摘要
目的基于国家药品抽检工作,评价碳酸钙D_(3)制剂的质量,分析存在的问题并完善质量标准,为该品种的质量控制提供一定的参考和建议。方法通过法定检验和探索性研究,从样品不合格原因、溶出度与溶出曲线、含量与含量均匀度、有关物质、咀嚼片的硬度等方面进行研究和评价。结果205批次样品按法定检验合格率为83.9%,不合格样品来自同一家企业,不合格项目为维生素D_(3)含量测定。除此以外,该品种还存在现行国家标准缺少有关物质、含量均匀度等关键质量属性项目,以及相同组分、相同规格制剂的通用名称和执行标准不一致等问题。探索性研究结果表明,处方(维生素D_(3)原料类型)和工艺(抗氧化)是导致样品不合格的主要原因。本研究建立了含量均匀度、溶出度、有关物质等方法,各个项目采用拟定方法检验的合格率较法定检验均有所下降。结论本次抽样的碳酸钙D_(3)制剂总体质量状况一般,现行质量标准基本可行,部分项目有待修订和完善。个别企业需重新优化处方工艺,提高制剂稳定性;个别企业应及时修订药品通用名称,执行国家现行标准;咀嚼片生产企业需对溶出度进行再研究,必要时优化处方工艺。
OBJECTIVE To evaluate the quality of calcium carbonate and vitamin D_(3)preparations based on national drug sampling tests,and analyze existing quality problems and improve quality standards,thereby providing references and suggestions for quality control of this variety.METHODS Through statutory specification and exploratory research,the causes of unqualified samples,dissolution and dissolution curve,content and content uniformity,related substances and hardness of chewable tablets were studied and evaluated.RESULTS The qualification rate of 205 batches of samples according to statutory specification was 83.9%,and the unqualified samples which were produced by the same manufacturer were all abnormal in assay of vitamin D_(3).In addition,the control for some key quality project such as related substances and uniformity of dosage units were lacking,and the common names and quality standards implemented of formulations with the same components and specifications were inconsistent.The exploratory study results indicated that the prescription(the type of the raw material of vitamin D_(3))and processes(antioxidant)were the main reasons for the unqualified samples.The methods for uniformity of dosage units,dissolution and related substances had been established to reanalysis the samples and the results showed the qualification rate were decreased compared to the statutory specification.CONCLUSION The overall quality status is generally average,and the current quality standards are basically feasible while remaining to be revised and improved.Individual manufacturers need to re-optimize the prescription and processes to improve the stability of the formulations.Individual manufacturers should revise the generic names of drugs and implement the current national standards.The manufacturers of chewable tablet need to conduct further research on dissolution and optimize prescription and processes if necessary.
作者
柯静
田向斌
张玉娟
张柏桃
孙莺
张晓明
KE Jing;TIAN Xiangbin;ZHANG Yujuan;ZHANG Botao;SUN Ying;ZHANG Xiaoming(Gansu Institute for Drug Control,Lanzhou 730070,China)
出处
《中国现代应用药学》
北大核心
2025年第19期3406-3415,共10页
Chinese Journal of Modern Applied Pharmacy
基金
2023年国家药品抽检计划(国药监药管[2023]2号)
甘肃省药品科研项目(2023GSMPA006)。
关键词
碳酸钙D_(3)片
碳酸钙D_(3)颗粒
碳酸钙D_(3)咀嚼片
质量分析
质量评价
calcium carbonate and vitamin D_(3)tablets
calcium carbonate and vitamin D_(3)granules
calcium carbonate and vitamin D_(3)chewable tablets
quality analysis
quality evaluation
