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中药分散片的处方设计与优选试验(1)
http://www.100md.com 2008年5月1日 《中国医药导报》 2008年第2期
     [摘要] 目的:优选确定适合中药分散片生产需要的工艺处方。方法:以分散均匀性及脆碎度为评判指标,在初筛的基础上进行比较试验。结果:崩解剂L-HPC的成型性优于PVPPXL,PVPPXL的崩解性能优于L-HPC,联用效果优于单用;填充剂MCC效果优于乳糖和和淀粉;润湿剂95%乙醇的成型性好,颗粒得率高;硬度小于4.0 kg/cm2时,药片比较疏松,大于8.0 kg/cm2时,崩解时间明显延长。结论:在中药分散片的制备工艺中,崩解剂采用外加L-HPC,内加PVPPXL较好,填充剂选择MCC较佳,润湿剂以95%乙醇溶液为宜,药片硬度控制在6~7 kg/cm2比较理想。

    [关键词] 中药分散片;处方设计;优选试验

    [中图分类号]R283.6 [文献标识码]A [文章编号]1673-7210(2008)01(b)-044-03

    The dispersible tablets formulation design of the traditional Chinese medicine and the optimization test
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    WU Pei-yuan1, DUAN Yun2, ZHU Zu-chi3

    (1.Department of Pharmacy of the People′s Hospital of Wuyuan,Jiangxi Province, Wuyuan333200,China;2.Department of Pharmacy of the People′s Hospital of Jiangxi Province, Nanchang 330006,China;3.Jiangxi Heshi Meikong Medicine Co.Ltd, Nanchang 330100,China)

    [Abstract] Objective: To select the technology and formulation suitable for the dispersible tablets of the traditional Chinese medicine. Methods: Judging by the dispersible homogeneity and friability, the comparative experiment was carried out based on the preliminary screening. Results: The forming property of L-HPC was better than PVPPXL; the disintegrating property of PVPPXL was better than L-HPC; the combination of two methods had a better effect than a single one. It was better to adopt MCC as fillers than lactose or starch. As for moistening agents, 95% alcohol could be more helpful to forming with a high grains yield. The hardness of the tablets controlled to 4.0 kg/cm2 was comparatively soft and loose, and to 8.0 kg/cm2 took a longer time to disintegrate. Conclusion: In preparing the dispersible tables of traditional Chinese medicine, it is better for disintegrants to adopt the method of mixing PVPPXL into the grains and adding L-HPC to the outside of the grains, for fillers to choose MCC, for moistening agents to be 95% alcohol solution and for the hardness of the tablets to be controlled to 6~7 kg/cm2.
, 百拇医药
    [Key words] Dispersible tablets of the traditional Chinese medicine;Formulation design;Optimization test

    分散片遇水后可迅速崩解形成均匀的黏性悬液,相对于普通片剂、胶囊剂而言,具有服用方便、吸收快、生物利用度高和不良反应少等优点,在现代制剂中日益受到人们的重视。《英国药典》1993年版中就收载有阿司匹林分散片、复方阿司匹林分散片和复方磺胺甲 唑分散片以及复方可待因分散片[1]。《中国药典》2005年版二部也收载了尼莫地平分散片、阿奇霉素分散片、罗红霉素分散片、琥乙红霉素分散片、硫糖铝分散片5个品种[2]。

    《英国药典》要求分散片在19~21℃水中3 min内完全崩解,并全部通过710 μm孔径的筛网;《中国药典》2000年版附录制剂通则片剂中规定:分散片置100 ml水中振摇,在(20±1)℃水中3 min内应全部崩解并通过2号筛,此即处方研究和辅料筛选的标准和依据。
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    中药分散片主要由原料药物与至少一种崩解剂和溶胀辅料配伍压制而成。控制其质量的关键因素:一是选用适宜的辅料,二是控制原料药物和辅料的粒度。

    1 原料药物的处理

    1.1 一般性处理

    原料主要有药粉、稠浸膏和干浸膏三类,原药材粉碎前必须经过洁净、灭菌处理,浸膏粉、半浸膏须新鲜制备或密封保存,除特殊情况外,应尽量使用以真空干燥或喷雾干燥制得的干浸膏。

    1.2 粒度控制

    为了控制原辅料的粒度和保证混合均匀,原料药一般要求过100目筛,辅料要求过80目筛。

    2 赋形剂的选择

    2.1 崩解剂的优选

    分散片处方设计的出发点是使片剂遇水后在尽可能短的时间(, 百拇医药(吴培源 段 韵 朱祖驰)
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