11种盐酸小檗碱片剂在不同溶出度介质中溶出度曲线特征的比较（英文）

发布时间：2022-02-14 17:05

　　盐酸小檗碱通常用于治疗细菌性痢疾、肠胃炎和其他疾病。当今市场上有许多生产厂家,生产过程和配方却大不相同,这可能直接影响药物的治疗效果。为此,根据药典中盐酸小檗碱溶出法（篮法）,检测了11种不同生产厂家的盐酸小檗碱片剂。此外,分别考察其在四种不同pH值的溶出介质中的溶出过程,采用相似因子访)评估。通过高效液相色谱（HPLC）对不同厂家的盐酸小檗碱片的体外溶出度进行测定。该方法具有线性好、精度高、稳定性好、重复性好等优点。基于f₂值,大部分生产厂家的盐酸小檗碱片剂的溶解行为存在显着差异。该研究也为以后的进一步深入研究奠定了基础。尽管药物规格（0.1 g）相同,但溶出曲线存在差异。这种现象可能是因为片剂的赋形剂和晶型影响片剂在体外的释放和溶解。 

【文章来源】：Journal of Chinese Pharmaceutical Sciences. 2020,29(02)CSCD

【文章页数】：11 页

【文章目录】：
1. Introduction
2. Materials and methods
    2.1. Materials
    2.2. Methods
        2.2.1. Weight variation
        2.2.2. HPLC method
        2.2.3. Preparation of berberine hydrochloride tablets
            2.2.3.1.Preparation of working standard solutions
            2.2.3. 2. Preparation of sample solutions
            2.2.3. 3. Preparation of medium dissolution solutions
        2.2.4. Method validation studies
            2.2.4. 1. Linearity and range[13,14]
            2.2.4. 2. Precision
            2.2.4. 3. Stability
            2.2.4. 4. Robustness
        2.2.5. Dissolution methods
        2.2.6. Dissolution of hydrochloride tablets
        2.2.7. Statistical analysis
3. Results
    3.1. Physical quality of berberine hydrochloride tablets
    3.2. Method validation studies
        3.2.1. Linearity and range[23]
        3.2.2. Precision
        3.2.3. Stability
        3.2.4. Robustness
    3.3. Dissolution medium selection
    3.4. Dissolution of berberine hydrochloride tablets
    3.5. Experimental results of dissolution evaluation
4. Discussion
5. Conclusions


【参考文献】：
期刊论文
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