色甘酸钠原料药及滴眼液质量标准的完善

Improvement of Quality Standards of Sodium Cromoglicate and Its Eye Drops

为了更好地控制色甘酸钠(1)原料药及滴眼液的质量,该研究参照欧洲药典(EP 10.0),采用HPLC法测定了1原料药及滴眼液中的有关物质。结果显示,18批次样品的有关物质总量为0.2%~0.4%,氧化环境会造成样品杂质含量增加。参照《中华人民共和国药典》2020年版(ChP 2020),对1原料药及滴眼液的溶液颜色进行目视法检查,结果显示,1滴眼液的颜色与现行药典标准性状描述的“无色或几乎无色”不符。此外,测定了1滴眼液的渗透压摩尔浓度比,结果显示,15批次样品中有8批次样品达不到等渗要求,测得的最低渗透压摩尔浓度比仅为0.26。通过增修订性状、溶液颜色、渗透压摩尔浓度及有关物质项目,可更有效地控制产品质量,也为其他药品标准的提高及药典标准的制定提供了参考。

In order to better control the qualities of sodium cromoglicate(1) and its eye drops, the related substances were determined by HPLC with reference to European pharmacopoeia(EP 10.0). The results showed that the total amount of related substances in eighteen batches of samples was 0.2%-0.4%, and the impurity content of the samples increased in the oxidation environment. According to the 2020 edition of the Pharmacopoeia of the People’s Republic of China(ChP 2020), the solution color was visually inspected. The results showed that the color of 1 eye drops was inconsistent with the "colorless or almost colorless" described in the current pharmacopoeia. In addition, the molar concentration ratio of osmotic pressure of 1 eye drops was determined. The results showed that eight out of fifteen batches of samples could not meet the isotonic requirements, and the lowest value of the osmolality ratio was only 0.26.The properties, solution color, osmotic molar concentration and related substances were added and revised, which could control the product quality more effectively, and also provide a reference for the improvement of other drug standards and the formulation of pharmacopoeia standards.