婴幼儿支气管炎中药洗液质量稳定性研究

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。

Study on quality stability of Chinese materia medica lotion for infant bronchitis

Objective Through the accelerated experiment and long-term experiment, the main contents of ephedrine and white peony root in Chinese materia medica (CMM) lotion were taken as the main indexes, and the stability of the medicine lotion of infants with bronchitis was investigated. Methods According to the quality standard of CMM lotion for infant bronchitis, the existence of Ephedrae Herba, Poria, Paeoniae Radix Alba, Aurantii Fructus and Epimedii Folium in the sample was identified by thin layer chromatography. The contents of Ephedrae Herba (ephedra hydrochloride and pseudoephedrine hydrochloride) and Paeoniae Radix Alba (paeoniflorin) were determined by HPLC, and the stability of CMM lotion samples was evaluated by plate method. Results The contents of Ephedrae Herba, Poria, Paeoniae Radix Alba, Aurantii Fructus, and Epimedii Folium were measured. The contents of Ephedrae Herba and Paeoniae Radix Alba were higher than 0.18 mg and 0.72 mg; The total contents of aerobic bacteria and mycorrhizal yeasts were not more than 100 cfu/mL, and Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus were not detected, in line with quality standards. Conclusion The three batches of CMM lotion prepared by the First People''s Hospital of Guangxi have good stability and long-term stability, for the goods packaging, transportation, and storage conditions to provide the necessary information.