目的 从完善药品质量标准、提升我国仿制药整体水平的角度,提出葡萄糖酸钙片一致性评价方法的建议。方法 以葡萄糖酸钙片的关键质量属性为评价出发点,结合生产工艺及国内外药典标准的比较,对本品的评价方法提出建议。结果 本品一致性评价药学研究的关注点应放在片剂生产工艺的考察及其对产品质量和稳定性的影响;多种pH值条件下溶出曲线测定方法的建立和验证;产品溶出曲线差异的考察;溶出度、脆碎度、含量等关键质量属性的考察等方面,体内评价是否必须开展有待商榷。结论 对此类无参比制剂的品种,生产企业应结合具体品种的具体情况开展一致性评价。
Abstract
OBJECTIVE To consummate drug specifications and improve the overall level of generic drugs in our country, the consistency evaluation method of calcium gluconate tablets is proposed. METHODS With its critical quality attributes(CQA) as the evaluation starting point, as well as combination of production process and specifications described in pharmacopoeias, the evaluation method of calcium gluconate tablets has been suggested. RESULTS The pharmaceutical research of calcium gluconate tablets should be focused on production process of tablets and its effect on the quality and stability of products, the method establishment and validation of determination for dissolution profiles, dissolution profiles investigation of products under different pH values, differences on the dissolution profiles of products. And some CQA such as dissolution, friability and content etc. should also be considered. The necessity of its in vivo evaluation is open to discuss. CONCLUSION When no reference listed drug(RLD) is available, eg calcium gluconate tablets, the consistency evaluation should be carried out by pharmaceutical factories case by case.
关键词
葡萄糖酸钙 /
片剂 /
一致性评价
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Key words
calcium gluconate /
tablet /
consistency evaluation
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中图分类号：
R951
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参考文献
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脚注
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基金
国家“重大新药创制”科技重大专项项目资助(2017ZX09101001)
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