Hospital preparations are frequently prepared in Japanese hospitals when ready-made formulations to meet patients’ needs are unavailable. Although the quality of hospital preparations have to be ensured for efficacy and safety, such quality evaluation tends to be insufficient mainly due to lack of manpower and experimental environments in hospitals. In this paper, we investigated the applicability of quantitative (q)NMR spectroscopy to the quality control of diclofenac gargles as examples of hospital preparations, as it has various merits for the quantitative analysis of mixtures in solutions. Diclofenac gargles are composed of diclofenac, tranexamic acid, and lidocaine, and are used for the pain relief of stomatitis induced by cancer chemotherapy. Aliquots of the gargles, which were prepared five times, were mixed with dimethylsulfone as an internal standard, followed by qNMR measurements. Water signal suppression was achieved using a pulse program, water suppression enhanced through T₁ effects, because the pulse program was superior to other ones such as presaturation and one-dimensional nuclear Overhauser effect spectroscopy in terms of quantitativeness. Concentrations of the three medicinal ingredients were simultaneously determined based on the signals selected by considering the spectral separation and the quantitativeness. Consequently, the gargles were found to be prepared with constant quality, and were stable at room temperature for at least four weeks. qNMR is considered to be potentially useful for the quality control of various hospital preparations because of minimal sample pretreatments, lack of need of calibration curves, and its comprehensive detection abilities.

当无法获得满足患者需求的现成制剂时，日本医院通常会准备医院制剂。虽然医院制剂的质量必须保证有效性和安全性，但由于医院缺乏人力和实验环境，这种质量评估往往不足。在本文中，我们研究了定量 (q) NMR 光谱在双氯芬酸漱口液质量控制中的适用性，作为医院制剂的例子，因为它在溶液中混合物的定量分析方面具有多种优点。双氯芬酸漱口液由双氯芬酸、氨甲环酸和利多卡因组成，用于缓解癌症化疗引起的口腔炎的疼痛。准备五次的漱口液等分试样，与作为内标的二甲基砜混合，然后进行 qNMR 测量。水信号抑制是使用脉冲程序实现的，水抑制通过T ₁效应，因为脉冲程序在定量方面优于预饱和和一维核奥弗豪泽效应光谱等其他程序。根据光谱分离度和定量性选择的信号，同时测定三种药用成分的浓度。因此，发现这些漱口水的制备质量稳定，并且在室温下稳定至少四个星期。qNMR 被认为对各种医院制剂的质量控制具有潜在的作用，因为它具有最少的样品预处理、不需要校准曲线以及其全面的检测能力。