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Optimal Solubility of Diclofenac B-Cyclodextrin in Combination with Mesotherapy Applications
简介
【 文献重点摘要 】
Because of low injection volume, the recently marketed injectable solution of diclofenac in complex with β-cyclodextrin (Akis, IBSA Farmaceutici Italia) is an ideal candidate for mesotherapy applications. In this study, we investigated the solubility of Akis, 25 and 50 mg/kg, in combination with various local anaesthetics (lidocaine, mepivacaine, bupivacaine, levobupivacaine, and ropivacaine) at different concentrations in aqueous vehicles (normal saline, sterile water, or bicarbonate). Final injection mixtures were classified as limpid, turbid, or milky at visual analysis under standardized conditions. We found that (i) the use of sterile water for injections or normal saline as vehicles to dilute Akis in combination with whatever local anaesthetic normally results in milky solutions and therefore is not recommended; (ii) using bicarbonate, optimal solubility was obtained combining Akis with lidocaine, both 1 and 2%, or mepivacaine, both 1 and 2%, whereas solutions were turbid in combination with bupivacaine, levobupivacaine, or ropivacaine. Thus, we recommend that Akis is used in combination with lidocaine or mepivacaine in a bicarbonate vehicle.
由于注射量小，最近上市的双氯芬酸与β-环糊精的复合物注射剂(AKIS，IBSA FarmPharmtici Italia)是中胚层疗法应用的理想候选者。在这项研究中，我们研究了25 mg/kg和50 mg/kg的Akis与不同浓度的局部麻醉剂(利多卡因、甲哌卡因、布比卡因、左旋布比卡因和罗哌卡因)在含水载体(生理盐水、无菌水或碳酸氢盐)中的溶解度。在标准化条件下的目测分析中，最终的注射混合物被分类为清澈、混浊或乳白色。我们发现(I)使用注射用无菌水或生理盐水作为载体稀释Akis，与通常会导致乳白色溶液的任何局部麻醉剂结合使用，因此不建议使用；(Ii)使用碳酸氢钠时，Akis与1%和2%的利多卡因或甲哌卡因(1%和2%)或甲哌卡因(均为1%和2%)配合使用时，溶液会混浊，而与布比卡因、左旋布比卡因或罗哌卡因联合使用时，溶液会混浊。因此，我们建议将Akis与利多卡因或甲哌卡因联合使用在碳酸氢盐载体中。
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