内容紹介
Evaluation of the Pharmaceutical Stability of Polaprezinc/Sodium Alginate Gargle Solution Containing Lidocaine
Summary
Objective: A gargle solution(L-P/AG)for the treatment of painful stomatitis was prepared by adding lidocaine to a polaprezinc/sodium alginate gargle solution(P/AG), and its pharmaceutical stability was evaluated. Methods: L-P/AG was stored at 5, 25, and 40℃. The strengths of polaprezinc and lidocaine were determined. The viscosity and pH of L-P/AG were also determined, and its appearance was evaluated. Results: When stored at 5 or 25℃ in a dark place, L-P/AG showed neither reduction in the strength of either drug nor did it show a change in the viscosity, pH, or appearance. When stored exposed to light at 40℃, L-P/AG showed reductions in the strength of both drugs, as well as in viscosity and pH; furthermore, a change in appearance was noted. Discussion: L-P/AG prepared for the treatment of painful stomatitis remains pharmaceutically stable for 28 days when stored at 25℃ in a dark place.
要旨
目的: 疼痛を伴う口内炎の治療を目的に,ポラプレジンク・アルギン酸ナトリウム含嗽液(P/AG)にリドカインを加えた含嗽液(L-P/AG)を調製し,製剤学的安定性を評価した。方法: L-P/AGの保存温度は5℃,25℃,40℃とした。ポラプレジンクおよびリドカインの含量を測定した。さらに,L-P/AGの粘度およびpHを測定し,外観を観察した。結果: L-P/AGは5℃暗所,25℃暗所条件下では両薬剤の含量低下はみられず,粘度,pH,外観に関しても変化はなかった。40℃曝光条件下では両薬剤の含量低下を認めた。また,粘度・pHの減少や外観変化を認めた。考察: 疼痛を伴う口内炎治療用含嗽液として調製したL-P/AGは,28日間25℃暗所において製剤学的に安定であることが示唆された。
目次
Summary
Objective: A gargle solution(L-P/AG)for the treatment of painful stomatitis was prepared by adding lidocaine to a polaprezinc/sodium alginate gargle solution(P/AG), and its pharmaceutical stability was evaluated. Methods: L-P/AG was stored at 5, 25, and 40℃. The strengths of polaprezinc and lidocaine were determined. The viscosity and pH of L-P/AG were also determined, and its appearance was evaluated. Results: When stored at 5 or 25℃ in a dark place, L-P/AG showed neither reduction in the strength of either drug nor did it show a change in the viscosity, pH, or appearance. When stored exposed to light at 40℃, L-P/AG showed reductions in the strength of both drugs, as well as in viscosity and pH; furthermore, a change in appearance was noted. Discussion: L-P/AG prepared for the treatment of painful stomatitis remains pharmaceutically stable for 28 days when stored at 25℃ in a dark place.
要旨
目的: 疼痛を伴う口内炎の治療を目的に,ポラプレジンク・アルギン酸ナトリウム含嗽液(P/AG)にリドカインを加えた含嗽液(L-P/AG)を調製し,製剤学的安定性を評価した。方法: L-P/AGの保存温度は5℃,25℃,40℃とした。ポラプレジンクおよびリドカインの含量を測定した。さらに,L-P/AGの粘度およびpHを測定し,外観を観察した。結果: L-P/AGは5℃暗所,25℃暗所条件下では両薬剤の含量低下はみられず,粘度,pH,外観に関しても変化はなかった。40℃曝光条件下では両薬剤の含量低下を認めた。また,粘度・pHの減少や外観変化を認めた。考察: 疼痛を伴う口内炎治療用含嗽液として調製したL-P/AGは,28日間25℃暗所において製剤学的に安定であることが示唆された。