目的 对目前国内市场 注射用盐酸万古霉素制剂 进行质量评价，为临床选择品种提供科学的 依据 。 方法 建立注射用盐酸万古霉素中万古霉素 B 及有关物质测定的高效液相色谱定量分析方法，同时考察性状、 pH 值、不溶性微粒和万古霉素效价，按国家药品标准方法对 4 个厂家共 10 个批次注射用盐酸万古霉素进行质量评价。 结果 在本实验条件下，按照国家药品标准评价， 4 个厂家注射用盐酸万古霉素性状、 pH 值、不溶性微粒和万古霉素效价均合格；万古霉素 B 及有关物质， A 厂、 C 厂 3 个批次 的产品均合格， B 厂的产品有 2 批次不合格， D 厂的产品有 1 批次不合格。 4 个厂家 10 批次产品按日本药局方、英国药典和美国药典标准评价均合格。 结论 本实验采集的样品按中国国家药品标准评价， A 厂和 C 厂的产品均合格， B 厂和 D 厂部分批次的产品质量不符合要求。

OBJECTIVE To evaluate the product quality of vancomycin hydrochloride for injection. METHODS The HPLC-UV method was established to determine the content of vancomycin B and related substances. The characteristics , pH, insoluble particulate matter and potency were evaluated at the same time. All the samples were evaluated based on National Drug Standards. RESULTS According to National Drug Standards, the results of the characteristics, pH, insoluble particulate matter and potency of all samples meet the standards, while the vancomycin B and related substances of 3 batches preparations of 2 manufactories were unqualified. All the samples meet the standard of JP15, USP30 and BP2007. CONCLUSION According to National Drug Standards, the products of manufactory A and C were all qualified, and the products of manufactory B and D were partially qualified.