鹽酸小檗堿通常用于治療細(xì)菌性痢疾、腸胃炎和其他疾病。當(dāng)今市場上有許多生產(chǎn)廠家,生產(chǎn)過程和配方卻大不相同,這可能直接影響藥物的治療效果。為此,根據(jù)藥典中鹽酸小檗堿溶出法（籃法）,檢測了11種不同生產(chǎn)廠家的鹽酸小檗堿片劑。此外,分別考察其在四種不同pH值的溶出介質(zhì)中的溶出過程,采用相似因子訪)評估。通過高效液相色譜（HPLC）對不同廠家的鹽酸小檗堿片的體外溶出度進(jìn)行測定。該方法具有線性好、精度高、穩(wěn)定性好、重復(fù)性好等優(yōu)點(diǎn)�；趂₂值,大部分生產(chǎn)廠家的鹽酸小檗堿片劑的溶解行為存在顯著差異。該研究也為以后的進(jìn)一步深入研究奠定了基礎(chǔ)。盡管藥物規(guī)格（0.1 g）相同,但溶出曲線存在差異。這種現(xiàn)象可能是因?yàn)槠瑒┑馁x形劑和晶型影響片劑在體外的釋放和溶解。 

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

【文章頁數(shù)】：11 頁

【文章目錄】：
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


【參考文獻(xiàn)】：
期刊論文
[1]鹽酸小檗堿片聯(lián)合美沙拉嗪治療遠(yuǎn)端潰瘍性結(jié)腸炎的臨床研究[J]. 竺添雨,王亞東,孔弘偉.  現(xiàn)代藥物與臨床. 2018(12)
[2]Determination of Berberine Hydrochloride Content in Qingwen Baidu Granule by HPLC[J]. Guo Shijin,Wang Yanping,Fu Shijun,Zhang Zhimei,Xu Qianqian,Shen Zhiqiang.  Animal Husbandry and Feed Science. 2014(01)
[3]Determination of Berberine Hydrochloride in Shihu Yeguang Pills by HPLC[J]. WANG De-fu,XU Qian-li,ZUO Ding,XIONG Hui-lin Guizhou Institute For Drug Control,Guiyang,Guizhou 550004,China.  Medicinal Plant. 2010(08)



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