1种复方利多卡因恩诺沙星凝胶临床初步应用

Compound Lidocaine Enrofloxacin Gel Applied in Clinic

为开发一种新型镇痛抗炎剂型,该试验制备了复方利多卡因恩诺沙星凝胶剂,用高效液相色谱(HPLC)法测定盐酸利多卡因和恩诺沙星的含量,初步开展稳定性试验,通过犬体外抗菌试验和体表创伤犬镇痛效果试验,对该凝胶剂的临床效果进行初步评价。结果表明,该处方工艺制备的复方凝胶剂中盐酸利多卡因、恩诺沙星的含量符合要求;产品在高温、高湿、强光试验及6个月的加速试验结果均符合规定;自然创伤感染犬的体外抗菌效果试验表明,复方凝胶剂中恩诺沙星含量在0.01%时体外抑菌效果依旧良好;体表创伤犬建模数据显示,复方凝胶剂镇痛起效时间(3.67 min)较对照样组(4.67 min)更快,镇痛效果优于对照组(33.33%有轻微疼痛反应)。该复方利多卡因恩诺沙星凝胶的处方和制备工艺可行,产品质量稳定,其体外抑菌效果良好,对犬的创伤镇痛治疗有效。

In order to develop a novel analgesic and anti-inflammatory formulation,compound lidocaine enrofloxacin gel was prepared,the contents of lidocaine hydrochloride and enrofloxacin were determined by high performance liquid chromatography(HPLC),the preliminary stability test was carried out,and the clinical effect of the gel was preliminarily evaluated through the in vitro antibacterial test of canine natural wound infection model and the analgesic effect test of canine body surface trauma modeling.The results show that:The contents of lidocaine and enrofloxacin in the compound gel prepared by the prescription process met the requirements;The products met the requirements in high temperature,high humidity,strong light tests and 6-month accelerated test results;Antibacterial effect test showed when the enrofloxacin contentdiluted to as low as 0.01%,the antibacterial effect was still good;Body surface trauma modeling results showed that the analgesic onset time of compound gel(3.67 min)was faster than the control group(4.67 min),and the analgesic effect was better than the control group(33.33%had mild pain reaction).In conclusion,the prescription and preparation process of the compound lidocaine enrofloxacin gel are feasible,the product has stable properties,and the in vitro antibacterial effect is good,it is effective for wound analgesia on dogs.