| CLa长效避孕埋植剂体外溶出度质量标准的研究 |
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| 引用本文： | 关艳敏,宋阳,李萍,王玲,李伟洲. CLa长效避孕埋植剂体外溶出度质量标准的研究[J]. 中国计划生育学杂志, 1995, 3(1): 18-20 |
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| 作者姓名： | 关艳敏 宋阳 李萍 王玲 李伟洲 |
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| 作者单位： | 辽宁省计划生育科研所 110031(关艳敏，宋阳，李萍，王玲)，辽宁省计划生育科研所 110031(李伟洲) |
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| 摘 要： | 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。
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| 关 键 词： | 埋植剂 左旋18甲基炔诺酮 溶出度 |
Study on the Quality Standard of in Vitro Solubility of Chinese CLa Subcutaneous Implants. |
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| Guan Yan-min,et al.. Study on the Quality Standard of in Vitro Solubility of Chinese CLa Subcutaneous Implants.[J]. Chinese Journal of Family Planning, 1995, 3(1): 18-20 |
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| Authors: | Guan Yan-min et al. |
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| Affiliation: | Province Institute of Family Planning 110031 |
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| Abstract: | The study was aimed at measuring in the vitro solubiltity of levonorgestrel from the Chinese CLa subcutaneous implants with high performance liquid chromatography. Chromatographic separation column was Rp-18t7μ,4. 6±250mm, the mobile phace was Meot:H2O(80/20v/v) and ultraviolet detection wavelength was 240nm. We used the Norplant aa the control in comparing the in vitro drug solubility of chinese CLa implants Fourteen sampples in seven parallel batches. The expermental CLa implanta were immersed continuously in double distilled water at 37℃±1℃ for three days. The solvent was changed every 24 hours. The levonorgestrel concentration of the solution was measured every day. The quality standard of the in vitro solubility of chipese CLa implants was 50. 0 - 70. 0℃g/six rods day of levonorgestrel concentration. The method of measuring the levonorgestrel was simple. highly effective , and reliabl. It is suitable for monitoring the solubility quality of Chinese CLa implant. |
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| Keywords: | CLa implant Levonorgestrel Solubility |
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