论文部分内容阅读
目的:比较四个不同厂家生产的六味地黄丸的质量差异。方法:按照2010年版《中国药典》质量标准,采用HPLC法测定六味地黄丸中丹皮酚和马钱苷的含量,并进行体外溶出度的测定。结果:两个厂家的产品含量不合格;不同厂家生产的六味地黄丸中,丹皮酚和马钱苷的含量及其体外溶出度有显著性差异。结论:为达到临床疗效的一致性,有必要对中成药的原料药材进行严格地质量控制,对制剂工艺进行标准化研究。
Objective: To compare the quality differences of Liu Wei Di Huang Wan produced by four different manufacturers. Methods: According to the 2010 edition of “Chinese Pharmacopoeia” quality standard, the content of paeonol and loganin in Liuweidihuangwan was determined by HPLC and the dissolution in vitro was determined. Results: The contents of the two manufacturers were unqualified. The contents of paeonol and loganin in Liuweidihuang Pill manufactured by different manufacturers were significantly different from those in vitro. Conclusion: In order to achieve the consistency of clinical efficacy, it is necessary to strictly control the quality of raw materials of Chinese patent medicines and standardize the preparation process.