中国药房2013，Vol.24Issue(9)：808-810,3.DOI:10.6039/j.issn.1001-0408.2013.09.14
复方双氯芬酸钠温敏型水凝胶的制备及质量控制
Preparation and Quality Control of Compound Diclofenac Sodium Thermosensitive Gel
摘要
Abstract
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.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Key words
Diclofenac sodium/ Drotaverine hydrochloride/ Thermosensitive gel/ Poloxamer/ Preparation/ Quality control/ HPLC分类
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刘铭佩,朱恒,王利..复方双氯芬酸钠温敏型水凝胶的制备及质量控制[J].中国药房,2013,24(9):808-810,3.
