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本文采用高效液相色谱法,色谱分离柱为Rp-18.7μ,4.6×250mm,流动相为甲醇:水(80/20V/V),紫外检测波长240nm。以国际Norplant Ⅰ型埋植剂为对照,利用外标法测定国产CLa埋植剂7个批次平行14套样品的体外溶出度。实验方法将CLa埋植剂在重蒸水中连续浸泡3天,(水浴温度37℃±1℃),每24小时更换溶剂,测每天溶液中,左旋18甲基炔诺酮(LNG)的浓度。以第三天溶液中LNG((?)±2SD),制定出CLa埋植剂体外溶出度的质量控制范围50.0～70.0μg/6支·日。该法简便准确,结果可靠,完全可适用于国产CLa埋植剂溶出度的质量监控。
In this paper, high performance liquid chromatography was used. The chromatographic column was Rp-18.7μ, 4.6 × 250 mm. The mobile phase consisted of methanol: water (80/20 V / V) and UV detection wavelength was 240 nm. The international Norplant Ⅰ implants as control, the use of external standard method for the determination of domestic CLa implants seven batches of parallel 14 sets of samples in vitro dissolution. EXPERIMENTAL METHODS CLa implants were immersed in double distilled water for 3 consecutive days with a water bath at 37 ° C ± 1 ° C. The solvent was changed every 24 hours and the concentration of levonorgestrel (LNG) was measured in the daily solution. The quality control range of in vitro dissolution of CLa implants was developed from 50.0 to 70.0 μg / 6 days on the third day with LNG (± 2 SD). The method is simple and accurate, the results are reliable, fully applicable to the quality control of domestic CLa implants dissolution.