| 拉米夫定片的制备及质量控制 |
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| 引用本文： | 曾军. 拉米夫定片的制备及质量控制[J]. 海峡药学, 2007, 19(4): 16-18 |
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| 作者姓名： | 曾军 |
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| 作者单位： | 厦门金日制药有限公司,厦门,361100 |
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| 摘 要： | 目的 研究拉米夫定片的制备工艺及产品的检测方法.方法 以拉米夫定为主药,PROSOLV SMCC、羧甲淀粉钠、硬脂酸镁等为辅料制备拉米夫定片,并摸索产品的检测方法.结果 该制剂处方合理,工艺可靠,高效液相色谱法测定拉米夫定的含量其标准曲线回归方程为A=33.60 C-174.3,r=0.9991.结论 处方合理,制备工艺可靠.采用高效液相色谱法测定有关物质、含量时,专属性强、准确度好、灵敏度高、辅料无干扰,方法可行,可用于产品的质量检测.
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| 关 键 词： | 拉米夫定片 制备工艺 质量控制 |
| 文章编号： | 1006-3765（2007）04-0016-03 |
Preparation and quality control of lamivudine tablets |
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| ZENG-Jun. Preparation and quality control of lamivudine tablets[J]. Strait Pharmaceutical Journal, 2007, 19(4): 16-18 |
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| Authors: | ZENG-Jun |
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| Affiliation: | Xiamen Golden Sun Pharmaceutical CO., Ltd. Goldensun Rd., Xiamen 361100, China |
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| Abstract: | OBJECTIVE To study the procedure for preparation of lamivudine tablets and quality control. METHODS The product was composed of primary ingredients as lamivudine and suitable auxiliary materials as PROSOLV SMCC, carboxymethylstarch sodium, magnesium stearate etc, and analyzed according to specifications. RESULTS The procedure for preparation is reasonable. The lamivudine concentration is measured by HPLC and the linearity is:A = 33. 60C-174. 3,r=0. 9991. CONCLUSION The procedure for preparation is reasonable. The reliable and rapid method to quantify lamivudine and its relevant is achievable. |
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| Keywords: | Lamivudine Tablets Preparation procedure Product inspection |
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