利多卡因羟甲唑啉溶液的制备及其质量控制

Preparation and Quality Control of Lidocaine Hydrochloride Oxymetazoline Solution

目的：制备具有麻醉作用的鼻腔血管减充剂利多卡因羟甲唑啉溶液，并对其进行质量控制。方法：以利多卡因、羟甲唑啉为主药制备利多卡因羟甲唑啉溶液，采用高效液相色谱法测定制剂中利多卡因和羟甲唑啉的含量。结果：所制备的样品为无色至微黄色的澄明液体，pH应为6～7，利多卡因、羟甲唑啉检测质量浓度的线性范围分别为400．6～2003μg／ml（r=O．9994）、10．04～50．2μg／ml（r=O．9990），平均回收率分别为99．90％（RSD=1．12％，n=3）、99．89％（RSD=1．74％，n=3）。结论：该制剂处方及制备工艺合理，制剂质量稳定可控。

OBJECTIVE： To prepare nasal vascular decongestion agent Lidocaine hydrochloride oxymetazoline solution with an- aesthetic effect, and to carry out quality control of it. METHODS： Lidocaine hydrochloride oxymetazoline solution was prepared with lidocaine and oxymetazoline as main components. The contents of lidocaine and oxymetazoline were determined by HPLC. RE- SULTS： The preparation was colourless or yellowish transparent liquid, pH 6-7. The linear range of lidocaine and oxymetazoline were 400.6-2 003 μg/ml （r=0.999 4） and 10.04-50.2 μg/ml （r=0.999 0）. Average recoveries were 99.90% （RSD=1.12%, n=3） and 99.89 % （RSD = 1.74 %, n = 3）. CONCLUSIONS： The formulation and preparation technology are reasonable, and the prepara- tion is controllable in quality.