| 金丽,张晓丹,杭娟,张心悦,卜莹.色甘酸钠滴眼液的质量评价研究[J].中国药品标准,2017,18(6):411-415 |
| 色甘酸钠滴眼液的质量评价研究 |
| Studies on quality evaluation of Sodium Cromoglicate |
| 投稿时间：2017-08-10 修订日期：2017-12-05 |
| DOI： |
| 中文关键词: 色甘酸钠滴眼液 色甘酸钠 溶液颜色 HPLC 渗透压摩尔浓度 |
| 英文关键词: Sodium Cromoglicate Eye Drops Sodium Cromoglicate solution color HPLC osmolality |
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| 中文摘要: |
| 目的 从色甘酸钠滴眼液的溶液颜色、渗透压摩尔浓度、色甘酸钠含量和有关物质等方面开展一系列探索性研究,以期为色甘酸钠滴眼液的安全性和有效性作出更加合理的评价。方法 参照《中国药典》2015年版四部通则,对色甘酸钠滴眼液的溶液颜色进行目视法和色差计法检查,并测定其渗透压摩尔浓度；采用高效液相色谱法测定色甘酸钠滴眼液中色甘酸钠的含量,并与现行药典标准的紫外吸收系数法测定结果比较；在含量测定色谱条件下对13批次样品的有关物质相对含量进行测定。结果 色甘酸钠滴眼液的溶液颜色与性状描述的“无色或几乎无色”不符；渗透压摩尔浓度的测定结果显示,13批次样品中有10批次样品达不到等渗要求；含量测定结果表明,HPLC法测得的色甘酸钠含量略低于UV法所测含量；有关物质测定结果显示,色甘酸钠滴眼液的杂质相对含量总体较低,但随着贮藏时间的延长,杂质相对含量会增大。结论 色甘酸钠滴眼液现行质量标准性状描述不准确,缺乏渗透压摩尔浓度检查项,紫外吸收系数法测定色甘酸钠含量专属性差,易受干扰,不能有效地控制产品内在质量,建议修订质量标准。 |
| 英文摘要: |
| Objective In order to make a more reasonable evaluation of Sodium Cromoglicate Eye Drops"s security and effectiveness, a series of exploratory research were carried out from its solution color, osmolarity, content of cromolyn sodium and related substances. Methods Referring to the general principles of the four edition of ChP2015, the color of Sodium Cromoglicate Eye Drops solution was examined by visual and colorimeter, and its osmolality was measured. A HPLC method for the determination of sodium hyaluronate in Sodium Cromoglicate Eye Drops was developed, comparing with the result of the ultraviolet absorption coefficient method in the current pharmacopoeia standard. The relative content of related substances in 13 samples was determined under the condition of chromatography of content determination. Results The solution color of Sodium Cromoglicate Eye Drops is inconsistent with the description of "colorless or almost colorless". Osmolality of 10 samples can not meet the requirements of isotonic. The content of sodium citrate measured by HPLC is slightly lower than that measured by UV. The relative content of impurities in Sodium Cromoglicate Eye Drops is generally low. But with the extension of storage time, the relative content of impurities increased. Conclusion Sodium Cromoglicate Eye Drops"s current quality standards are inaccurate in characterization. The method of ultraviolet absorption coefficient has poor specificity and is easily disturbed, which can not effectively control the inherent quality of products. Revising the current quality standard of Sodium Cromoglicate Eye Drops was Proposed. |
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