双氯芬酸钠注射液研制及临床疗效验证

发布时间：2018-04-27 12:09

  本文选题：双氯芬酸钠 + 注射液　； 参考：《山东农业大学》2017年硕士论文

【摘要】：兽用双氯芬酸钠注射液有效成分为双氯芬酸钠,适用靶动物为猪,可缓解手术、外伤、关节炎等原因引起的疼痛,降低细菌感染及其它病因引起的高烧发热;可缓解猪发热,关节、肌肉疼痛,跛行等病症。本文主要对其处方及工艺、质量、稳定性、临床有效性等进行研究总结及评价。以双氯芬酸钠为原料,依据药剂学等资料,结合药物的溶解性、稳定性对制备工艺进行一系列的相关试验,进行处方筛选,制备工艺验证,确定有效成分的含量、溶媒的处方量,成功制备了双氯芬酸钠注射液,并进行了工业化生产放大。在高温(60℃)、强光(4500±500LX)条件下对主药与溶剂之间进行了10天的影响因素考察,分别于第5天、第10天对性状、鉴别、检查、含量测定与第0天进行对比,结果显示选用的溶剂适宜,化学性质稳定,与主药不发生反应,对主药的含量测定没有干扰,配制的双氯芬酸钠注射液性质稳定(中华人民共和国兽药典,2015年版第一部)。建立了双氯芬酸钠注射液中双氯芬酸钠的含量测定方法,双氯芬酸钠线性方程为y=21.052x-30.792(R~2=0.9999,n=5),双氯芬酸钠在23.4~376.0μg/mL的浓度范围内线性良好;双氯芬酸杂质A线性方程为:y=36.324x-0.057(R~2=0.9998,n=5),双氯芬酸杂质A在0.4~4.8μg/mL的浓度范围内线性良好。双氯芬酸钠与双氯芬酸杂质A的最低定量检测浓度分别为105.8ng/mL、81.4ng/m L,最低检测浓度分别为52.9ng/mL、40.7ng/m L;在不同的C18色谱柱、柱温、流动相比例及流速条件下,其耐用性良好,主峰及杂质峰能达到基线分离,RSD为1.3%,含量测定结果准确。为验证双氯芬酸钠注射液对靶动物猪的抗炎解热镇痛效果及合理剂量,对靶动物猪进行了双氯芬酸钠注射液对内毒素诱导猪发热的临床解热试验、双氯芬酸钠注射液对仔猪去势疼痛的临床镇痛试验。确定5%双氯芬酸钠注射液用量为:一次量,每1kg体重,猪注射0.05mL,具有抗炎及解热镇痛作用,适用于手术、外伤、关节炎等炎性疼痛,细菌感染及其它疾病继发感染引起的高烧发热;可缓解发热,关节、肌肉疼痛,跛行等病症。双氯芬酸钠注射液制备工艺合理、质量可控、对靶动物猪的解热镇痛效果较好,具有良好的开发应用价值。
[Abstract]:The effective ingredient of diclofenac sodium injection is diclofenac sodium, which is suitable for target animals in pigs. It can relieve the pain caused by surgery, trauma, arthritis and other causes, reduce fever caused by bacterial infection and other causes, and relieve pig fever. Joint, muscle pain, lameness, etc. In this paper, the prescription and technology, quality, stability, clinical effectiveness and so on were summarized and evaluated. Using diclofenac sodium as raw material, according to the data of pharmacology, combining with the solubility and stability of the drug, a series of related experiments were carried out on the preparation process, and the prescription was screened, the preparation process was verified, and the content of the active components was determined. Diclofenac sodium injection was successfully prepared by the formulation of solvent and amplified in industrial production. The influencing factors between the main drug and the solvent were investigated at 60 鈩，

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