三七生粉入药灭菌工艺选择.docVIP

三七生粉入药灭菌工艺的选择 　　[摘要] 目的 选择三七生粉入药的灭菌工艺。 方法 通过对比三七在不同药用状态（药材、饮片和粉末）下的不同灭菌方式（干热灭菌、湿热灭菌和不灭菌）对总皂苷含量的影响，并考虑后续制剂环节的稀释作用和灭菌作用，选择最佳的三七生粉灭菌方式，并在三七益肾颗粒、三七痛风胶囊、三七通栓片3个中药制剂工艺中进行验证。 结果 只要饮片菌数控制在一定范围，三七生粉无需单独灭菌，经过后续的流化床制粒和填充、压片等工艺，所制得3个制剂的细菌总数、霉菌和酵母菌、大肠埃希菌和大肠菌群均符合中国药典的要求。 结论 无需单独灭菌的三七生粉直接用于含有流化床制粒工艺的固体制剂，能保证产品的微生物学指标合格 [关键词] 三七；生药粉；灭菌；中药制剂 [中图分类号] R282 [文献标识码] A [文章编号] 1673-7210（2016）07（a）-0035-04 [Abstract] Objective To choose the sterilization method for Panax Notoginseng Powder in Chinese medicine preparations. Methods The influence of different sterilization methods for Panax notoginseng in different physical states to the active ingredient stability was compared， and the dilution effect and the sterilization in the later preparation procedures was considered， the selected sterilization method for Panax Notoginseng Powder was established， which was validated in the Chinese medicine preparations of Sanqitongfeng Capsules， Sanqitongshuan Tablets and Sanqiyishen Granules. Results When the bacteria number of Panax notoginseng decoction pieces was controlled at a certain level and the fluidized bed granulation procedure （or with capsule filling procedure， or with tableting procedure） was contained in the preparation process， the microbiological examination including aerobic bacterial count， mold and yeast count， escherichia coli count and coliform bacteria count could be ensured while Panax Notoginseng Powder was not sterilized alone before mixing into solid preparations. Conclusion Panax notoginseng powder without sterilization is applied to the Chinese medicine preparations of Sanqitongfeng Capsules， Sanqitongshuan Tablets and Sanqiyishen Granules， and the bacteria test could be ensured to comply to relevant standards. [Key words] Panax Notoginseng； Chinese Material Medica Powder； Sterilization method； Chinese medicine preparations 中药三七是五加科植物三七Panax notoginseng （Burk.）F.H.Chen的干燥根和根茎，功效散瘀止血，消肿定痛，是应用历史悠久的贵重药材，在临床制剂上常以生药粉直接入药 《中国药典》只是规定了生药粉入药制剂的微生物学限度，但是没有单独对生药粉的微生物