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目的对全国药品流通领域中丹参舒心胶囊的质量现状进行全面评价。方法按丹参舒心胶囊的现行标准进行检验,同时开展探索性研究,并进行统计分析。结果按现行标准检验,96.9%的样品符合规定;探索性研究发现,丹参舒心胶囊原料工艺参数不明确,产品质量参差不齐,含量差异悬殊;个别企业未按工艺规定生产。结论丹参舒心胶囊的现行标准不能有效控制产品质量,工艺参数需研究明确,质量标准亟待修订提高。
Objective To evaluate the quality of Danshen Shuxin Capsule in the field of medicine circulation in China. Methods According to the current standard of Danshen Shuxin Capsule, we conducted exploratory research and conducted statistical analysis. Results according to the current standard test, 96.9% of the samples comply with the regulations; exploratory study found that Salvia Shuxin capsule raw material process parameters are not clear, uneven product quality, content disparity; individual companies not according to the provisions of the process. Conclusion The current standard of Danshen Shuxin Capsule can not effectively control the quality of the product, the process parameters need to be studied clearly, and the quality standard needs to be revised and improved urgently.