银黄口服液不同制备方法质量考察

Quality of Yinhuang Oral Solution Prepared with Different Methods

目的改进银黄口服液制备方法,解决制剂中绿原酸含量及药液pH不稳定问题,得到澄清、质量合格的制剂。方法在银黄口服液原制备方法中添加了5g枸橼酸钠、5g枸橼酸、0.5g EDTA做稳定剂,调节pH值至6.0,加适量纯化水至1000ml,滤过,即得银黄口服液成品药液。结果制剂澄清,质量合格,绿原酸含量稳定,药液pH值稳定。结论该制备方法简单,制剂稳定,方法可行,适合大规模生产。

Objective To obtain a clear and high-quality Yinhuangoral solution by improving preparation methods so as to solve content instability of chlorogenic acid and instability of pH.Methods Sodium citrate 5 g,citric acid 5 g and EDTA 0.5 g were used as stabilizers in the traditional method.The pH of the solution was adjusted to 6.0.An appropriate amount of water was added to 1000 ml.Finally,the solution was obtained after filtration.Results The preparation was clear and up to the standard.The pH of the solution and the content of chlorogenic acid were steady.Conclusion The improved method is feasible,simple,stable and suitable for mass production.