疏肝消脂颗粒剂的质量控制研究(1)
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2010年8月1日
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【摘要】目的 探讨疏肝消脂颗粒剂的质量控制标准,提高临床用药的效率和安全性。方法 制备颗粒剂是采用了水提纯沉法,白芍、泽泻、茯苓、山药、赤芍等共125g,加8倍量水煎煮2次,进行煎液滤过,滤液浓缩至每1ml相当于药材2g,加入浓缩液1倍量的乙醇,搅匀,静置24h,滤过,药液备用。对方中白芍与赤芍及佛手以薄层色谱法进行鉴别,取本品1g,加甲醇10ml使溶解,超声处理30min,取出,放冷,滤过,续滤液挥干,用1ml乙醇溶液作为供试品溶液。采用高效液相色谱法颗粒剂中芍药苷含量进行测定。结果 在白芍、赤芍供试品,芍药苷对照品,白芍、赤芍对照药材中分别都有相同斑点显示,阴性对照对此无干扰;能提取出佛手中的有效成分,特征斑点明显;高效液相色谱测得总芍药苷含量为34.585mg/g。结论 本疏肝消脂颗粒剂制备工艺合理可行,剂制备工艺合理科学,质量标准方法简便,专属性强,鉴别方法可靠,可以用于疏肝消脂颗粒的质量控制。
【关键词】疏肝消脂颗粒制备工艺质量控制
【中图分类号】R283【文献标识码】A 【文章编号】1004-7484(2010)08-0-02
【Abstract】Objective To investigate the Shugan quality control standards,Improve clinical efficiency and safety of drugs.Methods Preparation of granules are used in water purification precipitation, white peony root, Alisma, Poria, Chinese yam, red peony, etc. A total of 125 g, plus 8 times the amount of boiling water 2 times, to fry liquid filtration, the filtrate was concentrated to 1ml per the equivalent of herbs 2 g, 1-fold concentrated solution by adding ethanol, mix, standing 24 h, filtration, liquid reserve. Each other in the Alba and Radix and bergamot to TLC for identification, goods from the 1 g, add 10 ml of methanol Shirong Jie, ultrasonic treatment 30min, take out, let cool, filtered, evaporated the filtrate added with 1 ml ethanol solution as the sample solution. Granules by HPLC paeoniflorin were determined. Results peony root, red peony root for the test sample, paeoniflorin reference substance, white peony root, Radix control medicines have the same spots, respectively, showed no interference with this negative control; to extract the active ingredient in the hands of the Buddha, feature spots marked ; measured by HPLC paeoniflorin content of total 34.585 mg / g. Conclusion Shugan preparation reasonably practicable, reasonable and scientific agent preparation, quality standard method is simple, specific, and reliable identification method can be used for quality control of Shugan.
【Key words】Shugan; preparation process; quality control
疏肝消脂颗粒由白芍、赤芍、泽泻、茯苓、山药、佛手等多味药物组成,是在中医理论指导下以健脾化湿,化瘀降脂为治疗原则配伍中药材形成的中药复方制剂,用于高血脂治疗,疗效明显。按现代中药工艺制备方法及质量控制原则,研究疏肝消脂颗粒剂制备工艺及建立质量控制,现将报告如下。
1 实验材料
1.1 药材与对照品
药材购自广州市药材公司,经鉴定药材为正品。芍药苷对照品,批号10736-200527,中国药品生物制品检定所,供含量测定和鉴别用。
1.2 试剂
硅胶G、羧甲基纤维素购自青岛海洋化工厂20070409:三氯甲烷、乙酸乙酯、甲醇、甲酸、环己烷、乙醇等,分析纯,购自天津市大茂化学试剂厂,20070404 ......
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