Detect Ephedra, Poria cocos, white peony root, Citrus aurantium, Epimedium; Ephedra and white peony root active ingredients were higher than 0.18,0.72 mg / m L; the total number of aerobic bacteria and fungi did not exceed 100 cfu / mL, none of which detected Escherichia coli, Pseudomonas aeruginosa and Staphylococcus aureus, which met the quality standards. Conclusion The accelerating stability and long-term stability of Chinese lotion bronchitis lotion for 3 batches provide the necessary basis for packaging, transportation, storage and expiration date of this product.