复方双氯芬酸钠温敏型水凝胶的制备及质量控制
刘铭佩;朱恒;王利
【期刊名称】《中国药房》 【年(卷),期】2013(024)009
【摘要】OBJECTIVE: To prepare Compound diclofenac sodium thermosensitive gel, and to establish a method for quality control. METHODS: Thermosensitive gel was prepared using poloxamer 407 and poloxamer 188 as matrix, and diclofenac sodium and drotaverine hydrochloride as main ingredients. The contents of diclofenac sodium and drotaverine hydrochloride were determined by HPLC. RESULTS: The gelling temperature, gelling density and drug-loading amount and so on, were all in line with the requirements of Chinese Pharmacopoeia (2010 edition). The linear range was 30.10-301.03 mg/L for diclofenac sodium (r=0.999 6) and 10.15-91.32 mg/L for drotaverine hydrochloride (r=0.999 9). The average recoveries were 99.77% (RSD=1.19% ) and 100.88% (RSD=1.23%), respectively. CONCLUSIONS: The gel is simple inpreparation and controllable in quality.%目的:制备复方双氯芬酸钠温度敏感型水凝胶,并建立其质量控制方法.方法:以泊洛沙姆P407和P188为基质,以双氯芬酸钠和盐酸屈他维林为主药制备温敏型水凝胶；采用高效液相色谱法测定其中双氯芬酸钠和盐酸屈他维林的含量.结果:制剂的胶凝温度、胶凝强度和装量等均符合2010年版《中国药典》相关要求；双氯芬酸钠和盐酸屈他维林检测质量浓度线性范围分别为30.10～301.03、10.15～91.32 mg/L(r=0.999 6、
0.999 9),平均加样回收率分别为99.77％ (RSD=1.19％)、100.88％ (RSD=1.23％).结论:本制剂制备工艺简单,质量可控. 【总页数】3页(808-810)
【关键词】双氯芬酸钠;盐酸屈他维林;温敏型水凝胶;泊洛沙姆;制备;质量控制;高效液相色谱法
【作者】刘铭佩;朱恒;王利
【作者单位】兰州大学第二医院药剂科,兰州 730030 【正文语种】中文
【中图分类】R943;R971+.1 【文献来源】
https://www.zhangqiaokeyan.com/academic-journal-cn_china-pharmacy_thesis/0201242237364.html 【相关文献】
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复方双氯芬酸钠温敏型水凝胶的制备及质量控制
