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 参见附件。

  [摘要] 目的 制订益母草颗粒制剂工艺和质量标准，提高质量的可控性。 方法 采用沸腾制粒技术制备颗粒，TLC鉴别益母草，紫外-可见分光光度法测定含量。 结果 改进了颗粒的制剂工艺，薄层色谱法鉴别明显，盐酸水苏碱线性回归方程为：Y = 0.605 6X - 0.003 1，r = 0.999 4，线性范围为0～8.153 6 mg，样品的平均回收率为98.5%(n = 9)，RSD = 1.03%，平均含量为21.5 mg/袋，含量限度为每袋中含有盐酸水苏碱不得低于18.0 mg。 结论 所建立的方法可准确地进行定性、定量检测，重复性好，可作为益母草颗粒的质量控制。

 [关键词] 益母草颗粒；工艺改进；质量控制

 [中图分类号] R944.27 [文献标识码] A [文章编号] 1673-7210(2012)02(a)-0121-03

 Study on improving process and quality standard for Motherwort Granules

 ZHENG Yanchun LI Jun CUI Yahui LI Junfang DONG Hairong ZHU Lei

 Chengde Jingfukang Pharmaceutical Group Co. Ltd., the New Excipients of Traditional Chinese Medicine Engineering Research Center of Hebei, Hebei Province, Chengde 067000, China

 [Abstract] Objective To establish preparation process and quality standard for Motherwort Granules and improve the quality control. Methods The boiling pelletization techniques was used to prepare the nanoparticles. Motherwort was identified by TLC, Motherwort Granules was determined by UV-visible spectrophotometry. Results The results showed that, it improved the preparation process of Motherwort Granules, the spot of TLC was very clear, regression equation for Stachydrine Hydrochloride was Y = 0.605 6X-0.003 1, r = 0.999 4, Stachydrine Hydrochloride detected was stable during 0-8.153 6 mg, the average recovery of sample was 98.5% (n = 9), RSD = 1.03%, average concentration of samples was 21.5 mg/bag, limit for the content of each bag contained Stachydrine Hydrochloride not less than 18.0 mg. Conclusion The method is accurate and can be used for the quality control of Motherwort Granules.

 [Key words] Motherwort Granules; Process improvement; Quality control

 益母草颗粒现收载于《中国药典》2010年版一部，为妇科经产之要药，主要用于经闭、痛经、产后瘀血、腹痛等妇科疾病[1]。现在市面上规格是每袋装15 g，由于服用量相对较大，辅料用量多，不利于患者的服用，颗粒干燥时间长，没有控制质量的指标性成分。为此，通过对制剂工艺进行改造，制剂规格由原来的每袋装15 g变更为每袋装5 g，每袋疗效不改变，辅料量减少了60%以上，有效地控制了成品的质量，方便了患者的使用，增强患者依从性，降低企业生产成本。

 1 仪器与试药

 多功能提取罐(武汉制药机械厂)，DBP-3多功能制粒包衣机(重庆广厦生产)，UV-2401紫外-可见分光光度仪(日本岛津公司生产)，医用型超声清洗器KQ-700DE(昆山市超声仪器有限公司)，盐酸水苏碱对照品(中国药品生物制品检定所，供含量测定用，批号：110702-200709)，硫氰酸铬铵(上海天莲精细化工有限公司，批号：2006-08-12-520)，益母草药材、糊精、蔗糖均有承德颈复康药业集团提供，水为二次蒸馏水；其他试剂均为分析纯。

 2 方法与结果

 2.1 制剂工艺的研究

 益母草颗粒原工艺为提取浸膏湿法挤压制粒 ......