碳酸钙D3制剂的质量分析与评价

Quality Analysis and Evaluation of Calcium Carbonate and Vitamin D3 Preparations

关键词:  碳酸钙D3片  碳酸钙D3颗粒  碳酸钙D3咀嚼片  质量分析  质量评价

Key words:  Calcium Carbonate and Vitamin D3 Tablets  Calcium Carbonate and Vitamin D3 Granules  Calcium Carbonate and Vitamin D3 Chewable Tablets  quality analysis, quality evaluation

摘要:

目的 基于国家药品抽检工作，评价碳酸钙D3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D3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，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D3原料类型）和工艺（抗氧化）是导致样品不合格的主要原因；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均较法定检验有所下降。结论 本次抽检的碳酸钙D3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。

Abstract:

OBJECTIVE Based on the sampling test of national drugs, to evaluate the quality of Calcium Carbonate and Vitamin D3 preparation. The quality problems were analyzed and quality standards were improved to provide references and suggestions for the quality control of this variety. METHODS The statutory specification methods and exploratory study were used to research and evaluation the reasons for unqualified samples, dissolution and dissolution curve, assay and uniformity of dosage units, related substances and hardness of chewable tablets. RESULTS The qualification rate of batches of 205 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 D3. 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 are inconsistent. The exploratory study results indicated that the prescription (the type of the raw material of vitamin D3 ) and processes (antioxidant) were the main reasons for the unqualified samples; The methods for uniformity of dosage units, dissolution and related substances have been established to reanalysis the samples and the results showed the qualification rate has 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 enterprises need to re-optimize the prescription and processes to improve the stability of the formulations; Individual enterprises should revise the generic names of drugs and current national standards need to be executed promptly; The manufacturers of chewable tablet need to conduct further research on dissolution and optimize prescription and processes if necessary.